BD Statement on COVID-19 (Coronavirus) Updated November 2020. Improper specimen collection, such as swabbing the nostril too quickly, may cause insufficient specimen collection, resulting in limited amounts of viral genetic or antigenic material for detection. 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. Ellume's test results provided to the FDA showed the test demonstrated a sensitivity of 96 percent and specificity of 100 percent among individuals with COVID-19 symptoms. See FDA’s list of In Vitro Diagnostics EUAsexternal icon. o The BD Veritor System has alower sensitivity; therefore, negative test results are still considered “presumptive negative” and need PCR confirmation • NH DPHS continues to recommend that any patient presenting with even mild symptoms of COVID-19 be tested for COVID-19. Note: Antigen tests can be used in a variety of testing strategies to respond to the coronavirus disease 2019 (COVID-19) pandemic. h�b```��,|�� cb���G��Hu�Q8cCĵ�@i��3��8�Uzf�����޵L})��Xe������������������f �(��-b�s�|@, a`���d�x���ٓ9�9��/s��[��S�^��e��������Ľ���3�4#�b -���m���6|��J���gD�@� �c9 Analytic performance may differ from overall performance when considering issues of test availability, quality of specimen collection and transport, and turnaround times of results. Testing a symptomatic person – high pretest probability. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. 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. 10Quarantine is necessary. Xd.�} L.�����k I�������߃�g`�B�g`��` JI! A CLIA-certified laboratory or testing site must report antigen test results to the individual or the individual’s healthcare provider according to the instructions for use of the FDA-authorized SARS-CoV-2 in vitro diagnostic device that was used. See CDC’s Overview of Testing for SARS-CoV-2, and Testing Strategies for SARS-CoV-2. 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 report those results. Sensitivity and specificity are statistical measures of the performance of a binary classification test that are widely used in medicine: Sensitivity measures the proportion of positives that are correctly identified (i.e. The clinical performance of antigen diagnostic tests largely depends on the circumstances in which they are used. In the novel coronavirus disease (COVID-19) pandemic era, it is essential to rule out COVID-19 effectively to prevent transmission in both communities and medical facilities. Also see CMS’ Enforcement discretion for the use of SARS-CoV-2 point-of-care testing on asymptomatic individualspdf iconexternal icon. 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. In this case, and especially in settings where a rapid test turnaround time is required, there is value in providing immediate results with antigen tests, even though they may have lower sensitivity than NAATs. Persons who receive a positive antigen test result that should undergo confirmatory testing should quarantine while awaiting results of the confirmatory testing. 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. Pretest probability considers both the prevalence of the target infection in the community as well as the clinical context of the individual being tested. 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. See EPA’s List of Disinfectants for COVID-19external icon. BioFire has brought its syndromic approach to COVID-19 testing. endstream endobj 353 0 obj <. 368 0 obj <>/Filter/FlateDecode/ID[]/Index[352 23]/Info 351 0 R/Length 86/Prev 216543/Root 353 0 R/Size 375/Type/XRef/W[1 3 1]>>stream This U.S. Food and Drug Administration (FDA)- … Two studies were completed to determine clinical performance. Panbio COVID-19 Antigen Rapid Test IFU. Regulatory Requirements for Using Antigen Tests for SARS-CoV-2. Persons who receive a positive antigen test result that should undergo confirmatory testing should isolate while awaiting results of the confirmatory testing. On June 4, 2020, the U.S. Department of Health and Human Services published guidance on COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115pdf iconexternal icon that specifies what additional data should be collected and electronically reported to health departments along with COVID-19 diagnostic or screening test results. Laboratory and testing professionals who conduct diagnostic or screening testing for SARS-CoV-2 with antigen tests must also comply with Clinical Laboratory Improvement Amendments (CLIA) regulations. 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. 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. See FDA’s In Vitro Diagnostics EUAsexternal icon. IVD assays, research use only (RUO) assays and user-defined protocols (UDP) cannot be combined in the same rack. In addition to validating the sensitivity, specificity and detection limits of these instruments, the team also validated many kinds of viral transport media and swabs to ensure … Introduction . 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. 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. Reporting Antigen Test Results for SARS-CoV-2 to Health Departments and Patients. Xpert® Xpress SARS-CoV-2* Cepheid has developed an automated molecular test for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19. 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 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. The Conditions of Authorization in the antigen EUAs specify that CLIA-certified laboratories and testing sites are to follow the manufacturer’s instructions for use, typically found in the package insert, when performing the test and reading test results. CDC recommends following its antigen testing algorithm (Figure 1 below, also available as PDF pdf icon[PDF – 457 KB]) to determine when confirmatory testing is recommended. 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 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. CDC twenty four seven. Two of our patients were receiving immunosuppressive agents at COVID diagnosis. 9Isolation is necessary. 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. Sensitivity and specificity are measures of a test's ability to correctly classify a person as having a disease or not having a disease. Figure 3. BioGX SARS-CoV-2 Reagents for BD MAX ™ System. Antigen tests for SARS-CoV-2 are generally less sensitive than real-time reverse transcription polymerase chain reaction (RT-PCR) and other nucleic acid amplification tests (NAATs) for detecting the presence of viral nucleic acid. 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. Saving Lives, Protecting People, Recommendations for healthcare providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19. If more than 48 hours separate the two specimen collections, or if there have been opportunities for new exposures, a NAAT should be considered a separate test – not a confirmation of the earlier test. Facilities should refer to CDC’s LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests. %PDF-1.6 %���� The evaluation of an antigen test result should consider whether, and if so the length of time, the patient has experienced symptoms. Enforcement discretion for the use of SARS-CoV-2 point-of-care testing on asymptomatic individuals. COVID-19 resources and guidelines for labs and laboratory workers. Panbio COVID-19 Antigen Rapid Test Brochure. This may result in a negative antigen test result, while a more sensitive test, such as most NAATs, may return a positive result. You will be subject to the destination website's privacy policy when you follow the link. And rapid COVID-19 testing is only going to become more widespread. The CARES Act requires “every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19” to report the results of each such test. BD MAX ™ women's health and sexually transmitted infections (STI) assays. 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. 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. We enrolled 91 consecutive inpatients with COVID-19 at 6 hospitals in Toronto, Canada, and tested 1 nasopharyngeal swab/saliva sample pair from each patient using real-time RT-PCR for severe acute respiratory syndrome coronavirus 2. See CDC’s Clinical Questions about COVID-19: Questions and Answers. Laboratory and testing professionals should collect and report complete patient demographic information and ensure that they report antigen test results using the proper LOINC code for their particular FDA-authorized assays. If confirmatory testing is not available, clinical discretion can determine whether to recommend that the patient isolate or quarantine. (i) Limit of detection. The package insert for antigen tests also includes instructions about how to read the test results, including the appropriate time to read the results and whether the results should be interpreted visually or with an instrument analyzer. 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. See CDC’s guidance on Testing in Nursing Homes, Quarantine and Isolation, Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings, Discontinuation of Transmission-Based Precautions of Patients in Healthcare Settings, and Return to Work for Healthcare Personnel. See CDC’s guidance for Isolation. Table 1 summarizes the differences between NAATs and antigen tests. Becton Dickinson & Co. won a U.S. regulator’s approval for a portable Covid-19 test that delivers results in 15 minutes. 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. In response to the novel coronavirus (SARS-CoV-2) outbreak, Thermo Fisher Scientific has worked rapidly to develop a new multiplex real-time RT-PCR diagnostic kit to enable clinical and public health laboratories to quickly diagnose COVID-19 caused by SARS-CoV-2 infection. The role of a negative antigen test result in ending quarantine depends upon when it is performed in the quarantine period. When testing a person who is asymptomatic and has not had known exposure to a person with COVID-19 within the last 14 days, indicating that the pretest probability is low, the healthcare provider generally can interpret a negative antigen test to indicate that the person is not infected with SARS-CoV-2. Vaginitis is the most common women's health issue, accounting for more than 10 billion cases each year. For this reason, serial antigen testing may have benefits for early identification and controlling outbreaks in some situations, such as congregate living, compared to laboratory-based NAATs with prolonged turnaround times. In the first study, nasal specimens and either … The New Jersey-based company, also known as BD, said a “small number” of nursing homes are reporting multiple false-positive COVID-19 tests … See FDA’s In Vitro Diagnostics EUAsexternal icon. Performance of antigen tests. 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. 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. BD MAX™ Vaginal Panel Elevate the standard of care for Women’s Health. Testing for COVID-19: PCR, Antigen, and Serology . 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 … Also see information from the Centers for Medicare & Medicaid Services (CMS) on Enforcement discretion for the use of SARS-CoV-2 point-of-care testing on asymptomatic individuals.pdf iconexternal icon. See FDA’s In Vitro Diagnostics EUAsexternal icon for detailed information about the performance of specific authorized tests. 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. 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. Analytical Performance of Antigen Tests for SARS-CoV-2. “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 … 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. 7Nucleic acid amplification test; confirm within 48 hours using a NAAT, such as RT-PCR, that has been evaluated against FDA’s reference panel for analytical sensitivity The role of a negative antigen test result in ending quarantine depends upon when it is performed in the quarantine period. 6If prevalence of infection is not low in the community, clinical discretion should consider whether this negative antigen result requires confirmation Evaluating the Results of Antigen Testing for SARS-CoV-2. 1.1. 1Single, multiple, or continuous known exposure to a person with COVID-19 within the last 14 days; perform NAAT first if short turnaround time is available, if person cannot be effectively and safely quarantined, or if there are barriers to possible confirmatory testing The word “rapid” has been deleted because FDA has authorized laboratory-based antigen tests. ID NOW COVID -19 is an automated assay that utilizes isothermal nucleic acid amplification technology for the qualitative detection of SARS-CoV-2 viral nucleic acids. Previous reports have indicated that the sensitivity of chest computed tomography (CT) in the diagnosis of COVID-19 may be greater than 90% [1,2]. Additional evidencepdf iconexternal icon shows the value of repeat testing, using NAATs with fast turnaround times, for informing clinical and public health decision-making. When a symptomatic person receives a negative antigen test result followed by a negative confirmatory NAAT, the healthcare provider should take into consideration whether the person has had exposure to a person with COVID-19 within the past 14 days. Most of the currently authorized tests return results in approximately 15 minutes. 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. 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. CDC recommends using a NAAT that has been evaluated against the FDA reference panel for analytical sensitivity. See the antigen testing algorithm when pretest probability is low, Figure 4, which is excerpted directly from the full antigen testing algorithm in Figure 1. Quality assurance procedures should be followed to prevent cross-contamination and inaccurate 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. Testing an asymptomatic person with no known exposure to a person with COVID-19 – low pretest probability. Revised section on evaluating the results of antigen tests, introducing a new testing algorithm, and reflecting what has been learned about the performance of antigen tests and the need to implement confirmatory testing. 4In instances of higher pretest probability, such as high incidence of incidence of infection in the community, clinical discretion should determine if this positive antigen result requires confirmation 9Isolation is necessary. Detection of these relatively distant members of the SARS-related CoV clade suggests that all Asian viruses are likely to be detected. 10Quarantine is necessary. A negative antigen test result for a symptomatic person should be confirmed with an FDA-authorized NAAT. Because of concerns about false positive results when pretest probability is low, a positive antigen test result in this circumstance should be followed by a confirmatory NAAT, recognizing that the person will be tested at a later timepoint in their illness if truly infected. (SACRAMENTO) — Since testing for COVID-19 began two months ago, UC Davis Health has reached a milestone, performing its 10,000th molecular test. All BD COVID-19 diagnostic products have EUA and BD intends to pursue 510(k) clearance with the FDA at a later time. The currently authorized antigen tests are not restricted to use on persons of a certain age. Fast answers for patients: test results in 15-20 minutes Reliable, high performance *: Sensitivity: 93.3% (98.2% for samples with Ct values ≤ 33) / Specificity… CerTest Biotec launches CE Marked COVID-19 diagnostic test for the BD MAX™ System. Processing multiple specimens successively or in batch mode may make it more challenging to ensure that each specimen is incubated for the correct amount of time before the result is read. 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. They also may be informative in diagnostic testing situations in which the person has a known exposure to a person with COVID-19. 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. See CDC’s guidance for Isolation. 10Quarantine is necessary. 4In instances of higher pretest probability, such as high incidence of incidence of infection in the community, clinical discretion should determine if this positive antigen result requires confirmation 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. This means, when you use your BD Veritor™ Plus System you might see 0-2 false positives for every 100 tests you conduct. See CDC’s guidance on Point-of-Care Testing, and Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). 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. There is some variation in the sensitivity of ... • False positive results have been reported with the BD Max SARS-CoV-2 RT-PCR reagents on the BD Max system. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. 10Quarantine is necessary. The “gold standard” for clinical diagnostic detection of SARS-CoV-2 remains NAATs, such as RT-PCR. It is important for clinicians and testing personnel to understand the analytic performance characteristics, including sensitivity, specificity, and positive and negative predictive values, of the particular antigen test being used, and to follow the manufacturer’s instructions and package insert. 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. If the prevalence of SARS-CoV-2 infection is not low in the community, clinical judgement should consider whether this negative antigen test result should be followed by a confirmatory NAAT. Over the last two months, UC Davis Health clinical pathology departments were heavily involved in validating molecular COVID tests on four different platforms: AB StepOne Plus, Roche 6800, GenMark and BD Max. The molecular test for detection of COVID … 7Nucleic acid amplification test; confirm within 48 hours using a NAAT, such as RT-PCR, that has been evaluated against FDA’s reference panel for analytical sensitivity 2No known exposure to a person with COVID-19 within the last 14 days Depending on the stipulations of the FDA authorization, the laboratory or testing site may be required to report negative test results to patients as “presumptive negative.”. 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. For example, the performance of antigen tests can be affected if the test components are not stored and handled properly. The enteric parasite panel showed good specificity for all targets and good sensitivity for E. histolytica and Cryptosporidium spp. 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. Antigen Testing Algorithm – Low Pretest Probability. 2No known exposure to a person with COVID-19 within the last 14 days In this moderate pretest probability scenario, the healthcare provider should consider performing a NAAT first if short test turnaround time is available, if the person cannot be effectively and safely quarantined, or if there are barriers to possible confirmatory testing (e.g., travel barriers for follow-up testing, tolerance of multiple specimen collections). See the antigen testing algorithm when pretest probability is moderate, Figure 3, which is excerpted directly from the full antigen testing algorithm in Figure 1. The BD MAX System is designed to help address today’s challenges, while preparing your laboratory for tomorrow’s possibilities. However, RT-PCR can detect levels of viral nucleic acid that cannot be cultured, suggesting that the presence of viral nucleic acid does not always indicate contagiousness. See CDC’s guidance for Quarantine; clinical discretion should determine if and when additional testing is necessary. 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. Figure 4. the proportion of those who have some condition (affected) who are correctly identified as having the condition). Also see FDA’s FAQs on Testing for SARS-CoV-2external icon. In November, the U.S. Food and Drug Administration (FDA) approved the first rapid COVID-19 test for at-home use. SARS -CoV -2 has emerged as a novel cause of human infection, causing a global pandemic in the first 6 months of 2020, with >8.2 million confirmed cases of infection and 443K deaths (1). COVID-19 assays and test systems used for diagnostic or screening testing, including those for antigen testing, must have received an EUA from FDA or be offered under the policies in FDA’s Policy for COVID-19 Testsexternal icon.