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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

Perform Assay Label a specimen container with each specimen ID

Perform Assay Collect at least 150-200 ml or 3-4 drops of serum or plasma in a sample container

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

Perform Assay Remove the strip from specimen, and place it on a clean, flat surface Read the test result in 5-10 minutes, Positive result could be visible as short as 1 minute Do not read result after 10 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 or reactive results should be confirmed with alternative testing method(s) such as TPHA test and clinical findings before to make diagnostic decision

Perform Assay Discard the used strip device and protection sheet into a 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 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

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

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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