Chlamydia Antigen Rapid Test

Short Description:

Chlamydia Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis antigen in female cervical swab and male urethral swab specimen. The test results are intended to aid in the diagnosis of Chlamydia infection in people.

Used For: Chlamydia Antigen Rapid Test

Specimenfemale cervical swab or male urethral swab

CertificationCE

MOQ1000

Delivery time2-5 days after Get payment

Packing20 tests kits/Packing box

Shelf Life24 Months

PaymentT/T, Western Union, Paypal

Assay Time: 10-15 Minutes


Product Detail

Product Tags


PRINCIPLE

Chlamydia Antigen Rapid Test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted sample is added to the sample well of the test cassette. The sample flows through a pad containing antibodies against Chlamydia coupled to red-colored colloidal gold. If the sample contains Chlamydia antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which Chlamydia specific antibodies are immobilized separately. As the complexes reach the test line, they will bind to the antibody corresponding to the virus on the membrane to form of a line. A red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If virus is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.

MATERIALS

Materials Provided

· Individually packed test devices

· Extraction Tubes

· Disposable sampling swabs (Female Cervical)

· Dropper Tips

· Extraction Reagent 1 (0.2M NaOH)

· Workstation

· Extraction Reagent 2 (0.2 M HCI)

· Package insert

Materials Required but Not provided

· Sterile Male Urethral Swabs

· Timer

TEST PROCEDURE

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

  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. 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 for 2 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.
  1. 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.
  2. Wait for the colored line(s) to appear. Read the result at 10 minutes; 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. 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. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

Relative Sensitivity: 92.38% (95%CI: 85.54%~96.65%)

Relative Specificity: 98.48% (95%CI:96.49%99.50%)

Accuracy: 97.00% (95%CI:94.93%98.40%)


  • Previous:
  • Next:
  • Leave Your Message