Private Chlamydia home testing kits, full accessories kits, detecting private disease at home

Accessories:

Test tubes
Dropper tips
Sterile polyester tipped applicator
(Sterile female cervical swabs)
Reagent A
Reagent B
Workstation
Package insert

Summary:

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 inclusions 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.¹ Vertical transmission of the disease during parturition from mother to neonate can result in inclusion conjunctivitis pneumonia. In men, complications of Chlamydia infection include 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 (48-72 hours) and not routinely available in most institutions.

The Chlamydia Rapid Test Device is a rapid test to qualitatively detect the Chlamydia antigen from clinical specimens, providing results in 10 minutes. The test utilizes antibody specific for Chlamydia to selectively detect Chlamydia antigen from clinical specimens.

Intended Use:

The Chlamydia Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in clinical specimens to aid in the diagnosis of Chlamydia infection.

Specimen Collection and Handling

Consider any materials of human origin as infectious and handle them using standard biosafety procedures.

Swab specimen should be collected by standard male or female specimen collection methods.

Swabs should be processed as soon as possible after collection. If swabs are not processed immediately, they should be placed into a dry, sterile, tightly capped tube or bottle and stored in refrigerator (2°C -8°C) for up to 5 days, preferably in a transportation tube.

A specimen swab which contains too much blood may cause weak false positive results. Therefore, bloody swabs should be avoided.

Do not freeze the swab.

Swabs may be transported to the test site under ambient conditions. Transport media should not be used.

PERFORMANCE CHARACTERS:

A total of 110 samples from susceptible subjects were tested by the OnSite Chlamydia Rapid Test and by a commercial latex rapid test. Comparisons for all subjects are showed in the following table:

To confirm the specificity of OnSite Chlamydia Rapid Test, 15 serotypes were tested and demonstrated to yield Chlamydia-positive results. In addition C. Pneumonia and C. psittaci were tested with the OnSite Chlamydia Rapid Test and gave positive results.

Cross-reactivity with other organisms has been studied using suspensions of 107 CFU/ml (CFU — colony forming unit) and demonstrated to yield Chlamydia-negative results. Staphylococcus aureus was tested at 1x106 cells/test and also yielded negative results. The organisms tested are listed below: