TB (Tuberculosis) Rapid Test Kit

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

Main Features

♦ High Sensitivity

♦ Specificity

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

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



Principle

Tuberculosis remains an important socio-economical and medical problem throughout the world. According to the Centers for Disease Control, the incidence of TB is expected to increase from 7.5 million cases per year in 1995 to 11.9 million in 2005.

The case fatality rate is estimated at 55% for untreated people and 15% for the treated patients. The commonly used diagnostic tests for the tuberculosis such as sputum examination of acid fast bascilli, culture of sputum or other fluids, the tuberculin skin test and radiological investigations do not achieve the required diagnostic sensitivity.



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.

Interpretation of Results



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)

Storage and Stability

All reagents are ready to use as supplied. Store unused test device unopened at 2°C-30°C.

If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening.

The test device is stable through the expiration date printed on the sealed pouch.

Do not freeze the kit or expose the kit over 30°C.

Warnings and Precautions

1. For professional In Vitro diagnostic use only.

2. Warning: the reagents in this kit contain sodium azide which may react with lead or copper plumbing to form
potentially explosive metal azides. When disposing of such reagents, always flush with large volumes of water to
prevent azide build-up.

3. Do not use it if the tube pouch is damaged or broken.

4. Test is for single use only. Do not re-use under any circumstances.

5. Handle all specimens as if they contain infectious agents. Observe established standard procedure for proper
disposal of specimens

6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are
assayed.

7. Humidity and temperature can adversely affect results.