BinaxNow Rapid COVID-19 Antigen Test

Test Code

STCVD

Alias/See Also

COVID antigen test

Preferred Specimen

Sterile foam swab

Patient Preparation
Nasopharyngeal (NP) swab: Immobilize the patient’s head and insert swab through a nostril. Push forward using gentle downward pressure to keep the swab on the floor of the nasal cavity until the tip reaches the posterior wall of the nasopharynx. Rotate gently for a few seconds and remove. Specimen should be tested immediately after collection.

Minimum Volume

1 swab

Other Acceptable Specimens

None

Instructions

Insert the swab into a clean, unused plastic tube lebelled with the patient information, preserviing the sample integrity and capped tightly..

Transport Container

Unused general purpose plastic tube. See instructions.

Transport Temperature

Room temperature. Transport immediately to lab.

Specimen Stability

Test immediatley

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Visually bloody or overly visous samples
Samples sent in original packaging

Methodology
Immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from nasal swab specimens.

Setup Schedule

As needed

Report Available

24 hours

Limitations

This test detects both viable and non-viable SARS-CoV and SARS CoV-2. Test performance depends on the amount of virus in the sample and may not correlate with viral culture results performed on the same sample.
A negative test result may occur if the laevel of antigen in a sample is below the detection limit of the test.
The presence of mupirocin may interfere withthe BinaxNOW COVID-19 Ag test and may cause false negative results.

Reference Range

Negative

Clinical Significance

The BinaxNOW™ COVID-19 Ag is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab samples collected from individuals who are suspected of COVID-19 within seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests. The BinaxNOW COVID-19 Ag does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal swabs during the acute phase of infection. 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. The agent detected may not be the definite cause of disease. All negative results are presumptive and confirmation with a molecular assay may be performed. 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.

Performing Laboratory
AHC Labs

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.