INTENDED USE
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.
SUM
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.
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. Wait for the colored line(s) to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
PERFORMANCE CHARACTERIST
The Chlamydia Antigen Rapid Test has been evaluated with specimens obtained from patients of STD clinics. PCR is used as the reference method. The results show that Chlamydia Antigen Rapid Test has a high sensitivity and specificity relative to the reference method.
Table: Chlamydia Antigen Rapid Test vs. PCR kit
Method |
PCR |
Total Results |
Chlamydia Antigen Rapid Test |
Results |
Positive |
Negative |
Positive |
97 |
5 |
102 |
Negative |
8 |
324 |
332 |
Total Result |
105 |
329 |
434 |
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%)
COMPANY PROFILE
Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.
CERTIFICATIONS
