INTENDED USE
The neisseria gonorrhoeae antigen test card is a rapid visual immunoassay for the qualitative detection of neisseria gonorrhoeae in female endocervical swab and male urethral swab specimens. This kit is intended for use as an aid in the diagnosis of neisseria gonorrhoeae infection.
PRINCIPLE
The neisseria gonorrhoeae antigen test kit is designed to detect N. Gonorrhoeae through visual interpretation of the color development in the internal strip. The membrane was immobilized with gonococcal Antigen-specific polychonal antibody on the test region (T) and related antibodies on the control region(C).
During testing, the specimen is added to the sample region (S) and reacts with anti-gonococcus antibodies conjugated to colored particles and precoated onto the sample pad of the test. Then, the mixture migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient gonococcus antigens in the specimen, a colored band will form at the test region (T) of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
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