Chlamydia Antigen Rapid Test

SUMMARY

Chlamydia trachomatis is the most common cause of sexually transmitted venereal infection in the world. 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, 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 pneumonia. In men, complications of Chlamydia infection include urethritis and epididymitis. Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are asymptomatic.

The Chlamydia Antigen Rapid Test is a rapid test to qualitatively detect the Chlamydia antigen from female cervical swab and male urethral swab specimens.

MATERIALS

Materials Provided

Materials Required but Not provided

TEST PROCEDURE

Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

1. 1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. 2. Extract the Chlamydia antigen according to the specimen type.

 For Female Cervical or Male Urethral Swab Specimen:

• Hold the reagent 1 bottle vertically and add 5 drops of reagent 1 (approx. 300μl) to the extraction tube. Reagent 1 is colorless. Immediately insert the swab, compress the bottom of tube and rotate swab 15 times. Let stand for2 minutes.
• Hold the reagent 2 bottle vertically add 6 drops of reagent 2 (approx. 250μl) to the extraction tube. The solution would turn turbid. Compress the bottle of tube and rotate the swab 15 times until the solution turn clear with a slight green or blue tint. If the swab is bloody, the color will turn yellow or brown. Let stand 1 minute.
• Press the swab against the side of tube and withdraw the swab while squeezing the tube. Keep as much liquid in the tube as possible. Fit the dropper tip on top of extraction tube.

3. 3. Place the test cassette on a clean and level surface. Add 3 full drops of the extracted solution (approx. 100μl) to each specimen wells of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.
4. 4. Wait for the colored line(s) to appear. Read the result at 10minutes; do not interpret the result after 20 minutes.

Note: It is recommended to use the buffer within 6 months after opening the vial.

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded.

Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. 1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. 2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

3. LIMITATIONS OF THE TEST

   1. 1. The ChlamydiaAntigen Rapid Test is for professional in vitro diagnostic use, and should only be used for the qualitative detection of human Chlamydia infection.
   2. 2. The test result should be used only to evaluate with patient with signs and symptoms of the disease. A definitive clinical diagnosis should only be made by the physician after all clinical and laboratory finding have been evaluated.
   3. 3. As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results.

   4. As all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.