Mycobacterium Tuberculosis – Part 6 – Pathozyme Tuberculosis test (ELISA)
- This test is done on the serum of the patient.
- A random sample can be taken.
- This is a rapid diagnostic test for tuberculosis, based on immunological reaction.
The principle of the test
- In pathozyme three antibodies IgM, IgG, and IgA can be detected.
- 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.
- The other antigen is the 16 kDa antigen for M. Tuberculosis.
- E.coli is the best source to produce this 38-kDa M. Tuberculosis specific antigen.
- This test is specific for the diagnosis of disease due to M.Tuberculosis complex.
- To perform the test serum is diluted 1:50.
- It detects three types of antigens from three different varieties of Mycobacterium.
- The available kit is Pathozyme, Myco IgM, IgG, IgA.
- This is a very specific test for the diagnosis of Tuberculosis.
- The sensitivities and specificities of the tests varied widely, with sensitivities ranging from ∼20 to 60% and specificities ranging from ∼65 to 100%.
- The Patho-TB™ test could be a rapid and inexpensive method for the diagnosis of pulmonary tuberculosis.
- It has given its high sensitivity and negative predictive value.
- Concerning the high number of false-positive results, using a confirmatory diagnostic procedure is mandatory.
- Some people think that it can be used as a confirmatory test for tuberculosis.