New Method for Diagnosis of TUBERCULOSIS from AIIMS

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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.

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