NADAL® Tuberculosis IgG/IgM test cassette (individually packed)


30 individually packed test cassettes for detection of anti-Mycobacterium Tuberculosis (M.Tb) IgM and IgG in human serum, plasma or whole blood.


Package contents:

30 test cassettes

30 plastic droppers

1 sample diluent (5.0 mL)

1 package insert

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Product description

The NADAL® Tuberculosis IgG/IgM Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of anti-Mycobacterium Tuberculosis (M.Tb) IgM and IgG in human serum, plasma or whole blood. The test is intended to be used as a screening test and as an aid in the diagnosis of infection with M.Tb. Any reactive
specimen with the NADAL® Tuberculosis IgG/IgM Test should be confirmed with alternative testing method(s) and clinical findings.

Tuberculosis (Tb) is a chronic, communicable disease principally caused by M.Tb hominis (Koch’s bacillus), occasionally by M.Tb bovis. The lungs are the primary target
but any organ may be infected. The risk of Tb infection exponentially declined in the 20th century. However, the recent emergence of drug-resistant
strains, particularly among patients with AIDS, has rekindled interest in Tb. The incidence of infection was reported to be around 8 million cases per year with a death rate of 3 million annually. Mortality exceeded 50% in some African countries with high HIV rates. The initial clinical suspicion, radiographic findings with subsequent laboratory confirmation by sputum and by culture examination are traditional methods in the diagnosis of active Tb. However, these methods either lack sensitivity or are
time consuming. Moreover, they are not suitable for smearnegative patients, patients who are unable to produce adequate sputum or patients suspected to have extrapulmonary Tb. The NADAL® Tuberculosis IgG/IgM Test is developed to alleviate these obstacles. The test detects anti-M.Tb IgM and IgG in serum, plasma or whole blood in 15 minutes. An IgM positive result indicates a fresh M.Tb infection, while an IgG positive result suggests a previous or chronic infection. The NADAL® Tuberculosis IgG/IgM Test also detects anti-M.Tb IgM
in patients vaccinated with BCG using M.Tb specific antigens. In addition, the test can be performed by untrained or minimally-skilled personnel without cumbersome laboratory equipment.

More Information

More Information
SKU 322003N-30
Testformat test cassette
Test evaluation Provides a qualitative test result
Sample type Serum, Whole Blood, Plasma
Detected parameter Tuberculosis IgG/IgM
Package size 30 individually packed test cassettes
Detection time Test result after 15 minutes
Storage temperature The test should be stored at 2 - 30 °C
CE-Label Yes
Pathogentype Bacterial infection

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