Vitro Diagnostic TB Pulmonary IVD Tuberculosis Rapid Test Kit

Product Specification

TB (Tuberculosis) Rapid Test Kit

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

Main Features

♦ High Sensitivity

♦ 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 Clinical Performance Assessment"

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.

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.

TB is a chromatographic immunoassay test for the detection of TB antibody in human serum or plasma. Specific antigens are pre-coated onto membrane as a capture reagent on the test region.

During the test, specimen is allowed to react with the antigens firstly. The chasing buffer mixed with specific mouse anti-human antibody, which is conjugated with colloidal gold, will flow up the membrane. If TB antibody is present, a red colored band will appears on the test region of membrane.

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 C region will always appear regardless of the presence or absence of TB antibody.

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)

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.

Interpretation of Results

Negative: No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no TB antibody has been detected.

Positive: In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains TB.

Invalid: If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

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.