The Telomere Diagnostics SARS-CoV-2/COVID-19 Test is designed to detect the presence of the underlying virus (SARS-CoV-2) that causes COVID-19, and is for use with patients who meet current guidance for evaluation. This test has not been FDA cleared or approved.
The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. 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. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Laboratories within the United States and its territories are required to report all positive (and in many cases, negative) results to the appropriate public health authorities.