COVID-19 is a respiratory disease caused by infection with a new form of coronavirus (SARS-CoV-2) that has now been detected in multiple locations around the world. Worldwide and private domestic labs supporting the public health response are working at full capacity to expand the amount and methods of COVID-19 testing to combat and detect the spread of this virus.
Test for diagnosis
Most of the tests being rolled out against COVID-19 are based on reverse transcriptase polymerase chain reaction (RT-PCR). This type of ideal diagnostic is both specific and sensitive, which means that people who test positive truly have the disease and none of the people carrying the virus slip through the test as a false negative. RT-PCR meets both criteria, with specificity and sensitivity rates of 90 percent and above.
The RT-PCR test starts with a throat or nasal swab, which is designed to capture virus genetic material. SARS-CoV-2 is an RNA virus, so its genetic material is more transient and fragile than DNA. Because of that, samples should ideally be transported to testing laboratories on ice or in special media to prevent them from degrading.
What are acceptable samples types for 2019 Novel Coronavirus (COVID-19) testing?
- Nasopharyngeal (NP) swab in viral transport medium;
- Oropharyngeal (OP) collection in viral transport medium;
- OP or NP washes/aspirates in sterile cups; and
- bronchial washings or bronchoalveolar lavage (BAL) specimens in sterile cups.
Turnaround time for COVID-19 testing is typically less 2-3 days from the time of specimen pick-up from our facility, but can vary due to high demand.
- These tests have been authorized by the FDA under an EUA for use by authorized laboratories;
- These tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
- These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.