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

☀ High Specificity

☀ Reliable: high accurate, early detection of the presence of TP

☀ Simple: No Instrument Required

☀ Convenient: Room Temperature Storage, Built-In Control line

☀ 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.

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.

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.

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.

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).