Euroimmun; 2020. Kobokovich A, West R, Gronvall G. Serology based tests for COVID-19. Abbott Laboratories; 2020. If your antibody test result was negative, this means that the test did not detect any COVID-19 antibodies in your blood. Assess how many people have been infected with SARS-CoV-2 in a population, by identifying individuals who have developed antibodies to the virus. It could mean: You have not been infected with COVID-19 previously. Some patients with past infections may not have experienced any symptoms. Here’s what this means: A ‘Reactive’ (positive) result means your sample has antibodies that are reactive to the SARS-CoV-2 virus. At the date of this publication, no qualitative SARS-CoV-2 IgG and IgM assays, under FDA EUA, have an intended use for evaluating SARS-CoV-2 vaccine efficacy. An antibody test is a way of seeing if a person’s immune system has responded to something. This means you have not been infected with COVID-19. Fact sheet for healthcare providers: SARS-Co-V-2 IgG assay - Abbott Laboratories Inc. Although the relationship between IgG positivity and immunity to SARS-CoV-2 has not yet been established, detection of IgG may suggest an immune response to SARS-CoV-2 after resolution of infection. In the future, this test, along with other clinical data, may help identify individuals who may be less susceptible to reinfection. Li Z, Yi Y, Luo X, et al. US Food and Drug Administration. Need help? On May 4, 2020, the FDA revised this policy to require antibody test developers to submit requests for emergency use authorization (EUA), with their validation data, within 10 business days from the date they notified the FDA of their validation testing OR from the date of this policy, whichever is later.2 The FDA provided specific performance threshold recommendations for specificity and sensitivity.2, SARS-CoV-2 IgG and IgM antibody assays offered by Quest have been authorized through an EUA process.3-6 The FDA has created a website to summarize the performance of the serology tests that have been granted EUA.7. US Food and Drug Administration. WHAT SHOULD I DO WITH THESE RESULTS? Many people who have had COVID-19 may not form long-lasting antibodies. Fact sheet for healthcare providers: EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG). Center for Health Security. It is unclear at this time if a positive IgG infers immunity against future COVID-19 infection. No. Although the immune response may protect against reinfection, this has yet to be conclusively established.12 It is not known how long antibodies to the virus will protect someone, if at all.12  Cases of reinfection with COVID-19 have been reported but remain rare​.12​ Based on what we know from similar viruses, some reinfections are expected. It could mean you have never been exposed to the virus, and you are at risk of infection. Equivocal: Your test results could not be interpreted as Positive or Negative. Updated May 4, 2020. Test code 31672 qualitatively assesses and reports the presence or absence of SARS-CoV-2 IgM and IgG antibodies in patient serum specimens. The COVID-19 Antibody Test is a simple blood test that checks whether your immune system — your body’s defence against illness — has responded to the infection. A positive result for the SARS-CoV-2 antibody is indicative of an acute or recent infection. COVID-19 antibody test results could be: Positive. US Food and Drug Administration. Instructions for use. Accessed October 25, 2020. What Are the Different Types of COVID-19 Tests? The answer is no. An antibody test may not show if you have a current COVID-19 infection because it can take 1–3 weeks after infection for your body to make antibodies. Accessed April 23, 2020. A negative result should not be used to rule out infection. For example, a healthy person’s test result would not detect COVID-19, so the reference range would be “negative” or “not detected.” If your test result shows a value of “positive” or “detected,” that falls outside of the reference range and would be considered abnormal or atypical. Updated October 27, 2020. Negative: You tested negative for COVID-19 IgG antibody. Instructions for use. A clinician’s test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient. 12-14 Negative results suggest that a person has not been infected with SARS-CoV-2 or has been very recently infected (antibodies have not yet been produced). Identify whether people have been infected with SARS-CoV-2 and have mounted an immune response. Some patients with past infections may not have experienced any symptoms. A detectable IgG response usually takes at least 10 days after exposure but may take up to 3 weeks or longer to develop in some patients, and some people may not develop antibodies at all. The IgG response is usually slower in people who are either taking immunosuppressive therapies or are immunocompromised because of a health condition.12-14 Given the variability in timing of an IgG response, a repeat serology IgG test should be considered after an additional 2- to -3-week period for patients who are initially antibody negative and are thought to have clinically recovered from a SARS-CoV-2 infection.12-14, An equivocal (borderline) result indicates that IgG was detected at a level close to the threshold of the limit of detection for the test.12-14 Equivocal results may occur for unidentified reasons or may represent an early infection, detection of an IgG generated from a past infection (refer to Question 9 for cross-reactivity with non-SARS-CoV-2 coronavirus strains), or, in some cases, an underlying immune disorder, immunosuppression, or other conditions.12-14. This means you have not been infected with COVID-19. It is unclear at this time if a positive IgG infers immunity against future COVID-19 infection. Rapid diagnostic tests (RDT)s: These are typically lateral flow assays that can be used for point-of-care (POC) testing. Abbott Architect SARS-CoV-2 IgG. Accessed November 5, 2020. Here is what … Data suggest that IgM antibodies can be detected within a few days and IgG antibodies will be detectable from 10 days after COVID-19 symptom onset.3-5 after SARS-CoV-2 exposure or symptom onset.9,10 However, some people do not generate detectable IgG antibodies after infection, because of an underlying immune disorder, immunosuppression, or other, as yet unidentified, reasons.9,10 Additionally, an individual’s immune response can vary in the speed and strength of IgM and IgG production upon exposure to SARS-CoV-2, based on infective dose, viral burden, or other host factors.9,10. This means you have not been infected with COVID-19. Non-Reactive results If this test is non-reactive, it means you likely never had a COVID-19 infection and that you weren’t exposed to the virus. Clinical researchers continue to investigate what constitutes SARS-CoV-2 protective immunity and vaccine efficacy. The results may be reported as ‘Reactive’ (i.e. I got an antibody test. US Food and Drug Administration. Fact Sheet for Healthcare Providers: Abbott Laboratories AdviseDx SARS-CoV-2 IgM. For the best experience, please use Safari, Chrome, or Firefox while browsing our site. Q: I tested reactive (positive) for the antibody test, what should I do? False-positive test results can occur. FAQs on testing for SARS CoV-2. Negative means the test was non-reactive.It did not find detectable levels of antibodies. Accessed October 23, 2020. Copyright 2010 - 2021 City Practice Group of New York. Understanding your Serum Antibody (Blood Test) Results | CityMD Coronavirus antibody testing now is available at UAB. The most common reasons for equivocal results are presence of an immune response but unclear if against the infection being tested for (COVID-19 in this case) or similar infections (the common cold is a type of coronavirus). A positive test means you have COVID-19 antibodies in your blood, which indicates past infection with the virus. Infectious Diseases Society of America. Results of the test show whether you had a recent or prior COVID-19 Abbott AdviseDx SARS-CoV-2 IgM. Positive means the test was reactive. Antibody test results should not be used to diagnose someone with an active infection. | by … If you had symptoms consistent with COVID-19 within the past 3 weeks and tested negative, repeat testing in 1-2 weeks may yield a positive result. Reactive results If this test is reactive, it means protective antibodies are developed in the body. Accessed October 23, 2020. In these tests, serial dilutions of patient serum are incubated with known infectious virus concentrations and then added to virus susceptible cell lines.16 After incubation, infected cells are quantified to determine the effectiveness of patient antibodies in neutralizing the virus.16,17 The presence of NAbs may suggest in vivo immunity to viral infection, and convalescent serum with NAbs is being studied as a treatment for severe COVID-19.16-19 Testing for NAbs is only available at some specially equipped public health laboratories and research facilities. 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