COVID 19 - SARS CoV 2 RNA, QUALITATIVE NAAT

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 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.

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 and Quest in-office phlebotomists do not collect respiratory specimens, including those from patients suspected to have COVID-19. Anterior nares specimens (use one swab for both nares) should be collected by a healthcare professional or by healthcare-directed onsite self-collection by using a round foam swab.
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 | COVID-19: ACCEPTABLE SUPPLIES AND SPECIMEN REQUIREMENTS | SPUTUM SPECIMEN COLLECTION GUIDE for this test

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

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)
COVID19,Novel Coronavirus,nCOV,Wuhan,Coronavirus