CPT® Code 86328

Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19])

The CPT® Code 86328 refers to an immunoassay designed for the qualitative or semiquantitative detection of antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which is responsible for coronavirus disease (COVID-19). This procedure utilizes a single-step method, commonly known as a rapid reagent test strip, which allows for a swift diagnosis within approximately 10 to 15 minutes. The test is particularly effective in identifying antibodies produced by the body in response to SARS-CoV-2 infection, typically detectable between 3 and 7 days after the onset of symptoms. The immunoassay is performed using a membrane-based test strip that can analyze serum, plasma, or whole blood samples. The test strip consists of specific regions: one for detecting IgG antibodies, another for IgM antibodies, and a control area to ensure the test is functioning correctly. When a blood sample is applied to the test strip, it interacts with SARS-CoV-2 antigen-coated particles, and the resulting mixture moves along the membrane through capillary action. The appearance of colored lines in the test regions indicates the presence of antibodies, while the control line confirms the validity of the test. This rapid testing method is crucial for timely diagnosis and management of COVID-19, providing healthcare professionals with immediate results to guide further clinical decisions.