Rapid immunoassay for direct qualitative detection of Chlamydia trachomatis antigen.
Packaging specification: 20 tests/kit, 40 tests/kit
Application: Rapid immunoassay for direct qualitative detection of Chlamydia trachomatis antigen from endocervical or endourethral swab specimens.
Working principle
The kit utilizes the chemical extraction of a carbohydrate antigen from Chlamydia followed by the utilization of migratory color immunoassay technology for the qualitative detection of Chlamydia trachomatis. In the test procedure, a unique pair of monoclonal antibodies to Chlamydia Trachomatis are employed. One monoclonal antibody is immobilized on a porous nitrocellulous(NC) membrane while the other monoclonal antibody is conjugated to colloid gold as signaling component. If using swab, specimen from a patient is treated with extraction reagent A and B to extract the antigen. The extracted sample is added to the sample window of the cassette The liquid migrates through the absorbent area and along the NC membrane. If Chlamydia trachomatis antigen is present, the monoclonal antibody labeled colloid gold conjugate binds to it, forming a colloid gold conjugate-monoclonal antibody-antigen complex. As the complex flows along the membrane, the complex is captured by the other monoclonal antibody immobilized in the test zone (T) of the membrane, producing a visible rose pink color band. The excessive colloid gold conjugate migrating further is captured by the antibody immobilized in the control zone (C) of the membrane. A rose-pink line in the test zone ( T ) indicates the presence of Chlamydia trachomatis antigen. A rose-pink line in the control zone (C) indicates the test is working properly. When only one control line appears with no test line, Chlamydia trachomatis antigen has not been detected and the test result is considered negative. The control line gives an added measure of quality control by demonstrating antibody recognition, assuring that the procedure was performed correctly; and that the reagents are chemically active. A desiccant is enclosed with the test device to stabilize the reactive agents.
Main components
20tests/kit 40tests/kit
1. plastic extraction tube 20pcs 40pcs
2. lysis reagent A 1bottle 2bottles, containing1% NaOH and 1%NaCl
3. lysis reagent B 1bottle 2bottles, containing 5%Tris and 1%NaCl
4. test cassette 20pcs 40pcs, containing CT Mab and colloid gold
Storage and validity period
Keep at 2~30°C and freezing is prohibited. Validity period is 12 months.
Storage and Stability of Specimens
1.If a swab is not extracted immediately, store it refrigerated (2°-8°C) for up to 5 days, preferably in a transportation tube. Do not freeze.
2. Swabs may be transported to the test site under ambient conditions. Transport media should not be used.
Operation procedures
A. Extraction
1. For endocervical and endourethral specimens
1.1 Label an extraction tube for each patient and place in a tube holder or rack.
1.2. Add 5~6 drops (appx. 200ul) of lysis reagent A to the extraction tube. Rub and squeeze the tube and twirl the swab 15 times, then keep the swab soaked for 2 min.
1.3. Add the 5~6 drops (appx. 200ul) of lysis reagent B to the tube. Rub and squeeze the tube and twirl the swab 15 times, then keep the swab soaked for 1 minute. Wring all extract from the swab and discard it. Cover the tuber with a filtration tip.
2. For urine specimens
2.1. Add 5~6 drops (appx 200ul) of lysis reagent B to the extraction tube and shake to mix well enough (employ vortex mixer if necessary) Add lysis reagent A 5~6 drops (appx. 200ul). Rub and squeeze the tube for 15 times, and halt for 1 min.
B. Immunoassay of the Extract
1. Remove the test cassette from its sealed foil pouch by tearing along the notch. Dispense 2 drops of liquid from the extraction tube into the sample well (“S”) of the test cassette by inverting and squeezing the tube as shown.
2. Read the test results at 15 min.
Interpretation of the results
1. Positive: Two rose-pink bands appear — one in the control zone (“C”) and one in the test zone (“T”). The sample should be considered positive for the presence of Chlamydia trachomatis.
2. Negative: One rose-pink band appears in the control zone (“C”) with no apparent band in the test zone (“T”). The sample should be considered negative for Chlamydia trachomatis.
3. Invalid: If no rose-pink band appears in the control zone (“C”), or if a band appears in the test zone (“T”) but not in the control zone, then the test is invalid. It is recommended to retest the specimen using a new test cassette.
IMPORTANT: To avoid incorrect reading or invalid results, do not interpret test results after more
than 15 minutes.
Product characteristics
1.positive control coincidence: 100% (10/10)
2.negative control coincidence:100% (8/8)
3.assay sensitivity: ≥2×103IFU/ml
4.assay specificity:100% (8/8)
5.intra batch accuracy: all 5 tests from the same batch with one positive control should be positive.
6.inter batch accuracy: all tests choosen from consecutive 3 batches, 5 tests each, with one positive control should be positive.
Warnings and precautions
1. Wear gloves while handling specimens.
2. Dispose of gloves and swabs using good microbiological practices.
3. Do not touch the swab tip at any time.
4. Wash hands after performing the test.
5. Use only the sterile swabs provided. Swabs from any other source may give faulty results.
6. Do not allow a sample swab to come in contact with any reagent bottle tip.
7. Bacterial contamination will invalidate test performance.
8. Do not use the reagents after their expiration dates.
Manufactured by
Zhuhai Encode Medical Engineering Co., Ltd
Chlamydia Trachomatis Antigen Testing Kit (Colloidal Gold)
