SARS-CoV-2 RNA (COVID-19), Qualitative NAAT

Test Code

39448

CPT Codes
87635<br><br><strong>To meet regulatory reporting requirements for COVID-19 testing, the patient's address, phone number and other demographic details are required for this order.</strong>

Preferred Specimen

1 Nasopharyngeal swab collected in 3 mL V-C-M medium (green- or purple-cap) or equivalent, or multi microbe media (M4, M4RT, M5, M6), Amies liquid elution swab (ESwab), or equivalent Viral Transport Media (VTM), including saline or PBS

Minimum Volume

1 swab • 0.5 mL

Other Acceptable Specimens

Upper respiratory specimens such as: One (1) oropharyngeal (OP) swab; combination NP/OP swabs collected together; or an anterior nares specimen (collected using only a foam swab) in a multi microbe media (M4, M4RT, M5, M6), VCM (UTM) medium (green-top) tube, Amies liquid elution swab (ESwab), or equivalent Viral Transport Media (VTM), including saline or PBS
OR
Lower respiratory specimens such as: 0.85 mL bronchoalveolar lavage/wash, nasopharyngeal aspirate/wash, tracheal aspirate, or sputum sample collected in a plastic sterile leak-proof container

Instructions

Quest Diagnostic Patient Service Centers now offer observed anterior nares (AN) patient specimen self-collection for SARS-CoV-2 RNA (COVID-19) Qualitative NAAT, where allowed by state regulations, for patients who are asymptomatic or experiencing mild, cold-like symptoms.

If patients are experiencing severe symptoms such as a high-grade fever of 102 °F or more that has lasted for 48 hours or severe and constant shortness of breath, they will need to consult a healthcare provider and will not be eligible for testing at a Patient Service Center.

Cold packs/pouches must be used if placing specimens in a lockbox for courier pick-up. STAT pick-up cannot be ordered for this test.

Each COVID-19 specimen transport vial that is submitted should be accompanied by its own separate requisition and transported in its own sealed bag.

IMPORTANT: Please review the Specimen Collection instructions COVID-19 NASOPHARYNGEAL SAMPLE COLLECTION GUIDE | COVID-19 OROPHARYNGEAL SPECIMEN COLLECTION GUIDE | QUEST SPECIMEN REQUIREMENTS AND ACCEPTABLE SUPPLIES FOR COVID-19 TESTING | SPUTUM SPECIMEN COLLECTION GUIDE for this test.

Quest Diagnostic Patient Service Centers and Quest in-office phlebotomists do not collect respiratory specimens, including those from patients suspected to have COVID-19.

Transport Temperature

Frozen

Specimen Stability

Room temperature: 5 days
Refrigerated (2-8° C): 5 days
Frozen (-20° C): Acceptable
Frozen (-70° C): Acceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Calcium alginate swabs; Cotton swabs with wooden shaft • Amies liquid or gel transport used for bacterial cultures • Tubes with clot activator • Glass tubes • Snap-cap tubes • 3D printed swabs • Media with guanidine isothiocyanate (GITC) due to safety concerns

Methodology
Nucleic Acid Amplification Test (NAAT) includes RT-PCR or TMA

FDA Status
This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.

Setup Schedule

Monday-Sunday Morning Report available: Next Day

Reference Range

Not detected

Clinical Significance

The SARS-CoV-2 RNA (COVID-19), Nucleic-acid Amplification Test (NAAT) is a qualitative multi-target molecular diagnostics test that aids in the detection of COVID-19. This test is intended to be performed on respiratory specimens collected from individuals who meet the Centers for Diseases Control and Prevention (CDC) clinical and/or Epidemiological criteria for COVID-19 testing. For details visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html.

Result interpretation:
• A Detected result is considered a positive test result for COVID-19. This indicates that RNA from SARS-CoV-2 was detected and that the patient is considered infected with the virus and presumed to be contagious. If requested by public health authorities, specimens will be send for additional testing.
• A Not Detected (negative) test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, it does not rule out the possibility of COVID-19 and should not be used as the sole basis for patient management decisions.
• An Inconclusive result means not all of the testing targets were detected. This could be due to a sample with viral concentrations near the limit of detection of the test or other factors. An additional sample collection may be considered.

Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions.

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The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.