The Fulgent Coronavirus Disease (COVID-19) RT-PCR test is a reverse transcription polymerase chain reaction test to detect SARS-CoV-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 detect 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 positive result; amplification of one of two targets will signify an indeterminate (inconclusive) result; and no amplification of either target, but amplification of internal control, will signify a negative result. Inconclusive results will require a new sample for testing.
* This test has been authorized by the FDA under an Emergency Use Authorization (EUA). This means that while the 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. Please see the Patient Fact Sheet and the Healthcare Provider Fact Sheet for additional information. Additional information can be found on the FDA's website.
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No laboratory test is 100% accurate. A positive test is a strong indication that the sample we received is from someone who is infected, but there is some possibility of a false negative result due to test performance or sample contamination issues. A negative test does not completely rule out an infection. If you have symptoms (fever, cough, fatigue, etc.), you should take precautionary measures regardless of the result of this test. Consult a physician or the CDC website for more information.
How long a person needs to be infected before testing positive, and whether an infected person can be identified by the test before displaying symptoms, are currently unknown.
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