Chlamydia Schnelltest
Chlamydia Rapid Test
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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 infl ammatory disease (PID) and increased incidence of ectopic pregnancy
and infertility. Vertical transmission of the disease during parturition from mother
to neonate can result in inclusion conjunctivitis or pneumonia. In men, complications of
Chlamydia infection include urethritisand epididymitis. At least 40 % of the nongonococcal
urethritis cases are ossociated 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 specifi c 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 specifi c 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 fl ow immunoassay
for the detection of Chlamydia antigen from female cervical swab, male urethral swab and
male urine specimens. In this test, antibody specifi c 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.
Materials provided:
Test devices
Test tubes
Dropper tips
Package insert
Workstation
Quantitative pipette