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SARS-CoV-2 (COVID-19)
Ordering Recommendation
Use to detect the novel coronavirus (SARS-CoV-2).
Mnemonic
Methodology
Qualitative Nucleic Acid Amplification (NAA)
Performed
Mon-Sat
Reported
1-2 days
New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation:
Collect:
Nasopharyngeal swab, oropharyngeal swab, nasal swab, or saliva. To ensure the highest quality results, a nasopharyngeal swab is recommended.
Specimen Preparation:
Nasopharyngeal swab: Place in viral transport media 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 Liquid Amies, or saline (minimum volume 1.2mL).
Swab Collection Kit. Place each specimen in an individually sealed bag.
Saliva: Transport in COVID-19 Saliva Collection Tube
Storage/Transport Temperature:
Frozen.
Unacceptable Conditions:
Undiluted saliva. Saliva submitted in anything other than a 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.
Remarks:
Stability:
Swabs: Ambient: Unacceptable; Refrigerated: 2 days; Frozen: 1 month
Saliva: Ambient: 5 days; Refrigerated: 5 days, Frozen: 5 days
Reference Interval
Interpretive Data
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.
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.
Compliance Category: Depends on Specimen/Source/Method
Note
CPT Code
87635
Components
Component Chart Name
SARS-CoV-2 Source
Component Test Code
3002639
LOINC
31208-2
3002640
SARS-CoV-2 by NAA
94500-6
Aliases
2019-nCoV
Coronavirus disease - 2019
COVID-19
COVID-19 Illness
COVID-2019
SARS-CoV-2
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