100% High Sensitivity TP Syphilis Qualitative Detection Cassette

Treponema Pallidum(TP) Rapid Diagnostic Kit (Colloidal Gold)

For the qualitative detection of Syphilis antibodies in serum/plasma and whole blood

Main Features:

♦ High Sensitivity: 100%

♦ Specificity: 100%

♦ Reliable: Accuracy higher than 97.5%, early detection of the presence of TP Antibody

♦ Simple: No Instrument Required

♦ Convenient: Room Temperature Storage, Built-In Control

♦ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

♦ Certified by Authoritative Certification System and Standards

♦ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

Intended Use

The Syphilis Rapid Diagnostic Test is a qualitative test for the detection of antibodies to Syphilis in human serum/plasma and whole blood. It is considered as an initial screening test for Syphilis antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA.

Principle

Syphilis Rapid Diagnostic Test is a chromatographic immunoassay (CIA) for the detection of antibodies to Syphilis in human serum or plasma. Syphilis specific antigens are precoated onto membrane as a capture reagent on the test region.

During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with Syphilis specific antigens. Antibodies to Syphilis, if present, a red colored band will develop on the membrane in proportion to the amount of Syphilis antibodies present in the specimen.

Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, a red colored band in the control region will always appear regardless the presence of antibodies to Syphilis. The RDT is simple, rapid, sensitive and specific.

Direction of Use

A. For Whole Blood specimen:

1. Dispense 1 drops of Whole Blood specimen to the “s” well of the test card with the provided plastic dropper according to the figure.

2. Add 1 or 2 drops of Sample Diluent to the sample well, immediately after the specimen is added, from the dropper tip diluent vial (or all contents from the single test ampule).

3. Interpret test results in 20 minutes.

B. For serum or plasma specimens:

1. Dispense 2 or 3 drops (100 μl) of serum/plasma specimen to the “s” well of the test card with the provided plastic dropper according to the figure.

2. Start the timer and wait for the colored line(s) to appear.

3. Interpret test results in 20 minute.

Interpretation of Results:

Negative: No apparent band in the test region (T), Only one red band appears in the control region (C). This indicates that no TP antibodies have been detected.

Positive: In addition to one red band in the control region (C), a red band will appear in the test region (T). This indicates that the specimen contains TP antibodies.

Invalid: If no band appears in the control region(C), regardless of the presence or absence of band in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

Note:

1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid

2. Use it before expiry date.

3. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.

4. Old Serum can not be used. If the serum is thick, it can be used only after being separated.

Storage

Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).

Reagents and Materials Provided

♦ One sealed pouched cassette with desiccant & a disposable pipe.

♦ Blood diluent in a dropper bottle.

♦ One piece of operating instruction with 40 test pouches.

Warning and Precautions

♦ FOR IN VITRO DIAGNOSTIC USES ONLY.

♦ All patient samples should be treated as if capable of transmitting diseases.

♦ Do not interchange reagents from different lots or use test kit beyond expiration date.

♦ Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.