polymerase chain reaction (PCR) TEST

The COVID-19 RT-PCR test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test.

Also known as a nucleic acid amplification test (NAAT), for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, saliva, and nasal swabs) collected from individuals suspected of COVID-19. This test has been validated for performance by Swab Me Now LLC. that is certified under the Clinical Laboratory Improvement Amendment 2003 (CLIA), 42 U.S.C. ยง263a, to perform high complexity tests. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Detected result is considered a positive test result for COVID-19. This indicates that RNA fromSARS-CoV-2 (formerly 2019-nCoV) was detected, and the patient is infected with the virus and presumed to be contagious. If requested by public health authority, specimen will be sent for additional testing. A Not Detected (negative) test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. A negative result does not rule out the possibility of COVID-19 and should not be used as the sole basis for treatment or patient management decisions. If COVID-19 is still suspected, based on exposure history together with other clinical findings, retesting should be considered in consultation with public health authorities. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Please review the “Fact Sheets” and FDA authorized labeling available for health care providers and patients. For details visit https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html.