Related link: Coronavirus (COVID-19) Service and Support Business Continuity Statement Hologic’s global leadership in molecular diagnostics has enabled us to create a highly accurate, fully automated test that detects genetic material from SARS-CoV-2, the new coronavirus strain, in under three hours. All BD COVID-19 diagnostic products have EUA and BD intends to pursue 510(k) clearance with the FDA at a later time. The evaluation of an antigen test result should consider whether, and if so the length of time, the patient has experienced symptoms. The BinaxNOW™ COVID-19 test is a lateral flow test that detects the presence of protein antigens from SARS-CoV-2 in individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The healthcare provider should direct the person who received a negative antigen test result, or a negative confirmatory NAAT result, to quarantine for 14 days after the last known exposure to a person with COVID-19. This interim guidance is intended for clinicians who order antigen tests, receive antigen test results, and perform point-of-care testing, as well as for laboratory professionals who perform antigen testing in a laboratory setting or at the point of care and … Modeling evidenceexternal icon shows that outbreak control depends largely on the frequency of testing, the speed of reporting, and the application of interventions, and is only marginally improved by the sensitivity of the test. 6If prevalence of infection is not low in the community, clinical discretion should consider whether this negative antigen result requires confirmation The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for antigen tests that can identify SARS-CoV-2. Two studies were completed to determine clinical performance. BD MAX ™ women's health and sexually transmitted infections (STI) assays. The sensitivity of the tests was mostly above 90%, but specificity is more important when checking for evidence of past infection. 3If a symptomatic person has a low likelihood of SARS-CoV-2 infection, clinical discretion should determine if this negative antigen test result requires confirmatory testing b) Among 4220 patients who were negative on their first testing episode, and subsequently retested, only 85/4220 (2.5%) flipped from negative to positive. Healthcare professionals can purchase the Sofia SARS Antigen FIA through select authorized distributors. The decision to apply antigen testing depends on variables including: sensitivity and specificity of the test, prevalence/ outbreak of COVID-19 in the given population, remote location, availability of laboratories/ hospitals, cost, ability to perform serial testing, and other factors. The currently authorized antigen tests are not restricted to use on persons of a certain age. FDA regulates in vitro diagnostic devices and has provided recommendations and information regarding EUA requests for COVID-19 diagnostic tests in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) (“Policy for COVID-19 Tests”)external icon and the EUA templates referenced in that policy. In instances of higher pretest probability, such as high incidence of infection in the community, or a person with household or continuous contact to a person with COVID-19, clinical judgement should determine if a positive antigen result for an asymptomatic person should be followed by a confirmatory NAAT. For example, the performance of antigen tests can be affected if the test components are not stored and handled properly. Third, colchicine is the drug of choice for the prevention of recurrent mucocutaneous lesions of BD. If a specific testing site, such as a nursing home, has a test positivity rate near zero, the prevalence of disease in the community (e.g., cases among the population) should instead be used to help determine pretest probability. Clinicians and public health practitioners should understand test performance characteristics to recognize potentially false negative or false positive test results and to guide additional confirmatory testing and patient management. Objectives: New molecular tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being rapidly launched in response to the coronavirus disease 2019 (COVID-19) pandemic. The possibility of coronavirus disease 2019 (COVID-19) should be considered in patients with compatible symptoms , in particular fever and/or respiratory tract symptoms, who reside in or have traveled to areas with community transmission or who have had recent close contact with a confirmed or suspected case of COVID-19. BD clinical studies performed at more than 20 sites across the U.S. demonstrated that the test is capable of achieving 84% sensitivity and 100% specificity, which is in line with the performance from similar immunoassay tests for Flu A/B, RSV and Strep A on the BD Veritor™ Plus System — all of which are widely-used, highly relevant and clinically valid. If the person has a low likelihood of SARS-CoV-2 infection (e.g., no known exposure), clinical judgement should be used to determine whether a confirmatory NAAT should be performed. In general, the lower the prevalence of infection in the community, the higher the rate of false positive test results. Decontaminate work surfaces and equipment with appropriate disinfectants by using an EPA-approved disinfectant for SARS-CoV-2, following the manufacturer’s recommendations for use, such as dilution, contact time, and safe handling. 3If a symptomatic person has a low likelihood of SARS-CoV-2 infection, clinical discretion should determine if this negative antigen test result requires confirmatory testing ... Not all viral tests have equivalent sensitivity and specificity. Most of the currently authorized tests return results in approximately 15 minutes. The role of a negative antigen test result in ending quarantine depends upon when it is performed in the quarantine period. Panbio COVID-19 Antigen Rapid Test IFU. All testing for SARS-CoV-2, including antigen testing, depends on the integrity of the specimen, which is affected by procedures for both specimen collection and handling. The first showed that the IgG results displayed a 95% specificity in a cohort of PCR‐confirmed COVID‐19 cases, without comparing the IgG serology results to results obtained with an IgG serology reference method. Testing for COVID-19: PCR, Antigen, and Serology . Note: Antigen tests can be used in a variety of testing strategies to respond to the coronavirus disease 2019 (COVID-19) pandemic. Revisions were made on December 5, 2020 including: Note: Antigen tests can be used in a variety of testing strategies to respond to the coronavirus disease 2019 (COVID-19) pandemic. Generally, clinicians can rely upon a positive antigen test result for a symptomatic patient because the specificity of current FDA-authorized antigen tests is high. The clinical performance of antigen diagnostic tests largely depends on the circumstances in which they are used. This means, when you use your BD Veritor™ Plus System you might see 0-2 false positives for every 100 tests you conduct. The sensitivity observed in the testing clinic in … BioFire’s Respiratory Solutions with SARS-CoV-2. BD MAX™ Vaginal Panel Elevate the standard of care for Women’s Health. See CDC’s guidance for Quarantine; clinical discretion should determine if and when additional testing is necessary. Test sensitivity for rapid antigen tests is generally lower than for RT-PCR. The role of a negative antigen test result in ending quarantine depends upon when it is performed in the quarantine period. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments. The analytical sensitivity of the Xpert test (EUA version) was assessed with one lot of reagent and limiting dilutions of the quantitated SARS-CoV-2 (USA_WA1/2020) according to standard guidelines ().The virus stock (9.75 × 10 5 PFU/ml) was obtained from the University of Texas Medical Branch Arbovirus Reference Collection, Galveston, TX. Positive and negative predictive values of all in vitro diagnostic tests (e.g., NAAT and antigen assays) vary depending upon the pretest probability. Persons who receive a positive antigen test result that should undergo confirmatory testing should quarantine while awaiting results of the confirmatory testing. See CDC’s guidance for Quarantine; clinical discretion should determine if and when additional testing is necessary. This video is best viewed in Chrome or Firefox. Panbio COVID-19 Antigen Rapid Test Sell Sheet. the proportion of those who have some condition (affected) who are correctly identified as having the condition). The BD MAX system is cleared or approved by the U.S. FDA only when used with BD MAX ™ IVD assays, which have been cleared or approved by the FDA. The BD MAX™ System is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours*. We compared the performance of the BD Max enteric parasite panel to routine microscopy and an in-house PCR for the detection of Giardia intestinalis, Entamoeba histolytica, and Cryptosporidium spp. Panbio COVID-19 Antigen Rapid Test Brochure. CDC will update this guidance as more data become available. Serial testing, particularly in congregate settings when it has been possible to quarantine persons for 14 days, should not continue indefinitely. Sir John Bell, Regius Professor of Medicine at Oxford University , said: 'The data in this validation report demonstrates that these inexpensive, easy to use tests can play a major role in our fight against COVID 19. It may be appropriate to confirm antigen test results with another test. reported the sensitivity and specificity of the BD MAX Cdiff assay as 93.4% and 97.3% and the ribotype diversity did not appear to affect the performance of the BD MAX Cdiff assay. 5In certain settings, serial antigen testing could be considered for those with a negative antigen test result; serial testing may not require confirmation of negative results. See the antigen testing algorithm when pretest probability is high, Figure 2, which is excerpted directly from the full antigen testing algorithm in Figure 1. ECDC agrees with the minimum performance requirements set by WHO at ≥80% sensitivity and ≥97% specificity. If the results are discordant between the antigen test and the confirmatory NAAT, in general the confirmatory test result should be interpreted as definitive for the purpose of clinical diagnosis. Serial antigen testing within a closed congregate setting, such as a long-term care facility or a correctional or detention facility, could quickly identify someone with a SARS-CoV-2 infection and prevent further transmission. See CDC’s guidance on Testing in Nursing Homes and FDA’s Recommendations for healthcare providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19external icon. Failing to change gloves can increase the risk of cross-contamination and false antigen test results. Confirmatory testing when using antigen tests. There are increasing amounts of dataexternal icon to help guide the use of antigen tests as screening tests on asymptomatic persons to detect or exclude COVID-19, or to determine whether a person who previously was diagnosed with COVID-19 remains infectious. See FDA’s In Vitro Diagnostics EUAsexternal icon. See CDC’s guidance for Quarantine; clinical discretion should determine if and when additional testing is necessary. Confirmatory testing should take place as soon as possible after the antigen test, and not longer than 48 hours after the initial antigen testing. See each test’s instructions for use at FDA’s In Vitro Diagnostics EUAsexternal icon, and see FDA’s Recommendations for healthcare providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19external icon. When testing a person who is asymptomatic and has had exposure to a person with COVID-19 within the last 14 days, indicating that the pretest probability is moderate, the healthcare provider should confirm a positive antigen test result with an FDA-authorized NAAT. Chiang et al. 8Known exposure to a person with COVID-19 within the last 14 days; if unsure, clinical discretion should determine whether isolation is necessary If the prevalence of infection in the community is high, and the person being tested is symptomatic, then the pretest probability is generally considered high. Refer to the package insert for the correct incubation time for that test, and then monitor and ensure proper timing for each specimen during testing and when reading results. The sensitivity of current FDA-authorized antigen tests varies, and thus negative diagnostic testing results should be handled differently depending on the test, its stated performance characteristics, and intended application (e.g., clinical diagnosis, screening). Hospitals and laboratories are faced with increasing challenges in managing workload and patient needs. Through two sequential CNNs, they were automatically distinguished from normal lymphocytes and classical RL with sensitivity, specificity and overall accuracy values of 90.5%, 99.4% and 98.7%, respectively. If the prevalence of infection in the community is low, and the person being tested is asymptomatic and has not had any known contact to a person with COVID-19, then the pretest probability is generally considered low. The FDA provides helpful information on COVID-19 diagnostic and antibody tests, including videos and tables, via it’s Coronavirus Testing Basics Page . Widespread COVID-19 testing is paramount for the receipt of timely medical care and for curtailing transmission. Laboratories and testing sites should refer to the instructions for use and the package insert that are specific for the test that they are using regarding the use of VTM. “I am very proud of our clinical pathology teams, who have worked tirelessly to get our essential COVID-19 tests validated and available to our patients, employees and community,” said Iyda … COVID-19 resources and guidelines for labs and laboratory workers. 2) BD Veritor System for Rapid Detection of SARS-CoV-2 3) LumiraDx SARS-CoV-2 Antigen Test 4) Abbott BinaxNOW COVID-19 Ag CARD. See CDC’s Options to Reduce Quarantine for guidance on use of antigen testing for this purpose and when a negative antigen test result indicates not infected with SARS-CoV-2. However, several studies have documented persistent detection of virus using RT-PCR after recovery; in these cases, the persons did not seem to be infectious to others. Introduction . 1. Antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission. See CDC’s Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19. Testing an asymptomatic person who has had close contact with a person with COVID-19 – moderate pretest probability. See FDA’s Recommendations for healthcare providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19external icon. In addition to a SARS-CoV-2 antigen assay for the BD Veritor™ Plus System, BD and a network of partners offer a portfolio of COVID-19 testing solutions including highly sensitive molecular diagnostic tests on the BD MAX™ System. Analytical performance. Evaluating the results of an antigen test for SARS-CoV-2 should take into account the performance characteristics (e.g., sensitivity, specificity) and the instructions for use of the FDA-authorized assay, the prevalence of SARS-CoV-2 infection in that particular community (positivity rate over the previous 7–10 days or the rate of cases in the community), and the clinical and epidemiological context of the person who has been tested. The purpose of this interim technical guidance is to support effective clinical use of antigen tests for different testing situations. Gloves should be changed before collecting, handling, and processing a new specimen in the antigen test system. If the person has had exposure, that person should follow infection control measures for 14 days after their most recent exposure to a person with COVID-19. 352 0 obj <> endobj Also see FDA’s FAQs on Testing for SARS-CoV-2external icon. Also see FDA’s Letter to Clinical Laboratory Staff and Health Care Providersexternal icon on the potential for false positive results with antigen tests, and CDC’s guidance on Point-of-Care Testing. See CDC’s guidance for Isolation. The antigen level in specimens collected either before symptom onset, or late in the course of infection, may be below the limit of detection of virus of the test.