Arrayit Corporation (ARYC)

[mfdesigner]

Direct quote from FDA's emergency use authorization:

The SARS-CoV-2 assay is a [specify test technology such as, real-time RT-PCR test] intended for the [presumptive] qualitative detection of nucleic acid from the SARS-CoV-2 in [list respiratory specimens] from individuals suspected of COVID-19. Testing is limited to [Name of Clinical Laboratory(s)] that are Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a certified high-complexity laboratories.

Results are for the [presumptive] detection and identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results 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. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

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.

The assay is intended for use by CLIA certified high-complexity laboratories with experience in developing molecular diagnostics and is only for use under the Food and Drug Administration’s Emergency Use Authorization.