How To RunOnSite Syphilis Ab Rapid Test

(Strip)(Catalog: R0030S)

Tp and Syphilis

• Treponema pallidum (Tp), the agent of syphilis

• Epidemic outbreak o between 1986 and 1990 in U.S.o increase since 1992 in Europe

• 12 million new cases in 1995

• Increases in HIV-infected individuals recentlyTreponema 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

• 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

• 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.

Intended Use

Test Principle

• Key test strip contains:

Test Line System Control Line System

NC membrane coated with recombinant Tp Ags

NC membrane coated with 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• Package insert

• Protection sheet

• Rack to hold extraction tube

• Specimen container

• Clock or timer

• Disposable gloves

• Biohazard container

• Marker pen

Materials Required and Not Provided

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

• Bring the specimen to room temperature if refrigerated or frozen

• Mix the specimen well prior to assay once thawed

Preparation for Assay

Do not use expired test device

• Double check product’s name and expiration date

Preparation for Assay

Product Name

Expiration Date

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

Preparation for 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

Perform Assay

Do not allow the specimen to reach above the level indicated by the arrows on the strip

• 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

Perform Assay

Read Assay Result

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

• 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

• Discard the used strip device and protection sheet into a biohazard container after interpreting the result

Perform Assay

Quality Control

Internal Control

• Built-in control feature, the C bando 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:o a new operator uses the kito a new lot of test kit is usedo a new shipment of kits is usedo temperature used during storage of the kit falls outside of 2-30°Co the temperature of the test area falls outside of 15-30°Co to verify a higher than expected frequency of positive or negative

resulto 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:o Does not preclude the possibility of exposure to or infection with Tpo 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 USAEmail Address: tech@ctkbiotech.com Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739

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