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SARS CoV 2 RNA, QL RT PCR
Test Code70453
CPT Codes
87635, HCPCS: U0002<br /> Limited Access Code
Preferred Specimen
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)
Minimum Volume
1 swab • 0.35 mL
Other Acceptable Specimens
1.) 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)
(2.) Lower respiratory specimens such as:
0.85 mL Bronchial lavage/wash, nasopharyngeal aspirate/wash, tracheal aspirate, or sputum sample collected in a plastic, sterile, leak-proof container
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)
(2.) Lower respiratory specimens such as:
0.85 mL Bronchial lavage/wash, nasopharyngeal aspirate/wash, tracheal aspirate, or sputum sample collected in a plastic, sterile, leak-proof container
Instructions
Please read detailed instructions below related to collection and transport:
COVID-19 specimens can ONLY be collected in physician offices and hospitals. Quest Diagnostics Patient Service Centers and Quest in-office phlebotomist do not collect respiratory specimens, including those from patients suspected to have COVID-19.
Specimens should be transported to your local Quest Diagnostics accessioning laboratory according to standard operating procedures. Cold packs/pouches must be in a lockbox for courier pick-up. STAT pick-up cannot be ordered for this test.
The CDC has expanded their guidance regarding specimen collection. Nasopharyngeal (NP) and/or oropharyngeal (OP) swabs can now be collected and transported in their own vial or combined in a single vial for testing. 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 (preferred): Frozen
COVID-19 specimens can ONLY be collected in physician offices and hospitals. Quest Diagnostics Patient Service Centers and Quest in-office phlebotomist do not collect respiratory specimens, including those from patients suspected to have COVID-19.
Specimens should be transported to your local Quest Diagnostics accessioning laboratory according to standard operating procedures. Cold packs/pouches must be in a lockbox for courier pick-up. STAT pick-up cannot be ordered for this test.
The CDC has expanded their guidance regarding specimen collection. Nasopharyngeal (NP) and/or oropharyngeal (OP) swabs can now be collected and transported in their own vial or combined in a single vial for testing. 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 (preferred): Frozen
Transport Temperature
Frozen
Specimen Stability
Room temperature: 5 days
Refrigerated: 5 days
Frozen -20°C: Acceptable
Frozen -70°C: Acceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Calcium alginate swab; Cotton swabs with wooden shaft; Amies liquid or gel transport used for bacterial cultures
Methodology
Real-Time Reverse Transcriptase Polymerase Chain Reaction
FDA Status
This test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.
Setup Schedule
Set up: Daily; Report available: 1-2 days
Reference Range
Not detected
Clinical Significance
The SARS-CoV-2 RNA, Real-time RT-PCR test 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 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. 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, 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.
Test results are typically available 3-4 days from the time of specimen pickup, and may be impacted by high demand.
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 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. 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, 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.
Test results are typically available 3-4 days from the time of specimen pickup, and may be impacted by high demand.
