The COVID-19 Molecular test checks for genetic material (viral RNA) produced by the virus. This determines if an individual is actively infected with COVID-19 and can spread it to others.
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 detection of nucleic acid from SARS-CoV-2, 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and epidemiological information.
People with COVID-19 have a wide range of symptoms – ranging from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have COVID-19.
This test may be right for you if you:
This test may NOT be right for you if you:
This test was developed and performed per a Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) by Enzo Clinical Laboratories, which is certified under CLIA, 42 U.S.C. §263a, to perform high complexity tests.
Positive results (SARS-CoV-2 RNA Detected) are indicative of active infection with SARS-CoV-2 but do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results (SARS-CoV-2 RNA Not Detected) do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
A false negative result may occur if a specimen is improperly collected, transported or handled. False negative results may also occur if amplification inhibitors are present in the specimen or if inadequate numbers of organisms are present in the specimen.
Laboratories within the United States and its territories are required to report all positive results to the appropiate public health authorities.
A molecular test may not detect the virus in early stages of infection. In addition, a molecular test may not detect the virus if there was a problem with your sample, such as when the sample is not collected as directed. There is also the possibility of a false negative (a negative result that is incorrect) if you’ve had recent exposure to the virus along with symptoms consistent with COVID-19.