Materiały źródłowe

• #1 Development and Efficacy of Lateral Flow Point-of-Care Testing Devices for Rapid and Mass COVID-19 Diagnosis by the Detections of SARS-CoV-2 Antigen and Anti-SARS-CoV-2 Antibodies

  https://pubmed.ncbi.nlm.nih.gov/34679458/

  The COVID-19 pandemic is an ongoing global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2020-2021. […] Opportune detection, confinement, and early treatment of infected cases present the first step in combating COVID-19. […] However, antigen tests can be used for rapid and mass testing in high-risk congregate housing to quickly identify people with COVID-19, implementing infection prevention and control measures, thus preventing transmission. […] LFIA anti-SARS-CoV-2 antibody tests, IgM and/or IgG, known as serology tests, are used for identification if a person has previously been exposed to the virus or vaccine immunization.

• #2 Development and Efficacy of Lateral Flow Point-of-Care Testing Devices for Rapid and Mass COVID-19 Diagnosis by the Detections of SARS-CoV-2 Antigen and Anti-SARS-CoV-2 Antibodies

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8534532/

  The COVID-19 pandemic is an ongoing global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 20202021. […] Diagnosis via viral nucleic acid amplification tests (NAATs) is frequently employed and considered the standard procedure. However, with an increasing urge for point-of-care tests, rapid and cheaper immunoassays are widely utilized, such as lateral flow immunoassay (LFIA), which can be used for rapid, early, and large-scale detection of SARS-CoV-2 infection. […] Antigen tests can be used for rapid and mass testing in high-risk congregate housing to quickly identify people with COVID-19, implementing infection prevention and control measures, thus preventing transmission. […] LFIA has played a critical role in COVID-19 testing due to the benefit of delivering a result in 530 min. It has been used for mass testing for COVID-19 globally and complement other public health measures for COVID-19.

• #3 Development and Efficacy of Lateral Flow Point-of-Care Testing Devices for Rapid and Mass COVID-19 Diagnosis by the Detections of SARS-CoV-2 Antigen and Anti-SARS-CoV-2 Antibodies

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8534532/

  The detection of SARS-CoV-2 antigen has applied the immunoreaction of specific antibodies to recognize the viral proteins, e.g., SARS-CoV-2 N and/or S proteins. […] Rapid SARS-CoV-2 antigen tests for COVID-19 are one of the most helpful application tests and have provided global governments with several benefits. […] The Panbio COVID-19 Ag Rapid Test Device had been performed on symptomatic patients in primary healthcare centers. […] A national systematic evaluation of sensitivity and specificity for COVID-19 mass testing using Innova SARS-CoV-2 Antigen Rapid Qualitative Test was reported by the UK COVID-19 Lateral Flow Oversight Team. […] The authors concluded that the sensitivity range of the commercial SARS-CoV-2 rapid POC antigen tests was closely related to SARS-CoV-2 viral loads observed in the first week of symptoms, which marks the infectious period in most patients.

• #4 COVID-19 rapid antigen test – Wikipedia

  https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test

  COVID-19 rapid antigen tests or RATs, also frequently called COVID-19 lateral flow tests or LFTs, are rapid antigen tests used to detect SARS-CoV-2 infection (COVID-19). They are quick to implement with minimal training, cost a fraction of other forms of COVID-19 testing, and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches. […] Many RATs can be used for self-testing, in which an individual „collects their own specimen… and interpret[s] their test result themselves”. […] Despite this, COVID-19 RATs remain valuable in finding people who would otherwise not know they were infected, helping to prevent further transmission. The tests are more sensitive in the symptomatic and transmissive stages of disease when the viral load is higher.

• #5 Frontiers | Recent Progress on Rapid Lateral Flow Assay-Based Early Diagnosis of COVID-19

  https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2022.866368/full

  Recent Progress on Rapid Lateral Flow Assay-Based Early Diagnosis of COVID-19 […] The outbreak of the coronavirus disease 2019 (COVID-19) has resulted in enormous losses worldwide. […] Therefore, it is necessary to develop a simple, convenient, and rapid detection strategy for controlling disease recurrence and transmission. […] Taking advantage of their low-cost and simple operation, point-of-care test (POCT) kits for COVID-19 based on the lateral flow assay (LFA) chemistry have become one of the most convenient and widely used screening tools for pathogens in hospitals and at home. […] The LFA technique for the early diagnosis has great potential for preventing, monitoring, and controlling COVID-19, especially in the post-pandemic era. […] The principles, advantages and disadvantages of these methods will be discussed in detail to provide guidance and suggestions for the prevention and transmission control of the COVID-19 pandemic in the post-pandemic era from the prospective of a diagnostic strategy. […] The entire test process can be completed within 30 min. […] Although numerous LFA-based COVID-19 detection methods have been developed in a short time, few POCT diagnostic kits has been approved by the FDA. […] LFA-based diagnostic assays possess significant merits such as low costs, rapid testing, and easy deployment in any setting. […] This shows considerable potential for the mass screening of the SARS-CoV-2. […] For infection monitoring and epidemiology studies, it can be a crucial tool in the post-pandemic era. […]

• #6 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. […] 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. […] 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. […] 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.

• #7 Lateral Flow Tests Effective at Detecting COVID-19 When Used at Symptom Onset | Today’s Clinical Lab

  https://www.clinicallab.com/lateral-flow-tests-effective-at-detecting-covid-19-when-used-at-symptom-onset-25806

  A new study by researchers at Queen Mary University of London, University of Oxford, Institute for Advanced Studies, Vienna, and the Medical University of Graz, has found that lateral flow tests detect COVID-19 with similar accuracy to laboratory-based PCR tests, providing they are used at the onset of infection and soon after symptoms start. […] The lateral flow tests detected more than 95 percent of the cases found by PCR, and correctly identified 89 percent of cases as negative. […] Countries are considering using lateral flow tests to manage future waves of the pandemic. Our findings support this move, but ensuring tests are properly administered should be integral to any strategy. […] In our study, both shorter duration of symptoms and higher viral load were significantly associated with positive lateral flow tests. This highlights the necessity of testing at early infection with lateral flow tests, and shows that in patients who are newly symptomatic, the two testing methods have similar levels of accuracy.

• #8 Lateral flow tests are 95% effective at detecting Covid-19 when used at the onset of symptoms | University of Oxford

  https://www.ox.ac.uk/news/2021-07-14-lateral-flow-tests-are-95-effective-detecting-covid-19-when-used-onset-symptoms

  Lateral flow tests are 95% effective at detecting Covid-19 when used at the onset of symptoms. […] The lateral flow tests detected more than 95 per cent of the cases found by PCR, and correctly identified 89 per cent of cases as negative. […] Countries are considering using lateral flow tests to manage future waves of the pandemic. Our findings support this move, but ensuring tests are properly administered should be integral to any strategy. […] This highlights the necessity of testing at early infection with lateral flow tests, and shows that in patients who are newly symptomatic, the two testing methods have similar levels of accuracy. […] The study results provide the basis for future containment strategies in primary care, which can make an important contribution in control and prevention of a pandemic.

• #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

  Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] 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. […] 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%.

• #10 Lateral flow testing – rapid tests to detect COVID-19 – UK Health Security Agency

  https://ukhsa.blog.gov.uk/2020/12/08/lateral-flow-testing-new-rapid-tests-to-detect-covid-19/

  Lateral flow devices (LFDs) are one of the tools being used to help us detect COVID-19 and reopen society. […] It is particularly important that families of school-age children, secondary school pupils, and people going out to the workplace test regularly using lateral flow devices. […] We know that between one in four and one in three people who have COVID-19 never show any symptoms but that does not mean they are not infectious. Using LFDs enables us to rapidly identify people in the population who are asymptomatic, with results produced in 30 minutes. […] We also know that 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. […] LFDs alone arent a silver bullet for stopping the spread of the virus. But we are confident that they can detect large numbers of individuals in a rapid and timely manner. If used in combination with other vital infection prevention control measures such as wearing appropriate PPE, washing hands regularly and social distancing, they are another tool that will help us drive down levels of the virus and keep infection rates low.

• #11 Lateral Flow Assay Market Surges as COVID-19 Elevates Demand for Rapid Testing Solutions – ResearchAndMarkets.com

  https://www.businesswire.com/news/home/20231103885481/en/Lateral-Flow-Assay-Market-Surges-as-COVID-19-Elevates-Demand-for-Rapid-Testing-Solutions—ResearchAndMarkets.com

  The sudden outbreak of the COVID-19 pandemic was associated with an increase in the demand for simple, rapid, cost-effective, and point-of-care diagnostic devices, such as lateral flow assay kits and readers, needed by hospitals, clinics, airports, schools, and other workplaces for the detection and control of the SARS-CoV-2 virus as LFA test kits demonstrated the ability to detect both symptomatic and asymptomatic COVID-19 infections. […] The impact of the COVID-19 pandemic on the global lateral flow assay market turned out to be positive, as government organizations and healthcare associations increased their focus on mass population testing, infection prevention & control, and public awareness campaigns aimed at identifying the symptoms and creating patient awareness about the use of lateral flow assay COVID-19 kits.

• #12 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. […] Asymptomatic staff testing is a core component of the national infection control guidelines, which all organisations have a duty to adhere to. […] If a member of staff is unable to perform the test for whatever reason, NHS organisations should enable testing either by LFD or by other available technologies, such as the LAMP technology if it is available to the local NHS organisation. Where testing is not possible, the organisation should have mitigations in place.

• #13 Coronavirus » Use of lateral flow devices for asymptomatic staff testing at vaccination sites

  https://www.england.nhs.uk/coronavirus/documents/novel-coronavirus-covid-19-standard-operating-procedure/

  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. […] Regular LFD testing alongside PCR testing will improve virus detection, with the overall aim of preventing further transmission and spread. […] All staff at vaccination sites should be provided with access to testing using LFDs. […] Positive results will need to be confirmed by PCR tests as per the arrangements for the staff members employing organisation. […] Individuals with a positive test result should immediately self-isolate and follow the national infection control guidelines.

• #14 Beyond Covid, lateral flow testing is here to stay – MedCity News

  https://medcitynews.com/2021/07/beyond-covid-lateral-flow-testing-is-here-to-stay/

  Now, due to the Covid 19 pandemic, lateral flow is no longer unknown. As we can see from Google Trends the term itself has entered the public consciousness. […] That’s because across the world, the tests are being used by governments, health authorities and even large organizations to screen huge groups of people who don’t have Covid 19 symptoms. […] In the U.K., the government has said that regular rapid testing using lateral flow tests will be “fundamental” in helping to prevent future outbreaks. […] It’s positive that regular lateral flow testing is being seen by governments and others as a way out of this pandemic and back to normality. […] But to be an effective tool for the purpose of prevention, the data that lateral flow tests can produce needs to be collected at scale and shared easily and at speed. […] And with warnings that Covid won’t be the last pandemic we see in our lifetime, lateral flow must continue to be seen as a vital tool in future outbreaks.

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

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

  LFT testing has enabled healthcare workers to return to work, schools and workplaces to reopen, and economic recovery, including mass gatherings, border testing and travel testing. […] 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, or where molecular turnaround times obviate their utility. […] 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. […] Therefore, more rigorous implementation research is needed, including trials evaluating the clinical effectiveness and cost effectiveness of different LFT-based testing strategies and algorithms.

• #16

  https://www.gov.uk/government/publications/coronavirus-covid-19-testing-for-adult-social-care-settings/visitors-to-adult-social-care-settings-reporting-rapid-lateral-flow-tests-at-home

  Please do a rapid lateral flow test on the day of your visit to a care setting to help keep us safe, reduce the spread of coronavirus and prevent outbreaks. […] Adult social care settings can now provide you with a box of rapid lateral flow tests to take at home. You can find more information and order coronavirus (COVID-19) rapid lateral flow tests online. […] All results, including negatives, positives and voids, must be reported. Linking your test result to the setting you are visiting enables public health teams to better support us to reduce the transmission of coronavirus and prevent outbreaks.

• #17 Testing for COVID-19 | COVID-19 | CDC

  https://www.cdc.gov/covid/testing/index.html

  COVID-19 testing can help you know if you have COVID-19 so you can decide what to do next, like getting treatment to reduce your risk of severe illness and taking steps to lower your chances of spreading the virus to others. […] Antigen tests are rapid tests that usually produce results in 15-30 minutes. Positive results are accurate and reliable. However, in general, antigen tests are less likely to detect the virus than NAAT tests, especially when symptoms are not present. Therefore, a single negative antigen test cannot rule out infection. […] To be confident you do not have COVID-19, FDA recommends 2 negative antigen tests for individuals with symptoms or 3 antigen tests for those without symptoms, performed 48 hours apart. […] If you do not, your results may be less likely to correctly indicate whether you have COVID-19 or not.

• #18 COVID-19 testing – NHS

  https://www.nhs.uk/tests-and-treatments/covid-19-rapid-lateral-flow-test/

  A COVID-19 rapid lateral flow is a test you do yourself to check for COVID-19. […] If youre eligible for COVID-19 treatments, youll need to take a COVID-19 rapid lateral flow test if you have any symptoms of COVID-19. […] You may be able to get free COVID-19 rapid lateral flow tests if youre aged 12 or over and you’re eligible for COVID-19 treatment because youre at highest risk of getting seriously ill from COVID-19. […] You can get free COVID-19 rapid lateral flow tests from a pharmacy if youre eligible for COVID-19 treatments because youre at highest risk of getting seriously ill from COVID-19. […] If you test positive for COVID-19, try to stay home and avoid meeting people for: 3 days after the day the test was taken if youre under 18 years children and young people tend to be infectious for less time than adults; 5 days after the day you took your test if youre aged 18 or over. […] If you test negative and youre eligible for COVID-19 treatments, you need to do a total of 3 rapid lateral flow tests over 3 days (1 test a day) if you continue to have COVID-19 symptoms.

• #19 COVID-19 Testing Recommendations for January 2025

  https://assure-test.com/covid-19-testing-recommendations-for-january-2025/

  As the COVID-19 pandemic enters its fifth year, testing remains a critical tool for managing the spread of SARS-CoV-2. […] Early testing helps confirm infection and reduces transmission risk. […] Use a rapid COVID-19 test before attending events or gatherings, particularly when vulnerable individuals are present. […] Rapid COVID-19 tests continue to be a cornerstone of the pandemic response: […] Ideal for detecting infectiousness before gatherings or travel. […] Routine testing helps: […] Prevent superspreader events by identifying infections early. […] Testing remains a critical component of COVID-19 management in 2025. Whether through rapid COVID-19 tests or PCR tests, staying vigilant helps protect yourself and others. Following CDC guidelines ensures timely detection and effective prevention as SARS-CoV-2 continues to circulate globally.

• #20 Testing for COVID-19 | COVID-19 | CDC

  https://www.cdc.gov/covid/testing/index.html

  After a positive test result, you may continue to test positive for some time. […] Reinfections can occur within 90 days, which can make it hard to know if a positive test indicates a new infection. […] Take steps to prevent spreading COVID-19. […] Monitor your symptoms. If you have any emergency warning signs, seek emergency care immediately. […] Seek health care right away for treatment if you have risk factors for severe illness. Treatment may be an option to make your symptoms less severe and shorten the time you are sick. Treatment needs to be started within a few days of when your symptoms begin. […] A negative COVID-19 test means the test did not detect the virus, but this doesn’t rule out that you could have an infection. If you used an antigen test, follow FDA recommendations for repeat testing. […] Take actions to help protect yourself and others from health risks caused by respiratory viruses.

• #21 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/

  From 16 August 2021, fully vaccinated staff and students who are identified as a contact of a positive COVID-19 case will no longer be expected to isolate and will be expected to return to work. […] The majority of fully vaccinated health and social care staff will be able to continue in their usual role subject to the implementation of the following safeguards to enable them to safely do so: the staff member should not have any COVID-19 symptoms, a negative PCR test prior to returning to their NHS workplace. […] It is a statutory duty that all test results must be reported, whether they are positive, negative or invalid/void. […] NHS organisations are asked to undertake the following: Work with regional testing leads to ensure that all existing boxes of 25s delivered to the NHS are used in the most efficient fashion.

• #22 Coronavirus » Use of lateral flow devices for asymptomatic staff testing at vaccination sites

  https://www.england.nhs.uk/coronavirus/documents/novel-coronavirus-covid-19-standard-operating-procedure/

  LFD testing is not suitable for people with symptoms of COVID-19. Symptomatic people should obtain a PCR test through www.gov.uk/get-coronavirus-test. […] If the above criteria cannot be met, or if the staff member/student has not had both doses of the vaccine, or they are living directly (same household) with a positive COVID-19 case, they will be asked not to come to work. […] 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. […] The supporting organisation should ensure staff or volunteers who are participating in LFD testing are informed on how to perform the test, how to report results and what to do if the test is positive.

• #23 Development and Efficacy of Lateral Flow Point-of-Care Testing Devices for Rapid and Mass COVID-19 Diagnosis by the Detections of SARS-CoV-2 Antigen and Anti-SARS-CoV-2 Antibodies

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8534532/

  Overall, an AuNPs-based LFIA is a sensitive, simple and rapid assay for COVID-19 detection because of the visual analysis without skilled personnel, the availability of cost effectiveness, and the large-scale LFIA strips production ability. […] The study reported by Prez-Garca showed that the AllTest LFIA is a reliable complement of PCR to diagnose SARS-CoV-2 infection 14 days after the onset of symptoms in patients with pneumonia or patients with negative qRT-PCR for SARS-CoV-2.

• #24 Lateral flow test – Wikipedia

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

  LFTs have been used for mass testing for COVID-19 globally and complement other public health measures for COVID-19. […] Some scientists outside government expressed serious misgivings in late 2020 about the use of Innova LFDs for screening for Covid. […] Sensitivity of tests used in 2022 was around 70%.

• #25 Can Omicron evade detection from PCR, rapid antigen or lateral flow tests?verifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverified

  https://www.gavi.org/vaccineswork/can-omicron-evade-detection-pcr-rapid-antigen-or-lateral-flow-tests

  With lateral flow tests, false negatives (a lack of sensitivity) are more likely than false positives (a lack of specificity). A 2021 report by the UK Department of Health and Social Care estimated that only three or four people out of 10,000 would receive a false positive from lateral flow testing. […] The converse is not true, however, and a negative lateral flow result provides far less certainty that you are not infected with COVID-19. If you are symptomatic you should get a PCR test. […] For now, validating negative LFTs or antigen tests with PCR testing if symptoms persist could be the best option, and re-testing over the course of infection.

• #26 Do COVID-19 tests still work?verifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverified

  https://www.gavi.org/vaccineswork/do-covid-19-tests-still-work

  Another possibility is that you haven’t collected your sample correctly or there isn’t yet enough virus to be detected using a lateral flow test. […] These kits are most sensitive at identifying positive results when people have high viral concentrations. […] Rather than being directly caused by the pathogen, “disease symptoms are in large part mediated by an effective immune response, and because that immune response ignites very, very early during infection, it has anecdotally become quite common for people to report symptoms before their tests turn positive,” said Prof Joshua Schiffer, an infectious disease physician and researcher at the Fred Hutch Cancer Center in Seattle, US. […] Because of this variability, Schiffer warns against using a lateral flow test to definitively diagnose COVID-19 – particularly if you’re near the beginning of an infection: “If it’s negative, and you feel like you might have COVID-19, there’s a good chance it will return positive in the next few days – although there are so many other circulating viruses right now that you may well be contagious with something else.”

• #27 Free at-home COVID tests are back. How to get yours

  https://health.ucdavis.edu/news/headlines/can-you-use-an-expired-covid-test/2023/09

  Starting today (Sept. 25, 2023), people in the U.S. can order up to four free COVID tests for their households from COVIDTests.gov. […] The relaunch of the at-home testing program comes amid an increase in COVID hospitalizations. […] But Nam Tran, a professor and senior director of clinical pathology at UC Davis Health, explained that before using an old test, you first need to check the expiration date. […] Which is why Tran says you are probably better off using a new test. […] He explained that if even one of these components is compromised as the kit ages, the test could produce unreliable results. […] This is why Tran strongly advises people not to use expired tests. […] The risk is that you get a false negative and then spread the disease. […] The good news is that when used correctly, non-expired tests are very reliable.

• #28

  https://www.prevention.com/health/health-conditions/a38769630/false-positive-covid-test/

  To lower your already slim chances of a false positive, be sure the test you are using has not been recalled. […] Antigen COVID-19 tests usually require you to swab your nostrils to collect a samplebut the goal isnt to pick up mucus. […] If you test positive at home, dont assume its a false positive, especially if youre experiencing symptoms of COVID-19. […] If you have symptoms consistent with COVID, you test, and the result is positive, youve got COVID and you move on, Dr. Russo says. […] But if its positive and you really think its a false positive, he suggests taking another test. If its positive, that increases the likelihood that its actually positive, he says.

• #29 Free at-home COVID tests are back. How to get yours

  https://health.ucdavis.edu/news/headlines/can-you-use-an-expired-covid-test/2023/09

  But you should not rely on performing just a single test. […] In some cases, you may want to test more than once especially if you are asymptomatic or test early following an exposure event. […] For peace of mind, Tran said it may be easier and more reliable to simply get new tests. […] If you are symptomatic for COVID but dont have a test, its better to err on the side of safety and mask up and isolate, if possible.

• #30 Lateral flow tests are 95% effective at detecting Covid-19 when used at the onset of symptoms | University of Oxford

  https://www.ox.ac.uk/news/2021-07-14-lateral-flow-tests-are-95-effective-detecting-covid-19-when-used-onset-symptoms

  In the context of future relaxations of lockdown rules – in addition to vaccinations – the early detection of people with infection through reliable tests will be necessary in order to control COVID-19. […] It is important, however, that the tests are carried out correctly by qualified personnel, as was the case in our study.

• #31 What Does a Faint Line on a Rapid Test Mean?

  https://www.cedars-sinai.org/newsroom/healthcom-why-even-a-faint-line-on-your-rapid-test-still-means-youre-covid–positive/

  At-home antigen tests work by detecting whether the virus is found in testers nasal secretions, Vail told Health.com. If the window on the testing stick shows two lines, the tester is positive for COVID-19. […] Still, whether the line or lines are bright or faint, two lines still mean positive, one line still means negative, and the safety precautions remain the same: „Five days of [isolation] and then five days of masking if you have no symptoms, before going back to your normal routine, Vail said. […] The chance of getting a false positive is low with at-home tests, so following the antigen test directions and CDC guidelines to the letter prevents the possibility of spreading the virus to others.

• #32 Coronavirus & COVID-19 Overview: Symptoms, Risks, Prevention, Treatment & More

  https://www.webmd.com/covid/coronavirus

  Getting vaccinated against COVID-19 is a key part of prevention. But you should also take these steps: […] Cover your nose and mouth in public. If you have COVID-19, you can spread it even if you don’t feel sick. Wear a mask to protect others. This isn’t a replacement for social distancing. You still need to keep a 6-foot distance between yourself and those around you. […] Wash your hands often with soap and water or clean them with an alcohol-based sanitizer. This kills viruses on your hands. […] Don’t touch your face. Coronaviruses can live on surfaces you touch for several hours. If they get on your hands and you touch your eyes, nose, or mouth, they can get into your body. […] Practice social distancing. Because you can have and spread the virus without knowing it, you should stay home as much as possible. If you do have to go out, stay at least 6 feet away from others.

• #33 Coronavirus & COVID-19 Overview: Symptoms, Risks, Prevention, Treatment & More

  https://www.webmd.com/covid/coronavirus

  Clean and disinfect. You can clean first with soap and water, but disinfect surfaces you touch often, like tables, doorknobs, light switches, toilets, faucets, and sinks. […] There’s no proof that herbal therapies and teas can prevent infection. […] A mask is an added layer of protection for everyone, on top of vaccines and social distancing efforts. You can spread the virus when you talk or cough, even if you don’t know that you have it or if you aren’t showing signs of infection. […] It’s important to wear a high-quality mask in a variety of situations: Wear a mask indoors in public places if you’re in an area where there’s a high or substantial amount of COVID spreading around. […] If you have a chronic health condition or you’re taking meds that weaken your immune system, wear a mask in indoor public places even if you’re fully vaccinated. […] Precautions should still be followed even if you are vaccinated.

• #34 ViraDx™ | Lumos Diagnostics

  https://lumosdiagnostics.com/products/viradx

  ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from anterior nasal or nasopharyngeal swab specimens obtained from patients who are suspected of COVID-19 by their healthcare provider, within the first five days of onset of symptoms. […] A rapid, point-of-care test can help support the differential diagnosis of COVID-19, influenza A and B. […] The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vito diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

• #35 Emerging Viruses and the Next Generation of Respiratory Diagnostics: 2025 Outlook | Meridian Bioscience

  https://www.meridianbioscience.com/lifescience-blog/emerging-viruses-next-generation-of-respiratory-diagnostics-2025-outlook/

  Vaccination remains the cornerstone of prevention for respiratory viruses like influenza, RSV, and COVID-19, but typically targets only known pathogens and dominant strainsproviding only partial protection. […] As a result, early detection, surveillance, and adaptable diagnostics play a vital role in managing new and unpredictable threats. […] This transition has enabled quicker detection and differentiation of flu, COVID-19, and other respiratory pathogens outside of centralized labs. […] Meridians reagents are tailored to help developers build assays that detect and differentiate between common and emerging respiratory virusesincluding influenza, COVID-19, RSV, HMPV, and coronaviruseswith high sensitivity and minimal cross-reactivity.

• #36 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. […] 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. […] Self-testing offers a promising adjunct to centralized testing, potentially better enabling swift and effective management of life-threatening infectious outbreaks among those living in high-risk congregate living settings. […] Rapid self-testing using inexpensive lateral-flow tests could serve as an important adjunct to standard central testing as presumptive diagnosis of viral infections might be efficiently achieved without requiring additional healthcare supervision.

• #37 COVID-19 rapid antigen test – Wikipedia

  https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test

  M édecins Sans Frontières strongly endorsed the use of rapid tests in lower- and middle-income countries, noting „COVID-19 antigen tests can deliver rapid and actionable results, ensuring timely identification of people infected with the virus at the community level”. […] A similar approach was taken in Albania to enable music festivals. […] However, many experts were unsure of this approach believing that „rapid tests are not the solution to restart normal life” but might be used in conjunction with other infection control techniques. […] RATs were more sensitive when samples had more viral load, as measured by a low PCR „cycle threshold,” and less sensitive when the samples had less viral load. […] A modelling study in Canada estimated that half the deaths in care homes in British Columbia in 2020 could have been prevented if rapid testing had been available. […] Various concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used.

• #38 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. […] A study that started in June 2020 in the United Kingdom, FALCON-C19, confirmed the sensitivity of some lateral flow devices (LFDs) in this setting. […] 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.

• #39 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

  Self-testing to detect infectious individuals before interacting with facilities (e.g., schools, airports, and restaurants), along with mask-wearing and adherence to other public health guidelines can be highly effective in suppressing transmission of SARS-CoV-2. […] Rapid self-testing is an excellent tool for combating a particularly contagious virus, providing results in minutes or hours rather than days often associated with centralized nucleic acid testing. […] Widespread adoption of frequent rapid antigen self-testing in tandem with other infection prevention, mitigation, and identification strategies has the potential to prevent many COVID-19 deaths. […] Self-testing represents a powerful adjunct to current centralized testing strategies and holds considerable potential to save future lives. […] Rapid self-testing has demonstrated to not only be possible as shown by ones ability to complete a rapid test but preferred by a carceral community even increasing likelihood and frequency of viral testing.

• #40 Accessible Lateral Flow Assays: Test to Treat, Test to Protect | The Scientist

  https://www.the-scientist.com/accessible-lateral-flow-assays-test-to-treat-test-to-protect-71437

  Lateral flow antigen tests, also known as rapid tests, have a rich history in infectious disease detection and now enable self-testing as a key covid mitigation strategy. […] COVID-19 lateral flow tests detect up to roughly one million viruses per sample, so they detect the people with the highest risk of transmission. These tests took on a new and important public health role to interrupt the chain of transmission within communities. […] We would like to develop tests that reduce unnecessary prescriptions for antibiotics, and tests for diseases of epidemic potential that we want to detect early, such as respiratory syncytial virus (RSV), influenza, and coronaviruses. That is the biggest wish list right now.

• #41

  https://www.access-board.gov/tad/radx/

  In response to the COVID-19 pandemic, the National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) initiative in 2020 to speed the innovation, development, commercialization, and implementation of COVID-19 testing technologies. The RADx Tech program, one arm of the initiative, was specifically designed to compress the customary technology development timeline from years down to just months. While NIH RADx Tech has increased testing capacity in the U.S., there is a continuing need to develop COVID-19 home tests that are accessible to all users, including populations that have no vision or low vision, have a reduced range of dexterity or motor skills, and are aging. […] The primary objective of this best practices document is to capture and publicize learnings from the NIH RADx Tech accessibility program. What follows are detailed recommendations to assist manufacturers in the design of COVID-19 home tests that ensure greater accessibility for users that have no vision or low vision, have a reduced range of dexterity or motor skills, and are aging.

• #42

  https://www.access-board.gov/tad/radx/

  Accessible product design/redesign requires more than incremental improvements to individual test kit components. To create a truly accessible at-home COVID-19 testing experience, the end-to-end workflow should be considered. A holistic review includes consideration of how various test kit components function together to create a seamless testing experience from kit acquisition through component disposal. Features incorporated to improve usability for one user group should improve usability for all. Universal design the design and composition of an environment [or product] so that it can be accessed, understood, and used to the greatest extent possible by all people regardless of their age, ability or disability is an appropriate and achievable goal. […] Below are several guiding principles for universal design of COVID-19 home tests: Engage target end users early (see 7. Assessing Usability). Simplify workflow.

• #43

  https://www.access-board.gov/tad/radx/

  Provide multi-modal test instructions. […] Eliminate the need for precision, where possible. […] Avoid small components. […] Incorporate simultaneous nonvisual (e.g., audible, haptic) and visual cues. […] The general user population for these tests includes individuals that have no vision or low vision, have a reduced range of dexterity or motor skills, and are aging. […] To confirm that such products are safe and effective in the hands of the intended user, validation testing must be performed in accordance with FDA recommendations to confirm the end user can use the product as intended (see 7. Assessing Usability). […] The best practices outlined in this document will aid manufacturers in creating an accessible and usable home test kit; however, understanding how well (or poorly) a design meets user needs requires design assessments. […] Consider adding nonvisual indicators, such as audible and/or haptic feedback, to inform the user of test reader status. […] Consider adding nonvisual cues such as audible and/or haptic feedback to communicate results.

• #44 SARS-CoV-2 antigen rapid lateral flow test (LFT) sensitivity | CLEP

  https://www.dovepress.com/recalibrating-sars-cov-2-antigen-rapid-lateral-flow-test-relative-sens-peer-reviewed-fulltext-article-CLEP

  Testing for SARS-CoV-2 internationally has focused on COVID-19 diagnosis among symptomatic individuals using reverse transcriptase polymerase chain reaction (PCR) tests. Recently, however, SARS-CoV-2 antigen rapid lateral flow tests (LFT) have been rolled out in several countries for testing asymptomatic individuals in public health programmes. […] LFTs (intended to detect individuals shedding SARS-CoV-2 antigens) validated against PCR (intended to diagnose infection) are not reporting against a gold standard of equivalent measurements. […] We derive a formula for recalibrating relative performance statistics from LFT vs PCR validation studies to give likely absolute sensitivity of LFT for detecting individuals who are shedding SARS-CoV-2 antigens. […] Further studies are needed to ascertain the absolute sensitivity of LFT as a test of infectiousness in COVID-19 responses.

• #45 Can Omicron evade detection from PCR, rapid antigen or lateral flow tests?verifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverified

  https://www.gavi.org/vaccineswork/can-omicron-evade-detection-pcr-rapid-antigen-or-lateral-flow-tests

  When Omicron started racing around the world last December, scientists reported finding a ‘stealth’ version of the variant that had a genetic mutation, meaning it couldn’t be differentiated from other variants by rapid PCR tests. That, coupled with anecdotal reports that people might repeatedly test negative for COVID-19 on home lateral flow tests (LFTs) but test positive on a PCR test, has raised concerns that Omicron may not be picked up by available tests. The good news is that, according to the World Health Organization (WHO), PCR and rapid antigen tests can still detect Omicron as well as previous variants. […] Accurate testing remains crucial to our response to the pandemic. Although Omicron has seemingly milder symptoms, the perception of this new variant as less dangerous could lead to complacency, warned WHO Director-General Dr Tedros, who pointed out earlier this month that the virus still hospitalises and kills millions, which is leading to hospitals being utterly overwhelmed. Vaccination remains hugely important, and still not enough people have access to vaccines worldwide.

• #46 Lateral Flow Tests Are 95% Effective at Detecting COVID-19 | Clinical Lab Products

  https://clpmag.com/diagnostic-technologies/immunoassay/rapid-assays/lateral-flow-tests-are-95-effective-at-detecting-covid-19/

  Lateral Flow Tests Are 95% Effective at Detecting COVID-19. A new study by researchers at Queen Mary University of London, University of Oxford, Institute for Advanced Studies, Vienna, and the Medical University of Graz, has found that lateral flow tests detect COVID-19 with similar accuracy to laboratory-based PCR tests, providing they are used at the onset of infection and soon after symptoms start. […] The finding could be pivotal to national strategies looking to tackle the next phase of the pandemic, especially as timely and rapid testing becomes even more important once the current restrictions lift in England. […] Countries are considering using lateral flow tests to manage future waves of the pandemic. Our findings support this move, but ensuring tests are properly administered should be integral to any strategy.

• #47 Lateral Flow Tests Are 95% Effective at Detecting COVID-19 | Clinical Lab Products

  https://clpmag.com/diagnostic-technologies/immunoassay/rapid-assays/lateral-flow-tests-are-95-effective-at-detecting-covid-19/

  This highlights the necessity of testing at early infection with lateral flow tests, and shows that in patients who are newly symptomatic, the two testing methods have similar levels of accuracy. […] The study results provide the basis for future containment strategies in primary care, which can make an important contribution in control and prevention of a pandemic. In the context of future relaxations of lockdown rules in addition to vaccinations the early detection of people with infection through reliable tests will be necessary in order to control COVID-19. […] In summary, this study provides evidence that lateral flow tests can accurately detect SARS-CoV-2 infection as an alternative to PCR testing among symptomatic patients in a real-life primary care setting across a large geographical area.

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