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2019 Novel Coronavirus (COVID-19), NAA
Test CodeCOVID-19 (LabCorp 139900)
Alias/See Also
SARS CoV-2
COVID
COVID
CPT Codes
U0003
Preferred Specimen
Nasopharyngeal swab collected in M4 (Viral) Media
Nares swab collected in Saline
Nares swab collected in Saline
Instructions
Nasopharyngeal swabs must be collected by a nurse or Laboratory MLS/MLT.
Transport Temperature
Frozen
Specimen Stability
Frozen: 1 year
Refrigerated: 72 hours
Room Temp: 24 hours
Refrigerated: 72 hours
Room Temp: 24 hours
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
*Broken or Leaking specimens*
Transport media containing Calcium Alginate in ingredients.
Hank's balanced salt solution
Swabs in gel-based media
Transport media containing Calcium Alginate in ingredients.
Hank's balanced salt solution
Swabs in gel-based media
Methodology
Nucleic Acid Amplification (NAA)
FDA Status
Emergency Use Authorization
Report Available
Test reported 2-4 days from receipt of specimen at LabCorp.
Higher test volumes at LabCorp can affect turn around times.
Higher test volumes at LabCorp can affect turn around times.
Limitations
This nucleic acid amplification test was developed and its
performance characteristics determined by LabCorp
Laboratories. Nucleic acid amplification tests include RT-
PCR and TMA. This test has not been FDA cleared or
approved. This test has been authorized by FDA under an
Emergency Use Authorization (EUA). This test is only
authorized for the duration of time the declaration that
circumstances exist justifying the authorization of the
emergency use of in vitro diagnostic tests for detection of
SARS-CoV-2 virus and/or diagnosis of COVID-19 infection
under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)
(1), unless the authorization is terminated or revoked
sooner.
When diagnostic testing is negative, the possibility of a
false negative result should be considered in the context
of a patient's recent exposures and the presence of
clinical signs and symptoms consistent with COVID-19. An
individual without symptoms of COVID-19 and who is not
shedding SARS-CoV-2 virus would expect to have a negative
(not detected) result in this assay.
performance characteristics determined by LabCorp
Laboratories. Nucleic acid amplification tests include RT-
PCR and TMA. This test has not been FDA cleared or
approved. This test has been authorized by FDA under an
Emergency Use Authorization (EUA). This test is only
authorized for the duration of time the declaration that
circumstances exist justifying the authorization of the
emergency use of in vitro diagnostic tests for detection of
SARS-CoV-2 virus and/or diagnosis of COVID-19 infection
under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)
(1), unless the authorization is terminated or revoked
sooner.
When diagnostic testing is negative, the possibility of a
false negative result should be considered in the context
of a patient's recent exposures and the presence of
clinical signs and symptoms consistent with COVID-19. An
individual without symptoms of COVID-19 and who is not
shedding SARS-CoV-2 virus would expect to have a negative
(not detected) result in this assay.
Reference Range
Not Detected
Clinical Significance
Detection of SARS-CoV-2 to assist in the diagnosis of COVID-2019 infections.
Performing Laboratory
LabCorp