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 94.1% (32/34) and 95.8% (23/24), respectively. The predictive values of positive InSTIcheck™ and negative InSTIcheck™ were 96.9% (32/33) and 98.8% (23/25), 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.