TB (Tuberculosis) Rapid Test Kit

For the Qualitative Detection of Antibody against Tuberculosis in serum and plasma

In Vitro Diagnostic For Tuberculosis In Serum Plasma IgG/IgM Colloidal Gold

Main Features

♦ High Sensitivity

♦ High Specificity

♦ Simple: No Instrument Required

♦ Reliable: high accurate, early detection of the presence of TB

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

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

♦ Certified by Authoritative Certification System and Standards

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

Intended Use

The TB Rapid Test is a chromatographic immunoassay (CIA) for direct qualitative detection of Tuberculosis antibody in human serum or plasma

Summary

Tuberculosis Rapid Test (Whole Blood/Serum/Plasma) is a membrane-based screening test for the rapid detection of IgM anti-Mycobacterium Tuberculosis and IgG anti-Mycobacterium Tuberculosis in human whole blood, serum or plasma.

This innovative rapid screening test is based on lateral flow immunochromatography and is among the easiest point of care (POC) assay diagnostics.

The Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)is suitable to test for antibodies in whole blood, serum or plasma. It is for professional in vitro diagnostic use only.

Sample Collection and Preparation

Plasma

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

2. Separate the plasma by centrifugation.

3. Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to 5 days. Plasma may be frozen at -20℃ for up to 3 months.

Serum

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

2. Allow the blood to clot.

3. Separate the serum by centrifugation.

4. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to 5 days. Serum may be frozen at -20℃ for up to 3 months.

Materials Supplied

1.Test Cassette

2 Pipette Dropper

3.Desiccant

4.Buffer

5.Package Insert

Material Required But Not Provided

1. Clock or Timer

2. Specimen collection containers.

3. Timer

4. Lancets (for fingerstick whole blood only)

5. Centrifuge (for plasma only)