InSTIcheck™ Gonorrhea Rapid Test – CE

INTENDED USE
InSTIcheck™ Gonorrhea is a rapid chromatographic immunoassay for the qualitative detection of Neisseria Gonorrhoeae directly from endocervical swab or urine specimens to aid in the diagnosis of Gonorrhea infection.

SUMMARY
Neisseria gonorrhoeae species of gram negative, aerobic bacteria is primarily found in purulent venereal discharges; it is the causative agent of gonorrhea. It is spread from person to person by contact with infected secretions, most often by sexual contact. N. gonorrhoeae (GC) is a leading cause of sexually transmitted disease with over 300,000 cases reported annually in the United States. The genital site most commonly infected in women is the cervix. In men, the genital site most commonly infected is the urethra. For neonates, there is significant risk for developing gonococcal conjunctivitis from passage through an infected birth canal. Regardless of the anatomical site of infection, gonococcal disease left untreated may become disseminated throughout the body and lead to arthritis, carditis, and/or meningitis. Bacterial culture using a variety of selective media is considered the “gold standard” for detecting the presence of N. gonorrhoeae. These methods, however, may require up to 72 hours to obtain a result. The sensitivity and specificity of the InSTIcheck™ Gonorrhea test compared with the results of standard cultures were 92% and 99%, respectively. The predictive values of positive InSTIcheck™ and negative InSTIcheck™ were 93% and 97%, respectively. In contrast to standard cultures,
gonococcal antigens in specimens were still detectable by this method up to 45 h of storage at either room temperature or 4°C. Considering the rapidity and ease of this method, the InSTIcheck™ Gonorrhea method is a useful and reliable diagnostic screening tool for gonococcal urethritis.

PRINCIPLE
The InSTIcheck™ Gonorrhea Rapid Test Device (Swab/Urine) is a qualitative, lateral flow immunoassay for the detection of Gonorrhea antigen from cervical swabs and urine specimens. In this test, antibody specific to the Gonorrhea antigen is coated on the test line region of the test. During testing, the extracted antigen solution reacts with an antibody to Gonorrhea that is coated onto particles. The mixture migrates up to react with the antibody to Gonorrhea on the membrane and generates a colored line in the test line region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.