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SARS-CoV-2 RNA (COVID-19) and Influenza A and B, Qualitative NAAT
Test Code31688
CPT Codes
87636<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
One (1) nasopharyngeal (NP) swab collected in VCM (UTM) medium tube, UTM-RT or equivalent Viral Transport Media (VTM); phosphate buffered saline (PBS) or 0.9% physiological saline
OR
One (1) nasal swab (Anterior Nares) collected in VCM (UTM) medium tube or equivalent Viral Transport Media (VTM); 0.9% physiological saline; phosphate buffered saline (PBS)
OR
One (1) nasal swab (Anterior Nares) collected in VCM (UTM) medium tube or equivalent Viral Transport Media (VTM); 0.9% physiological saline; phosphate buffered saline (PBS)
Minimum Volume
1 swab • 1 mL
Instructions
Quest Patient Service Centers, where allowed by state regulations, offer observed anterior nares (AN) self- collection for molecular (PCR) SARS-CoV-2 RNA (COVID-19) and Influenza A and B, Qualitative NAAT, 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.
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 Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 7 days
Refrigerated: 14 days
Frozen:
Nasopharyngeal swab or Nasal (Anterior Nares) swab collected in VCM (UTM) medium tube, UTM-RT or equivalent Viral Transport media (VTM): 30 days
Nasal (Anterior Nares) swab collected in 0.9% physiological saline: 7 days
Nasopharyngeal swab or Nasal (Anterior Nares) swab collected in phosphate buffered saline (PBS): Unacceptable
Refrigerated: 14 days
Frozen:
Nasopharyngeal swab or Nasal (Anterior Nares) swab collected in VCM (UTM) medium tube, UTM-RT or equivalent Viral Transport media (VTM): 30 days
Nasal (Anterior Nares) swab collected in 0.9% physiological saline: 7 days
Nasopharyngeal swab or Nasal (Anterior Nares) swab collected in phosphate buffered saline (PBS): Unacceptable
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
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
Sets up 7 days a week.
Report Available
Reports in 1 to 3 days.
Clinical Significance
SARS-CoV-2 RNA (COVID-19) and Influenza A and B, Qualitative NAAT is a qualitative multi-target molecular diagnostics test that aids in simultaneous detection of COVID-19, influenza A and influenza B. This test is intended to be performed on respiratory specimens collected by a healthcare provider from individuals suspected of respiratory viral infection consistent with COVID-19 or influenza.
Result Interpretation:
• A Detected result indicates that RNA from SARS-CoV-2, influenza A, or influenza B was Detected. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Test results will be reported to the appropriated public health authorities.
• A Not Detected (negative) test result for this test means that RNA from SARS-CoV-2, influenza A and influenza B was not present in the specimen above the limit of detection. However, it does not rule out the possibility of infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for patient management decisions.
• An Inconclusive result for SARS-CoV-2 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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Result Interpretation:
• A Detected result indicates that RNA from SARS-CoV-2, influenza A, or influenza B was Detected. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Test results will be reported to the appropriated public health authorities.
• A Not Detected (negative) test result for this test means that RNA from SARS-CoV-2, influenza A and influenza B was not present in the specimen above the limit of detection. However, it does not rule out the possibility of infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for patient management decisions.
• An Inconclusive result for SARS-CoV-2 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.
Click here to see turnaround time
