Allergen Lab


Allergen Testing Lab


Allergen 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.


The 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 control.


In 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.


To 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 allergen extracts.

Allergen 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.



Future Lab Activity


1) Constitution of an Expert Committee in Consultation with DCG(I) is being considered as per approved TOR.

2) Expansion of network for collection of sera from patient who are SPT positive for Cockroach and / or Moth allergens.

3) Identification of major and minor allergens by Western Blot technique using individual patient sera.

4) Standardization of ELISA for allergen specific IgE determination and estimation.

5) Isolation, quantitation and characterization of one major allergen from each extract.

6) Standardize ELISA/ELISA inhibition assays with purified major allergen to develop QC tests and reagents.

7) To take up Allergen standardization work in India in collaboration with stakeholders, manufacturers, regulators, clinicians, researchers and NIB.





Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2013


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