Comparative Study of Two ELISA Kits for Estimation of Antibodies to Hepatitis B Virus in Human Normal Immunoglobulin and Specific Immunoglobulin Intended for Intravenous or Intramuscular Use

Abstract

Current study is conducted to evaluate method verification of two locally available kits manufactured by DSI & BIORAD for quantitative estimation of Hepatitis B virus antibodies in human normal immunoglobulin by using International standard of National Institute of Biological Standards and Control. Four analyst perform five sets of test in duplicate analysing accuracy, precision, and limit of detection, sensitivity and specificity. Our results suggest that both DSI and BIORAD kits fulfil the validation criteria and are sensitive to detect up to 10 mIU concentration precisely and accurately. DSI kit is more precise at concentration 100 mIU and economically 4-5 times cheaper in local market; on the other hand, BIORAD kits provide larger detection range up to 1000 mIU.

Keywords: Accuracy; Hepatitis B virus; Immunoglobulin; Limit of detection; Precision; Sensitivity; Specificity.

Fig. 1

Showing comparative performance study between DSI (DS-EIA-Anti HBs AG) and BIO RAD (MONALISA Anti HBs Plus) ELISA kits using 2nd International Standard for anti-hepatitis B surface antigen (anti-HBs) Immunoglobulin, human, and NIBSC code: 07/164 at concentration a 25 mIU/ml, b 50 mIU/ml, c 100 mIU/ml, d 125 mIU/ml, and e 150 mIU/ml, f showing recovery studies of 10 mIU/ml