OnSite Chlamydia Ag Rapid Test How To Run OnSite Chlamydia Ag Rapid Test (Catalog: R0080C)

C. trachomatis and Chlamydia Chlamydia Trachomatis Chlamydia trachomatis (C. trachomatis) The most common sexually transmitted bacterial pathogen Major cause of cervicitis, urethritis, endometritis, and pelvic inflammatory disease in women urethritis and epididymitis in men Chlamydia infection 80 million worldwide annually At least 3 million new cases in U.S. Chlamydia Trachomatis

Current Diagnosis Methods Cell culture Direct fluorescence assay (DFA) Enzyme immunoassays (EIA) PCR Immunological antigen test Method Rapid Test DFA EIA PCR Culture Time to result 15 minutes 2-3 hours 1-4 hours > 4 hours >3 days Facility General Lab Special Lab Equipment No Expensive Reader, incubator, pipette PCR machine Pipette Incubator, microscopy Skill Minimal Well trained Moderate Specialist Comments Cost effective Costly

OnSite Chlamydia Ag Rapid Test

Intended Use Lateral flow chromatographic immunoassay Qualitative detection of C. trachomatis antigen in endocervical or encourethral swab specimens Used as a screening test for diagnosis of infection with C. trachomatis

Pre-coated with another mouse monoclonal anti-C. trachomatis Ab Test Principle Double antibody-sandwich immunoassay A unique pair of Abs to selectively identify C. trachomatis Ag in the specimen Test kit key components: Test Band Control Band Pre-coated with another mouse monoclonal anti-C. trachomatis Ab Pe-coated with goat anti-mouse IgG Ab

Kit Components 25 test devices (individually sealed pouches containing with 1 cassette device & 1 desiccant) 1 Extraction Buffer A (6 mL/vial) 1 Extraction Buffer B (6 mL/vial) 25 sample extraction tubes 1 package insert

Materials Required and Not Provided Swab for collecting specimen Clock or timer Disposable gloves Rack to hold extraction tube Biohazard container Marker pen

Precautions Precautions Explanation Package insert MUST be read completely before testing Pay attention to updated information Do NOT open the pouch unless ready to test Test device become moisture when expose to humidity air, affect flow Do NOT use components in any other type of test kit Component in each kit is unique Do NOT use expired devices Expired product gives error result Bring all reagents to room temperature (15-30°C) before use Cold reagent has different viscosity, affect flow migration and results The testing results should be read within 10 minutes after a specimen is applied to the sample pad of the device Extend reading time may lead to false positive result. Do NOT perform the test in a room with strong air flow as the specimens might evaporate before reach Strong air flow causes specimen evaporation during assay, leads to error result

Specimen Collection and Handling Consider any materials of human origin as infectious and handle them using standard biosafety procedures Swab specimen should be collected by standard male or female specimen collection methods Swabs should be processed as soon as possible after collection. If swabs are not processed immediately, they should be placed into a dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to 5 days, preferably in a transportation tube Do NOT use bloody swabs Do NOT freeze swabs

Preparation for Assay Wear protective clothing and disposable gloves

Preparation for Assay Set up work area Bring all kit components to room temperature (15-30°C) prior to testing

Preparation for Assay Double check product’s name and expiration date Product Name Expiration Date Do not use expired test device

Perform Assay Label an extraction tube for each patient and place in a tube holder or rack

Perform Assay Place specimen swab into the extraction tube Add 4 drops (200 mL) of Extraction Buffer A while holding the bottle vertically All drops must be free falling with the reagent bottles held vertically. Do not allow the tips of the bottles to come in contact with the extraction cups

Perform Assay Twirl briefly to mix the reagent This picture may has to be replaced according to the description on the flier

Perform Assay Incubate at room temperature (15-30°C) for 5 minutes, but no longer than 10 minutes

Perform Assay Add 4 drops (200 mL) of Extraction Buffer B while holding the bottle vertically All drops must be free falling with the reagent bottles held vertically. Do not allow the tips of the bottles to come in contact with the extraction cups

Perform Assay Twirl the swab vigorously for 10 seconds and incubate for 1 minute, but no longer than 10 minutes

Perform Assay Expunge as much liquid as possible from swab by pressing and rotating the fiber portion against the wall of the tube

Perform Assay Discard used swab into biohazard container

Perform Assay Cap the tube and mix contents by gentle swirling The swab extract can be tested immediately or remain at room temperature for up to 3 hours without affecting test results

Perform Assay Remove a test device from its protective pouch Place the test device on a clean, flat surface Label the device with specimen’s ID number Do not open pouch unless ready to run the test

Perform Assay Hold extraction tube vertically Dispense 2 drops (100 mL) of extract to the sample pad Do not over load samples

Perform Assay Set up timer Read test result within 15 minutes. Some positive results may be visible as soon as 1 minute Complete reaction time of 15 minutes is required to confirm negative results Do not read result after 15 minutes

Read Assay Result Negative or non-reactive result Only C band is developed Positive or reactive result Both C and T bands are developed In valid result No C band is developed Samples with positive results should be confirmed with alternative testing method(s) such as antibody test, PCR and clinical findings before to make diagnostic decision If C band isn’t developed, review whole procedure and repeat the assay with a new device

Perform Assay Discard the used cassette device and the protection sheet into biohazard container after interpreting the result

Quality Control Internal Control Built-in control feature, the C band Developed C band indicates the procedure is correct External Control Run 1 Positive Control and 1 Negative Control to assure proper performance of the assay, when: a new operator uses the kit a new lot of test kit is used a new shipment of kits is used temperature used during storage of the kit falls outside of 2-30°C the temperature of the test area falls outside of 15-30°C to verify a higher than expected frequency of positive or negative result to investigate the cause of repeated invalid results

Limitation of Test For optimal test performance, proper sample collection and storage procedures are critical. Failure to follow the procedure may give inaccurate results Limited to the qualitative detection of C. trachomatis antigen in swab specimens. The intensity of the test band does not correlate with antigen titer of the specimen Do not specifically differentiate between C. Trachomatis, C. Pneumonia or C. Psittasi A negative or non-reactive test result: does not preclude the possibility of exposure to C. trachomatis It can occur if the concentration of the C. trachomatis antigen present in the specimen is below the level detectable by the assay, or the antigen is not present in the specimen or improper sample treatment procedure If the symptom persists, while the result is negative or non-reactive result, it is recommended to re-sample the patient few days later or test with an alternative test device or method The results should only be interpreted in conjunction with other diagnostic procedures and clinical findings

Technical Support Contact Info.: 10110 Mesa Rim Rd. San Diego, CA 92121 USA Email Address: tech@ctkbiotech.com  Telephone: 1 (858) 457-8698 Fax: 1 (858) 535-1739

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