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The Thermo BioStar® GC OIA assay is an Optical ImmunoAssay test for the rapid qualitative detection of gonococcal antigen (L7/L12 ribosomal protein) in female endocervical swab and male urine specimens. Urine specimens must be prepared using an accessory Urine Filtration Device (UFD) for concentration and extraction. This test is intended for in vitro diagnostic use as an aid in identifying the presence of Neisseria gonorrhoeae antigen. The assay is intended for use with symptomatic females and males, in populations at risk for sexually transmitted diseases.

The GC OIA test involves the qualitative extraction and detection of an antigen unique to N. gonorrhoeae. The Optical ImmunoAssay technology enables the direct visual detection of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When an extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antibody-enzyme conjugate is then added for form an immune complex "sandwich" of immobilized antibody-sample-antibody HRP on the surface. After washing, the substrate is added, increasing the thickness (mass enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.