1. OnSite Syphilis Ab Rapid Test (Strip)
How To Run
OnSite Syphilis Ab Rapid Test (Strip)
(Catalog: R0030S)

2. Tp and Syphilis Treponema pallidum (Tp), the agent of syphilis
Epidemic outbreak
between 1986 and 1990 in U.S.
increase since 1992 in Europe
12 million new cases in 1995
Increases in HIV-infected individuals recently
Treponema pallidum(Tp)
Characteristic rash on
palms of secondary syphilis

3. Current Diagnosis Method
Darkfield Microscopy
Serological Method
Nontreponemal Test, such as VDRL, RPR
Treponemal Test, such as FTA-ABS, TP-PA, EIA
Expensive equipment
Specialist
Simple, inexpensive
Used for screening
Earlier Detection
Highly specific
Rarely used
Not specific for syphilis;
Insufficient for diagnosis;
May remain detectable for life

4. OnSite Syphilis Ab Rapid Test (Strip)
A treponema test using Tp specific antigens

5. Intended Use Lateral flow chromatographic immunoassay
Qualitative detection of Abs (IgG/IgM/IgA) to Tp in human serum or plasma specimens
Used as a screening test for diagnosis of infection with Tp.

6. Test Principle Key test strip contains: Test Line System
Control Line System
NC membrane coated with
recombinant Tp Ags
goat anti-rabbit IgG
Gold conjugated Tp antigen
Gold conjugated rabbit IgG

7. Kit Components Kit box package
Individually sealed foil pouch with 1 dip strip device and 1 desiccant inside
Package insert
Tube package
25 Strips and 1 desiccant

8. Materials Required and Not Provided
Protection sheet
Rack to hold extraction tube
Specimen container
Clock or timer
Disposable gloves
Biohazard container
Marker pen

9. Precautions Precautions Explanation
Read entire package insert 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
Plasma
Collect blood specimen into a lavender, blue or green top collection tube (containing EDTA, citrate or heparin, respectively in Vacutainer) by veinpuncture
Separate the plasma by centrifugation
Carefully withdraw the plasma into new pre-labeled tube
Serum
Collect blood specimen into a red top collection tube (containing no anticoagulants in Vacutainer) by veinpuncture
Allow the blood to clot
Separate the serum by centrifugation
Carefully withdraw the serum into a new pre-labeled tube

11. Important to Know To know Explanation
Test specimen as soon as possible after collecting
Changes happen from time to time
Store specimens at 2-8°C if not tested immediately for up to 5 days
Refrigeration to avoid microbe grow
The specimens should be frozen at -20°C for longer storage
Prevent microbe grow
AVOID multiple freeze-thaw cycles
Blood components will precipitate, leading to false result
Do NOT use samples demonstrating gross lipemia, gross hemolysis or turbidity
These types of specimens can lead to false result

12. Preparation for Assay Set up work area with a clean protection sheet
Wear protective clothing and disposable gloves

13. Preparation for Assay
Bring all kit components to room temperature (15-30°C) prior to testing

14. Preparation for Assay
Bring the specimen to room temperature if refrigerated or frozen
Mix the specimen well prior to assay once thawed

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

16. Preparation for Assay For Tube package
The first time a new tube is used, write down the date it is opened along with the estimated expiration date on the tube label
When ready to use, remove a desirable quantity of strips from the tube
Immediately close the tube to prevent from contamination and humidity
The test strips in the tube MUST be used within 30 days from the date it is first opened

17. Preparation for Assay For Kit box package
Take the desired quantity of sealed pouches from the box
When ready to use, open the pouch at the notch and remove the test strip

18. Perform Assay
Label a specimen container with each specimen ID

19. Perform Assay
Collect at least ml or 3-4 drops of serum or plasma in a sample container

20. Perform Assay Dip the strip into specimen for at least 10 seconds
Do not allow the specimen to reach above the level indicated by the arrows on the strip

21. Perform Assay
Remove the strip from specimen, and place it on a clean, flat surface
Read the test result in minutes, Positive result could be visible as short as 1 minute
Do not read result after 10 minutes

22. 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 or reactive results should be confirmed with alternative testing method(s) such as TPHA test and clinical findings before to make diagnostic decision

23. Perform Assay
Discard the used strip device and protection sheet into a biohazard container after interpreting the result

24. 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 product, 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

25. 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 anti-Tp antibody in human serum or plasma. The intensity of the test band does not linear correlation with the antibody titer in the specimen
A negative or non-reactive test result:
Does not preclude the possibility of exposure to or infection with Tp
It can occur if the quantity of the anti-Tp antibody present in the specimen is below the detection limits of the assay, or the antibodies are not present during the stage of disease
If the symptom persists, while the result is negative or non-negative result, it is recommended to re-sample the patient few days later or test with an alternative test such as TPHA test
The results should only be interpreted in conjunction with other diagnostic procedures and clinical findings

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

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