The Mount Sinai SARS-CoV-2 Assay is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens that are collected at home using the Mount Sinai SARS-CoV-2 Collection Kit by any individuals age 18 years and older (self-collected), 14 years and older (self-collected under adult supervision), or 5 years and older (collected with adult assistance), including from individuals without symptoms or other reasons to suspect COVID-19, when determined to be appropriate by a healthcare provider. Saliva specimens collected at home can be transported at ambient temperature to the laboratory for testing.
Testing is limited to Mount Sinai COVID Laboratory, located at 281 First Avenue, 12th Floor Dazian Building, Room 1201, New York, NY 10003, which is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva 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. Laboratories within the United States and its territories are required to report all 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. Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.
The Mount Sinai SARS-CoV-2 Assay is intended for use by qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Mount Sinai SARS-CoV-2 Assay and the Mount Sinai SARS-CoV-2 Collection Kit are only for use under the Food and Drug Administration’s Emergency Use Authorization.
