Chlamydia Antigen Rapid Test

Chlamydia Antigen Rapid Test

INTENDED USE

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.

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 (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.

PRINCIPLE

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.

REAGENTS

The test device contains Chlamydia antibody coated particles and Chlamydia antigen coated on the membrane.

PRECAUTIONS

• 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.

STORAGE AND STABILITY

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

SPECIMEN COLLECTION AND PREPARATION

• The Chlamydia Rapid Test Device (Swab/Urine) can be performed using female cervical swab, male urethral swab and 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 Specimens:

• 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 360o 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 collecting samples.

• 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 one hour prior to specimen collection.

• Insert the swab into the urethra about 2-4 cm, rotate the swab 360o in one direction (clockwise or counterclockwise), let stand for 10 seconds, then withdraw. Do not use 0.9% sodium chloride to treat swabs before collecting samples.

• If the test is to be conducted immediately, put the swab into the extraction tube.