COVID-19 & Flu TestDetect active SARS-CoV-2 and influenza A/B infections. Read more
The COVID-19 and Flu test collection kit tests for SARS-CoV-2 (the virus causing COVID-19) and the influenza A and influenza B viruses.
About COVID-19 COVID-19 is highly contagious. Cases of COVID-19 range from mild to severe. Most people infected with this virus have mild symptoms. Some people who are infected don’t have any symptoms and don’t feel sick but can still transmit the virus to others. More severe cases of COVID-19 have been seen in older adults and those with weakened immune systems or pre-existing health issues. However, serious illness can also occur in younger adults. About the flu Flu is a contagious respiratory illness caused by the influenza A and B viruses. It infects the nose, throat, and sometimes the lungs. There are 2 main types of influenza (flu) viruses: Types A and B. Some people, such as those who are 65 or older, young children, and people with certain health conditions, such as asthma and diabetes, are at higher risk of serious flu complications.
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The IgG and IgM antibody tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Results are for the detection of SARS CoV-2 antibodies. IgG and IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Individuals may have detectable virus present for several weeks following seroconversion. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, molecular testing for SARSCoV-2 is necessary. The tests should not be used to diagnose acute SARS-CoV-2 infection. False positive results for the test may occur due to cross-reactivity from pre-existing antibodies or other possible causes. The sensitivity of the IgM test early after infection is unknown. Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgM assay or an IgG assay. Samples should only be tested for IgM from individuals with 15 days to 30 days post symptom onset. SARS-CoV-2 antibody negative samples collected 15 days or more post symptom onset should be reflexed to a test that detects and reports SARS-CoV-2 IgG.
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and influenza B virus, and not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.