Sign in →

Test ID FCOV2 2019 Novel Coronavirus (COVID-19), NAA


Specimen Required


Submit one of the following (Swabs are preferred) only submit one sample type per patient:

 

Note: Viral transport medium acceptable for collection of influenza specimens in 1 mL or 3 mL volumes can be used to transport swabs for COVID-19 testing.

 

Specimen Type: Nasopharyngeal swab or Oropharyngeal (throat) swab

Container/Tube: Sterile container with viral transport media M4, M5, M6 VCM,UTM, 0.85-0.9% saline, or ESwab â„¢;

Specimen Volume: 1 swab

Collection Instructions:

1. Order SARS-CoV-2 NAA separately from other tests.

2.  Transport frozen on dry ice.

Shipping and storage: -70° C is acceptable

 

 

Specimen Type: Nasopharyngeal (NP) or Oropharyngeal (OP) aspirate or washing

Sources: Nasopharyngeal (NP) aspirate or washing

Container/Tube: Sterile leak proof container

Specimen Volume: 1-3 mL

1. Order SARS-CoV-2 NAA separately from other tests

2.  Transport frozen on dry ice.

Shipping and storage: -70° C is acceptable

 

 

Specimen Type: Lower respiratory tract

Sources: Bronchoalveolar lavage (BAL), bronchial washings, tracheal aspirate or sputum

Container/Tube: Sterile leak proof container

Specimen Volume: 1-3 mL

1. Order SARS-CoV-2 NAA separately from other tests

2.  Transport frozen on dry ice.

Shipping and storage: -70° C is acceptable


Useful For

Detection of SARS-CoV-2 to assist in the diagnosis of COVID-19 infections.

Method Name

Nucleic Acid Amplification (NAA)

Reporting Name

SARS-CoV-2, NAA

Specimen Type

Varies

Specimen Minimum Volume

0.8 mL
Note: This volume does not allow for repeat testing

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Frozen (preferred)
  Refrigerated  72 hours

Reference Values

Not Detected

Day(s) and Time(s) Performed

Sunday through Saturday

Performing Laboratory

LabCorp Burlington

Test Classification

This test was developed and its performance characteristics determined by LabCorp Laboratories. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test has been validated in accordance with the FDA's Guidance Document "Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency issued on February 29th, 2020. FDA independent review of this validation is pending. 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. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. This test is pending the Food and Drug Administration's Emergency Use Authorization.

CPT Code Information

87635

U0002 (if appropriate for government payers)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FCOV2 SARS-CoV-2, NAA 94309-2

 

Result ID Test Result Name Result LOINC Value
FCOV2 SARS-CoV-2, NAA 94309-2

NY State Approved

Yes