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

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

Test Code

39448
87635

To meet regulatory reporting requirements for COVID-19 testing, the patient's address, phone number and other demographic details are required for this order.
39448
87635

To meet regulatory reporting requirements for COVID-19 testing, the patient's address, phone number and other demographic details are required for this order.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

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

Test Details

Methodology

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

Assay Category

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

Reference Range(s)

Not detected

Alternative Name(s)

Novel Coronavirus,Wuhan,COVID19,nCOV,Coronavirus

LOINC® Codes, Performing Laboratory

Methodology

Nucleic Acid Amplification Test (NAAT) includes RT-PCR or TMA
This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.

Reference Range(s)

Not detected

Alternative Name(s)

Novel Coronavirus,Wuhan,COVID19,nCOV,Coronavirus

Preferred Specimen(s)

One (1) nasopharyngeal (NP) swab collected 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

Alternative Specimen(s)

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

Minimum Volume

1 swab • 0.6 mL

Collection 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.

Transport Container

Preferred: Multi microbe media (M4, M4RT, M5, M6), VCM medium (green-cap) tube or equivalent (UTM)
Acceptable: Plastic sterile leak-proof container

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

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

Setup Schedule

One (1) nasopharyngeal (NP) swab collected 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
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
1 swab • 0.6 mL
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.
Preferred: Multi microbe media (M4, M4RT, M5, M6), VCM medium (green-cap) tube or equivalent (UTM)
Acceptable: Plastic sterile leak-proof container
Frozen
Room temperature: 5 days
Refrigerated (2-8° C): 5 days
Frozen (-20° C): Acceptable
Frozen (-70° C): Acceptable
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
In-home collection is not available in your area through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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