Materiały źródłowe

• #1 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] Only 0.4% of the 3 billion COVID-19 tests performed through to mid-2022 were conducted in low-income regions, raising ethical concerns and constraining our collective ability to respond to a pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] We recommend investing in an international LFT research and development hub network to spearhead the development of a pipeline of innovative bioengineering approaches to design next-generation LFTs.

• #2 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Diagnostics have emerged as a crucial countermeasure to the spread of COVID-19, and by late 2022, more than 3 billion tests for SARS-CoV-2 had been conducted worldwide. […] The simplicity of LFTs comes with technical limitations and usage trade-offs. Notably, they are less sensitive than PCR and rely on visual readout. […] In this Review, we discuss the design principle of LFTs, and highlight key lessons learned from their use in the COVID-19 pandemic, including access, accuracy, affordability, manufacturing, regulation and funding. […] LFTs were adopted on an unprecedented scale during the COVID-19 pandemic, demonstrating their feasibility and acceptability on a global basis. […] Professional use and self-tests have enabled LFT-based testing to be expanded beyond healthcare facilities and into community settings and homes.

• #3 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. […] We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test results from surveillance data were matched by individual where both LFT and PCR were taken on the same day. […] We calculated sensitivity, specificity, positive and negative predictive values, and agreement using Matthew’s correlation coefficient. […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. […] Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted.

• #4 Lateral flow test – Wikipedia

  https://en.wikipedia.org/wiki/Lateral_flow_test

  Lateral flow assays have played a critical role in COVID-19 testing as they have the benefit of delivering a result in 15–30 minutes. […] The systematic evaluation of lateral flow assays during the COVID-19 pandemic was initiated at Oxford University as part of a UK collaboration with Public Health England. […] Four out of 64 LFDs tested had desirable performance characteristics according to these early tests; the Innova SARS-CoV-2 Antigen Rapid Qualitative Test performed moderately in viral antigen detection/sensitivity with excellent specificity, although kit failure rates and the impact of training were potential issues. […] After closure of schools in January 2021, biweekly LFTs were introduced in England for teachers, pupils, and households of pupils when schools re-opened on March 8, 2021 for asymptomatic testing.

• #5 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data

  https://pmc.ncbi.nlm.nih.gov/articles/PMC10446167/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. […] We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test results from surveillance data were matched by individual where both LFT and PCR were taken on the same day. […] Sensitivity and specificity were 25.65% (95%CI 22.0229.67) and 99.91% (95%CI 99.8999.93), respectively. […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. […] Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted.

• #6 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  The WHO has established a target product profile for COVID-19 antigen LFTs for use in suspected COVID-19 cases and close contacts, highlighting the application of LFTs in areas where reference molecular testing is unavailable. […] Millions of LFTs can be produced per month to meet global demand at affordable prices; however, such scale-up requires investment in manufacturing infrastructure and time. […] The rapid development of target product profiles, first by the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) and later by the WHO, provided clear expectations to manufacturers on desired design features. […] The COVID-19 pandemic has affected the approach of regulators with regard to approving lateral flow tests (LFTs), including early engagement with and guidance to test developers.

• #7 New analysis of lateral flow tests shows specificity of at least 99.9% – GOV.UK

  https://www.gov.uk/government/news/new-analysis-of-lateral-flow-tests-shows-specificity-of-at-least-999

  Rapid testing can help detect asymptomatic cases quickly, preventing the virus from entering schools, colleges or workplaces, and stopping outbreaks before they occur […] Using LFDs enables us to rapidly identify people in the population who are asymptomatic, with results produced in 30 minutes […] Lateral flow devices are effective at finding people with high viral loads who are most infectious and most likely to transmit the virus to others […] Weve looked very carefully at the evidence thats emerging from LFD tests that have been delivered at home and in testing sites over recent weeks, and real-life scenarios suggests they are at least 99.9% specific which means that the risk of false positives is extremely low less than one in a thousand which is a very good test […] Regular, rapid testing is already well established for NHS and care home staff

• #8 CIC – I-Corps: Lateral flow home-use diagnostic for detection of COVID-19

  https://cic-apps.datascience.columbia.edu/grants/1005?keyword=Lateral%20flow%20home-use%20diagnostic%20for%20detection%20of%20COVID-19

  The broader impact/commercial potential of this I-Corps project is the development of a rapid test for diagnosis and surveillance of SARS-CoV-2. […] The tests developed here may enable substantial cost savings in testing and encourage home self-testing with greater convenience and speed. […] The proposed technology can be readily modified into either a point-of-care, rapid home diagnostic test or a surveillance testing system. […] The proposed diagnostic pipeline developed relies on the use of a different antibody. […] This custom monoclonal antibody test may improve the overall accuracy of the testing and make the tests more accurate early in the infection period where IgM and IgG based tests can be less accurate. […] Testing accuracy is improved by using multiple antigens; The use of only one or two antigens has been associated with high rates of false test results with the new variants.

• #9 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 testing programmes have been implemented on a city scale (for example, the United Kingdom Liverpool Community testing pilot), and on a national scale (for example, nationwide testing in Slovakia). […] In many high-income regions, COVID-19 self-tests have been widely available since 2021, often subsidized or free to the public through pharmacies or online ordering. […] Despite wide use and acceptability, COVID-19 LFTs and the care pathways in which they are used have limitations, particularly in terms of false positives and false negatives. […] The accuracy and, in particular, the sensitivity of LFTs is lower than that of reference RT-PCR methods, ranging between 34.1% and 88.1% for SARS-CoV-2 antigen LFTs, with an overall specificity of 99.6%. […] Thus, LFTs benefit COVID-19 testing in identifying infectiousness or risk of transmission.

• #10 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data – PubMed

  https://pubmed.ncbi.nlm.nih.gov/37611000/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. Between May and August 2021, adult care home staff policy was for biweekly Innova LFT and weekly Polymerase Chain Reaction (PCR) testing while asymptomatic. We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test result agreement was 99.59% (95%CI 99.55-99.63; MCC: 0.38, p0.001). Sensitivity and specificity were 25.65% (95%CI 22.02-29.67) and 99.91% (95%CI 99.89-99.93), respectively. PPV was 55.90% (95%CI 49.42-62.17) and NPV was 99.68% (95%CI 99.64-99.71). […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted. Performance improved at times of higher prevalence during the study. These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed.

• #11 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data

  https://pmc.ncbi.nlm.nih.gov/articles/PMC10446167/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. […] We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test results from surveillance data were matched by individual where both LFT and PCR were taken on the same day. […] Sensitivity and specificity were 25.65% (95%CI 22.0229.67) and 99.91% (95%CI 99.8999.93), respectively. […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. […] Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted.

• #12 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data – PubMed

  https://pubmed.ncbi.nlm.nih.gov/37611000/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. Between May and August 2021, adult care home staff policy was for biweekly Innova LFT and weekly Polymerase Chain Reaction (PCR) testing while asymptomatic. We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test result agreement was 99.59% (95%CI 99.55-99.63; MCC: 0.38, p0.001). Sensitivity and specificity were 25.65% (95%CI 22.02-29.67) and 99.91% (95%CI 99.89-99.93), respectively. PPV was 55.90% (95%CI 49.42-62.17) and NPV was 99.68% (95%CI 99.64-99.71). […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted. Performance improved at times of higher prevalence during the study. These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed.

• #13 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406

  With the data generated as a result of the implementation of the Testing Strategy for Wales, we aim in this paper to measure the sensitivity and specificity of LFTs against PCRs for those tests taken in Adult Care Home settings in Wales during the period 1st May 2021 – 31st August 2021. […] Overall sensitivity of the lateral flow devices was 25.65% (95%CI 22.02–29.67) and specificity was 99.91% (95%CI 99.89, 99.93). […] Negative Predictive Value (NPV) was estimated to be 99.68% (95%CI 99.64, 99.71), whilst Positive Predictive Value (PPV) was estimated to be 55.90% (95%CI 49.42, 62.17). […] The low sensitivity of lateral flow tests identified in this study therefore does not support the use of lateral flow tests as a reliable diagnosis platform as the test cannot reliably rule out infection, particularly during times of low prevalence where NPV will be reduced. […] Public messaging must continue to promote the reliability of lateral flow tests whilst making clear the limited ability of the test to rule out SARS-CoV-2 infection.

• #14 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406

  With the data generated as a result of the implementation of the Testing Strategy for Wales, we aim in this paper to measure the sensitivity and specificity of LFTs against PCRs for those tests taken in Adult Care Home settings in Wales during the period 1st May 2021 – 31st August 2021. […] Overall sensitivity of the lateral flow devices was 25.65% (95%CI 22.02–29.67) and specificity was 99.91% (95%CI 99.89, 99.93). […] Negative Predictive Value (NPV) was estimated to be 99.68% (95%CI 99.64, 99.71), whilst Positive Predictive Value (PPV) was estimated to be 55.90% (95%CI 49.42, 62.17). […] The low sensitivity of lateral flow tests identified in this study therefore does not support the use of lateral flow tests as a reliable diagnosis platform as the test cannot reliably rule out infection, particularly during times of low prevalence where NPV will be reduced. […] Public messaging must continue to promote the reliability of lateral flow tests whilst making clear the limited ability of the test to rule out SARS-CoV-2 infection.

• #15 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406

  Performance improved at times of higher prevalence during the study. […] These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. […] When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed. […] In January 2021, the Welsh Government launched a COVID-19 testing strategy that included the use of LFTs to aid in preventing the transmission of COVID-19 across Wales. […] A part of this strategy involved the use of LFTs in closed settings such as care homes to reduce the risk of transmission from staff to care home residents. […] Interpretation of this evaluation will be affected by restrictions and management of cases deemed to be ‘false positive’ and the use of LFTs as a routine screening tool.

• #16 Lateral flow test – Wikipedia

  https://en.wikipedia.org/wiki/Lateral_flow_test

  Lateral flow assays have played a critical role in COVID-19 testing as they have the benefit of delivering a result in 15–30 minutes. […] The systematic evaluation of lateral flow assays during the COVID-19 pandemic was initiated at Oxford University as part of a UK collaboration with Public Health England. […] Four out of 64 LFDs tested had desirable performance characteristics according to these early tests; the Innova SARS-CoV-2 Antigen Rapid Qualitative Test performed moderately in viral antigen detection/sensitivity with excellent specificity, although kit failure rates and the impact of training were potential issues. […] After closure of schools in January 2021, biweekly LFTs were introduced in England for teachers, pupils, and households of pupils when schools re-opened on March 8, 2021 for asymptomatic testing.

• #17 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 testing programmes have been implemented on a city scale (for example, the United Kingdom Liverpool Community testing pilot), and on a national scale (for example, nationwide testing in Slovakia). […] In many high-income regions, COVID-19 self-tests have been widely available since 2021, often subsidized or free to the public through pharmacies or online ordering. […] Despite wide use and acceptability, COVID-19 LFTs and the care pathways in which they are used have limitations, particularly in terms of false positives and false negatives. […] The accuracy and, in particular, the sensitivity of LFTs is lower than that of reference RT-PCR methods, ranging between 34.1% and 88.1% for SARS-CoV-2 antigen LFTs, with an overall specificity of 99.6%. […] Thus, LFTs benefit COVID-19 testing in identifying infectiousness or risk of transmission.

• #18 COVID Testing – COVID-19 Protocols

  https://covidprotocols.org/chapters/covid-testing/

  Scenarios Antigen RDT Can be Used for Screening of Asymptomatic Individuals: To respond to suspected outbreaks of COVID-19 in remote settings, institutions and semi-closed communities. […] To support outbreak investigations (e.g. in closed or semi-closed groups including schools, care-homes, cruise ships, prisons, workplaces and dormitories, etc.). […] To monitor trends in disease incidence in communities, and particularly among essential workers and health workers in regions of widespread community transmission.

• #19 Written Statement: Learning more about the use of rapid COVID-19 testing using Lateral Flow Devices (LFDs) (1 July 2021) | GOV.WALES

  https://www.gov.wales/written-statement-learning-more-about-use-rapid-covid-19-testing-using-lateral-flow-devices-lfds

  Regular COVID-19 testing has been offered to health and social care workers, education staff, students and workers in the public and private sector since the beginning of 2021. […] Public Health Wales publishes a weekly surveillance report on LFD tests for Welsh residents including the number of tests reported and the result. […] The percentage of positive episodes has increased over the last two weeks in line with the increase in prevalence shown for symptomatic (PCR) testing over the same period. […] People are required to report the results of their LFD tests whether positive or negative on a UK government website but we are concerned not all are reporting the results, particularly if they are negative. […] We are also working on our communications to improve participation in testing and ensuring understanding of the need to register both negative and positive results.

• #20 SARS-CoV-2 antigen lateral flow tests for detecting infectious people: linked data analysis | The BMJ

  https://www.bmj.com/content/376/bmj-2021-066871

  Objectives To investigate the proportion of lateral flow tests (LFTs) that produce negative results in those with a high risk of infectiousness from SARS-CoV-2, to investigate the impact of the stage and severity of disease, and to compare predictions made by influential mathematical models with findings of empirical studies. […] The proportion of infectious people with SARS-CoV-2 missed by LFTs is substantial enough to be of clinical importance. The proportion missed varied between settings because of different viral load distributions and is likely to be highest in those without symptoms. Key models have substantially overestimated the sensitivity of LFTs compared with empirical data. An urgent need exists for additional robust well designed and reported empirical studies from intended use settings to inform evidence based policy.

• #21 SARS-CoV-2 antigen lateral flow tests for detecting infectious people: linked data analysis | The BMJ

  https://www.bmj.com/content/376/bmj-2021-066871

  An assessment of the current evidence base to understand the sensitivity of LFTs for detecting infectious people within such applications is critical. Without this understanding, the resulting impacts on transmission cannot be accurately ascertained. […] The analysis predicts that of those with a viral culture positive result, Innova would miss 20% attending an NHS Test-and-Trace centre, 29% without symptoms attending municipal mass testing, and 81% attending university screen testing without symptoms, along with 38%, 47%, and 90% of sources of secondary cases. […] The findings raise concerns about the utility and cost effectiveness of applying LFTs in test-to-enable and test-to-protect applicationsfurther evaluation is required. […] The current analysis of these empirical data highlights inaccuracies in the assumptions made by key models about the relationships between viral loads and infectiousness, resulting in an overestimation of test sensitivity.

• #22 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 testing programmes have been implemented on a city scale (for example, the United Kingdom Liverpool Community testing pilot), and on a national scale (for example, nationwide testing in Slovakia). […] In many high-income regions, COVID-19 self-tests have been widely available since 2021, often subsidized or free to the public through pharmacies or online ordering. […] Despite wide use and acceptability, COVID-19 LFTs and the care pathways in which they are used have limitations, particularly in terms of false positives and false negatives. […] The accuracy and, in particular, the sensitivity of LFTs is lower than that of reference RT-PCR methods, ranging between 34.1% and 88.1% for SARS-CoV-2 antigen LFTs, with an overall specificity of 99.6%. […] Thus, LFTs benefit COVID-19 testing in identifying infectiousness or risk of transmission.

• #23 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data – PubMed

  https://pubmed.ncbi.nlm.nih.gov/37611000/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. Between May and August 2021, adult care home staff policy was for biweekly Innova LFT and weekly Polymerase Chain Reaction (PCR) testing while asymptomatic. We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test result agreement was 99.59% (95%CI 99.55-99.63; MCC: 0.38, p0.001). Sensitivity and specificity were 25.65% (95%CI 22.02-29.67) and 99.91% (95%CI 99.89-99.93), respectively. PPV was 55.90% (95%CI 49.42-62.17) and NPV was 99.68% (95%CI 99.64-99.71). […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted. Performance improved at times of higher prevalence during the study. These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed.

• #24 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406

  Performance improved at times of higher prevalence during the study. […] These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. […] When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed. […] In January 2021, the Welsh Government launched a COVID-19 testing strategy that included the use of LFTs to aid in preventing the transmission of COVID-19 across Wales. […] A part of this strategy involved the use of LFTs in closed settings such as care homes to reduce the risk of transmission from staff to care home residents. […] Interpretation of this evaluation will be affected by restrictions and management of cases deemed to be ‘false positive’ and the use of LFTs as a routine screening tool.

• #25 Daily Rapid Antigen Exit Testing to Tailor University COVID-19 Isolation Policy – Volume 28, Number 12—December 2022 – Emerging Infectious Diseases journal – CDC

  https://wwwnc.cdc.gov/eid/article/28/12/22-0969_article

  Incorporation of exit rapid antigen testing into its managed isolation program enabled the university to tailor isolation durations on the basis of onward transmission risk. […] The recommended full 5-day isolation period may be too short, especially for persons using symptom onset as their isolation start or those with diagnoses early in their infections. […] Future research analyzing what, if any, onward transmission has resulted from the recommended 5-day isolation period would further refine our understanding of its suitability. […] In addition, the risk posed by a still-infectious person released from isolation after 5 days must also be considered in the broader context. […] These considerations illustrate the complexity of recommending isolation periods for the general population, but our study adds to evidence that the recommended 5-day isolation period may be too short. […] Finally, our study highlights the utility of using exit RATs to tailor isolation periods on the basis of risk, especially in dense settings or ones with vulnerable populations.

• #26 SARS-CoV-2 antigen lateral flow tests for detecting infectious people: linked data analysis | The BMJ

  https://www.bmj.com/content/376/bmj-2021-066871

  Objectives To investigate the proportion of lateral flow tests (LFTs) that produce negative results in those with a high risk of infectiousness from SARS-CoV-2, to investigate the impact of the stage and severity of disease, and to compare predictions made by influential mathematical models with findings of empirical studies. […] The proportion of infectious people with SARS-CoV-2 missed by LFTs is substantial enough to be of clinical importance. The proportion missed varied between settings because of different viral load distributions and is likely to be highest in those without symptoms. Key models have substantially overestimated the sensitivity of LFTs compared with empirical data. An urgent need exists for additional robust well designed and reported empirical studies from intended use settings to inform evidence based policy.

• #27 Lateral flow tests detect most people at risk of transmitting Covid-19 | Institute of Epidemiology & Health Care – UCL – University College London

  https://www.ucl.ac.uk/epidemiology-health-care/news/2021/oct/lateral-flow-tests-detect-most-people-risk-transmitting-covid-19

  Lateral flow tests are more accurate than previously reported and cannot be compared directly to how PCR tests work, finds a new paper led by Professor Irene Petersen (UCL Institute of Epidemiology Health Care). […] The peer-reviewed paper, published today in Clinical Epidemiology, uses a new formula to show that lateral flow tests (LFTs) are likely more than 80% effective at detecting any level of Covid-19 infection and likely more than 90% effective at detecting those who are most infectious when using the test. […] The researchers from UCL, Liverpool University, Harvard University and the University of Bath highlight that LFTs work in a very different way to polymerase chain reaction (PCR) tests and cannot be compared like for like. […] Professor Michael Mina (Harvard School of Public Health) said: There is a spectrum of infectious amounts of the Covid-19 virus and we show that LFTs are likely to detect cases 90-95% of the time when people are at their most infectious.

• #28 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 LFT results from self-testing, positive or negative, are often not reported, leaving test use data and true case counts unknown, thereby complicating surveillance. […] The future of public health is increasingly digital. […] LFTs may make a difference in detecting a range of other infections, particularly the WHO’s list of priority diseases of epidemic potential, antimicrobial resistance and other acute and chronic infections. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The Access to COVID-19 Tools (ACT)-Accelerator diagnostic pillar (ACT-A Dx), part of the ACT-A mechanism, was established to increase equitable access to COVID-19 testing globally. […] The COVID-19 pandemic has shown that rapid antigen tests can be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission.

• #29 Written Statement: Learning more about the use of rapid COVID-19 testing using Lateral Flow Devices (LFDs) (1 July 2021) | GOV.WALES

  https://www.gov.wales/written-statement-learning-more-about-use-rapid-covid-19-testing-using-lateral-flow-devices-lfds

  Regular COVID-19 testing has been offered to health and social care workers, education staff, students and workers in the public and private sector since the beginning of 2021. […] Public Health Wales publishes a weekly surveillance report on LFD tests for Welsh residents including the number of tests reported and the result. […] The percentage of positive episodes has increased over the last two weeks in line with the increase in prevalence shown for symptomatic (PCR) testing over the same period. […] People are required to report the results of their LFD tests whether positive or negative on a UK government website but we are concerned not all are reporting the results, particularly if they are negative. […] We are also working on our communications to improve participation in testing and ensuring understanding of the need to register both negative and positive results.

• #30 JMIR Public Health and Surveillance – A Smartphone-Based Platform Assisted by Artificial Intelligence for Reading and Reporting Rapid Diagnostic Tests: Evaluation Study in SARS-CoV-2 Lateral Flow Immunoassays

  https://publichealth.jmir.org/2022/12/e38533

  Background: Rapid diagnostic tests (RDTs) are being widely used to manage COVID-19 pandemic. However, many results remain unreported or unconfirmed, altering a correct epidemiological surveillance. […] The web platform serves as a real-time epidemiological tracking tool and facilitates reporting of positive RDTs to relevant health authorities. […] Nevertheless, self-testing strategies have some limitations; the general population is not familiar with the use of RDTs; and a minimum training is needed for sampling, testing, and result interpretation. Furthermore, as it has been seen during the latest waves, many results go unreported, impairing posttesting counseling and epidemiological surveillance. […] Combining RDTs with digital tools, artificial intelligence (AI) and mobile health approaches can help standardize result interpretation and facilitate immediate reporting and monitoring of results.

• #31 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 LFT results from self-testing, positive or negative, are often not reported, leaving test use data and true case counts unknown, thereby complicating surveillance. […] The future of public health is increasingly digital. […] LFTs may make a difference in detecting a range of other infections, particularly the WHO’s list of priority diseases of epidemic potential, antimicrobial resistance and other acute and chronic infections. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The Access to COVID-19 Tools (ACT)-Accelerator diagnostic pillar (ACT-A Dx), part of the ACT-A mechanism, was established to increase equitable access to COVID-19 testing globally. […] The COVID-19 pandemic has shown that rapid antigen tests can be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission.

• #32 Coronavirus » Use of lateral flow devices for asymptomatic staff testing for SARS CoV-2 in all NHS Staff

  https://www.england.nhs.uk/coronavirus/documents/12184-2/

  Asymptomatic staff testing is a core component of the national infection control guidelines, which all organisations have a duty to adhere to. […] It is a statutory duty that all test results must be reported, whether they are positive, negative or invalid/void. This must happen every time an LFD test is completed. […] All positive results using an LFD will be followed up by standard PCR testing in the local designated COVID-19 testing laboratory. The request should be made following each NHS organisations local protocol. If the result is positive, the information will be reported through to Public Health England (PHE) second generation surveillance system (SGSS) via the standard route. PHE will compare results from lateral flow devices and PCR tests to ensure that there is no double counting of an individuals positive result.

• #33 Written Statement: Learning more about the use of rapid COVID-19 testing using Lateral Flow Devices (LFDs) (1 July 2021) | GOV.WALES

  https://www.gov.wales/written-statement-learning-more-about-use-rapid-covid-19-testing-using-lateral-flow-devices-lfds

  Regular COVID-19 testing has been offered to health and social care workers, education staff, students and workers in the public and private sector since the beginning of 2021. […] Public Health Wales publishes a weekly surveillance report on LFD tests for Welsh residents including the number of tests reported and the result. […] The percentage of positive episodes has increased over the last two weeks in line with the increase in prevalence shown for symptomatic (PCR) testing over the same period. […] People are required to report the results of their LFD tests whether positive or negative on a UK government website but we are concerned not all are reporting the results, particularly if they are negative. […] We are also working on our communications to improve participation in testing and ensuring understanding of the need to register both negative and positive results.

• #34 JMIR Public Health and Surveillance – A Smartphone-Based Platform Assisted by Artificial Intelligence for Reading and Reporting Rapid Diagnostic Tests: Evaluation Study in SARS-CoV-2 Lateral Flow Immunoassays

  https://publichealth.jmir.org/2022/12/e38533

  The proposed reading system is automatic, reducing variability and uncertainty associated with RDTs interpretation and can be used to read different RDT brands. […] Our AI algorithm demonstrates excellent performance, especially in prospective validation of real-life scenarios and for both antibody and antigen detection tests. […] This is especially important in contexts where massive testing is to be done and the likelihood of subjectivity and errors in the interpretation of the result is higher. It is also important in the validation of self-diagnostic tests performed by untrained users, as it avoids the loss of information in case the user does not report it, and it provides an efficient system to confirm and report data, which has been a key challenge during the latest pandemic waves.

• #35 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx

  LFT feasibility and acceptability for large-scale SARS-CoV-2 testing to improve population health have been observed during the coronavirus disease 2019 (COVID-19) pandemic. […] In the present review, researchers described the evolution of LFT testing, the advantages and disadvantages of LFTs, and identified roadblocks in developing next-generation LFTs based on the lessons learnt from the COVID-19 pandemic. […] The COVID-19 period accelerated LFT development, during which cases of unknown-cause pneumonia were reported in Wuhan, genetic sequencing information was shared, and the World Health Organization (WHO) released interim guidelines on rapid antigen test usage. […] However, only 0.40% of three billion SARS-CoV-2 tests performed until the middle of 2022 were conducted in low-resource settings, raising ethical concerns and affecting the collective pandemic response abilities.

• #36 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] Only 0.4% of the 3 billion COVID-19 tests performed through to mid-2022 were conducted in low-income regions, raising ethical concerns and constraining our collective ability to respond to a pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] We recommend investing in an international LFT research and development hub network to spearhead the development of a pipeline of innovative bioengineering approaches to design next-generation LFTs.

• #37 COVID Testing – COVID-19 Protocols

  https://covidprotocols.org/chapters/covid-testing/

  Scenarios Antigen RDT Can be Used for Screening of Asymptomatic Individuals: To respond to suspected outbreaks of COVID-19 in remote settings, institutions and semi-closed communities. […] To support outbreak investigations (e.g. in closed or semi-closed groups including schools, care-homes, cruise ships, prisons, workplaces and dormitories, etc.). […] To monitor trends in disease incidence in communities, and particularly among essential workers and health workers in regions of widespread community transmission.

• #38 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data – PubMed

  https://pubmed.ncbi.nlm.nih.gov/37611000/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. Between May and August 2021, adult care home staff policy was for biweekly Innova LFT and weekly Polymerase Chain Reaction (PCR) testing while asymptomatic. We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test result agreement was 99.59% (95%CI 99.55-99.63; MCC: 0.38, p0.001). Sensitivity and specificity were 25.65% (95%CI 22.02-29.67) and 99.91% (95%CI 99.89-99.93), respectively. PPV was 55.90% (95%CI 49.42-62.17) and NPV was 99.68% (95%CI 99.64-99.71). […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted. Performance improved at times of higher prevalence during the study. These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed.

• #39 New analysis of lateral flow tests shows specificity of at least 99.9% – GOV.UK

  https://www.gov.uk/government/news/new-analysis-of-lateral-flow-tests-shows-specificity-of-at-least-999

  The government has also confirmed twice-weekly testing using LFDs for free to all adults in households with primary, secondary school and college aged children and young people, including childcare and support bubbles […] Testing using LFDs should be a regular habit. Clinical advice is to be tested twice a week every week, which is the same policy for NHS and care home staff.

• #40 Coronavirus » Use of lateral flow devices for asymptomatic staff testing for SARS CoV-2 in all NHS Staff

  https://www.england.nhs.uk/coronavirus/documents/12184-2/

  Asymptomatic staff testing is an important component of the infection prevention and control (IPC), which all organisations and staff have a duty to adhere to. Continued efforts are required to keep staff and patients safe from potential transmission of COVID-19 in healthcare settings by ensuring that all staff continue to participate in this important programme. […] Lateral flow antigen testing detects the presence of the COVID-19 viral antigen from a swab sample. The test is administered by handheld devices producing results in around 30 minutes and can be self-administered. […] Over the 27 week period from 26 October 2020 to 9 May 2021, 37,300 healthcare workers registered a positive result using LFDs. These individuals were either detected before they became symptomatic, or would never have become symptomatic, the intervention provided by this core IPC measure reduced the transmission risk among colleagues, patients and other close contacts.

• #41 Evaluation of feasibility and user acceptance of lateral-flow self-testing for viral illness in a residential treatment rehabilitation facility | Health & Justice | Full Text

  https://healthandjusticejournal.biomedcentral.com/articles/10.1186/s40352-022-00173-x

  The role of rapid testing has proven vital in reducing infection incidence in communities through swift identification and isolation of infected individuals. […] The COVID-19 pandemic has been particularly catastrophic for residential carceral and rehabilitation facilities that are high-risk settings for transmission of contagious diseases. […] We hypothesized that rehabilitation residents could successfully test themselves employing inexpensive, disposable, antigen-based influenza lateral-flow tests and would be willing to self-isolate and self-report to health authorities if positive. […] Among the participants, 96% (48 of 50) achieved a positive-control line from their lateral-flow test. […] Notably, 98% (49 of 50) indicated that they would self-isolate if the lateral-flow test returned a positive indicator suggesting the presence of a viral infection and 96% (48 of 50) would report positive results to their corresponding public health department.

• #42 New analysis of lateral flow tests shows specificity of at least 99.9% – GOV.UK

  https://www.gov.uk/government/news/new-analysis-of-lateral-flow-tests-shows-specificity-of-at-least-999

  Rapid testing can help detect asymptomatic cases quickly, preventing the virus from entering schools, colleges or workplaces, and stopping outbreaks before they occur […] Using LFDs enables us to rapidly identify people in the population who are asymptomatic, with results produced in 30 minutes […] Lateral flow devices are effective at finding people with high viral loads who are most infectious and most likely to transmit the virus to others […] Weve looked very carefully at the evidence thats emerging from LFD tests that have been delivered at home and in testing sites over recent weeks, and real-life scenarios suggests they are at least 99.9% specific which means that the risk of false positives is extremely low less than one in a thousand which is a very good test […] Regular, rapid testing is already well established for NHS and care home staff

• #43 Coronavirus » Use of lateral flow devices for asymptomatic staff testing for SARS CoV-2 in all NHS Staff

  https://www.england.nhs.uk/coronavirus/documents/12184-2/

  Asymptomatic staff testing is an important component of the infection prevention and control (IPC), which all organisations and staff have a duty to adhere to. Continued efforts are required to keep staff and patients safe from potential transmission of COVID-19 in healthcare settings by ensuring that all staff continue to participate in this important programme. […] Lateral flow antigen testing detects the presence of the COVID-19 viral antigen from a swab sample. The test is administered by handheld devices producing results in around 30 minutes and can be self-administered. […] Over the 27 week period from 26 October 2020 to 9 May 2021, 37,300 healthcare workers registered a positive result using LFDs. These individuals were either detected before they became symptomatic, or would never have become symptomatic, the intervention provided by this core IPC measure reduced the transmission risk among colleagues, patients and other close contacts.

• #44 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx

  During COVID-19, LFTs used SARS-CoV-2 antigens, and their use was expanded to surveillance efforts. […] LFT sensitivity is reportedly lesser than RT-PCR analysis, in the range of 34.0% to 88.0% in detecting SARS-CoV-2 and 99.6% specificity. […] However, LFTs were used successfully during COVID-19 due to the high SARS-CoV-2 transmissibility and short incubation periods to assess the infectiousness or transmission risks of SARS-CoV-2. […] Major roadblocks in LFT development and use include the lack of accessibility to well-characterized samples for testing and validation, low sensitivity, limited digital connectivity, scarce cost-efficacy evidence, delays in regulatory processes, and centralized manufacture of materials. […] Observations from the pandemic have shown that LFT self-testing at a large scale could offer several benefits, such as early identification and prompt self-isolation, increased accessibility to diagnostic tests, increased frequency of testing, increased compliance with public health measures, curtailed viral transmission, and facilitated early recovery.

• #45 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data – PubMed

  https://pubmed.ncbi.nlm.nih.gov/37611000/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. Between May and August 2021, adult care home staff policy was for biweekly Innova LFT and weekly Polymerase Chain Reaction (PCR) testing while asymptomatic. We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test result agreement was 99.59% (95%CI 99.55-99.63; MCC: 0.38, p0.001). Sensitivity and specificity were 25.65% (95%CI 22.02-29.67) and 99.91% (95%CI 99.89-99.93), respectively. PPV was 55.90% (95%CI 49.42-62.17) and NPV was 99.68% (95%CI 99.64-99.71). […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted. Performance improved at times of higher prevalence during the study. These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed.

• #46 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data

  https://pmc.ncbi.nlm.nih.gov/articles/PMC10446167/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. […] We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test results from surveillance data were matched by individual where both LFT and PCR were taken on the same day. […] Sensitivity and specificity were 25.65% (95%CI 22.0229.67) and 99.91% (95%CI 99.8999.93), respectively. […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. […] Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted.

• #47 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406

  With the data generated as a result of the implementation of the Testing Strategy for Wales, we aim in this paper to measure the sensitivity and specificity of LFTs against PCRs for those tests taken in Adult Care Home settings in Wales during the period 1st May 2021 – 31st August 2021. […] Overall sensitivity of the lateral flow devices was 25.65% (95%CI 22.02–29.67) and specificity was 99.91% (95%CI 99.89, 99.93). […] Negative Predictive Value (NPV) was estimated to be 99.68% (95%CI 99.64, 99.71), whilst Positive Predictive Value (PPV) was estimated to be 55.90% (95%CI 49.42, 62.17). […] The low sensitivity of lateral flow tests identified in this study therefore does not support the use of lateral flow tests as a reliable diagnosis platform as the test cannot reliably rule out infection, particularly during times of low prevalence where NPV will be reduced. […] Public messaging must continue to promote the reliability of lateral flow tests whilst making clear the limited ability of the test to rule out SARS-CoV-2 infection.

• #48 COVID Testing – COVID-19 Protocols

  https://covidprotocols.org/chapters/covid-testing/

  Rapid Antigen RDTs are an alternative to NAAT as screening tests where testing capacity is limited and the proportion of test positivity is high (10%) (ECDC Recommendation). […] In a high prevalence setting CDC considers high prevalence to be when NAAT positivity over the last 14 days is greater than 5% or when there are greater than 20 new cases of COVID-19 per 100,000 persons within the last 14 days., rapid antigen tests will have a high PPV, meaning a positive result from a rapid antigen test is likely to indicate a true infection and may not require confirmation by RT-PCR. […] In a low prevalence setting CDC considers low prevalence to be when NAAT positivity over the last 14 days is less than 5% or when there are fewer than 20 new cases of COVID-19 per 100,000 persons within the last 14 days., rapid antigen tests will have a high NPV but a low PPV.

• #49 New analysis of lateral flow tests shows specificity of at least 99.9% – GOV.UK

  https://www.gov.uk/government/news/new-analysis-of-lateral-flow-tests-shows-specificity-of-at-least-999

  The government has also confirmed twice-weekly testing using LFDs for free to all adults in households with primary, secondary school and college aged children and young people, including childcare and support bubbles […] Testing using LFDs should be a regular habit. Clinical advice is to be tested twice a week every week, which is the same policy for NHS and care home staff.

• #50 A systematic review of the sensitivity and specificity of lateral flow devices in the detection of SARS-CoV-2 | BMC Infectious Diseases | Full Text

  https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06528-3

  This study highlights the potential utility of rapid antigen testing to support RT-PCR in the scaling up of a country’s testing program to include mass testing, contact tracing programs and potentially surge-testing. […] Our evidence gives support to the practice of self-swabbing for sample collection compared to the test being performed by a trained healthcare professional. LFDs potentially offer a new form of COVID-19 testing that might ease the pressure on the RT-PCR testing program. Enhanced capacity for mass testing, contact tracing and surge-testing, may in turn help stop the chain of transmission of COVID-19.

• #51 Look familiar? How rapid tests changed the pandemic

  https://www.bbc.com/news/health-59895258

  „The PCR programme is such a complete waste of resources. It’s there because it was the only thing we had at the beginning. It should be phased out sooner rather than later,” says Prof Irene Petersen at UCL. […] „The cost of mass testing has been staggering,” she says. „The best advice is if you have symptoms is to simply stay at home until you are better, and that way you will avoid spreading Covid, flu and a host of other viral infections.” […] Scientists think mass testing may have opened the door to other more efficient ways of detecting disease in the near future. A new generation of lateral flow tests are going into production – designed to detect not just Covid but different forms of influenza and other viruses at the same time.

• #52

  https://www.who.int/publications/i/item/9789240067172

• #53 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx

  LFT feasibility and acceptability for large-scale SARS-CoV-2 testing to improve population health have been observed during the coronavirus disease 2019 (COVID-19) pandemic. […] In the present review, researchers described the evolution of LFT testing, the advantages and disadvantages of LFTs, and identified roadblocks in developing next-generation LFTs based on the lessons learnt from the COVID-19 pandemic. […] The COVID-19 period accelerated LFT development, during which cases of unknown-cause pneumonia were reported in Wuhan, genetic sequencing information was shared, and the World Health Organization (WHO) released interim guidelines on rapid antigen test usage. […] However, only 0.40% of three billion SARS-CoV-2 tests performed until the middle of 2022 were conducted in low-resource settings, raising ethical concerns and affecting the collective pandemic response abilities.

• #54 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] Only 0.4% of the 3 billion COVID-19 tests performed through to mid-2022 were conducted in low-income regions, raising ethical concerns and constraining our collective ability to respond to a pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] We recommend investing in an international LFT research and development hub network to spearhead the development of a pipeline of innovative bioengineering approaches to design next-generation LFTs.

• #55 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 testing programmes have been implemented on a city scale (for example, the United Kingdom Liverpool Community testing pilot), and on a national scale (for example, nationwide testing in Slovakia). […] In many high-income regions, COVID-19 self-tests have been widely available since 2021, often subsidized or free to the public through pharmacies or online ordering. […] Despite wide use and acceptability, COVID-19 LFTs and the care pathways in which they are used have limitations, particularly in terms of false positives and false negatives. […] The accuracy and, in particular, the sensitivity of LFTs is lower than that of reference RT-PCR methods, ranging between 34.1% and 88.1% for SARS-CoV-2 antigen LFTs, with an overall specificity of 99.6%. […] Thus, LFTs benefit COVID-19 testing in identifying infectiousness or risk of transmission.

• #56 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx

  During COVID-19, LFTs used SARS-CoV-2 antigens, and their use was expanded to surveillance efforts. […] LFT sensitivity is reportedly lesser than RT-PCR analysis, in the range of 34.0% to 88.0% in detecting SARS-CoV-2 and 99.6% specificity. […] However, LFTs were used successfully during COVID-19 due to the high SARS-CoV-2 transmissibility and short incubation periods to assess the infectiousness or transmission risks of SARS-CoV-2. […] Major roadblocks in LFT development and use include the lack of accessibility to well-characterized samples for testing and validation, low sensitivity, limited digital connectivity, scarce cost-efficacy evidence, delays in regulatory processes, and centralized manufacture of materials. […] Observations from the pandemic have shown that LFT self-testing at a large scale could offer several benefits, such as early identification and prompt self-isolation, increased accessibility to diagnostic tests, increased frequency of testing, increased compliance with public health measures, curtailed viral transmission, and facilitated early recovery.

• #57 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] Only 0.4% of the 3 billion COVID-19 tests performed through to mid-2022 were conducted in low-income regions, raising ethical concerns and constraining our collective ability to respond to a pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] We recommend investing in an international LFT research and development hub network to spearhead the development of a pipeline of innovative bioengineering approaches to design next-generation LFTs.

• #58 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx

  However, access to self-tests is inequitable, with considerably lower adoption by low-income and middle-income nations. […] Next-generation LFTs would target antigens, antibodies, and molecules, with AMR (antimicrobial resistance) panels and quick response (QR) codes, for use not only for self-testing, clinical diagnosis, screening and surveillance testing but also for environmental monitoring. […] To conclude, based on the review findings, next-generation of next-generation LFTs could provide means for rapid and decentralized testing with high sensitivity and specificity at a mass scale. […] Efforts must be made to overcome LFT shortcomings, such as high false-negative rates, to provide next-generation diagnostic LFTs, with an equitable distribution, across the globe, to improve global preparedness against pathogens.

• #59 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 testing programmes have been implemented on a city scale (for example, the United Kingdom Liverpool Community testing pilot), and on a national scale (for example, nationwide testing in Slovakia). […] In many high-income regions, COVID-19 self-tests have been widely available since 2021, often subsidized or free to the public through pharmacies or online ordering. […] Despite wide use and acceptability, COVID-19 LFTs and the care pathways in which they are used have limitations, particularly in terms of false positives and false negatives. […] The accuracy and, in particular, the sensitivity of LFTs is lower than that of reference RT-PCR methods, ranging between 34.1% and 88.1% for SARS-CoV-2 antigen LFTs, with an overall specificity of 99.6%. […] Thus, LFTs benefit COVID-19 testing in identifying infectiousness or risk of transmission.

• #60 Look familiar? How rapid tests changed the pandemic

  https://www.bbc.com/news/health-59895258

  Lateral flow tests are now part of life for much of the UK. Billions of pounds of public money have been spent on test kits. Has it all been worth it? […] „I’m serious when I say they have been the single most powerful tool in reducing transmission of the virus,” says Irene Petersen, professor of epidemiology at University College London. […] But data now suggests much of that concern was misplaced. Since March, 183,939 pupils in England have tested positive on a lateral flow test at home and then had a sample sent off to a laboratory for a follow-up PCR test. In total 89% of those swabs returned the same positive result. […] A recent analysis of the first Liverpool pilot, which has not yet been peer reviewed by other scientists, found that the early roll out of mass testing in the city was linked to a 32% fall in Covid hospital admissions, and relieved significant pressure on the NHS.

• #61 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  The WHO has established a target product profile for COVID-19 antigen LFTs for use in suspected COVID-19 cases and close contacts, highlighting the application of LFTs in areas where reference molecular testing is unavailable. […] Millions of LFTs can be produced per month to meet global demand at affordable prices; however, such scale-up requires investment in manufacturing infrastructure and time. […] The rapid development of target product profiles, first by the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) and later by the WHO, provided clear expectations to manufacturers on desired design features. […] The COVID-19 pandemic has affected the approach of regulators with regard to approving lateral flow tests (LFTs), including early engagement with and guidance to test developers.

• #62

  https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays

  Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). […] This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. […] Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions.

• #63 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 LFT results from self-testing, positive or negative, are often not reported, leaving test use data and true case counts unknown, thereby complicating surveillance. […] The future of public health is increasingly digital. […] LFTs may make a difference in detecting a range of other infections, particularly the WHO’s list of priority diseases of epidemic potential, antimicrobial resistance and other acute and chronic infections. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The Access to COVID-19 Tools (ACT)-Accelerator diagnostic pillar (ACT-A Dx), part of the ACT-A mechanism, was established to increase equitable access to COVID-19 testing globally. […] The COVID-19 pandemic has shown that rapid antigen tests can be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission.

• #64 COVID Testing – COVID-19 Protocols

  https://covidprotocols.org/chapters/covid-testing/

  Testing Asymptomatic Patients: If test capacity permits, testing asymptomatic people with known exposure to COVID-19 may be helpful (ideally as a part of a contact tracing initiative). […] Asymptomatic Screening and Public Health Surveillance: To understand population-level prevalence and incidence, local institutions or departments of health may perform testing (PCR or Antibody) on entire cohorts regardless of exposure or symptoms. […] Asymptomatic people who have a high likelihood of transmission to others should they become infected may be regularly tested for COVID-19, even without a confirmed contact. […] More options for the use of rapid antigen tests for COVID-19 for asymptomatic screening and in public health surveillance have been published by the European Center for Disease Prevention and Control and by the Africa CDC.

• #65 COVID Testing – COVID-19 Protocols

  https://covidprotocols.org/chapters/covid-testing/

  Testing Asymptomatic Patients: If test capacity permits, testing asymptomatic people with known exposure to COVID-19 may be helpful (ideally as a part of a contact tracing initiative). […] Asymptomatic Screening and Public Health Surveillance: To understand population-level prevalence and incidence, local institutions or departments of health may perform testing (PCR or Antibody) on entire cohorts regardless of exposure or symptoms. […] Asymptomatic people who have a high likelihood of transmission to others should they become infected may be regularly tested for COVID-19, even without a confirmed contact. […] More options for the use of rapid antigen tests for COVID-19 for asymptomatic screening and in public health surveillance have been published by the European Center for Disease Prevention and Control and by the Africa CDC.

• #66

  https://www.who.int/publications/i/item/9789240067172

  Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including malaria, HIV and COVID-19. […] Their utility is, however, compromised every time a test is incorrectly performed or interpreted or its result is not available in a timely manner for clinical decisionmaking and surveillance. […] one that acts within the narrow bounds of a non-medical reader, recording the users interpretation of the test as the definitive result and transmitting the readers interpretation only for non-medical uses such as public health surveillance, monitoring, evaluation and external quality assessment.

• #67

  https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays

  Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). […] This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. […] Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions.

• #68 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 LFT results from self-testing, positive or negative, are often not reported, leaving test use data and true case counts unknown, thereby complicating surveillance. […] The future of public health is increasingly digital. […] LFTs may make a difference in detecting a range of other infections, particularly the WHO’s list of priority diseases of epidemic potential, antimicrobial resistance and other acute and chronic infections. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The Access to COVID-19 Tools (ACT)-Accelerator diagnostic pillar (ACT-A Dx), part of the ACT-A mechanism, was established to increase equitable access to COVID-19 testing globally. […] The COVID-19 pandemic has shown that rapid antigen tests can be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission.

• #69 New Research Finds Ways to Improve Accuracy of Lateral Flow Tests | Today’s Clinical Lab

  https://www.clinicallab.com/new-research-finds-ways-to-improve-accuracy-of-lateral-flow-tests-25733

  Lateral flow devices were introduced late in 2020 on a global scale to help detect novel coronavirus infection in individuals, with test results produced rapidly in half an hour or less. […] However, their potential has been somewhat hindered by inadequate sensitivity, with a high number of false-negative results. […] They identified that the underlying technology of many lateral flow devices is highly accurate and able to theoretically detect trace amounts of the COVID-19 virus, but the limitations fall to the read-out of the device the technology used to communicate the result of the test. […] Professor Owen Addison from King’s College London said: „Methods to detect infectious individuals who do not show or are yet to show symptoms remain essential for the management of the current pandemic. Lateral flow devices are the simplest and most accessible tests available, and our findings show great scope for improving the deficiencies that these tests have been recently criticized for.”

• #70 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx

  However, access to self-tests is inequitable, with considerably lower adoption by low-income and middle-income nations. […] Next-generation LFTs would target antigens, antibodies, and molecules, with AMR (antimicrobial resistance) panels and quick response (QR) codes, for use not only for self-testing, clinical diagnosis, screening and surveillance testing but also for environmental monitoring. […] To conclude, based on the review findings, next-generation of next-generation LFTs could provide means for rapid and decentralized testing with high sensitivity and specificity at a mass scale. […] Efforts must be made to overcome LFT shortcomings, such as high false-negative rates, to provide next-generation diagnostic LFTs, with an equitable distribution, across the globe, to improve global preparedness against pathogens.

• #71 Look familiar? How rapid tests changed the pandemic

  https://www.bbc.com/news/health-59895258

  „The PCR programme is such a complete waste of resources. It’s there because it was the only thing we had at the beginning. It should be phased out sooner rather than later,” says Prof Irene Petersen at UCL. […] „The cost of mass testing has been staggering,” she says. „The best advice is if you have symptoms is to simply stay at home until you are better, and that way you will avoid spreading Covid, flu and a host of other viral infections.” […] Scientists think mass testing may have opened the door to other more efficient ways of detecting disease in the near future. A new generation of lateral flow tests are going into production – designed to detect not just Covid but different forms of influenza and other viruses at the same time.

• #72 JMIR Public Health and Surveillance – A Smartphone-Based Platform Assisted by Artificial Intelligence for Reading and Reporting Rapid Diagnostic Tests: Evaluation Study in SARS-CoV-2 Lateral Flow Immunoassays

  https://publichealth.jmir.org/2022/12/e38533

  The proposed reading system is automatic, reducing variability and uncertainty associated with RDTs interpretation and can be used to read different RDT brands. […] Our AI algorithm demonstrates excellent performance, especially in prospective validation of real-life scenarios and for both antibody and antigen detection tests. […] This is especially important in contexts where massive testing is to be done and the likelihood of subjectivity and errors in the interpretation of the result is higher. It is also important in the validation of self-diagnostic tests performed by untrained users, as it avoids the loss of information in case the user does not report it, and it provides an efficient system to confirm and report data, which has been a key challenge during the latest pandemic waves.

• #73 New Research Finds Ways to Improve Accuracy of Lateral Flow Tests | Today’s Clinical Lab

  https://www.clinicallab.com/new-research-finds-ways-to-improve-accuracy-of-lateral-flow-tests-25733

  Lateral flow devices were introduced late in 2020 on a global scale to help detect novel coronavirus infection in individuals, with test results produced rapidly in half an hour or less. […] However, their potential has been somewhat hindered by inadequate sensitivity, with a high number of false-negative results. […] They identified that the underlying technology of many lateral flow devices is highly accurate and able to theoretically detect trace amounts of the COVID-19 virus, but the limitations fall to the read-out of the device the technology used to communicate the result of the test. […] Professor Owen Addison from King’s College London said: „Methods to detect infectious individuals who do not show or are yet to show symptoms remain essential for the management of the current pandemic. Lateral flow devices are the simplest and most accessible tests available, and our findings show great scope for improving the deficiencies that these tests have been recently criticized for.”

• #74 Rapid Detection of Active Coronavirus Infection by Lateral Flow Test Strips: A New Approach to Distinguish Replicating Viruses from Non-Replicating Viruses | bioRxiv

  https://www.biorxiv.org/content/10.1101/2024.07.18.604218v1.full-text

  This manuscript describes the development of an alternative method to detect active coronavirus infection, which targets negative-sense RNA, a product of active viral replication. […] We propose strand-specific nucleic acid diagnostics as a means of distinguishing between active and inactive RNA virus infections and prototype a CRISPR-based lateral flow assay that specifically detects replicating coronaviruses. […] Such a paradigm in diagnostics could guide more effective public health measures to curb the spread of SARS-CoV-2 and other single-stranded viruses. […] The COVID-19 pandemic, caused by the rapid spread of SARS-CoV-2, was significantly exacerbated by delays in the development of rapid and affordable diagnostics. […] Understanding viral shedding patterns and the duration of infectiousness is crucial for effective disease management and public health interventions.

• #75 Rapid Detection of Active Coronavirus Infection by Lateral Flow Test Strips: A New Approach to Distinguish Replicating Viruses from Non-Replicating Viruses | bioRxiv

  https://www.biorxiv.org/content/10.1101/2024.07.18.604218v1.full-text

  However, the inability to distinguish replicating viruses from non-replicating viruses limits the utility of the current detection methods. […] We described the development of an alternative active coronavirus detection system that uses the -ssRNA antigenome as a marker for the presence of a replicating virus. […] One of the key advantages of using the -ssRNA antigenome as a target for detection is its ability to distinguish between active and non-active infections. […] This can help reduce the burden on healthcare systems and prevent the unnecessary isolation of individuals. […] Another key strength of this approach is its high sensitivity and specificity. […] This information can be used to guide treatment decisions and optimize patient outcomes. […] Our LFT overcomes this limitation by specifically targeting a unique molecular signature present only in actively replicating viruses.

• #76 Rapid Detection of Active Coronavirus Infection by Lateral Flow Test Strips: A New Approach to Distinguish Replicating Viruses from Non-Replicating Viruses | bioRxiv

  https://www.biorxiv.org/content/10.1101/2024.07.18.604218v1.full-text

  This innovative approach represents a significant advancement in diagnostic capabilities, particularly in the context of the current pandemic landscape. […] The use of the -ssRNA strand as a marker allows for the direct detection of replicating viruses, rather than relying on indirect indicators, such as the presence of viral proteins or antigens. […] Overall, our findings support the establishment of the -ssRNA strand as a valuable target for active coronavirus detection.

• #77 Rapid Detection of Active Coronavirus Infection by Lateral Flow Test Strips: A New Approach to Distinguish Replicating Viruses from Non-Replicating Viruses | bioRxiv

  https://www.biorxiv.org/content/10.1101/2024.07.18.604218v1.full-text

  Here, based on our earlier work, we propose and show the effectiveness of a detection system that can directly target negative-sense viral RNA, produced only during replication. […] We show that the replicating mouse coronavirus, a model for SARS-CoV, continues to produce both its genome, positive-sense RNA (+ssRNA genome), and antigenome, negative-sense RNA (-ssRNA antigenome), throughout the infection process in cells. […] We therefore prototype a user-friendly CRISPR-based lateral flow assay to overcome such shortcomings in the market of available detection technologies. […] The distinction between active infection and non-replicating infection afforded by stranded diagnostics can nevertheless inform containment strategies. […] The COVID-19 pandemic has had a profound impact on the world, with the virus spreading rapidly and causing significant illness and death since it started in 2020.

• #78 Rapid Detection of Active Coronavirus Infection by Lateral Flow Test Strips: A New Approach to Distinguish Replicating Viruses from Non-Replicating Viruses | bioRxiv

  https://www.biorxiv.org/content/10.1101/2024.07.18.604218v1.full-text

  A prominent publication reported persistent diffuse viral replication months after symptom onset in COVID-19 patients. […] However, it remains unclear how these findings from fatal cases relate to less severe infections. […] One study found fragmented SARS-CoV-2 RNA and viral proteins in non-apoptosing non-classical monocytes of a patient 15 month post-infection without any indications of active replication. […] Culture-dependent methods are the gold standard for determining viral replication competence, and by inference, infectivity, but they are low-throughput and require several days to perform by trained staff; a fact that would preclude their use in preventing transmission during solid organ transplant, or could lead to ill-informed guidelines for quarantining. […] A new, simpler method is urgently needed for determining if a person is harboring actively replicating virus to infer infectivity.

• #79 Mass COVID testing and sequencing is unsustainable – here’s how future surveillance can be done

  https://theconversation.com/mass-covid-testing-and-sequencing-is-unsustainable-heres-how-future-surveillance-can-be-done-177404

  Several European countries are drastically reducing the number of COVID tests performed. […] The volume of coronavirus genome sequences produced during the pandemic is equally unprecedented. […] The real-world value of the gigantic sequencing effort is also questionable. […] While the current volume of testing and sequencing is unsustainable in the long term, there are major questions over when these schemes should be scrapped and what elements of viral surveillance should be kept in place or introduced as replacements. […] The UK Office for National Statistics Infection Survey provides reliable and unbiased COVID prevalence surveillance. […] Surveillance could also take advantage of wastewater monitoring of the coronavirus. […] It will be critical to maintain careful monitoring of the evolution of the virus to inform future vaccine updates. […] A truly global surveillance framework would in effect be preferable to the current situation, where the vast majority of viral sequences come from a handful of rich countries. […] The scrapping of mass testing will represent a major step in this delicate transition.

• #80 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 LFT results from self-testing, positive or negative, are often not reported, leaving test use data and true case counts unknown, thereby complicating surveillance. […] The future of public health is increasingly digital. […] LFTs may make a difference in detecting a range of other infections, particularly the WHO’s list of priority diseases of epidemic potential, antimicrobial resistance and other acute and chronic infections. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The Access to COVID-19 Tools (ACT)-Accelerator diagnostic pillar (ACT-A Dx), part of the ACT-A mechanism, was established to increase equitable access to COVID-19 testing globally. […] The COVID-19 pandemic has shown that rapid antigen tests can be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission.

• #81 Mass COVID testing and sequencing is unsustainable – here’s how future surveillance can be done

  https://theconversation.com/mass-covid-testing-and-sequencing-is-unsustainable-heres-how-future-surveillance-can-be-done-177404

  Several European countries are drastically reducing the number of COVID tests performed. […] The volume of coronavirus genome sequences produced during the pandemic is equally unprecedented. […] The real-world value of the gigantic sequencing effort is also questionable. […] While the current volume of testing and sequencing is unsustainable in the long term, there are major questions over when these schemes should be scrapped and what elements of viral surveillance should be kept in place or introduced as replacements. […] The UK Office for National Statistics Infection Survey provides reliable and unbiased COVID prevalence surveillance. […] Surveillance could also take advantage of wastewater monitoring of the coronavirus. […] It will be critical to maintain careful monitoring of the evolution of the virus to inform future vaccine updates. […] A truly global surveillance framework would in effect be preferable to the current situation, where the vast majority of viral sequences come from a handful of rich countries. […] The scrapping of mass testing will represent a major step in this delicate transition.

• #82 Mass COVID testing and sequencing is unsustainable – here’s how future surveillance can be done

  https://theconversation.com/mass-covid-testing-and-sequencing-is-unsustainable-heres-how-future-surveillance-can-be-done-177404

  Several European countries are drastically reducing the number of COVID tests performed. […] The volume of coronavirus genome sequences produced during the pandemic is equally unprecedented. […] The real-world value of the gigantic sequencing effort is also questionable. […] While the current volume of testing and sequencing is unsustainable in the long term, there are major questions over when these schemes should be scrapped and what elements of viral surveillance should be kept in place or introduced as replacements. […] The UK Office for National Statistics Infection Survey provides reliable and unbiased COVID prevalence surveillance. […] Surveillance could also take advantage of wastewater monitoring of the coronavirus. […] It will be critical to maintain careful monitoring of the evolution of the virus to inform future vaccine updates. […] A truly global surveillance framework would in effect be preferable to the current situation, where the vast majority of viral sequences come from a handful of rich countries. […] The scrapping of mass testing will represent a major step in this delicate transition.

• #83 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] Only 0.4% of the 3 billion COVID-19 tests performed through to mid-2022 were conducted in low-income regions, raising ethical concerns and constraining our collective ability to respond to a pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] We recommend investing in an international LFT research and development hub network to spearhead the development of a pipeline of innovative bioengineering approaches to design next-generation LFTs.

• #84 Lateral Flow Testing Beyond COVID-19 | Technology Networks

  https://www.technologynetworks.com/diagnostics/articles/lateral-flow-testing-beyond-covid-19-348140

  Before 2020, the words lateral flow meant little to anyone outside the scientific community. […] Now, thanks to COVID-19, lateral flow is no longer an unknown as we can see from Google Trends, the term has entered the public consciousness. That is because across the world, rapid lateral flow tests are being used by governments and health authorities to screen huge numbers of people who dont have COVID-19 symptoms. In the UK, the government has said that regular rapid testing using lateral flow tests will be fundamental in helping to prevent future outbreaks. […] It is positive that governments and health agencies see regular lateral flow testing as a way out of this pandemic and back to normality. […] Lateral flow is the only viable option when large scale surveillance, rapid response and results with rapid data are required. […] So, lateral flow is here to stay. It has grown beyond the home pregnancy test in the eyes of the public and truly proved its worth in the pandemic.

• #85 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  The WHO has established a target product profile for COVID-19 antigen LFTs for use in suspected COVID-19 cases and close contacts, highlighting the application of LFTs in areas where reference molecular testing is unavailable. […] Millions of LFTs can be produced per month to meet global demand at affordable prices; however, such scale-up requires investment in manufacturing infrastructure and time. […] The rapid development of target product profiles, first by the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) and later by the WHO, provided clear expectations to manufacturers on desired design features. […] The COVID-19 pandemic has affected the approach of regulators with regard to approving lateral flow tests (LFTs), including early engagement with and guidance to test developers.

• #86 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] Only 0.4% of the 3 billion COVID-19 tests performed through to mid-2022 were conducted in low-income regions, raising ethical concerns and constraining our collective ability to respond to a pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] We recommend investing in an international LFT research and development hub network to spearhead the development of a pipeline of innovative bioengineering approaches to design next-generation LFTs.

• #87 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Diagnostics have emerged as a crucial countermeasure to the spread of COVID-19, and by late 2022, more than 3 billion tests for SARS-CoV-2 had been conducted worldwide. […] The simplicity of LFTs comes with technical limitations and usage trade-offs. Notably, they are less sensitive than PCR and rely on visual readout. […] In this Review, we discuss the design principle of LFTs, and highlight key lessons learned from their use in the COVID-19 pandemic, including access, accuracy, affordability, manufacturing, regulation and funding. […] LFTs were adopted on an unprecedented scale during the COVID-19 pandemic, demonstrating their feasibility and acceptability on a global basis. […] Professional use and self-tests have enabled LFT-based testing to be expanded beyond healthcare facilities and into community settings and homes.

• #88 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data

  https://pmc.ncbi.nlm.nih.gov/articles/PMC10446167/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. […] We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test results from surveillance data were matched by individual where both LFT and PCR were taken on the same day. […] Sensitivity and specificity were 25.65% (95%CI 22.0229.67) and 99.91% (95%CI 99.8999.93), respectively. […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. […] Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted.

• #89 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data – PubMed

  https://pubmed.ncbi.nlm.nih.gov/37611000/

  Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. Between May and August 2021, adult care home staff policy was for biweekly Innova LFT and weekly Polymerase Chain Reaction (PCR) testing while asymptomatic. We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test result agreement was 99.59% (95%CI 99.55-99.63; MCC: 0.38, p0.001). Sensitivity and specificity were 25.65% (95%CI 22.02-29.67) and 99.91% (95%CI 99.89-99.93), respectively. PPV was 55.90% (95%CI 49.42-62.17) and NPV was 99.68% (95%CI 99.64-99.71). […] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted. Performance improved at times of higher prevalence during the study. These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed.

• #90 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406

  Performance improved at times of higher prevalence during the study. […] These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. […] When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed. […] In January 2021, the Welsh Government launched a COVID-19 testing strategy that included the use of LFTs to aid in preventing the transmission of COVID-19 across Wales. […] A part of this strategy involved the use of LFTs in closed settings such as care homes to reduce the risk of transmission from staff to care home residents. […] Interpretation of this evaluation will be affected by restrictions and management of cases deemed to be ‘false positive’ and the use of LFTs as a routine screening tool.

• #91 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406

  Performance improved at times of higher prevalence during the study. […] These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. […] When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed. […] In January 2021, the Welsh Government launched a COVID-19 testing strategy that included the use of LFTs to aid in preventing the transmission of COVID-19 across Wales. […] A part of this strategy involved the use of LFTs in closed settings such as care homes to reduce the risk of transmission from staff to care home residents. […] Interpretation of this evaluation will be affected by restrictions and management of cases deemed to be ‘false positive’ and the use of LFTs as a routine screening tool.

• #92 New analysis of lateral flow tests shows specificity of at least 99.9% – GOV.UK

  https://www.gov.uk/government/news/new-analysis-of-lateral-flow-tests-shows-specificity-of-at-least-999

  The government has also confirmed twice-weekly testing using LFDs for free to all adults in households with primary, secondary school and college aged children and young people, including childcare and support bubbles […] Testing using LFDs should be a regular habit. Clinical advice is to be tested twice a week every week, which is the same policy for NHS and care home staff.

• #93 Lateral Flow Tests Detect Most People At Risk Of Transmitting Covid-19 – William A. Haseltine PhD William A. Haseltine PhD

  https://williamhaseltine.com/lateral-flow-tests-detect-most-people-at-risk-of-transmitting-covid-19/

  Routine testing to identify those infected followed by efficient contact tracing, and supported isolation is still the most effective public health measure we have to control Covid-19. […] Rapid testing has been unfortunately de-prioritized in the US in favor of unrealistic expectations placed on vaccines and has often been mischaracterized as less sensitive and therefore less effective in detecting Covid-19. […] Covid-19 testing has traditionally focused on diagnosing symptomatic individuals using reverse PCR tests. However, mass antigen rapid lateral flow tests have recently been rolled out in several countries for regularly testing asymptomatic individuals as part of public health policy. […] The study by UCL researchers published in Clinical Epidemiology uses a new formula that recalibrates relative performance statistics from Lateral flow vs PCR validation studies to give absolute sensitivity of lateral flow tests for detecting individuals who are shedding SARS-CoV-2 antigens.

• #94 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx

  However, access to self-tests is inequitable, with considerably lower adoption by low-income and middle-income nations. […] Next-generation LFTs would target antigens, antibodies, and molecules, with AMR (antimicrobial resistance) panels and quick response (QR) codes, for use not only for self-testing, clinical diagnosis, screening and surveillance testing but also for environmental monitoring. […] To conclude, based on the review findings, next-generation of next-generation LFTs could provide means for rapid and decentralized testing with high sensitivity and specificity at a mass scale. […] Efforts must be made to overcome LFT shortcomings, such as high false-negative rates, to provide next-generation diagnostic LFTs, with an equitable distribution, across the globe, to improve global preparedness against pathogens.

• #95 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  The WHO has established a target product profile for COVID-19 antigen LFTs for use in suspected COVID-19 cases and close contacts, highlighting the application of LFTs in areas where reference molecular testing is unavailable. […] Millions of LFTs can be produced per month to meet global demand at affordable prices; however, such scale-up requires investment in manufacturing infrastructure and time. […] The rapid development of target product profiles, first by the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) and later by the WHO, provided clear expectations to manufacturers on desired design features. […] The COVID-19 pandemic has affected the approach of regulators with regard to approving lateral flow tests (LFTs), including early engagement with and guidance to test developers.

• #96 Azthena logo with the word Azthena

  https://www.news-medical.net/health/Types-of-COVID-19-Test.aspx

  Testing, tracking, tracing, and isolating (TTTI) quickly and on a large scale have proven essential to public health policy responses during the coronavirus disease 2019 (COVID19) pandemic. […] Effective testing strategies can combine different tests to achieve complementarity, given their respective advantages and disadvantages. […] These tests are important in the understanding of infection rates in a population and are of epidemiological value. […] Although these tests play an important role in epidemiology and vaccine development, given they are unsuitable for detecting current, active viral infections, they play no role in implementing TTTI strategies. […] The given objectives are: […] Epidemiological monitoring of specific populations e.g., groups of people such as in nursing homes, schools and universities, companies, geographic localities. […] Ultimately, great care should be taken when choosing which COVID-19 test to take to ensure the safety of yourself and those around you.

• #97 Written Statement: Learning more about the use of rapid COVID-19 testing using Lateral Flow Devices (LFDs) (1 July 2021) | GOV.WALES

  https://www.gov.wales/written-statement-learning-more-about-use-rapid-covid-19-testing-using-lateral-flow-devices-lfds

  Regular COVID-19 testing has been offered to health and social care workers, education staff, students and workers in the public and private sector since the beginning of 2021. […] Public Health Wales publishes a weekly surveillance report on LFD tests for Welsh residents including the number of tests reported and the result. […] The percentage of positive episodes has increased over the last two weeks in line with the increase in prevalence shown for symptomatic (PCR) testing over the same period. […] People are required to report the results of their LFD tests whether positive or negative on a UK government website but we are concerned not all are reporting the results, particularly if they are negative. […] We are also working on our communications to improve participation in testing and ensuring understanding of the need to register both negative and positive results.

• #98 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  COVID-19 LFT results from self-testing, positive or negative, are often not reported, leaving test use data and true case counts unknown, thereby complicating surveillance. […] The future of public health is increasingly digital. […] LFTs may make a difference in detecting a range of other infections, particularly the WHO’s list of priority diseases of epidemic potential, antimicrobial resistance and other acute and chronic infections. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The Access to COVID-19 Tools (ACT)-Accelerator diagnostic pillar (ACT-A Dx), part of the ACT-A mechanism, was established to increase equitable access to COVID-19 testing globally. […] The COVID-19 pandemic has shown that rapid antigen tests can be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission.

• #99 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] Only 0.4% of the 3 billion COVID-19 tests performed through to mid-2022 were conducted in low-income regions, raising ethical concerns and constraining our collective ability to respond to a pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] We recommend investing in an international LFT research and development hub network to spearhead the development of a pipeline of innovative bioengineering approaches to design next-generation LFTs.

• #100 Lateral flow tests detect most people at risk of transmitting Covid-19 | Institute of Epidemiology & Health Care – UCL – University College London

  https://www.ucl.ac.uk/epidemiology-health-care/news/2021/oct/lateral-flow-tests-detect-most-people-risk-transmitting-covid-19

  Professor Petersen added: As LFTs are becoming widely used in schools, workplaces and for admittance to venues such as those used for large events, it is important that health professionals and the public have clear information about the operating characteristics of the tests. We have demonstrated that the absolute sensitivity to detect SARS-CoV-2 antigens is likely high with LFTs. […] To improve our understanding of their characteristics, longitudinal studies where individuals, and ideally contacts of cases, are tested daily by LFTs and PCR tests would help to further understand false negatives (and false positives) and, importantly, the time differences of between turning PCR positive, LFT positive, and symptom onset.

• #101 A systematic review of the sensitivity and specificity of lateral flow devices in the detection of SARS-CoV-2 | BMC Infectious Diseases | Full Text

  https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06528-3

  Lateral flow devices (LFDs) are viral antigen tests for the detection of SARS-CoV-2 that produce a rapid result, are inexpensive and easy to operate. They have been advocated for use by the World Health Organisation to help control outbreaks and break the chain of transmission of COVID-19 infections. […] The primary objective was to identify the sensitivities and specificities of lateral flow devices in the detection of SARS-CoV-2 compared to reverse transcriptase polymerase chain reaction in patients with symptoms of COVID-19 or those screened as part of mass testing programmes. […] This systematic review identified that the performance of lateral flow devices is heterogeneous and dependent on the manufacturer. […] Potentially, LFDs could support the scaling up of mass testing to aid track and trace methodology and break the chain of transmission of COVID-19 with the additional benefit of providing individuals with the results in a much shorter time frame.

• #102 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner

  https://www.nature.com/articles/s44222-022-00007-3

  Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] Only 0.4% of the 3 billion COVID-19 tests performed through to mid-2022 were conducted in low-income regions, raising ethical concerns and constraining our collective ability to respond to a pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] We recommend investing in an international LFT research and development hub network to spearhead the development of a pipeline of innovative bioengineering approaches to design next-generation LFTs.

• #103 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx

  However, access to self-tests is inequitable, with considerably lower adoption by low-income and middle-income nations. […] Next-generation LFTs would target antigens, antibodies, and molecules, with AMR (antimicrobial resistance) panels and quick response (QR) codes, for use not only for self-testing, clinical diagnosis, screening and surveillance testing but also for environmental monitoring. […] To conclude, based on the review findings, next-generation of next-generation LFTs could provide means for rapid and decentralized testing with high sensitivity and specificity at a mass scale. […] Efforts must be made to overcome LFT shortcomings, such as high false-negative rates, to provide next-generation diagnostic LFTs, with an equitable distribution, across the globe, to improve global preparedness against pathogens.

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