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

2. 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

3. 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

4. OnSite Chlamydia Ag Rapid Test

5. 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

6. 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

7. 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

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

9. 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

10. 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

11. Preparation for Assay
Wear protective clothing and disposable gloves

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

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

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

15. 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

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

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

18. 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

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

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

21. Perform Assay
Discard used swab into biohazard container

22. 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

23. 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

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

25. 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

26. 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

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

28. 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

29. 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

30. Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA USA
Telephone: 1 (858) Fax: 1 (858)

31. QUALITY . INNOVATION . SIMPLICITY
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