INTENDED USE

The Gonorrhea Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Neisseria gonorrhoeae in female cervical swab and male urethral swab specimens to aid in the diagnosis of Gonorrhea infection.

SUMMARY

Gonorrhea is a sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae. Gonorrhea is one of the most common infectious bacterial diseases and is most frequently transmitted during sexual intercourse, including vaginal, oral and anal sex. The causative organism can infect the throat, producing a severe sore throat. It can infect the anus and rectum, producing a condition called proctitis. With females, it can infect the vagina, causing irritation with drainage (vaginitis). Infection of the urethra may cause urethritis with burning, painful urination, and a discharge. When women have symptoms, they often note vaginal discharge, increased urinary frequency, and urinary discomfort. Spread of the organism to the fallopian tubes and abdomen may cause severe lower-abdominal pain and fever. The average incubation for Gonorrhea is approximately 2 to 5 days following sexual contact with an infected partner. However, symptoms may appear as late as 2 weeks. A preliminary diagnosis of Gonorrhea can be made at the time of examination1 In women, Gonorrhea is a common cause of pelvic inflammatory disease (PID). PID can lead to internal abscesses and long-lasting, chronic pelvic pain. PID can damage the fallopian tubes enough to cause infertility or increase the risk of ectopic pregnancy.2A smear or swab of urethral or cervical discharge may be taken and tested using a Gonorrhea Rapid Test.

PRINCIPLE

The Gonorrhea Rapid Test Cassette (Swab) is a qualitative, lateral flow immunoassay for the detection of Gonorrhea antigen from female cervical and male urethral. In the 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 color line in the test 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.