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Chlamydia Home Test Kit

Chlamydia Home Test Kit

R 175.00
Tax included.

A rapid test for the qualitative detection of Chlamydia antigen in female cervical swab, male urethral swab or male urine specimens.
For professional in vitro diagnostic use only.

INTENDED USE
The Chlamydia Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in female cervical swab, male urethral swab or male urine specimens to aid in the diagnosis of Chlamydia infection.

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 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. 1 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.
The Chlamydia Rapid Test Cassette (Swab/Urine) is a rapid test to qualitatively detect the Chlamydia antigen from female cervical swab, male urethral swab or male urine specimens.

Test cassette
Extraction tube
Extraction reagent 1 (0.2M NaOH)
Sterile swab
Extraction reagent 2 (0.2 M HCl)
Dropper tip
Package insert

SPECIMEN COLLECTION AND PREPARATION
The Chlamydia Rapid Test Cassette (Swab/Urine) can be performed using female cervical swab, male urethral swab or male urine specimens.
The quality of specimens obtained is of extreme importance. Detection of Chlamydia requires a vigorous and thorough collection technique that provides cellular material rather than just body fluids.

To collect Female Cervical Swab Specimen:
Use the swab provided in the kit. Alternatively, any plastic-shaft swab may be used. Before specimen collection, remove excess mucus from the endocervical area with a cotton ball and
discard. The swab should be inserted into the endocervical canal, past the squamocolumnar junction until most of the tip is no longer visible. This will permit acquisition of columnar or cuboidal epithelial cells, which are the main reservoir of the Chlamydia organism. Firmly rotate the swab 360°in one direction (clockwise or counterclockwise), let stand for 15 seconds, then withdraw the swab.
Avoid contamination from exocervical or vaginal cells. Do not use 0.9% sodium chloride to treat swabs before specimen
collection.
If the test is to be conducted immediately, put the swab into the extraction tube.
To collect Male Urethral Swab Specimens: Standard plastic or wire-shaft sterile swabs should be used for urethral specimen collection. Instruct patients not to urinate for at least 1 hour period to specimen collection. Insert the swab into the urethral about 2-4 cm, rotate the swab 360° in one direction (clockwise or counterclockwise), let stand for 10 seconds, then withdraw. Do not use 0.9% sodium chloride to treat swabs before specimen collection.
If the test is to be conducted immediately, put the swab into the extraction tube.
To collect Male Urine Specimens:
Collect 15-30 ml of clean first morning urine in a sterile urine cup. First morning urine specimens are preferred to achieve the highest concentrations of Chlamydia antigen.
Mix the urine specimen by inverting container. Transfer 10 ml of the urine specimen into a centrifuge tube, add 10 ml distilled water and centrifuge at 3,000 rpm for 15 minutes.
Carefully discard the supernatant, keep the tube inverted and remove any supernatant from the rim of the
tube by blotting onto absorbent pad. If the test is to be conducted immediately, treat the urine pellet according to the Directions for Use.
It is recommended that specimens be processed as soon as possible after collection. If immediately testing is not possible, the patient swab specimens should be placed in a dry transport tube for storage or transport. The swab may be stored for 4-6 hours at room temperature (15-30 °C) or refrigerated (2-8 °C) for 24 hours.
Do not freeze. All specimens should be allow to reach the room temperature (15-30 °C) before testing.

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