Materiały źródłowe

• #1 COVID-19 – Wikipedia

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

  COVID19 can provisionally be diagnosed on the basis of symptoms and confirmed using reverse transcription polymerase chain reaction (RT-PCR) or other nucleic acid testing of infected secretions. […] Along with laboratory testing, chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection. […] The standard methods of testing for presence of SARS-CoV-2 are nucleic acid tests, which detects the presence of viral RNA fragments. […] The test is typically done on respiratory samples obtained by a nasopharyngeal swab; however, a nasal swab or sputum sample may also be used. […] Chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection but are not recommended for routine screening. […] Bilateral multilobar ground-glass opacities with a peripheral, asymmetric, and posterior distribution are common in early infection. […] Characteristic imaging features on chest radiographs and computed tomography (CT) of people who are symptomatic include asymmetric peripheral ground-glass opacities without pleural effusions.

• #2 Coronavirus Disease (COVID-19): Symptoms & Treatment

  https://my.clevelandclinic.org/health/diseases/21214-coronavirus-covid-19

  COVID-19 is an illness caused by the SARS-CoV-2 virus. […] COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus, a type of coronavirus. […] COVID spreads through respiratory droplets. This means you can get it from coughing, sneezing and talking. […] Healthcare providers diagnose COVID by swabbing your nose with a soft-tipped stick and testing it with a nucleic acid amplification test (NAAT), like a PCR test. You can also test at home with a rapid antigen test. […] COVID can be treated with antiviral medications. These include nirmatrelvir/ritonavir (Paxlovid), remdesivir (Veklury) and molnupiravir (Lagevrio). […] Making sure youre up to date with a current COVID vaccine is the best way to reduce your risk of getting sick with COVID and reduce your risk of severe illness if you do get sick. […] Vaccinations and antiviral medications can help reduce your risk of severe illness.

• #3 COVID-19 Diagnosis: A Comprehensive Review of the RT-qPCR Method for Detection of SARS-CoV-2

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9221722/

  The world is grappling with the coronavirus disease 2019 (COVID-19) pandemic, the causative agent of which is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). […] This review attempts to encapsulate the current knowledge of the viral pathophysiology with disease diagnosis and to critically analyze the reverse transcriptase-polymerase chain reaction (RT-qPCR) technique, one of the gold standards for the detection of SARS-CoV-2 infection. […] Identifying infected individuals and asymptomatic viral carriers with rapid and accurate testing has played a pivotal role in containing and mitigating the COVID-19 pandemic. […] The primary steps for COVID-19 diagnosis are examining the presence of classical signs and symptoms such as fever or chills, cough, shortness of breath, muscle or body aches, headache, fatigue, sore throat, the new loss of taste or smell, dyspnoea, congestion, or runny nose, nausea or vomiting, conjunctivitis, and gastrointestinal issues.

• #4 COVID-19 Test Basics | FDA

  https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics

  COVID-19 testing plays a critical role in the fight against the virus. Understanding COVID-19 tests, including the different types of tests and their uses, and the types of samples the tests use, is key to making an informed decision that meets your needs. […] There are different types of COVID-19 tests diagnostic tests and antibody tests. […] Diagnostic tests can show if you currently are infected with SARS-CoV-2, the virus that causes COVID-19. There are two common types of COVID-19 diagnostic tests: […] Samples for COVID-19 diagnostic tests are typically collected using an anterior nares (nasal) swab sample. […] Depending on the intended use, COVID-19 diagnostic tests can be performed at a laboratory, a standalone testing site, a doctors office or health clinic, or at home. […] Be aware that COVID-19 diagnostic tests are authorized for specific uses and that laboratory-based molecular COVID-19 tests, are generally more accurate than at-home tests.

• #5 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. […] Viral tests look for a current infection with SARS-CoV-2, the virus that causes COVID-19, by testing specimens from your nose or mouth. […] Nucleic acid amplification tests (NAATs), including PCR tests, are more likely to detect the virus than antigen tests. NAATs tests are the gold standard for COVID-19 tests. […] 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.

• #6 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Viral tests, including nucleic acid amplification tests (NAATs) and PCR tests, as well as antigen tests, are used as diagnostic tests to detect current infection with SARS-CoV-2, determine the need for prevention measures, and inform a person’s medical care. […] Positive viral test results indicate current infection and the person with COVID-19 should take steps to prevent spreading COVID-19 to others. […] Negative viral test results mean the test did not detect the virus, but this doesn’t rule out that the person could have an infection. […] Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. […] A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT.

• #7 COVID-19 Diagnosis: A Comprehensive Review of the RT-qPCR Method for Detection of SARS-CoV-2

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9221722/

  SARS-CoV-2 enters the human body as respiratory aerosols; samples from the oropharyngeal or nasopharyngeal are primarily used for viral detection. […] Predominantly, there are two types of diagnostic methods in use: the first category is molecular genetics-based (viral test) and the second is serological-based (antibody test). […] The nucleic acid amplification test (NAAT) by RT-qPCR is a sensitive, accurate, and globally accepted gold standard diagnostic method for the SARS-CoV-2 detection. […] In clinical settings, real-time RT-qPCR is a revolutionary advancement where detection and expression analysis of gene(s) can be carried out in real time, as PCR reaction progresses, and amplification and analysis are done simultaneously in a closed system. […] The genetic material of SARS-CoV-2 (RNA) is first converted into complementary DNA (cDNA) by the action of RNA-dependent DNA polymerase (reverse transcriptase) prior to the actual amplification.

• #8 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  Diagnostic tests are useful to confirm the clinical diagnosis in patients presenting with symptoms consistent with COVID-19, regardless of their vaccination status. Infected individuals can present with mild to severe symptoms of the infection, such as fever or chills, a persistent cough, shortness of breath, and headaches, and these symptoms typically occur 2-14 days after initial exposure. […] Given the high sensitivity and high specificity of molecular tests, false-positive or false-negative test results are rare. A positive result confirms the diagnosis and should trigger patient management procedures and public health measures such as self-isolation and contact tracing. Although studies have shown that a positive molecular test cannot be interpreted to mean that the patient is infectious, public health measures should be carried out nevertheless.

• #9 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. […] Viral tests look for a current infection with SARS-CoV-2, the virus that causes COVID-19, by testing specimens from your nose or mouth. […] Nucleic acid amplification tests (NAATs), including PCR tests, are more likely to detect the virus than antigen tests. NAATs tests are the gold standard for COVID-19 tests. […] 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.

• #10 COVID-19 diagnostic testing: Navigating your options

  https://www.cardinalhealth.com/en/product-solutions/medical/laboratory-products/poc-infectious-diseases/seasonal-respiratory-diagnostic-insights/respiratory-insights/covid-19-diagnostic-testing-options0.html

  With high sensitivity and specificity, molecular testing remains the gold standard for when the highest level of accuracy is a priority. As such, it is typically the preferred option for clinical settings. Molecular tests are also used as a reference for identifying active infections, and for testing symptomatic people. […] When speed and scale is a priority, rapid antigen testing is the standard. Because rapid antigen tests come with an acceptable level of accuracy for symptomatic patients and provide information quickly, they are well suited for screening on a massive scale as well as monitoring of specific population groups. […] Automated, high throughput antigen testing may be a viable alternative to PCR testing as a more affordable and faster method without a loss in performance. […] Antibody testing may become of particular interest as more of the population is vaccinated and people want to understand their immunity. Because we don’t yet know how long vaccine efficacy lasts, antibody testing could see an increase in demand.

• #11 COVID-19 – Wikipedia

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

  COVID19 can provisionally be diagnosed on the basis of symptoms and confirmed using reverse transcription polymerase chain reaction (RT-PCR) or other nucleic acid testing of infected secretions. […] Along with laboratory testing, chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection. […] The standard methods of testing for presence of SARS-CoV-2 are nucleic acid tests, which detects the presence of viral RNA fragments. […] The test is typically done on respiratory samples obtained by a nasopharyngeal swab; however, a nasal swab or sputum sample may also be used. […] Chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection but are not recommended for routine screening. […] Bilateral multilobar ground-glass opacities with a peripheral, asymmetric, and posterior distribution are common in early infection. […] Characteristic imaging features on chest radiographs and computed tomography (CT) of people who are symptomatic include asymmetric peripheral ground-glass opacities without pleural effusions.

• #12 COVID-19 Diagnosis: A Comprehensive Review of the RT-qPCR Method for Detection of SARS-CoV-2

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9221722/

  SARS-CoV-2 enters the human body as respiratory aerosols; samples from the oropharyngeal or nasopharyngeal are primarily used for viral detection. […] Predominantly, there are two types of diagnostic methods in use: the first category is molecular genetics-based (viral test) and the second is serological-based (antibody test). […] The nucleic acid amplification test (NAAT) by RT-qPCR is a sensitive, accurate, and globally accepted gold standard diagnostic method for the SARS-CoV-2 detection. […] In clinical settings, real-time RT-qPCR is a revolutionary advancement where detection and expression analysis of gene(s) can be carried out in real time, as PCR reaction progresses, and amplification and analysis are done simultaneously in a closed system. […] The genetic material of SARS-CoV-2 (RNA) is first converted into complementary DNA (cDNA) by the action of RNA-dependent DNA polymerase (reverse transcriptase) prior to the actual amplification.

• #13 COVID-19 Diagnosis: A Comprehensive Review of the RT-qPCR Method for Detection of SARS-CoV-2

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9221722/

  The RT-qPCR reaction can be performed in either one or two steps. […] In detecting SARS-CoV-2 for COVID-19 diagnosis, this one-step RT-qPCR is preferred over the two-step method owing to it being fast and efficient and involving limited sample handling, minimal experimental errors, and a reduced bench time. […] The correlation between Ct value and viral load may be a useful tool for comparison purposes of certain populations including symptomatic and asymptomatic populations. […] Despite wide acceptance and use of the real-time PCR (qPCR) method as a gold standard molecular test of choice with high specificity and accuracy, it has limitations. […] The first step in containing SARS-CoV-2 is the detection of infected persons and appropriate isolation and treatment.

• #14 What tests could potentially be used for the screening, diagnosis and monitoring of COVID-19 and what are their advantages and disadvantages?  | The Centre for Evidence-Based Medicine

  https://www.cebm.net/covid-19/what-tests-could-potentially-be-used-for-the-screening-diagnosis-and-monitoring-of-covid-19-and-what-are-their-advantages-and-disadvantages/

  Many diagnostic tests for coronavirus disease 2019 (COVID-19) are available so far, with more gaining emergency approval every day. These tests are largely based on four different techniques, 1) reverse transcription polymerase chain reaction (RT-PCR) the current standard test for COVID-19, 2) loop-mediated isothermal amplification (LAMP) a simple, but less developed testing method, 3) lateral flow hand-held single-use assays providing results for an individual patient in as short as 15 minutes, and 4) enzyme-linked immunosorbent assay (ELISA) quick and technically simple assays that are easily read and offer relatively high throughput. […] A range of molecular techniques ranging from central laboratory testing to point-of-care tests are under development or already available for the diagnosis and management of COVID-19 patients.

• #15

  https://link.springer.com/article/10.1007/s13206-022-00078-9

  Although RT-qPCR is the gold standard possessing high sensitivity, specificity, and accuracy, it is labor-intensive and relies on expensive instrumentation. […] As an alternative to traditional RT-qPCR, a novel LFA was developed for the simultaneous detection of SARS-CoV-2 genes, RdRp, ORF3a, and N genes. […] Isothermal nucleic acid amplification is an alternative strategy that allows amplification at a constant temperature and eliminates the need for heavy equipment, such as thermocyclers. […] Therefore, integrating this technique into an LFA contributes to achieving POC tests for SARS-CoV-2 RNA detection. […] The CRISPR/Cas9 system is widely recognized as an adaptive immune defense system that can resist foreign genetic material in most prokaryotes. […] Broughton et al. developed a rapid (40 min), easy-to-implement, and accurate CRISPR-Cas12-based lateral flow assay to detect SARS-CoV-2, called SARS-CoV-2 DNA endonuclease-targeted CRISPR trans reporter (DETECTR).

• #16

  https://link.springer.com/article/10.1007/s13206-022-00078-9

  Although RT-qPCR is the gold standard possessing high sensitivity, specificity, and accuracy, it is labor-intensive and relies on expensive instrumentation. […] As an alternative to traditional RT-qPCR, a novel LFA was developed for the simultaneous detection of SARS-CoV-2 genes, RdRp, ORF3a, and N genes. […] Isothermal nucleic acid amplification is an alternative strategy that allows amplification at a constant temperature and eliminates the need for heavy equipment, such as thermocyclers. […] Therefore, integrating this technique into an LFA contributes to achieving POC tests for SARS-CoV-2 RNA detection. […] The CRISPR/Cas9 system is widely recognized as an adaptive immune defense system that can resist foreign genetic material in most prokaryotes. […] Broughton et al. developed a rapid (40 min), easy-to-implement, and accurate CRISPR-Cas12-based lateral flow assay to detect SARS-CoV-2, called SARS-CoV-2 DNA endonuclease-targeted CRISPR trans reporter (DETECTR).

• #17

  https://link.springer.com/article/10.1007/s40291-020-00492-5

  Point-of-care (POC) testing has great potential for widespread diagnosis of COVID-19 because of its rapidity, low cost, and easy distribution. Currently, the most common techniques involve reverse transcriptase PCR (RT-PCR), but many recent POC approaches involve using loop-mediated isothermal amplification (LAMP). Other nucleic acid-based tests, such as those involving digital droplet PCR and nanoparticle-based DNA amplification, are also being examined because of their superior limit of detection (LOD), sensitivity, and specificity. Antibody tests for immunoglobulin G and M also exist, using lateral flow assays for a POC approach. Lab-on-a-chip (LOC) and microfluidic devices show particular promise. […] The use of various biological fluids has been proposed to test for COVID-19. Perhaps the most prominent of these is saliva, which has been shown to contain SARS-CoV-2 RNA. SARS-CoV-2 has also been detected in blood and fecal samples, whereas several studies have shown it is not detectable in urine. There is potential for diagnostic tests to use any of these fluids that contain SARS-CoV-2, and development of these tests could allow for cross-verification between assays to ensure patients are diagnosed correctly.

• #18 The Role of Antigen Rapid Diagnostic Test in COVID-19 Diagnosis

  https://opencovidjournal.com/VOLUME/1/PAGE/108/FULLTEXT/

  Since the emergence of a novel infection due to the SARS-CoV-2 virus (COVID-19), the World Health Organization has urged countries to develop diagnostic tests to combat the pandemic. […] Reverse transcription-quantitative PCR (RT-qPCR) is taken as the gold standard for the diagnosis of COVID-19. However, due to its limitations, highly sensitive methods for detecting antigens (antigen rapid diagnostic tests) have been developed that would help in a timely and accurate diagnosis. Antigen rapid diagnostic tests (Ag-RDTs) can help guide patient management at the point of care by random screening, re-testing, and timely decision-making in the field of public health. […] This led to the need for highly sensitive immunological diagnostic methods, which detect on-site viral antigens in clinical specimens that would help in early and accurate diagnosis of COVID-19.

• #19 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  Diagnostics have proven to be crucial to the COVID-19 pandemic response. There are three major methods for the detection of SARS-CoV-2 infection and their role has evolved during the course of the pandemic. Molecular tests such as PCR are highly sensitive and specific at detecting viral RNA, and are recommended by WHO for confirming diagnosis in individuals who are symptomatic and for activating public health measures. Antigen rapid detection tests detect viral proteins and, although they are less sensitive than molecular tests, have the advantages of being easier to do, giving a faster time to result, of being lower cost, and able to detect infection in those who are most likely to be at risk of transmitting the virus to others. Antigen rapid detection tests can be used as a public health tool for screening individuals at enhanced risk of infection, to protect people who are clinically vulnerable, to ensure safe travel and the resumption of schooling and social activities, and to enable economic recovery. With vaccine roll-out, antibody tests (which detect the host’s response to infection or vaccination) can be useful surveillance tools to inform public policy, but should not be used to provide proof of immunity, as the correlates of protection remain unclear. All three types of COVID-19 test continue to have a crucial role in the transition from pandemic response to pandemic control.

• #20

  https://link.springer.com/article/10.1007/s13206-022-00078-9

  Paper-based analytical devices show great potential in delivering POC diagnostic systems to the developing world because of their remarkable properties such as biocompatibility, porosity, ease of modification, flexibility, chemical inertness, eco-friendliness, and ease of storage and transportation. […] Paper-based POC tests have also played a crucial role in the current COVID-19 pandemic. […] The technology that can best meet the strong demand for practical POC diagnostic tests in COVID-19 control is paper-based POC testing. […] Antigen-based diagnosis is based on immunoassay reactions that involve antigens and antibodies. […] All proteins constituting SARS-CoV-2 can be targeted to diagnose COVID-19, but antigen tests for COVID-19 have been developed mainly targeting the S and N proteins.

• #21 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. […] Viral tests look for a current infection with SARS-CoV-2, the virus that causes COVID-19, by testing specimens from your nose or mouth. […] Nucleic acid amplification tests (NAATs), including PCR tests, are more likely to detect the virus than antigen tests. NAATs tests are the gold standard for COVID-19 tests. […] 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.

• #22 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  Diagnostics have proven to be crucial to the COVID-19 pandemic response. There are three major methods for the detection of SARS-CoV-2 infection and their role has evolved during the course of the pandemic. Molecular tests such as PCR are highly sensitive and specific at detecting viral RNA, and are recommended by WHO for confirming diagnosis in individuals who are symptomatic and for activating public health measures. Antigen rapid detection tests detect viral proteins and, although they are less sensitive than molecular tests, have the advantages of being easier to do, giving a faster time to result, of being lower cost, and able to detect infection in those who are most likely to be at risk of transmitting the virus to others. Antigen rapid detection tests can be used as a public health tool for screening individuals at enhanced risk of infection, to protect people who are clinically vulnerable, to ensure safe travel and the resumption of schooling and social activities, and to enable economic recovery. With vaccine roll-out, antibody tests (which detect the host’s response to infection or vaccination) can be useful surveillance tools to inform public policy, but should not be used to provide proof of immunity, as the correlates of protection remain unclear. All three types of COVID-19 test continue to have a crucial role in the transition from pandemic response to pandemic control.

• #23 What’s New

  https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/CDPH-Guidance-on-the-Use-of-Antigen-Tests-for-Diagnosis-of-Acute-COVID-19.aspx

  Antigen tests directly detect fragments of SARS-CoV-2 viral protein (as opposed to viral RNA detected by nucleic acid amplification tests [NAAT aka PCR tests]). […] The main advantages of antigen tests are fast turnaround time, simple to perform point-of-care use, identification of current viral infection, and lower cost. […] The main drawbacks are lower sensitivity (more false negatives) and intended use limited to individuals suspected of COVID-19 within 5-12 days of symptom onset (number of days varies by manufacturer). […] Positive results in symptomatic individuals are likely to reflect an active infection, but negative tests are presumptive negative and depending on level of clinical concern may need to be confirmed with a NAAT/PCR. […] A negative antigen test may not exclude infection and is of insufficient sensitivity to make decisions about discontinuing isolation.

• #24 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. […] Viral tests look for a current infection with SARS-CoV-2, the virus that causes COVID-19, by testing specimens from your nose or mouth. […] Nucleic acid amplification tests (NAATs), including PCR tests, are more likely to detect the virus than antigen tests. NAATs tests are the gold standard for COVID-19 tests. […] 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.

• #25 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. […] Viral tests look for a current infection with SARS-CoV-2, the virus that causes COVID-19, by testing specimens from your nose or mouth. […] Nucleic acid amplification tests (NAATs), including PCR tests, are more likely to detect the virus than antigen tests. NAATs tests are the gold standard for COVID-19 tests. […] 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.

• #26 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  Diagnostics have proven to be crucial to the COVID-19 pandemic response. There are three major methods for the detection of SARS-CoV-2 infection and their role has evolved during the course of the pandemic. Molecular tests such as PCR are highly sensitive and specific at detecting viral RNA, and are recommended by WHO for confirming diagnosis in individuals who are symptomatic and for activating public health measures. Antigen rapid detection tests detect viral proteins and, although they are less sensitive than molecular tests, have the advantages of being easier to do, giving a faster time to result, of being lower cost, and able to detect infection in those who are most likely to be at risk of transmitting the virus to others. Antigen rapid detection tests can be used as a public health tool for screening individuals at enhanced risk of infection, to protect people who are clinically vulnerable, to ensure safe travel and the resumption of schooling and social activities, and to enable economic recovery. With vaccine roll-out, antibody tests (which detect the host’s response to infection or vaccination) can be useful surveillance tools to inform public policy, but should not be used to provide proof of immunity, as the correlates of protection remain unclear. All three types of COVID-19 test continue to have a crucial role in the transition from pandemic response to pandemic control.

• #27 The Role of Antigen Rapid Diagnostic Test in COVID-19 Diagnosis

  https://opencovidjournal.com/VOLUME/1/PAGE/108/FULLTEXT/

  Ag-RDTs diagnose SARS-CoV-2 active infection by the detection of viral proteins in different types of specimens. […] Even though these rapid tests are very specific, they are not as sensitive as molecular assays. […] Despite having lesser sensitivity than molecular tests, Ag-RDT appears beneficial in guiding patient management at the point of care and also for random screening or re-testing; this helps in making timely public health decisions in order to curb the transmission of the virus. […] Nevertheless, Ag-RDTs can play a complementary role in the response and case management of COVID-19. […] To ensure proper patient management and public health action, countries need to maintain a balance between benefits and risk outcomes of rapid Ag-RDT. […] More research is needed to better understand the validity of rapid Ag-RDTs in various settings and to know how often and when to use these tests. This would support testing strategies and health policies and would disrupt the transmission of disease. However, antigen rapid diagnostic tests can play a supporting role in the management of the COVID-19 pandemic.

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

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

  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. A single NAAT test can be used to confirm an antigen test result. […] After a positive test result, you may continue to test positive for some time. Some tests, especially NAAT tests, may continue to show a positive result for up to 90 days. […] Reinfections can occur within 90 days, which can make it hard to know if a positive test indicates a new infection. […] A positive COVID-19 test means the virus was detected and you have or recently had an infection. […] 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.

• #29 Coronavirus disease 2019 (COVID-19) – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/coronavirus/diagnosis-treatment/drc-20479976

  Antigen tests. These tests look for viral proteins called antigens. […] Antigen tests are reliable and accurate, but they are less accurate than PCR tests. This is especially true if you don’t have symptoms. […] If you have a positive COVID-19 PCR or antigen test, you almost certainly have COVID-19. Another test isn’t needed. […] If you get a negative PCR test, you most likely do not have COVID-19. […] If you have a negative antigen test, the FDA recommends that you repeat an antigen test two days after the first test. With or without symptoms, repeating the test helps get the correct diagnosis. […] If you test positive, call a healthcare professional immediately to find out what options are available.

• #30 COVID-19 Test Basics | FDA

  https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics

  COVID-19 testing plays a critical role in the fight against the virus. Understanding COVID-19 tests, including the different types of tests and their uses, and the types of samples the tests use, is key to making an informed decision that meets your needs. […] There are different types of COVID-19 tests diagnostic tests and antibody tests. […] Diagnostic tests can show if you currently are infected with SARS-CoV-2, the virus that causes COVID-19. There are two common types of COVID-19 diagnostic tests: […] Samples for COVID-19 diagnostic tests are typically collected using an anterior nares (nasal) swab sample. […] Depending on the intended use, COVID-19 diagnostic tests can be performed at a laboratory, a standalone testing site, a doctors office or health clinic, or at home. […] Be aware that COVID-19 diagnostic tests are authorized for specific uses and that laboratory-based molecular COVID-19 tests, are generally more accurate than at-home tests.

• #31 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  For symptomatic individuals suspected of having COVID-19, the IDSA panel suggests collecting and testing swab specimens from either the nasopharynx, anterior nares, oropharynx, or mid-turbinate (MT) regions; saliva, or mouth gargle (conditional recommendation, low certainty evidence). […] The IDSA panel suggests that for symptomatic individuals suspected of having COVID-19, anterior nasal (AN) and MT swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or healthcare providers (conditional recommendation, moderate certainty evidence). […] The IDSA panel suggests using either rapid or standard laboratory-based NAATs in symptomatic individuals suspected of having COVID-19 (conditional recommendation, moderate certainty of evidence). […] The IDSA panel suggests performing a single NAAT and not repeating testing routinely in symptomatic or asymptomatic individuals suspected of having COVID-19 whose initial NAAT result is negative (conditional recommendation, very low certainty of evidence).

• #32 Coronavirus disease 2019 (COVID-19) – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/coronavirus/diagnosis-treatment/drc-20479976

  Here are some guidelines for when to take a COVID-19 test: If you have COVID-19 symptoms, test for the illness right away. If you were exposed to the COVID-19 virus but don’t have symptoms, wait at least five days after exposure then test. If you have symptoms and tested positive for COVID-19 within the last 30 days, you can test again. But if you were just exposed to the coronavirus and don’t have symptoms, you don’t need to test. […] COVID-19 tests use a sample taken from your nose or throat, or a sample of saliva. […] Two types of tests can help diagnose COVID-19. […] Molecular tests. These tests look for genetic material from the COVID-19 virus. Polymerase chain reaction tests, shortened to PCR tests, are molecular tests. […] PCR tests are more accurate than the other type of COVID-19 test, called an antigen test.

• #33 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  For symptomatic individuals suspected of having COVID-19, the IDSA panel suggests collecting and testing swab specimens from either the nasopharynx, anterior nares, oropharynx, or mid-turbinate (MT) regions; saliva, or mouth gargle (conditional recommendation, low certainty evidence). […] The IDSA panel suggests that for symptomatic individuals suspected of having COVID-19, anterior nasal (AN) and MT swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or healthcare providers (conditional recommendation, moderate certainty evidence). […] The IDSA panel suggests using either rapid or standard laboratory-based NAATs in symptomatic individuals suspected of having COVID-19 (conditional recommendation, moderate certainty of evidence). […] The IDSA panel suggests performing a single NAAT and not repeating testing routinely in symptomatic or asymptomatic individuals suspected of having COVID-19 whose initial NAAT result is negative (conditional recommendation, very low certainty of evidence).

• #34 COVID-19 Testing and Diagnosis | American Lung Association

  https://www.lung.org/lung-health-diseases/lung-disease-lookup/covid-19/covid-19-testing

  There are two kinds of tests available to diagnose COVID-19: tests for current infection (viral tests) and tests for past infection (antibody tests). […] COVID-19 tests are widely available at pharmacies nationwide. […] Viral tests look for a current COVID-19 infection. They use respiratory samples, such as a swab from inside your nose or saliva from your mouth, to determine if you are currently infected with SARS-CoV-2, the virus that causes COVID-19. […] If you think you are exhibiting symptoms of COVID-19, get tested right away. […] You should get tested for COVID-19 if you: Are experiencing symptoms of COVID-19, test right away. […] Antibody tests are performed by drawing blood and conducting a laboratory test to check for antibodies that would only be present if you had a past infection of SARS-CoV-2, the virus that causes COVID-19. An antibody test should not be used to determine current infection as it can take your body one to three weeks after infection to make antibodies. […] Results from your antibody test will be positive if you were previously infected with COVID-19 and negative if you have not been previously infected.

• #35 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Antibody (or serology) tests are used to test for the presence of antibodies from previous infection or vaccination and can aid in fulfilling the case definition for multisystem inflammatory syndrome in children (MIS-C) and adults (MIS-A). Antibody testing does not diagnose current infection. […] Antibody testing can be used in the diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) or Multisystem Inflammatory Syndrome in Adults (MIS-A).

• #36 IDSA Guidelines on the Diagnosis of COVID-19: Serologic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-serology/

  To seek evidence for prior SARS-CoV-2 infection, the panel suggests testing for IgG, IgG/IgM, or total antibodies to nucleocapsid protein three to five weeks after symptom onset (conditional recommendation, low certainty of evidence). In individuals with previous SARS-CoV-2 infection or vaccination, we suggest against routine serologic testing given no demonstrated benefit to improving patient outcomes (conditional recommendation, very low certainty of evidence.) […] The high seroprevalence of antibodies against SARS-CoV-2 worldwide limits the utility of detecting anti-SARS CoV-2 antibody. The certainty of available evidence supporting the use of serology for diagnosis was graded as very low to low. […] The current IDSA guideline includes two new recommendations. The first is a weak recommendation to use serologic assays that target nucleocapsid protein rather than spike protein when evidence of prior COVID-19 is desired.

• #37 COVID-19 Test Basics | FDA

  https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics

  To increase the accuracy of an at-home COVID-19 antigen diagnostic test, it is important to perform repeat testing, after 48 hours, following a negative test result, whether you have symptoms or not, to reduce your risk of a false negative test result. […] Antibody (or serology) tests look for antibodies in your blood that your immune system produced in response to SARS-CoV-2, the virus that causes COVID-19. Antibody tests should not be used to diagnose a current SARS-CoV-2 infection or COVID-19 and, at this time, should also not be used to check for immunity. […] Samples for antibody tests are typically collected by a doctor or other medical professional by taking blood from a finger stick or your vein.

• #38

  https://link.springer.com/article/10.1007/s13206-022-00078-9

  IgM antibodies can mainly be used for the early detection of SARS-CoV-2 infection, whereas IgG antibodies may be more appropriately used to identify past infections. […] Although various paper-based antigen diagnostic tests have been developed, the sensitivity of the rapid antigen test is unclear and is lower than that of RT-qPCR. […] Several studies have been conducted to overcome these limitations. […] The configuration of the serological LFA platforms for detecting IgM and IgG antibodies is shown in Fig. 2b. […] IgM antibodies first appear in the serum a few days after infection and become detectable approximately 5-10 days after symptom onset. […] IgM antibodies are present in serum for several weeks, followed by IgG production. […] Efforts to improve the performance of lateral flow immunochromatographic assay (LFIA) for simultaneous detection of SARS-CoV-2-specific antibodies have increased.

• #39 IDSA Guidelines on the Diagnosis of COVID-19: Serologic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-serology/

  IDSA has released Version 2.0 of the Diagnosis of COVID-19: Serologic Testing guidelines. Key recommendations advise against early serologic testing, discourage routine testing for those previously infected or vaccinated, and suggest specific antibody tests three to five weeks after symptom onset. […] The panel recommends against serologic testing to diagnose SARS-CoV-2 infection in the first two weeks after symptom onset (strong recommendations, low certainty of evidence). Serologic testing should not be used to provide evidence of COVID-19 in symptomatic patients with a high clinical suspicion and repeatedly negative nucleic acid amplification test results (strong recommendation, very low certainty of evidence). Serologic testing may assist with the diagnosis of multisystem inflammatory syndrome in children (strong recommendation, very low certainty of evidence).

• #40 IDSA Guidelines on the Diagnosis of COVID-19: Serologic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-serology/

  The second new recommendation suggests against routine serologic testing in patients with previous SARS-CoV-2 infection or vaccination, given that no demonstrated benefits for improving patient outcomes were identified. […] Summarized below are specific recommendations and comments related to the use of SARS-CoV-2 serologic testing in clinical practice. […] The IDSA panel recommends against using serologic testing to diagnose SARS-CoV-2 infection during the first two weeks following symptom onset (strong recommendation, low certainty of evidence). […] The IDSA panel recommends against using IgG antibodies to provide evidence of COVID-19 in symptomatic patients with a high clinical suspicion and repeatedly negative NAAT (strong recommendation, very low certainty of evidence). […] To assist with the diagnosis of multisystem inflammatory syndrome in children (MIS-C), the IDSA panel recommends using both IgG antibody testing and NAAT to provide evidence of current or recent past COVID-19 (strong recommendation, very low certainty of evidence).

• #41 Coronavirus Disease 2019 (COVID-19) and Diagnostic Error | PSNet

  https://psnet.ahrq.gov/primer/coronavirus-disease-2019-covid-19-and-diagnostic-error

  Routine serologic testing is not recommended to assess for immunity in either unvaccinated persons or persons who have received currently available COVID-19 vaccines because a positive antibody test for spike protein IgM/IgG may not differentiate previous infection from the anticipated effect of vaccination.

• #42 IDSA Guidelines on the Diagnosis of COVID-19: Serologic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-serology/

  To seek evidence for prior SARS-CoV-2 infection, the panel suggests testing for IgG, IgG/IgM, or total antibodies to nucleocapsid protein three to five weeks after symptom onset (conditional recommendation, low certainty of evidence). In individuals with previous SARS-CoV-2 infection or vaccination, we suggest against routine serologic testing given no demonstrated benefit to improving patient outcomes (conditional recommendation, very low certainty of evidence.) […] The high seroprevalence of antibodies against SARS-CoV-2 worldwide limits the utility of detecting anti-SARS CoV-2 antibody. The certainty of available evidence supporting the use of serology for diagnosis was graded as very low to low. […] The current IDSA guideline includes two new recommendations. The first is a weak recommendation to use serologic assays that target nucleocapsid protein rather than spike protein when evidence of prior COVID-19 is desired.

• #43 IDSA Guidelines on the Diagnosis of COVID-19: Serologic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-serology/

  The second new recommendation suggests against routine serologic testing in patients with previous SARS-CoV-2 infection or vaccination, given that no demonstrated benefits for improving patient outcomes were identified. […] Summarized below are specific recommendations and comments related to the use of SARS-CoV-2 serologic testing in clinical practice. […] The IDSA panel recommends against using serologic testing to diagnose SARS-CoV-2 infection during the first two weeks following symptom onset (strong recommendation, low certainty of evidence). […] The IDSA panel recommends against using IgG antibodies to provide evidence of COVID-19 in symptomatic patients with a high clinical suspicion and repeatedly negative NAAT (strong recommendation, very low certainty of evidence). […] To assist with the diagnosis of multisystem inflammatory syndrome in children (MIS-C), the IDSA panel recommends using both IgG antibody testing and NAAT to provide evidence of current or recent past COVID-19 (strong recommendation, very low certainty of evidence).

• #44 Coronavirus Disease 2019 (COVID-19) and Diagnostic Error | PSNet

  https://psnet.ahrq.gov/primer/coronavirus-disease-2019-covid-19-and-diagnostic-error

  Routine serologic testing is not recommended to assess for immunity in either unvaccinated persons or persons who have received currently available COVID-19 vaccines because a positive antibody test for spike protein IgM/IgG may not differentiate previous infection from the anticipated effect of vaccination.

• #45 Coronavirus disease 2019 (COVID-19) – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/coronavirus/diagnosis-treatment/drc-20479976

  Antigen tests. These tests look for viral proteins called antigens. […] Antigen tests are reliable and accurate, but they are less accurate than PCR tests. This is especially true if you don’t have symptoms. […] If you have a positive COVID-19 PCR or antigen test, you almost certainly have COVID-19. Another test isn’t needed. […] If you get a negative PCR test, you most likely do not have COVID-19. […] If you have a negative antigen test, the FDA recommends that you repeat an antigen test two days after the first test. With or without symptoms, repeating the test helps get the correct diagnosis. […] If you test positive, call a healthcare professional immediately to find out what options are available.

• #46 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Viral tests, including nucleic acid amplification tests (NAATs) and PCR tests, as well as antigen tests, are used as diagnostic tests to detect current infection with SARS-CoV-2, determine the need for prevention measures, and inform a person’s medical care. […] Positive viral test results indicate current infection and the person with COVID-19 should take steps to prevent spreading COVID-19 to others. […] Negative viral test results mean the test did not detect the virus, but this doesn’t rule out that the person could have an infection. […] Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. […] A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT.

• #47 Understanding COVID-19 PCR Testing

  https://www.genome.gov/about-genomics/fact-sheets/Understanding-COVID-19-PCR-Testing

  Beginning with the Human Genome Project 30 years ago, NHGRI has supported research that reduced the cost and increased the speed of genetic and genomic sequencing, enabling the rapid pivot towards COVID-19 research and development. […] COVID-19 PCR tests use primers that match a segment of the viruss genetic material. This allows many copies of that material to be made, which can be used to detect whether or not the virus is present. […] A positive COVID-19 PCR test means that SARS-CoV-2 is present. A negative result could either mean that the sample did not contain any virus or that there is too little viral genetic material in the sample to be detected. […] COVID-19 testing uses a modified version of PCR called quantitative polymerase chain reaction (qPCR). This method adds fluorescent dyes to the PCR process to measure the amount of genetic material in a sample. In this instance, healthcare workers measure the amount of genetic material from SARS-CoV-2.

• #48 COVID-19 diagnostic testing – Mayo Clinic

  https://www.mayoclinic.org/tests-procedures/covid-19-diagnostic-test/about/pac-20488900

  Don’t use at-home COVID-19 tests that the FDA has not cleared for use. […] Your COVID-19 diagnostic test result could be positive or negative. […] Positive test results most often are correct, even if you have no symptoms. […] Negative result means that you likely don’t have an infection with the COVID-19 virus. But you may have a false-negative test result.

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

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

  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. A single NAAT test can be used to confirm an antigen test result. […] After a positive test result, you may continue to test positive for some time. Some tests, especially NAAT tests, may continue to show a positive result for up to 90 days. […] Reinfections can occur within 90 days, which can make it hard to know if a positive test indicates a new infection. […] A positive COVID-19 test means the virus was detected and you have or recently had an infection. […] 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.

• #50 COVID-19 diagnostic testing – Mayo Clinic

  https://www.mayoclinic.org/tests-procedures/covid-19-diagnostic-test/about/pac-20488900

  COVID-19 diagnostic testing shows current infection with the virus that causes coronavirus disease 2019 (COVID-19). The U.S. Food and Drug Administration (FDA) approved the following types of tests for diagnosing COVID-19. […] PCR tests are more accurate than the other type of COVID-19 test, called an antigen test. […] Antigen tests are accurate, but they are less accurate than PCR tests. […] A COVID-19 diagnostic test can have a false-negative result. This means that the test didn’t show you have the virus even though you do. […] The FDA requires that rapid antigen diagnostic tests catch at least 80% of infections. […] Rarely, COVID-19 rapid antigen tests can give false-positive results. […] False-positive results mean the test results show that you have the virus when you don’t.

• #51 Understanding COVID-19 PCR Testing

  https://www.genome.gov/about-genomics/fact-sheets/Understanding-COVID-19-PCR-Testing

  A positive result happens when the SARS-CoV-2 primers match the DNA in the sample and the sequence is amplified, creating millions of copies. This means the sample is from an infected individual. […] A negative result happens when the SARS-CoV-2 primers do not match the genetic material in the sample and there is no amplification. This means the sample did not contain any virus. […] A false negative result happens when a person is infected, but there is not enough viral genetic material in the sample for the PCR test to detect it. This can happen early after a person is exposed. Overall, false negative results are much more likely than false positive results.

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

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

  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. A single NAAT test can be used to confirm an antigen test result. […] After a positive test result, you may continue to test positive for some time. Some tests, especially NAAT tests, may continue to show a positive result for up to 90 days. […] Reinfections can occur within 90 days, which can make it hard to know if a positive test indicates a new infection. […] A positive COVID-19 test means the virus was detected and you have or recently had an infection. […] 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.

• #53 COVID-19 Testing and Diagnosis | American Lung Association

  https://www.lung.org/lung-health-diseases/lung-disease-lookup/covid-19/covid-19-testing

  There are two kinds of tests available to diagnose COVID-19: tests for current infection (viral tests) and tests for past infection (antibody tests). […] COVID-19 tests are widely available at pharmacies nationwide. […] Viral tests look for a current COVID-19 infection. They use respiratory samples, such as a swab from inside your nose or saliva from your mouth, to determine if you are currently infected with SARS-CoV-2, the virus that causes COVID-19. […] If you think you are exhibiting symptoms of COVID-19, get tested right away. […] You should get tested for COVID-19 if you: Are experiencing symptoms of COVID-19, test right away. […] Antibody tests are performed by drawing blood and conducting a laboratory test to check for antibodies that would only be present if you had a past infection of SARS-CoV-2, the virus that causes COVID-19. An antibody test should not be used to determine current infection as it can take your body one to three weeks after infection to make antibodies. […] Results from your antibody test will be positive if you were previously infected with COVID-19 and negative if you have not been previously infected.

• #54 What tests could potentially be used for the screening, diagnosis and monitoring of COVID-19 and what are their advantages and disadvantages?  | The Centre for Evidence-Based Medicine

  https://www.cebm.net/covid-19/what-tests-could-potentially-be-used-for-the-screening-diagnosis-and-monitoring-of-covid-19-and-what-are-their-advantages-and-disadvantages/

  Antibody tests provide a hugely important ability to detect past infection with virus to identify people who were asymptomatic, people who have cleared the virus and so no longer risk being infected or spreading the virus to others. […] ELISA tests to detect antibodies are detecting the antibody response to COVID-19 infection. […] A negative result (no colour change) would mean that the patient has not been infected with COVID-19 and may have no immunity against it. […] ELISA antigen tests may be developed in the future to detect current infections. Such an antigen test using ELISA would show a positive result (colour change) if a patient has COVID-19 in their blood. […] Four main types of tests are being used or being developed to test for SARS-CoV-2, the virus causing COVID-19. […] Each test type has its own distinct advantages and disadvantages inherent to the underlying technology.

• #55 What tests could potentially be used for the screening, diagnosis and monitoring of COVID-19 and what are their advantages and disadvantages?  | The Centre for Evidence-Based Medicine

  https://www.cebm.net/covid-19/what-tests-could-potentially-be-used-for-the-screening-diagnosis-and-monitoring-of-covid-19-and-what-are-their-advantages-and-disadvantages/

  Antibody tests provide a hugely important ability to detect past infection with virus to identify people who were asymptomatic, people who have cleared the virus and so no longer risk being infected or spreading the virus to others. […] ELISA tests to detect antibodies are detecting the antibody response to COVID-19 infection. […] A negative result (no colour change) would mean that the patient has not been infected with COVID-19 and may have no immunity against it. […] ELISA antigen tests may be developed in the future to detect current infections. Such an antigen test using ELISA would show a positive result (colour change) if a patient has COVID-19 in their blood. […] Four main types of tests are being used or being developed to test for SARS-CoV-2, the virus causing COVID-19. […] Each test type has its own distinct advantages and disadvantages inherent to the underlying technology.

• #56 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  Early recognition and rapid diagnosis are essential to prevent transmission and provide supportive care in a timely manner. Have a high index of clinical suspicion for COVID-19 in all patients who present with fever and/or acute respiratory illness; however, be aware that some patients may not present with signs or symptoms of a febrile respiratory illness. […] COVID-19 is a notifiable disease. Report all suspected or confirmed cases to your local health authorities. […] Isolate all suspected or confirmed cases immediately. Triage patients with a standardized triage tool and evaluate the severity of disease. Follow local infection prevention and control guidelines. […] Suspect the diagnosis in patients with the following signs/symptoms: a new continuous cough, fever, altered sense of taste or smell, sore throat, fatigue, headache, dyspnea, myalgia, arthralgia, rhinorrhea, nasal congestion, sneezing, malaise, expectoration, or chest tightness/pain, particularly if the person has been in contact with a suspected or confirmed case.

• #57 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  Order a real-time reverse transcription polymerase chain reaction (RT-PCR) to confirm the diagnosis. Upper and lower respiratory specimens are preferred. […] Order the following laboratory investigations in hospitalized patients: complete blood count, comprehensive metabolic panel, arterial blood gas, thyroid function tests, blood glucose level, coagulation screen, inflammatory markers, cardiac biomarkers, serum creatine kinase, and blood and sputum cultures for other pathogens. […] Prioritize a chest x-ray in patients who are seriously ill with suspected pneumonia. Consider a computed tomography (CT) scan of the chest if chest x-ray is uncertain or normal. […] COVID-19 care pathways should be established at local, regional, and national levels for people with suspected or confirmed COVID-19.

• #58 COVID-19 Diagnosis: A Comprehensive Review of the RT-qPCR Method for Detection of SARS-CoV-2

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9221722/

  The world is grappling with the coronavirus disease 2019 (COVID-19) pandemic, the causative agent of which is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). […] This review attempts to encapsulate the current knowledge of the viral pathophysiology with disease diagnosis and to critically analyze the reverse transcriptase-polymerase chain reaction (RT-qPCR) technique, one of the gold standards for the detection of SARS-CoV-2 infection. […] Identifying infected individuals and asymptomatic viral carriers with rapid and accurate testing has played a pivotal role in containing and mitigating the COVID-19 pandemic. […] The primary steps for COVID-19 diagnosis are examining the presence of classical signs and symptoms such as fever or chills, cough, shortness of breath, muscle or body aches, headache, fatigue, sore throat, the new loss of taste or smell, dyspnoea, congestion, or runny nose, nausea or vomiting, conjunctivitis, and gastrointestinal issues.

• #59 COVID-19 Symptoms, Diagnosis, & Treatment | UPMC

  https://www.upmc.com/services/division-infectious-diseases/conditions/coronavirus/what-is-covid-19

  COVID-19 symptoms can start anytime from 2 to 14 days after exposure to SARS-CoV-2. They’re similar to symptoms of a cold or flu and may include: […] Because COVID-19 symptoms are similar to other respiratory diseases, lab tests are necessary to confirm a COVID-19 diagnosis. […] If you think you have symptoms of COVID-19 or have been exposed to someone with COVID-19, call your doctor or use UPMC AnywhereCare. They can arrange testing for you.

• #60 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  Diagnostic tests are useful to confirm the clinical diagnosis in patients presenting with symptoms consistent with COVID-19, regardless of their vaccination status. Infected individuals can present with mild to severe symptoms of the infection, such as fever or chills, a persistent cough, shortness of breath, and headaches, and these symptoms typically occur 2-14 days after initial exposure. […] Given the high sensitivity and high specificity of molecular tests, false-positive or false-negative test results are rare. A positive result confirms the diagnosis and should trigger patient management procedures and public health measures such as self-isolation and contact tracing. Although studies have shown that a positive molecular test cannot be interpreted to mean that the patient is infectious, public health measures should be carried out nevertheless.

• #61 COVID-19 Symptoms, Diagnosis, & Treatment | UPMC

  https://www.upmc.com/services/division-infectious-diseases/conditions/coronavirus/what-is-covid-19

  COVID-19 symptoms can start anytime from 2 to 14 days after exposure to SARS-CoV-2. They’re similar to symptoms of a cold or flu and may include: […] Because COVID-19 symptoms are similar to other respiratory diseases, lab tests are necessary to confirm a COVID-19 diagnosis. […] If you think you have symptoms of COVID-19 or have been exposed to someone with COVID-19, call your doctor or use UPMC AnywhereCare. They can arrange testing for you.

• #62 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  No single sign or symptom can accurately diagnose COVID-19, and neither the absence or presence of specific signs or symptoms are accurate enough to rule in or rule out disease. […] A Cochrane review found that the presence of anosmia and/or ageusia may be useful as a red flag for diagnosis. Cough or fever may also increase the probability of diagnosis to an extent that is clinically relevant and should prompt further testing. […] The diagnostic accuracy of molecular tests and rapid antigen tests does not appear to be influenced by the Omicron variant. […] Testing strategies vary widely between countries, and you should consult your local public health authority for advice when deciding which test to use. […] The choice of which test to use in which setting requires careful consideration of the purpose of testing and the resources available, while also balancing test characteristics of accuracy, accessibility, affordability, and the rapidity with which results are needed.

• #63 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  Order a real-time reverse transcription polymerase chain reaction (RT-PCR) to confirm the diagnosis. Upper and lower respiratory specimens are preferred. […] Order the following laboratory investigations in hospitalized patients: complete blood count, comprehensive metabolic panel, arterial blood gas, thyroid function tests, blood glucose level, coagulation screen, inflammatory markers, cardiac biomarkers, serum creatine kinase, and blood and sputum cultures for other pathogens. […] Prioritize a chest x-ray in patients who are seriously ill with suspected pneumonia. Consider a computed tomography (CT) scan of the chest if chest x-ray is uncertain or normal. […] COVID-19 care pathways should be established at local, regional, and national levels for people with suspected or confirmed COVID-19.

• #64 Coronavirus Disease 2019 (COVID-19) Workup: Approach Considerations, Laboratory Studies, CT Scanning

  https://emedicine.medscape.com/article/2500114-workup

  Signs and symptoms of coronavirus disease 2019 (COVID-19) may overlap with those of other respiratory infections; therefore, it is important to perform laboratory testing to specifically identify symptomatic individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). […] Three types of tests may be utilized to determine if an individual has been infected with SARS-CoV-2: […] Viral tests (nucleic acid or antigen detection tests) are used to assess acute infection, whereas antibody tests provide evidence of prior infection with SARS-CoV-2. […] The FDA has advised against the use of antibody tests to ascertain immunity or protection from COVID-19, particularly in patients who have been vaccinated against the disease. […] Laboratory findings in patients with COVID-19

• #65 COVID-19 – Wikipedia

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

  COVID19 can provisionally be diagnosed on the basis of symptoms and confirmed using reverse transcription polymerase chain reaction (RT-PCR) or other nucleic acid testing of infected secretions. […] Along with laboratory testing, chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection. […] The standard methods of testing for presence of SARS-CoV-2 are nucleic acid tests, which detects the presence of viral RNA fragments. […] The test is typically done on respiratory samples obtained by a nasopharyngeal swab; however, a nasal swab or sputum sample may also be used. […] Chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection but are not recommended for routine screening. […] Bilateral multilobar ground-glass opacities with a peripheral, asymmetric, and posterior distribution are common in early infection. […] Characteristic imaging features on chest radiographs and computed tomography (CT) of people who are symptomatic include asymmetric peripheral ground-glass opacities without pleural effusions.

• #66 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  Molecular testing is recommended to confirm the diagnosis. […] Antigen testing is recommended in settings likely to have the most impact on early detection of cases for care and contact tracing, and where test results are most likely to be correct. […] Serology cannot be used as a standalone diagnostic test for acute SARS-CoV-2 infections, and should not be used to establish the presence or absence of acute infection. […] Imaging should be used as one element of the diagnostic workup that otherwise includes clinical and laboratory data. […] Chest imaging is considered safe in pregnant women. […] Order a chest x-ray in all patients who are seriously ill (e.g., SpO 94% or NEWS2 score 3) or those who are stable but a chest x-ray is clinically indicated (e.g., suspected pneumonia). […] Typical features include ground-glass opacity and consolidation.

• #67 Coronavirus disease 2019 (COVID-19) – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/coronavirus/diagnosis-treatment/drc-20479976

  If you have symptoms of coronavirus disease 2019, known as COVID-19, or you’ve been exposed to the COVID-19 virus, contact your healthcare team. Let them know if you’ve had close contact with anyone diagnosed with COVID-19. […] In the United States, at-home COVID-19 tests are available. Free tests can be mailed to U.S. addresses, or you can purchase tests in stores, pharmacies or online. The U.S. Food and Drug Administration, also known as the FDA, approves or authorizes the tests. On the FDA website, you can find a list of the tests that are validated and their expiration dates. You also can check with your healthcare professional before buying a test if you have any concerns. […] COVID-19 tests also are available from healthcare professionals, some pharmacies and clinics, or at community testing sites.

• #68 Coronavirus disease 2019 (COVID-19) – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/coronavirus/diagnosis-treatment/drc-20479976

  Here are some guidelines for when to take a COVID-19 test: If you have COVID-19 symptoms, test for the illness right away. If you were exposed to the COVID-19 virus but don’t have symptoms, wait at least five days after exposure then test. If you have symptoms and tested positive for COVID-19 within the last 30 days, you can test again. But if you were just exposed to the coronavirus and don’t have symptoms, you don’t need to test. […] COVID-19 tests use a sample taken from your nose or throat, or a sample of saliva. […] Two types of tests can help diagnose COVID-19. […] Molecular tests. These tests look for genetic material from the COVID-19 virus. Polymerase chain reaction tests, shortened to PCR tests, are molecular tests. […] PCR tests are more accurate than the other type of COVID-19 test, called an antigen test.

• #69 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  Version 3.0 has been released and contains recommendations for SARS-CoV-2 nucleic acid testing based on new systematic reviews of the diagnostic literature. […] Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. […] The IDSA panel agreed on 12 diagnostic recommendations. […] Access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. […] The IDSA panel recommends a SARS-CoV-2 NAAT in symptomatic individuals suspected of having COVID-19 (strong recommendation, moderate certainty evidence).

• #70 Artificial intelligence–enabled rapid diagnosis of patients with COVID-19 | Nature Medicine

  https://www.nature.com/articles/s41591-020-0931-3

  For diagnosis of coronavirus disease 2019 (COVID-19), a SARS-CoV-2 virus-specific reverse transcriptase polymerase chain reaction (RT-PCR) test is routinely used. However, this test can take up to 2d to complete, serial testing may be required to rule out the possibility of false negative results and there is currently a shortage of RT-PCR test kits, underscoring the urgent need for alternative methods for rapid and accurate diagnosis of patients with COVID-19. […] Chest CT is a valuable component in the evaluation of patients with suspected SARS-CoV-2 infection. Nevertheless, CT alone may have limited negative predictive value for ruling out SARS-CoV-2 infection, as some patients may have normal radiological findings at early stages of the disease. […] In this study, we used artificial intelligence (AI) algorithms to integrate chest CT findings with clinical symptoms, exposure history and laboratory testing to rapidly diagnose patients who are positive for COVID-19.

• #71 A simple and fast spectroscopy-based technique for Covid-19 diagnosis | Scientific Reports

  https://www.nature.com/articles/s41598-021-95568-5

  The coronavirus pandemic, which appeared in Wuhan, China, in December 2019, rapidly spread all over the world in only a few weeks. Faster testing techniques requiring less resources are key in managing the pandemic, either to enable larger scale testing or even just provide developing countries with limited resources, particularly in Africa, means to perform tests to manage the crisis. Here, we report an unprecedented, rapid, reagent-free and easy-to-use screening spectroscopic method for the detection of SARS-CoV-2 on RNA extracts. This method, validated on clinical samples collected from 280 patients with quantitative predictive scores on both positive and negative samples, is based on a multivariate analysis of FTIR spectra of RNA extracts. This technique, in agreement with RT-PCR, achieves 97.8% accuracy, 97% sensitivity and 98.3% specificity while reducing the testing time post RNA extraction from hours to minutes. Furthermore, this technique can be used in several laboratories with limited resources.

• #72 COVID-19 Diagnosis: A Review of Rapid Antigen, RT-PCR and Artificial Intelligence Methods

  https://www.mdpi.com/2306-5354/9/4/153

  The findings from the study revealed that the rapid antigen detection kit was 100 times less sensitive than RT-PCR. […] The clinical sensitivity of the rapid antigen detection test for identifying specimens from COVID-19 patients was 68.6%. […] The study reported an accuracy of 87.5% and an AUC of 91%. […] The review concluded that ML could be used for COVID-19 diagnosis, precise and personalised patient treatment, patient behaviour analysis, and future symptoms prediction. […] The study showed that the RF algorithm extracted the features, enabling the predictive model to achieve an accuracy of 96.7%. […] The study reported an accuracy of 87.5% and an AUC of 91%. […] The study concluded that the ML algorithms obtained excellent performance and opened a new dimension in designing and generating peptides with desired targets. […] Overall, a comprehensive review of COVID-19 diagnostic methods has been conducted in this research.

• #73

  https://link.springer.com/article/10.1007/s13206-022-00078-9

  Although RT-qPCR is the gold standard possessing high sensitivity, specificity, and accuracy, it is labor-intensive and relies on expensive instrumentation. […] As an alternative to traditional RT-qPCR, a novel LFA was developed for the simultaneous detection of SARS-CoV-2 genes, RdRp, ORF3a, and N genes. […] Isothermal nucleic acid amplification is an alternative strategy that allows amplification at a constant temperature and eliminates the need for heavy equipment, such as thermocyclers. […] Therefore, integrating this technique into an LFA contributes to achieving POC tests for SARS-CoV-2 RNA detection. […] The CRISPR/Cas9 system is widely recognized as an adaptive immune defense system that can resist foreign genetic material in most prokaryotes. […] Broughton et al. developed a rapid (40 min), easy-to-implement, and accurate CRISPR-Cas12-based lateral flow assay to detect SARS-CoV-2, called SARS-CoV-2 DNA endonuclease-targeted CRISPR trans reporter (DETECTR).

• #74 The importance of Point-of-Need diagnostics for COVID-19 and beyond – Mammoth Biosciences

  https://mammoth.bio/2020/07/07/the-importance-of-point-of-need-diagnostics-for-covid-19-and-beyond/

  Point-of-Need diagnostics rapidly identify the cause of an ailment wherever the patient is. […] Patients and healthcare workers can particularly benefit from Point-of-Need diagnostics when facing the challenges of infectious diseases like COVID-19. […] At Mammoth, were in a development partnership with GSK to develop a Point-of-Need diagnostic device for COVID-19. […] Point-of-Care molecular tests for COVID-19 have already hit the market. […] The wide scale testing afforded by a distributable, portable Point-of-Need diagnostic is particularly necessary for stopping COVID-19. […] We are working to make better Point-of-Need-diagnostics for COVID-19 using our CRISPR-based DETECTRTM platform. […] With a Point-of-Need diagnostic we can more effectively control and halt the COVID-19 pandemic. […] We hope our ultimate product will be of great use to healthcare workers, patients, and epidemiologists around the world. […] Thus, people will get peace of mind from COVID-19 testing in the comfort of their own homes.

• #75 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  Version 3.0 has been released and contains recommendations for SARS-CoV-2 nucleic acid testing based on new systematic reviews of the diagnostic literature. […] Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. […] The IDSA panel agreed on 12 diagnostic recommendations. […] Access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. […] The IDSA panel recommends a SARS-CoV-2 NAAT in symptomatic individuals suspected of having COVID-19 (strong recommendation, moderate certainty evidence).

• #76 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  For symptomatic individuals suspected of having COVID-19, the IDSA panel suggests collecting and testing swab specimens from either the nasopharynx, anterior nares, oropharynx, or mid-turbinate (MT) regions; saliva, or mouth gargle (conditional recommendation, low certainty evidence). […] The IDSA panel suggests that for symptomatic individuals suspected of having COVID-19, anterior nasal (AN) and MT swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or healthcare providers (conditional recommendation, moderate certainty evidence). […] The IDSA panel suggests using either rapid or standard laboratory-based NAATs in symptomatic individuals suspected of having COVID-19 (conditional recommendation, moderate certainty of evidence). […] The IDSA panel suggests performing a single NAAT and not repeating testing routinely in symptomatic or asymptomatic individuals suspected of having COVID-19 whose initial NAAT result is negative (conditional recommendation, very low certainty of evidence).

• #77 Coronavirus disease 2019 (COVID-19) – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/coronavirus/diagnosis-treatment/drc-20479976

  Here are some guidelines for when to take a COVID-19 test: If you have COVID-19 symptoms, test for the illness right away. If you were exposed to the COVID-19 virus but don’t have symptoms, wait at least five days after exposure then test. If you have symptoms and tested positive for COVID-19 within the last 30 days, you can test again. But if you were just exposed to the coronavirus and don’t have symptoms, you don’t need to test. […] COVID-19 tests use a sample taken from your nose or throat, or a sample of saliva. […] Two types of tests can help diagnose COVID-19. […] Molecular tests. These tests look for genetic material from the COVID-19 virus. Polymerase chain reaction tests, shortened to PCR tests, are molecular tests. […] PCR tests are more accurate than the other type of COVID-19 test, called an antigen test.

• #78 COVID-19 Testing and Diagnosis | American Lung Association

  https://www.lung.org/lung-health-diseases/lung-disease-lookup/covid-19/covid-19-testing

  There are two kinds of tests available to diagnose COVID-19: tests for current infection (viral tests) and tests for past infection (antibody tests). […] COVID-19 tests are widely available at pharmacies nationwide. […] Viral tests look for a current COVID-19 infection. They use respiratory samples, such as a swab from inside your nose or saliva from your mouth, to determine if you are currently infected with SARS-CoV-2, the virus that causes COVID-19. […] If you think you are exhibiting symptoms of COVID-19, get tested right away. […] You should get tested for COVID-19 if you: Are experiencing symptoms of COVID-19, test right away. […] Antibody tests are performed by drawing blood and conducting a laboratory test to check for antibodies that would only be present if you had a past infection of SARS-CoV-2, the virus that causes COVID-19. An antibody test should not be used to determine current infection as it can take your body one to three weeks after infection to make antibodies. […] Results from your antibody test will be positive if you were previously infected with COVID-19 and negative if you have not been previously infected.

• #79 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  For individuals who have clinical or epidemiologic reasons that might make testing desirable, the IDSA panel suggests SARS-CoV-2 RNA testing in asymptomatic individuals who are either known or suspected to have been exposed to COVID-19 (conditional recommendation, moderate certainty evidence). […] The IDSA panel suggests against routine SARS-CoV-2 NAAT in asymptomatic individuals without a known exposure to COVID-19 who are being hospitalized (conditional recommendation, very low certainty evidence). […] The IDSA panel suggests against routine SARS-CoV-2 NAAT of asymptomatic individuals without a known exposure to COVID-19 who are undergoing a medical or surgical procedure (conditional recommendation, very low certainty evidence). […] The IDSA panel suggests against routinely repeating NAAT before medical or surgical procedures in patients with a recent history of COVID-19 (conditional recommendation, very low certainty evidence). […] The IDSA panel suggests against routinely repeating NAAT in patients with COVID-19 to guide release from isolation (conditional recommendation, very low certainty evidence). […] The IDSA panel suggests neither for nor against home-testing for SARS-CoV-2 (evidence gap).

• #80 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  No single sign or symptom can accurately diagnose COVID-19, and neither the absence or presence of specific signs or symptoms are accurate enough to rule in or rule out disease. […] A Cochrane review found that the presence of anosmia and/or ageusia may be useful as a red flag for diagnosis. Cough or fever may also increase the probability of diagnosis to an extent that is clinically relevant and should prompt further testing. […] The diagnostic accuracy of molecular tests and rapid antigen tests does not appear to be influenced by the Omicron variant. […] Testing strategies vary widely between countries, and you should consult your local public health authority for advice when deciding which test to use. […] The choice of which test to use in which setting requires careful consideration of the purpose of testing and the resources available, while also balancing test characteristics of accuracy, accessibility, affordability, and the rapidity with which results are needed.

• #81 COVID-19 diagnostic testing: Navigating your options

  https://www.cardinalhealth.com/en/product-solutions/medical/laboratory-products/poc-infectious-diseases/seasonal-respiratory-diagnostic-insights/respiratory-insights/covid-19-diagnostic-testing-options0.html

  The COVID-19 pandemic has been anything but predictable, and testing needs seem to follow along with that trend. Now, as more of the population is vaccinated, we may continue to see the needs for various types of testing rise and fall. Ideally, we will reach a state of “normalcy” where testing needs become easier to forecast. Conversely, just as we work each year to accurately plan for flu, we may have the same battle with COVID-19. […] As there is likely not a “one-size-fits-all” solution, the future of COVID-19 testing may require a holistic approach: testing programs that offer the full spectrum of options to serve various circumstances. […] It will be important to have an array of testing methods, including those reviewed below, to best serve patients and consumers in a variety of settings and circumstances.

• #82 COVID-19 diagnostic testing: Navigating your options

  https://www.cardinalhealth.com/en/product-solutions/medical/laboratory-products/poc-infectious-diseases/seasonal-respiratory-diagnostic-insights/respiratory-insights/covid-19-diagnostic-testing-options0.html

  With high sensitivity and specificity, molecular testing remains the gold standard for when the highest level of accuracy is a priority. As such, it is typically the preferred option for clinical settings. Molecular tests are also used as a reference for identifying active infections, and for testing symptomatic people. […] When speed and scale is a priority, rapid antigen testing is the standard. Because rapid antigen tests come with an acceptable level of accuracy for symptomatic patients and provide information quickly, they are well suited for screening on a massive scale as well as monitoring of specific population groups. […] Automated, high throughput antigen testing may be a viable alternative to PCR testing as a more affordable and faster method without a loss in performance. […] Antibody testing may become of particular interest as more of the population is vaccinated and people want to understand their immunity. Because we don’t yet know how long vaccine efficacy lasts, antibody testing could see an increase in demand.

• #83 Coronavirus disease 2019 (COVID-19) – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/coronavirus/diagnosis-treatment/drc-20479976

  Antigen tests. These tests look for viral proteins called antigens. […] Antigen tests are reliable and accurate, but they are less accurate than PCR tests. This is especially true if you don’t have symptoms. […] If you have a positive COVID-19 PCR or antigen test, you almost certainly have COVID-19. Another test isn’t needed. […] If you get a negative PCR test, you most likely do not have COVID-19. […] If you have a negative antigen test, the FDA recommends that you repeat an antigen test two days after the first test. With or without symptoms, repeating the test helps get the correct diagnosis. […] If you test positive, call a healthcare professional immediately to find out what options are available.

• #84 At-Home OTC COVID-19 Diagnostic Tests | FDA

  https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

  At-home over-the-counter (OTC) COVID-19 diagnostic tests can show if you have an active COVID-19 infection. […] These at-home OTC COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations) without a prescription. Tests are available online or at local stores and you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. […] With most at-home OTC COVID-19 diagnostic tests, you should repeat testing following a negative result, whether you have symptoms or not, to reduce your risk of a false negative test result. […] The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. […] An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized.

• #85 At-Home OTC COVID-19 Diagnostic Tests | FDA

  https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

  At-home over-the-counter (OTC) COVID-19 diagnostic tests can show if you have an active COVID-19 infection. […] These at-home OTC COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations) without a prescription. Tests are available online or at local stores and you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. […] With most at-home OTC COVID-19 diagnostic tests, you should repeat testing following a negative result, whether you have symptoms or not, to reduce your risk of a false negative test result. […] The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. […] An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized.

• #86 Coronavirus disease 2019 (COVID-19) – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/coronavirus/diagnosis-treatment/drc-20479976

  If you have symptoms of coronavirus disease 2019, known as COVID-19, or you’ve been exposed to the COVID-19 virus, contact your healthcare team. Let them know if you’ve had close contact with anyone diagnosed with COVID-19. […] In the United States, at-home COVID-19 tests are available. Free tests can be mailed to U.S. addresses, or you can purchase tests in stores, pharmacies or online. The U.S. Food and Drug Administration, also known as the FDA, approves or authorizes the tests. On the FDA website, you can find a list of the tests that are validated and their expiration dates. You also can check with your healthcare professional before buying a test if you have any concerns. […] COVID-19 tests also are available from healthcare professionals, some pharmacies and clinics, or at community testing sites.

• #87 At-Home OTC COVID-19 Diagnostic Tests | FDA

  https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

  At-home over-the-counter (OTC) COVID-19 diagnostic tests can show if you have an active COVID-19 infection. […] These at-home OTC COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations) without a prescription. Tests are available online or at local stores and you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. […] With most at-home OTC COVID-19 diagnostic tests, you should repeat testing following a negative result, whether you have symptoms or not, to reduce your risk of a false negative test result. […] The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. […] An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized.

• #88 COVID-19 Test Basics | FDA

  https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics

  COVID-19 testing plays a critical role in the fight against the virus. Understanding COVID-19 tests, including the different types of tests and their uses, and the types of samples the tests use, is key to making an informed decision that meets your needs. […] There are different types of COVID-19 tests diagnostic tests and antibody tests. […] Diagnostic tests can show if you currently are infected with SARS-CoV-2, the virus that causes COVID-19. There are two common types of COVID-19 diagnostic tests: […] Samples for COVID-19 diagnostic tests are typically collected using an anterior nares (nasal) swab sample. […] Depending on the intended use, COVID-19 diagnostic tests can be performed at a laboratory, a standalone testing site, a doctors office or health clinic, or at home. […] Be aware that COVID-19 diagnostic tests are authorized for specific uses and that laboratory-based molecular COVID-19 tests, are generally more accurate than at-home tests.

• #89 Prediction models for diagnosis and prognosis of covid-19: systematic review and critical appraisal | The BMJ

  https://www.bmj.com/content/369/bmj.m1328

  The reported C indexes varied between 0.77 and 0.93 in development studies with low risk of bias, and between 0.56 and 0.78 in external validations with low risk of bias. […] Prediction models for covid-19 entered the academic literature to support medical decision making at unprecedented speed and in large numbers. […] Most published prediction model studies were poorly reported and at high risk of bias such that their reported predictive performances are probably optimistic. […] Models with low risk of bias should be validated before clinical implementation, preferably through collaborative efforts to also allow an investigation of the heterogeneity in their performance across various populations and settings. […] Finally, prediction modellers should adhere to the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) reporting guideline.

• #90 Coronavirus Disease 2019 (COVID-19) and Diagnostic Error | PSNet

  https://psnet.ahrq.gov/primer/coronavirus-disease-2019-covid-19-and-diagnostic-error

  Routine serologic testing is not recommended to assess for immunity in either unvaccinated persons or persons who have received currently available COVID-19 vaccines because a positive antibody test for spike protein IgM/IgG may not differentiate previous infection from the anticipated effect of vaccination.

• #91 COVID-19 diagnostic testing – Mayo Clinic

  https://www.mayoclinic.org/tests-procedures/covid-19-diagnostic-test/about/pac-20488900

  COVID-19 diagnostic testing shows current infection with the virus that causes coronavirus disease 2019 (COVID-19). The U.S. Food and Drug Administration (FDA) approved the following types of tests for diagnosing COVID-19. […] PCR tests are more accurate than the other type of COVID-19 test, called an antigen test. […] Antigen tests are accurate, but they are less accurate than PCR tests. […] A COVID-19 diagnostic test can have a false-negative result. This means that the test didn’t show you have the virus even though you do. […] The FDA requires that rapid antigen diagnostic tests catch at least 80% of infections. […] Rarely, COVID-19 rapid antigen tests can give false-positive results. […] False-positive results mean the test results show that you have the virus when you don’t.

• #92

  https://link.springer.com/article/10.1007/s40291-020-00492-5

  Rapid COVID-19 testing should be achieved without compromises in reagent conservation and detection specificity. […] A further important factor to consider is the evaluation of false-positive and false-negative results. False-negative results have a risk of admitting infected patients into public areas and spreading COVID-19 further, whereas false-positive results risk patients thinking they are immune when they are actually not. […] In addition, isothermal amplification techniques, such as LAMP, have been shown to produce higher rates of false negatives than PCR. […] As such, to minimize incorrect diagnoses, the sensitivity and specificity of diagnostic tests must be optimized. […] The number of asymptomatic COVID-19 cases is rising, and the wide testing of high-risk asymptomatic individuals creates challenges. Improvements in testing time and sensitivity, as well as screening for drug resistance, should be priorities in the path forward for COVID-19 diagnostics.

• #93 A simple and fast spectroscopy-based technique for Covid-19 diagnosis | Scientific Reports

  https://www.nature.com/articles/s41598-021-95568-5

  Currently, diagnosis of SARS-Cov-2 virus is mainly based on the quantitative polymerase chain reaction (RT-PCR) for the detection of viral nucleic acids. These methods have several limitations such as sample handling, requiring samples in the acute phase, and testing time, which ranges from 2 to 4 h for a simple PCR acquisition to more than 12 h for the overall processing and handling time. Moreover, this technique also requires the use of expensive kits that are mostly sourced from western and Chinese suppliers and cannot be guaranteed for African countries particularly during lockdown periods. In other words, the diagnosis of SARS-Cov-2 infected patients in African countries using the PCR technique is inadequate and requires, in several countries, more than 5 days to get the test results to the patients.

• #94 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  No single sign or symptom can accurately diagnose COVID-19, and neither the absence or presence of specific signs or symptoms are accurate enough to rule in or rule out disease. […] A Cochrane review found that the presence of anosmia and/or ageusia may be useful as a red flag for diagnosis. Cough or fever may also increase the probability of diagnosis to an extent that is clinically relevant and should prompt further testing. […] The diagnostic accuracy of molecular tests and rapid antigen tests does not appear to be influenced by the Omicron variant. […] Testing strategies vary widely between countries, and you should consult your local public health authority for advice when deciding which test to use. […] The choice of which test to use in which setting requires careful consideration of the purpose of testing and the resources available, while also balancing test characteristics of accuracy, accessibility, affordability, and the rapidity with which results are needed.

• #95 Long COVID has unique symptoms, persistence not seen in flu, pneumonia, research suggests | CIDRAP

  https://www.cidrap.umn.edu/covid-19/long-covid-has-unique-symptoms-persistence-not-seen-flu-pneumonia-research-suggests

  We found differences in the prevalence of symptoms as well as different times to resolution better characterizing 'long COVID’ and identifying that this persistence of symptoms is unique to COVID-19. […] „We found that COVID-19 symptomology could not be perfectly described by previously seen influenza or pneumonia symptomology,” the study authors concluded. „We found differences in the prevalence of symptoms as well as different times to resolution better characterizing 'long COVID’ and identifying that this persistence of symptoms is unique to COVID-19.”

• #96

  https://link.springer.com/article/10.1007/s40291-020-00492-5

  Rapid COVID-19 testing should be achieved without compromises in reagent conservation and detection specificity. […] A further important factor to consider is the evaluation of false-positive and false-negative results. False-negative results have a risk of admitting infected patients into public areas and spreading COVID-19 further, whereas false-positive results risk patients thinking they are immune when they are actually not. […] In addition, isothermal amplification techniques, such as LAMP, have been shown to produce higher rates of false negatives than PCR. […] As such, to minimize incorrect diagnoses, the sensitivity and specificity of diagnostic tests must be optimized. […] The number of asymptomatic COVID-19 cases is rising, and the wide testing of high-risk asymptomatic individuals creates challenges. Improvements in testing time and sensitivity, as well as screening for drug resistance, should be priorities in the path forward for COVID-19 diagnostics.

• #97 13 Things To Know About Paxlovid, the Latest COVID-19 Pill > News > Yale Medicine

  https://www.yalemedicine.org/news/13-things-to-know-paxlovid-covid-19

  Paxlovid, an oral antiviral pill that can be taken at home, is the go-to treatment for COVID-19. If you are at high risk for severe disease from COVID, and you take it within the first five days of experiencing symptoms, it will lower your risk of getting so sick that you need to be hospitalized. […] The FDA’s approval of Paxlovid for adults in 2023 was based on the totality of scientific evidence submitted by Pfizer, including efficacy data from a Phase 2/3 study showing an 86% reduction in risk of COVID-related hospitalization or death from any cause in patients who took Paxlovid within five days of symptom onset. […] In November 2022, the CDC reported on a real-world study that showed adults who took Paxlovid within five days of a COVID diagnosis had a 51% lower hospitalization rate within the next 30 days than those who were not given the drug.

• #98 13 Things To Know About Paxlovid, the Latest COVID-19 Pill > News > Yale Medicine

  https://www.yalemedicine.org/news/13-things-to-know-paxlovid-covid-19

  However, a study by Pfizer, published in the New England Journal of Medicine in April 2024, suggested that Paxlovid may not be beneficial for people at low to moderate risk who have mild illness and those who have been fully vaccinated. […] Vaccination, testing, and mitigation efforts such as masking, remain a key part of prevention, even as more drugs become available, says Dr. Topal. […] Early testing is key to making these drugs work, he says. It’s always been the Achilles heel of these antiviral drugs that most people don’t get tested or they don’t have access to testing. […] Dr. Topal says people also should remember that Paxlovid, even with its high efficacy, is not perfect, and even if it were, viruses can mutate and develop resistance to antiviral medications. Will some people still be hospitalized? Yes, no medication is perfect, he says. But for many high-risk patients, this medication can really reduce that risk.

• #99 COVID-19: making the right diagnosis

  https://www.degruyter.com/document/doi/10.1515/dx-2020-0063/html?lang=en

  Currently little is known about the characteristics of a myriad of emerging serologic tests which look for antibodies to provide evidence of prior infection and potential immunity. It will be especially important to know more about variations in lab techniques and products as they emerge, the optimal timing, and interpretation of the results, such as which detectable antibody levels confer immunity or ability to carry and spread infection. […] We need to remind ourselves that not every patient with malaise, pneumonia, cough, shortness of breath, or fever has COVID-19 infection. Currently there may be a high pretest likelihood we are dealing with coronavirus when a patient presents with these symptoms. But we cant forget about, for example, bacterial pneumonia, tuberculosis, endocarditis, HIV, or polymyalgia/temporal arteritis, all of which are serious conditions that require specific, urgent therapy.

• #100 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  Diagnostics have proven to be crucial to the COVID-19 pandemic response. There are three major methods for the detection of SARS-CoV-2 infection and their role has evolved during the course of the pandemic. Molecular tests such as PCR are highly sensitive and specific at detecting viral RNA, and are recommended by WHO for confirming diagnosis in individuals who are symptomatic and for activating public health measures. Antigen rapid detection tests detect viral proteins and, although they are less sensitive than molecular tests, have the advantages of being easier to do, giving a faster time to result, of being lower cost, and able to detect infection in those who are most likely to be at risk of transmitting the virus to others. Antigen rapid detection tests can be used as a public health tool for screening individuals at enhanced risk of infection, to protect people who are clinically vulnerable, to ensure safe travel and the resumption of schooling and social activities, and to enable economic recovery. With vaccine roll-out, antibody tests (which detect the host’s response to infection or vaccination) can be useful surveillance tools to inform public policy, but should not be used to provide proof of immunity, as the correlates of protection remain unclear. All three types of COVID-19 test continue to have a crucial role in the transition from pandemic response to pandemic control.

• #101 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  If there is sustained clinical suspicion owing to an epidemiological link and other clinical or radiological findings, but the repeat molecular testing is negative, the patient could be further evaluated using an antibody test, but only for the purpose of documenting retrospectively a recent infection with SARS-CoV-2. […] Testing strategies have evolved with different phases of the pandemic. Although a mainstay for patient diagnosis and management, testing has also been used at an unprecedented scale in settings outside health care, for screening to protect the clinically vulnerable, at border crossings to release people from quarantine, and in communities to enable safe environments for the resumption of economic recovery and social and cultural activities.

• #102 North Carolina Respiratory Virus Summary Dashboard | NC COVID-19

  https://covid19.ncdhhs.gov/dashboard

  This dashboard includes summary information about COVID-19 wastewater monitoring. […] This metric shows the percent of emergency department visits that are for a diagnosis of flu (influenza ICD-9/ICD-10 codes) or symptoms and diagnosis of COVID-19, RSV and acute respiratory illnesses. […] This metric shows the number of hospital admissions from emergency departments for a diagnosis of flu (influenza ICD-9/ICD-10 codes) or symptoms and diagnosis of COVID-19, RSV, and acute respiratory illnesses. […] NCDHHS is testing samples of wastewater from select treatments plants across the state to look for COVID-19. This metric helps us understand spread of COVID-19 at the community level. […] Research suggests that the virus that causes COVID-19 can appear in wastewater 4-6 days before the first cases are identified and can serve as an early warning indicator before changes are seen in other metrics.

• #103

  https://link.springer.com/article/10.1007/s13206-022-00078-9

  The SARS-CoV-2 DETECTR comprises RT-LAMP for RNA extraction and gene amplification, Cas12 detection of predefined viral sequences, and confirmation of the detection of viral RNA by cleavage of reporter molecules. […] Rapid and accurate diagnosis is the first step in preventing and controlling the COVID-19 epidemic. […] Various rapid and cost-effective POC tests, including LFA-based diagnostic tests, have been developed as powerful and effective methods to control the COVID-19 outbreak and have contributed significantly to the rapid identification of new infections and implementation of quarantine measures.

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