Real-Time Reverse Transcriptase PCR Analysis
Integrity Laboratories received Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on April 13, 2020 for its SARS-Cov-2 laboratory developed test.
High Complexity Molecular-Based Laboratory Developed Testing
The SARS-CoV-2 assay is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to Integrity Laboratories, which is a Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a certified high-complexity laboratory.
Results are for the 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 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 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. This assay is intended for use under the Food and Drug Administration’s Emergency Use Authorization.