Novel Matrix for Immunoassay calibrators and controls

by Dr. Anand Akerkar
CSTTI, Great Neck, NY

Abstract

Manufacturers of Immunodiagnostic kits instruments reagents, etc. have regulatory requirements that involves providing controls material to the end user that will assure consistently precise and accurate potential results. Calibrators also sometimes refer as standards and controls with long term, preferably stable at ambient temperature and appropriate but accurate concentration of analytes and accurate assignment and target values are absolutely critical for this purpose. Unfortunately, even though calibrators prepared from human sources, lot to lot variation in their makeup make it very difficult if not impossible to make them behave as patient samples. These variations or properties are sometimes referred to as matrix effects.

Since non-isotopic immunoassay introduced in the early 70s, a number of manufacturers have made several attempts to manufacture or synthesize various matrices, that includes human blood, animal serum and other endogenous or non-endogenous proteins, or protein-like substances in various configurations to mimic human serum. Although some manufacturers were able to synthesize formulation that works well for one or two analytes, they were unable to make universal “cocktail” which could be substituted as “matrix solution.” In addition, they encountered another problem associated with protein based calibrators.

Our study with synthetic matrix revealed that even most sensitive proteins can be stabilized at ambient temperature for over twelve months without the need of refrigeration or lyophilization

Biography

Dr. Akerkar has over 50 years of experience in the healthcare industry. Anand held several senior management positions at Ciba Giegy, Becton Dickinson, and Technicon Corporation. Dr. Akerkar has successfully managed the development, launch and management of in-vitro diagonostic products. While at Becton Dickinson, he was a member of the industry review board for the FDA that helped to define the 510(K) submission requirements and other clinical chemistry standards. Dr. Akerkar holds 11 patents and has been published over 150 times in recognized scientific journals. Dr. Akerkar has been a consultant to the healthcare industry since 1986. Dr. Akerkar was the Scientific Advisor to ex-U.S. Congressman Benjamin Gilman and ex Majority leader Tom Delay He has been President and CEO of CST technology Inc since 1986

Presenting author details
Full name: Dr. Anand Akerkar
Session name/ number: Bioanalytical Methodology
Category: Poster
Email id: anand@cstti.com
Contact number: 516-482-9001


The Abstract related to “Novel Matrix for Immunoassay calibrators and controls” in the track Bioanalytical Methodology has been accepted for Poster Presentation at Analytical Chemistry 2019.

Analytical Chemistry 2019
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