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

☀ Convenient: Room Temperature Storage, Built-In Control

☀ Simple: No Instrument Required

☀ 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.

Reagents and Materials Provided

☀ Blood diluent in a dropper bottle.

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

☀ One piece of operating instruction with 40 test pouches.

Storage

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

Sample Collection and Preparation

Whole Blood ( Finger stick Specimens)

☀ Clean the area to be lanced with an alcohol swab.

☀ Squeeze the end of the fingertip and pierce it with a sterile lancet.

☀ Wipe away the first drop of blood with sterile gauze or cotton.

☀ Allow the second drop to flow directly into a sample well.

Plasma

☀ Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

☀ Separate the plasma by centrifugation.

☀ Carefully withdraw the plasma for testing or label and store it at 4°C for up to five days. Plasma may be frozen at -20°C for at least three months.

Serum

☀ Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

☀ Allow the blood to clot.

☀ Separate the serum by centrifugation.

☀ Carefully withdraw the serum for testing or label and store it at 4°C for up to five days. Serum may be frozen at -20°C for at least three months.

Assay Procedure

Serum or Plasma Sample

Add 2 drops of serum or plasma into sample well. Observe the result in 120 minutes.

Whole Blood Sample

Add 1 drop of whole blood into sample well, after all blood completely absorbed. Add 2 drop of whole blood diluent. Observe the result in 20 minutes.

Limitation

1. This Rapid Test is a qualitative test for the detection of anti-Tp antibody in human serum or plasma. The intensity of the test band does not correlate with the antibody concentration in the specimen.

2. A negative result for an individual subject indicates absence of detectable anti-Tp antibodies . However, a negative test result does not preclude the possibility of exposure to or infection with Tp.

3. A negative result 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 that are detected are not present during the stage of disease in which a sample is collected.

4. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.

5. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.

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.

Precision

Within run and between run precisions have been determined by testing 10 replicates with three of the samples: a negative, a weak positive, and a strong positive sample. The negative, weaker positive, and strong positive samples were correctly identified in all of the tests every time.