Use to detect the 2019 novel coronavirus (SARS-CoV-2).
Qualitative Nucleic Acid Amplification
New York DOH Approval Status
Saliva: Patients should not eat or drink for 30 minutes prior to providing a saliva sample.
Nasopharyngeal swab, oropharyngeal swab, nasal swab, or saliva.
Refer to the "COVID-19 Specimen Collection Guide" at https://www.aruplab.com/infectious-disease/coronavirus/testing
Nasopharyngeal swab: Place in viral transport media (ARUP supply #12884) available online thorugh eSupply using ARUP Connect or contact ARUP Client Services at (800) 522-2787, Liquid Amies, or saline (minimum volume 1.2mL). Place each specimen in an individually sealed bag.
Oropharyngeal or nasal swab: Place in viral transport media (ARUP supply #12884) available online thorugh eSupply using ARUP Connect or contact ARUP Client Services at (800) 522-2787, Liquid Amies, or saline (minimum volume 1.2mL). Or collect using the Aptima Multitest Swab Collection Kit. Place each specimen in an individually sealed bag.
Saliva: Transport in COVID-19 ARUP Transport Media (ATM) Saliva Collection Tube (ARUP supply #56257) available online through eSupply using ARUP Connect or contact ARUP Client Services at (800) 522-2787.
Undiluted saliva. Saliva submitted in anything other than the ARUP Saliva Collection Tube. Swabs not in media. Wood swabs, calcium alginate swabs. Media with guanidine-containing materials, 'molecular media' that indicates inactivation of pathogens and preservation of RNA/DNA, charcoal media. Specimens sent in tubes with pop-top lids/caps. Specimens in glass tubes.
Specimen source required. If submitting media that is not listed in the "COVID-19 Specimen Collection Guide," send the package insert or ingredient list to COVID-19Requests@aruplab.com so it can be reviewed for compatibility with ARUP testing platforms.
Swabs: Ambient: Unacceptable; Refrigerated: 2 days; Frozen: 1 month
Saliva: Ambient: 5 days; Refrigerated: 5 days, Frozen: 5 days
This test should be ordered for the detection of the 2019 novel coronavirus SARS-CoV-2 in individuals who meet SARS-CoV-2 clinical and/or epidemiological criteria.
The Coronavirus SARS-CoV-2 (COVID-19) by nucleic acid amplification test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for U.S. laboratories certified under CLIA to perform high complexity tests. This test has not been FDA cleared or approved. In compliance with this authorization, please visit https://www.aruplab.com/infectious-disease/coronavirus for more information and to access the applicable information sheets.
Not Detected results do not rule out the presence of PCR inhibitors in the patient specimen or assay-specific nucleic acid in concentrations below the level of detection by the assay.
Detected results are indicative of the presence of SARS-CoV-2 RNA. Due to the complexity of nucleic acid amplification methodologies, there may be a risk of false-positive results. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.
Reliable results are dependent on adequate specimen collection, transport, storage, and handling.
Depends on Specimen/Source/Method
U0003; (Alt code: 87635)
|Component Test Code*||Component Chart Name||LOINC|
|3002640||SARS-CoV-2 by NAA||94500-6|
- Coronavirus disease - 2019
- COVID-19 Illness