Testsealabs TB Tuberculosis Rapid Test Kit(whole blood, serum or plasma)

Short Description:

Detection for: Anti TB antibodies (lsotypes IgG,IgM and igA)in whole blood, serum or plasma.
Specimen volume:75uLSerumor Plasma Specimen
75uL Fingerstick or Venipuncture Whole Blood Specimen,
Reading time:10 minutes
Relative Sensitivity:83.8%(95%C1*:75.3%~90.3%)
Relative Specificity:98.8%(95%C1*:97.2%~99.6%)
Relative Accuracy:95.7%(95%C1*:93.6%~97.3%)


Product Detail

Product Tags

Intended Use

The Tuberculosis(TB) whole blood Rapid Test Strip (whole blood/Serum/plasma) is a rapid chromatographic immunoassay for the qualitative detection of anti-TB (M. tuberculosis, M. bovis and M. africanum) antibodies (all isotypes: IgG, IgM, IgA, etc.) in Serum or plasma.

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Summary

Tuberculosis (TB) is spread primarily via airborne transmission of aerosolized droplets developed by coughing, sneezing and talking. Areas of poor ventilation pose the greatest risk of exposure to infection. TB is a major cause of morbidity and mortality worldwide, resulting in the greatest number of deaths due to a single infectious agent. The World Health Organization reports that more than 8 million new cases of active tuberculosis are diagnosed annually. Almost 3 million deaths are attributed to TB as well. Timely diagnosis is crucial to TB control, as it provides early initiation of therapy and limits further spread of infection. Several diagnostic methods for detecting TB have been used over the years including skin test, sputum smear, and sputum culture and chest x-ray. But these have severe limitations. Newer tests, such as PCR-DNA amplification or interferon-gamma assay, have been recently introduced. However, the turn-around time for these tests is long, they require laboratory equipment and skilled personnel, and some are neither cost effective nor easy to use.

Test Procedure

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Limitations

1.Testsealabs TB Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only The test should be used for the detection of ant-TB antibodies in whole blood, serum or plasma specimens Neither the quantitative value nor the rate of increase in ant-TB antibodies concentration can be determined by this qualitative test.

2.ACCU-TELLTB Rapid Test Cassette (Whole Blood/Serum Plasma) will only indicate the presence of ant-TB antibodies in the specimen and should not be used as the sole criteria for the diagnosis of active tuberculosis diagnosis.

3.As with all diagnostic tests, all results must be considered with other clinical information available to the physician

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