Mycobacterium Tuberculosis – Part 6 – Pathozyme Tuberculosis test (ELISA)

Sample

1. This test is done on the serum of the patient.
2. A random sample can be taken.

Indication

• This is a rapid diagnostic test for tuberculosis, based on immunological reaction.

The principle of the test

1. In pathozyme three antibodies IgM, IgG, and IgA can be detected.
   1. The PATHOZYME-TB complex test detects serum IgG antibody to a recombinant 38-kDa antigen-specific for  M. Tuberculosis and this is expressed in and purified from E. coli.
   2. The other antigen is the 16 kDa antigen for M. Tuberculosis.
2. E.coli is the best source to produce this 38-kDa M. Tuberculosis specific antigen.
3. This test is specific for the diagnosis of disease due to M.Tuberculosis complex.

Procedure

1. To perform the test serum is diluted 1:50.
2. It detects three types of antigens from three different varieties of Mycobacterium.
   1. The available kit is Pathozyme, Myco IgM, IgG, IgA.
3. This is a very specific test for the diagnosis of Tuberculosis.
4. The sensitivities and specificities of the tests varied widely, with sensitivities ranging from ∼20 to 60% and specificities ranging from ∼65 to 100%.

Literature references

1. The Patho-TB™ test could be a rapid and inexpensive method for the diagnosis of pulmonary tuberculosis.
2. It has given its high sensitivity and negative predictive value.
3. Concerning the high number of false-positive results, using a confirmatory diagnostic procedure is mandatory.
   1. Some people think that it can be used as a confirmatory test for tuberculosis.
      

      TB bacilli look like Red Color Bacilli