The Fulgent Coronavirus Disease (COVID-19) RT-PCR test is a reverse transcription polymerase chain reaction test to detect SARSCoV- 2, the virus that causes COVID-19. This method is also called a nucleic acid amplification test (NAAT).
The SARS-CoV-2 primer and probe sets are designed to RNA from 2019-nCoV in specimens from patients who meet CDC 2019- nCoV clinical criteria. Primer and probe set sequences are based on CDC recommended guidelines that identify two known distinct regions within the SARS-CoV-2 genome. Amplification of both targets will signify a laboratory performing this test has validation data to support offering this test, it has not been approved or cleared by the FDA. This test has only been authorized by the FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen. It is only authorized during the duration of the COVID-19 emergency declaration by federal regulators under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Additional information can be found on the FDA’s website.