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SARS-CoV-2 RNA (COVID-19), Qualitative NAAT : 39448
Test CodeCOVIDP or 39448
Alias/See Also
SARS, Novel Coronavirus, nCOV, COVID-19, COVID, Wuhan, Coronavirus
CPT Codes
87635
Preferred Specimen
Preferred Specimen(s)
One (1) nasopharyngeal 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), or 3 mL Saline (0.85% to 0.90%) and 3 mL phosphate buffered saline (PBS) 1X pH (range of pH 7.2-7.4).
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 and use one swab for both nares) in a multi microbe media (M4, M4RT, M5, M6), VCM (UTM) medium (green-top) tube, Amies liquid elution swab (ESwab), equivalent* Viral Transport Media (VTM), or 3 mL Saline (0.85% to 0.90%) and 3 mL phosphate buffered saline (PBS) 1X pH (range of pH 7.2-7.4).
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.
Please note that Lower Respiratory specimens will be sent out to Quest SJC, California and turnaround time may be 3-4 days from the time of specimen pickup.
*Equivalent VTM: Specifically, Copan Universal Transport Medium (UTM), BD UVT, Cepheid XPert Sample Collection Kit for Viruses, Hardy-HealthLink UTM and Quest VCM transports are equivalent products.
One (1) nasopharyngeal 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), or 3 mL Saline (0.85% to 0.90%) and 3 mL phosphate buffered saline (PBS) 1X pH (range of pH 7.2-7.4).
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 and use one swab for both nares) in a multi microbe media (M4, M4RT, M5, M6), VCM (UTM) medium (green-top) tube, Amies liquid elution swab (ESwab), equivalent* Viral Transport Media (VTM), or 3 mL Saline (0.85% to 0.90%) and 3 mL phosphate buffered saline (PBS) 1X pH (range of pH 7.2-7.4).
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.
Please note that Lower Respiratory specimens will be sent out to Quest SJC, California and turnaround time may be 3-4 days from the time of specimen pickup.
*Equivalent VTM: Specifically, Copan Universal Transport Medium (UTM), BD UVT, Cepheid XPert Sample Collection Kit for Viruses, Hardy-HealthLink UTM and Quest VCM transports are equivalent products.
Transport Container
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 Temperature
Frozen.
Specimen Stability
Room temperature: 5 days; Refrigerated: 5 days; Frozen (Preferred): Acceptable at -70 C or -20 C
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Calcium alginate swabs, Cotton swabs with wooden shaft, Amies liquid or gel transport used for bacterial cultures
Methodology
Real-Time Reverse Transcriptase Polymerase Chain Reaction
Setup Schedule
Sunday - Saturday
Report Available
1-2 days
Reference Range
Not Detected.
Result Interpretation:
A Detected result is considered a positive test result for COVID-19. This indicates that RNA from SARS-CoV-2 (formerly 2019-nCoV) was detected, and the patient is infected with the virus and presumed to be contagious. If requested by public health authority, specimen will be sent 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. A Negative result does not rule out the possibility of COVID-19 and should not be used as the sole basis for treatment or patient management decisions. If COVID-19 is still suspected, based on exposure history together with other clinical findings, re-testing should be considered in consultation with public health authorities. 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.
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.
TNP (Test Not Performed): “Unable to report” due to one or more target results were not valid
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.
Result Interpretation:
A Detected result is considered a positive test result for COVID-19. This indicates that RNA from SARS-CoV-2 (formerly 2019-nCoV) was detected, and the patient is infected with the virus and presumed to be contagious. If requested by public health authority, specimen will be sent 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. A Negative result does not rule out the possibility of COVID-19 and should not be used as the sole basis for treatment or patient management decisions. If COVID-19 is still suspected, based on exposure history together with other clinical findings, re-testing should be considered in consultation with public health authorities. 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.
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.
TNP (Test Not Performed): “Unable to report” due to one or more target results were not valid
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.
Clinical Significance
The SARS Coronavirus with CoV-2 RNA, Qualitative Real-Time RT-PCR test is a qualitative multi-target molecular diagnostic 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.
Performing Laboratory
med fusion
