! The iCARE One Step Chlamydia Rapid Screen Test (Swab) is a rapid home test kit for direct detection of Chlamydia. This product is for in vitro diagnostic use only, and can be used at home. ! Chlamydia is a curable sexually transmitted infectious disease (STD), which is caused by the bacteria Chlamydia trachoma. With our Chlamydia Rapid home test kit you can detect Chlamydia on your own in 100% privacy. Our test kit is easy to use and the result can be read within 15 minutes. ! This test can not be used more than once. iCARE Chlamydia Rapid Home Test Kit User Manual ! PRECAUTIONS 1. This kit is for in vitro use only. Do not swallow. 2. All specimens should be treated as potential infectious diseases. 3. Discard after use. The test cannot be used more than once. 4. Do not use test kit beyond the expiration date. 5. Do not use the kit if the pouch is punctured or not well sealed. 6. Do not mix the covers of Buffer A and Buffer B. 7. Keep out of the reach of children. 8. DISPOSAL OF THE DIAGNOSTIC: The used-device has the infectious risk. The process of disposing the diagnostic device must be done properly. !CONTENT OF THE KIT: 1. One test in one pouch. 2. One pouch contains a test cassette, dropper (micro pipette), 2 swabs, desiccant and a tube with cap. The desiccant is for storage purposes only, and is not used in the test procedure. 3. Leaflet with instructions for use (this one). 4. Buffer A and Buffer B. Please note: For the female procedure both swabs will be needed to collect the specimen. Only one swab is required for the male collection of the specimen. ! Collecting the specimen: 1. Start up by adding 300ul (about 8-9 drops) of buffer A to the attached mixing tube. Then use a swab to collect specimen in the following suggested method: a) For male patient: Insert the swab into the urethra of the penis. Gently rotate with sufficient pressure to dislodge the epithelial cells. Allow the swab to remain inserted for a few seconds after rotation. Carefully remove the swab avoiding contact with any external surfaces. . b) For female patient: Use swab number 1 to remove discharges from the vaginal track opening. Then insert swab number 2 into vaginal track for half a minute and retrieve swab. Carefully remove the swab avoiding contact with any external surfaces. !! !! ! !! !! !! !! !! !! 2. Place swab into the tube and mix well with buffer A so that discharges are well suspended in the buffer A. Discard swab into disinfectant container. 3. Add 300 ul (about 8-9 drops) of buffer B to the tube, cap the tube and mix well. TEST PROCEDURE 1. Use the dropper, draw 0.1ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette. 2. Wait 10 –15 minutes and read results. Do not read results after 30 minutes. !Positive (+) Rose-pink bands are visible both in the control region and the test region. The sample should be considered positive for Gonorrhea. !Negative (-) A rose-pink band is visible in the control region. No color band appears in the test region. The sample should be considered negative for Gonorrhea. !Invalid: No visible band at all, or there is a visible band only in the test region but not in the control region. Another test should be run to re-evaluate the specimen. If test still fails, please contact us for further instructions. !