Testing Laboratory :- It is estimated that in India about 22-30 percent
of population suffers with respiratory allergy. For identification of
offending allergens in these patients, various disgnostic tests are
performed which is followed by administration of immunotherapy with the
causative allergens. Both, the diagnostic efficiency as well as
therapeutic efficacy of these procedures depends on the bio-potency of
these allergen extracts.
importance of identification of major allergens in crude allergen extracts
and their quantitation for biological activity was recognized in the early
nineties and is now established in the WHO recommendations, European
Pharmacopoeia as well as in US Position Paper. It has been recommended
that allergen extracts should be standardized by measuring at least one of
their major allergens. The common allergen extracts in Western countries
are now available as standardized products or are pending standardization.
Presently, in India, patients are diagnosed and treated with crude,
aqueous allergen extracts, which have not been properly characterized or
standardized, because procedures and reagents are not available for their
quality control. Therefore, there is an urgent need to undertake a
systematic and comprehensive study on the (i) identification of major and
minor allergens of clinically important allergen extracts of our country
and generating a national database, and (ii) developing techniques,
prepare reference reagents and generate parameters for their quality
view of above facts, Allergen Testing Laboratory has been
established in Sep, 2009 to undertake work on standardization of
indegenous allergen extracts for the first time in the country. The
proposed work titled 'Development of Techniques and Reagents for
Quality Control of Clinically Important Indegenous Allergen Extracts'
has been undertaken in collaboration of Metro Hospital, NOIDA where skin
Prick Testing of Allergic patients is routinely done.
start with, work on standardization of Cockroach (Periplanata americana)
and Moth allergens has been undertaken to serve as a model for developing
Quality control techniques for other clinically important indigenous
extraction procedure from lyophilised whole body power of Cockroach,
carbohydrate and protein estimation, SDS-PAGE, ELISA for total IgE
detection and Western Blot have been carried out. Further standardization
work is in progress.
Constitution of an Expert Committee in Consultation with DCG(I) is being
considered as per approved TOR.
Expansion of network for collection of sera from patient who are SPT
positive for Cockroach and / or Moth allergens.
Identification of major and minor allergens by Western Blot technique
using individual patient sera.
Standardization of ELISA for allergen specific IgE determination and
Isolation, quantitation and characterization of one major allergen from
Standardize ELISA/ELISA inhibition assays with purified major allergen to
develop QC tests and reagents.
To take up Allergen standardization work in India in collaboration with
stakeholders, manufacturers, regulators, clinicians, researchers and NIB.