FDA Whole Blood Qualitative Detection Syphilis Rapid Test Kit

Product Specification

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

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

TP Syphilis Rapid Test Kit In Vitro Test Fast Detection Cassette Home Use

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.

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.

Storage

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

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.