Ordering Recommendation

Use to detect the 2019 novel coronavirus (SARS-CoV-2).

Mnemonic

COVID19NAA

Methodology

Qualitative Nucleic Acid Amplification (NAA)

Performed

Sun-Sat

Reported

1-4 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation

Saliva: Patients should not eat or drink for 30 minutes prior to providing a saliva sample.

Collect

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

Specimen Preparation

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.

Storage/Transport Temperature

Frozen

Unacceptable Conditions

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.

Remarks

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.

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. 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.

Compliance Category

Depends on Specimen/Source/Method

Note

Hotline History

N/A

CPT Codes

87635

Components

Component Test Code* Component Chart Name LOINC
3002639 SARS-CoV-2 Source 31208-2
3002640 SARS-CoV-2 by NAA 94500-6
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • 2019-nCoV
  • Coronavirus disease - 2019
  • COVID-19
  • COVID-19 Illness
  • COVID-2019
  • SARS-CoV-2
SARS-CoV-2 (COVID-19) by NAA