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Test Code COVG SARS-CoV-2 Antigen Assay, Nasal

Performing Laboratory

Hunterdon Medical Center Laboratory

Useful For

 The qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs, using lateral flow immunoassay.

The antigen is generally detectable in nasal swabs during the acute phase of the infection.

Specimen Requirements

Kit containing the BinaxNOW™ sterile swab and transport tube is supplied by the laboratory. This kit must be must be used for collection and transport of the specimen.

Collection:

  • Carefully insert the swab into the nostril exhibiting the most drainage, or appearing to be the more congested. Using gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab 5 times or more against the nasal wall then slowly remove from the nostril. Using the same swab, repeat sample collection in the other nostril.
  • Place swab in the clean plastic tube contained in the kit; label with the patient  information and date/time of collection.
  • Cap tightly and send to the laboratory immediately.

Specimen Type

Nasal Swab

Specimen Transport Temperature

Ambient, must be received within 30 minutes of collection

Specimen Stability

Testing must be performed within 30 minutes of collection. Specimens >30 minutes old must be recollected.

Reject Specimen Due To

Specimen collection time is > 30 minutes.

If unable to obtain valid results, repeat collection will be required.

Day(s) Test Set up

Sunday through Monday

Reference Values

Negative.

 

Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

 

Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

Methodology

Lateral flow immunoassay

Test Classification

This test has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration.

CPT Code

87426

Loinc Code

94558-4