ANNUAL REPORT - Department of Biotechnology

USP method. These included 59 smear negative and
18 smear positive samples (17 of 1+ and 1 of 3+
grade). So far five sputa yielded culture in liquid
medium that was confirmed as M. tuberculosis. PCR
positivity was estimated to be 71.4%, 83.1%, 76.6%
for gel-based, visual and fluorimetric detection
formats, respectively. At present the group is
analyzing with molecular beacons obtained from US
collaborator.
Further a total of 120 samples have been collected
from pulmonary as well as extra-pulmonary patient
samples. The samples have been processed by the
USP method. The extracted DNA is being used in the
N-PCR hupB assay for the detection of M.
tuberculosis and M. bovis. The hupB molecular
beacons are being designed. Analysis of the human
samples is near completion to standardize the
beacon assay with PHRI collaboration.
Leishmania:
Studies were conducted at the Institute of Pathology,
New Delhi and CBER, FDA, USA on discovery of
virulence-related genes in Leishmania donovani
using genomic microarray. The study has identified
the full length ORF of 3 clones and found them to be
Calpain, NAD/FAD dependent dehydrogenase and
a trypanosomatid specific hypothetical protein.
Transcripts for each of these genes have been
demonstrated in bone marrow of kala-azar patients,
implicating their role in disease pathogenesis.
Cloning, expression and functional characterization
of these three genes in underway.
Respiratory Syncytial Virus (RSV) and
Metapneumovirus (hMPV)
The first community-based study of viral ALRI in
India in the past three decades has been conducted
at AIIMS, New Delhi and UAB School of Medicine,
Albama, USA.. These data will be useful for planning
the study of future respiratory virus vaccines or other
interventions to reduce the disease due to viral ARIs.
Molecular characterization of RSV strains from New
Delhi revealed variation in proportion of infections by
different RSV genotypes. This is the first study of
RSV molecular epidemiology from India and the first
description of the circulation pattern of RSV
genotypes in both rural and urban Indian settings.
The present sero-epidemiological study gives
information on RSV infection in the rural community
in India. Further longitudinal sero-epidemiological
studies with both group A and group B specific
antigens of RSV are required to define the role of
antibodies in immunity and pathogenesis of RSV
infection. This information is crucial for development
of RSV vaccine strategies.
Group A Streptococcus (GAS)
Epidemiological surveillance studies were
conducted at PGIMER, Chandigarh; CMC, Vellore
and NIAID, NIH, USA. At PGIMER, Chandigarh, out
of a total of 178 group A positive samples of
pharyngitis and impetigo, emm typing of 111 has
been done. emm typing of rest will be completed
soon. Anti Streptolysin O and Anti Dnase B titration
shall also continue.
Joint Workshops
In order to have trained personnel to carry out clinical
trials and conduct clinical research, DBT, ICMR,
DCGI and USDHHS have organized a series of
workshops on clinical trials and clinical research over
the next 2-3 years with a goal to provide state-of-theart
training on clinical research with particular
emphasis on clinical trials and the complex
requirements necessary for the testing and licensure
of drugs, vaccines, diagnostics, and devices for
therapeutic and preventive use. The first workshop of
the series was organized from April 4-6, 2006 at
G.S.Medical College & KEM Hospital, Mumbai in
which about 140 scientists/clinicians participated.
The workshop focussed on issues like selecting
relevant research question, protocol development,
biostatistics, managing a study, good clinical
practice (GCP), good laboratory practice (GLP),
Indian regulations agencies etc. Lectures, group and
panel discussions on specific topics were also
presented by faculty which comprises of national and
international experts.
The second workshop on Bioethics in Clinical
Research was organized from June 20-22, 2006 in
New Delhi in which more than 100 member
secretaries of institutional ethical committees and
others participated. The workshop focused on a
specific aspect of clinical research, the need for
171 International Collaboration