International Journal of Medical Laboratory Research (IJMLR)

PERFORMANCE EVALUATION OF BIOLOGICAL REFERENCE PREPARATIONS HUMAN ALBUMIN AND HUMAN IMMUNOGLOBULIN FOR ELECTROPHORESIS (PROTEIN COMPOSITION) AFTER RECOMMENDED PERIOD FOR ITS USE IN TESTING LABORATORIES

 

AA Talwar, Girija L.V, Y. Madhu, V Singh, V Singh, M Kumari

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Abstract: A study had been conducted in our laboratory along with the routine regulatory testing to evaluate the performance of Biological Reference Preparations (BRP) Human Albumin for Electrophoresis BRP (Code: H0900000, Batch 2, EDQM, France) and Human Immunoglobulin for Electrophoresis BRP (Code: H1000000, Batch 3, EDQM, France) after recommended period i.e fourteen days after reconstitution.  These reference preparations are recommended for Protein Composition test in EP/IP monographs for quality control evaluation.  Protein composition by Horizontal Zone Electrophoresis using cellulose acetate membrane strips is recommended for determination of Purity in Human Albumin and Human Immunoglobulin preparations in EP/IP. The aliquots stored at recommended temperature after reconstitution verified for its performance and from the results obtained, it was observed that all data points are within the stated limit for both BRP and significant effect of time period after reconstitution was not observed during the study period i.e. from 32nd day to up to 406th day for human albumin BRP and from 20th day to up to 350th day for Immunoglobulin BRP.  The %RSD obtained for both is less than 1%.  From this study, it is found that these BRP can be used even after fourteen days of recommended period, if reconstituted and stored as per instructions of EDQM, France, to avoid wastage of precious material.  

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KEYWORDS: Human Albumin, Human Immunoglobulin, BRP, Horizontal Electrophoresis, Protein Composition, Quality Control

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