TB Rapid Screen Test Kit

Short Description:

1.Jiqing offers CE authorized TB Rapid Test.
2.Quick Results
3.Detects Presence of antigen to Malaria in human body.
4.Made Start to Finish in China at CE Registered Facilities


  • Size: 1 Test/Kit,4 Tests/Kit, 6 Tests/Kit, 20 Tests/Kit, 50 Tests/Kit
  • Product Detail

    Product Tags

    INTENDED USE

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

    Test Principle

    Tuberculosis remains an important socio-economical and medical problem throughout the world. According to the Centers for 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 RST is a chromatographic immunoassay (CIA) 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. And then chasing buffer mixed with specific Mouse anti human antibody, which conjugated with colloidal gold, will flow onto the membrane. If TB antibody present, a pink colored band will develop on the area of membrane. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the B region will always appear regardless the presence of TB antibody.

    Storage conditions and validity
    1.Store at 4℃~40℃,the validity period is tentatively set for 24 months.
    2.After opening the aluminum foil bag, the test card should be used as soon as possible within 30 minutes. The sample diluent should be capped immediately after opening and placed in a cool place. Please use it within the validity period.

    Specimen Request

    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 two weeks. Plasma may be frozen at -20°C for up to one year.

    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 two weeks. Serum may be frozen at -20°C for up to one year.

    Testing method

    1.Open a pouch containing a cassette and lay the cassette on a flat surface.
    2.Carefully apply 3l of sample on the center area of membrane as illustrated in figure 1 below:

    figure 1

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    Note: Do not overload sample, 3 l is enough. Do Not Scratch the Membrane.
    3.Wait one minute and let sample solution absorb on the membrane.
    4.Add two drops (40~80ul) of chasing buffer into the sample well.
    5.Read the result in 15 minute.

    Interpretation of test results

    Negative: Only one pink band appears on test region of the Cassette. This indicates that there is no detectable TB antibody in the specimen .
    Positive: Two pink bands appear on test region of the Cassette. This indicates that the specimen contains detectable amount of TB antibody.
    Invalid: If no colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.

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    Note:
    1.Do not consider the line, if there is, on the position of sample indicating line.
    2.Do not interpret the result after 20 minute.

    Limitations of inspection methods

    The test is to be used for the qualitative detection of TB antibody.
    A negative result does not rule out infection by Tuberculosis because the TB antibody may not be present in sufficient quality. To confirm the disease, it must combine with other methods.

    PERFORMANCE CHARACTERISTICS
    1. Sensitivity and Specificity: The TB Rapid Screen Test have tested with positive and negative clinical samples tested by microscopic examination of whole blood.

    TB evaluation results

    Reference

    TB

    Total Results

    Method

    Result

    Positive (T)

    Negative

    microscopic examination

    TB Positive

    162

    21

    183

    TB Negative

    5

    214

    219

    Total Results

    167

    235

    402

    In a comparison of the TB test versus microscopic examination of whole blood, results gave sensitivity of 88.52% (162/183), a specificity of 91.06% (214/235), and a total agreement of 93.53% (376/402).

    2. Precision

    Within run precision was determined by using 10 replicates of four different specimens containing different concentrations of antibody. The negative and positive values were correctly identified 100% of the time.
    Between run precision was determined by using the four different specimens containing different concentrations of antibody in 3 different replicates with 3 different lots of test devices. Again negative and positive results were observed 100% of the time.

    PROCAUTION

    1. FOR IN VITRO DIAGNOSTIC USES ONLY
    2. All patient samples should be treated as if capable of transmitting diseases.
    3. Do not interchange reagents from different lots or use test kit beyond expiration date.
    4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

    【Index of CE Symbols】

    【Index of CE Symbols】


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