A rapid test for the qualitative detection of Chlamydia antigen in
female cervical swab, male urethral swab and male urine specimens.
For professional in vitro diagnostic use only.
The Chlamydia Rapid Test Device (Swab/Urine) is a rapid
chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine
specimens to aid in the diagnosis of Chlamydia infection.
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 (Swab/Urine) is a rapid test to
qualitatively detect the Chlamydia antigen from female cervical
swab, male urethral swab and male urine specimens, providing
results in 10 minutes. The test utilizes antibody specific for
Chlamydia to selectively detect Chlamydia antigen from female
cervical swab, male urethral swab and male urine specimens.
The Chlamydia Rapid Test Device (Swab/Urine) is a qualitative,
lateral flow immunoassay for the detection of Chlamydia antigen
from female cervical swab, male urethral swab and male urine
specimens. In this test, antibody specific to the Chlamydia antigen
is coated on the test line region of the test. During testing, the
extracted antigen solution reacts with an antibody to Chlamydia
that is coated onto particles. The mixture migrates up to react
with the antibody to Chlamydia on the membrane and generate 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.
The test device contains Chlamydia antibody coated particles and
Chlamydia antigen coated on the membrane.
• For professional in vitro diagnostic use only. Do not use after expiration date.
• The test device should remain in the sealed pouch until use.
• Do not eat, drink or smoke in the area where the specimens or
kits are handled.
• Do not use test if pouch is damaged.
• Handle all specimens as if they contain infectious agents.
Observe established precautions against microbiological hazards
throughout testing and follow standard procedures for proper
disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are being tested.
• Humidity and temperature can adversely affect results.
• Use only sterile swabs to obtain endocervical specimens.
Contact Rebecca Yan