Method for Diagnosis of Tuberculosis

The technology ‘Method for diagnosis of tuberculosis by smear microscopy, culture and polymerase chain reaction using processed clinical samples and kit thereof’ developed by All India Institute of Medical Sciences (AIIMS), New Delhi, was transferred by Biotech Consortium India Limited (BCIL) to Arbro Pharmaceuticals Ltd., a Delhi based pharmaceutical and diagnostics company. The licence agreement was executed by Dr. Purnima Sharma, Executive Director & CEO, BCIL and Shri Vijay Kumar Arora, Managing Director, Arbro Pharmaceuticals Ltd.

The technology developed by Dr. Jaya Sivaswami Tyagi, Professor, Department of Biotechnology, at AIIMS with support from the Department of Biotechnology, Government of India, enables TB detection (pulmonary and extra-pulmonary infection) with high sensitivity and specificity.

M/s. Arbro Pharmaceuticals Limited is leading manufacturer and exporter of pharmaceutical and diagnostic products. The company has state-of-the-art facilities that have been certified and internationally accredited for Good Manufacturing Practices (GMP). Arbro Pharmaceuticals Limited has been awarded the status of Star Export House. Its Analytical Division is a well equipped lab which has been rated amongst the top five labs of India and has been accredited by number of national agencies. It has been the vision of Mr. Vijay Kumar Arora, MD of Arbro to bring the highest level of healthcare within the reach of the common man. In the area of diagnostics Arbro manufactures kits for detection of diseases like tuberculosis, Hepatitis and food and water borne pathogens. Till now these products have mainly been imported at exorbitant costs keeping them out of the reach of masses.

Biotech Consortium India Limited (BCIL) that has facilitated this technology transfer, is a company promoted by Department of Biotechnology (DBT), Government of India and set up by all India financial institutions including IDBI, ICICI, IFCI, etc. BCIL has been engaged in facilitating accelerated commercialization of biotechnology based products for more than a decade by establishing linkages among the various stake holders which includes industry, R&D institutions, Government, financial institutions and international agencies. Also, the company provides access to technologies, creating awareness about business opportunities, regulatory and biosafety requirements, drafting feasibility and detailed project reports and manpower training and placement.

The diagnostic technology, designated as USP technology, comprises of a robust sample processing procedure and provides a single platform for performing conventional and nucleic acid-based tests for the laboratory diagnosis of pulmonary and extrapulmonary tuberculosis using any type of clinical specimen. USP smear microscopy can reproducibly detect positive specimens containing as low as 300-400 bacilli/ml, which is nearly 30 times more sensitive than the direct method of smear microscopy (detection limit of ~10,000 bacilli/ml). The USP smear test promises to be a rapid and inexpensive technique for the rapid diagnosis of paucibacillary disease, especially in sputum. According to Dr. Atul Thatai (VP, Biotechnology, Arbro Pharmaceuticals) this technology has the potential to replace the 66 million conventional TB smears which are carried out each year in our country because of its sensitivity and ease of use.

The devR gene of M. tuberculosis was identified in Dr. Jaya S. Tyagi’s laboratory at AIIMS and used to develop PCR assays. The PCR test is based on amplification of a short segment of the devR gene. The sensitivity of PCR is >90 % in both sputum and CSF samples and 45 – 85 % in extra pulmonary samples including pleural fluid, pleural tissue and lymph node biopsy specimens. The specificity has ranged between 66 – 100% in various studies carried out on pulmonary and extra pulmonary samples. The performance of PCR is significantly better than the conventional tests and PCR promises to be a very valuable tool for rapidly diagnosing extra pulmonary tuberculosis. An Indian patent was granted for this technology and national phase filing in various countries was completed. The results of most of the studies are published in international peer reviewed journals.

Thus, the technology will find use in any laboratory that handles M. tuberculosis and MOTT bacilli-containing specimens. In addition to tuberculosis it is also suitable for the diagnosis of other mycobacterial diseases by smear microscopy and culture and by PCR with the use of species-specific amplification primers.

Source : Press Information Bureau
Date : February 22, 2008