Chlamydia/Gonorrhoeae Ag Combo Rapid Test

Background of Clinical Indications

Chlamydia trachomatis is the most common cause of sexually transmitted venereal infection in the world. It is composed of elementary bodies (the infectious form) and reticulate or inclusion bodies (the replicating form). Chlamydia trachomatis has both a high prevalence and asymptomatic carriage rate, with frequent serious complications in both women and neonates. Complications of Chlamydia infection in women include cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID) and increased incidence of ectopic pregnancy and infertility. Vertical transmission of the disease during parturition from to neonate can result in inclusion conjunctivitis or pneumonia. In men, complication of Chlamydia includes urethritis and epididymitis. At least 40% of the nongonococcal urethritis cases are associated with Chlamydia infection. Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are asymptomatic. Traditionally, Chlamydia infection has been diagnosed by detection of Chlamydia inclusions in tissue culture cells. Culture method is the most sensitive and specific laboratory method, but it is labor intensive, expensive, long (18-72 hours) and not routinely available in most situations.

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 examination. 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.

The Chlamydia/Gonorrhoeae Ag Combo Rapid Test utilizes of specific monoclonal antibodies to qualitatively detect Chlamydia and Neisseria gonorrhoeae antigen in female cervical swab and male urethral swab specimens . The test can be performed without cumbersome laboratory equipment, and the results are available within 20 minutes.