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Evaluation of the Performance of the HBsAb Rapid Test for Hepatitis B Antibody Detection
Zhang Lei*, Yang Feng and Zhu Junzhe
The Hepatitis B is a serious liver infection caused by the Hepatitis B Virus (HBV), remains a significant public health concern due to its global prevalence and related complications. The presence of HBsAg in whole blood, serum or plasma is an indication of an active Hepatitis B infection, either acute or chronic. As a result, vaccination against HBV was introduced to control the morbidity and mortality associated with the virus. As part of the World Health Organization program for control Hepatitis B. Many people, especially new born, receive vaccination. HBsAb, the antibody to HBsAg, can be detected after receiving the HBV vaccination, and will gradually decrease over time. The minimum standard titer of HBsAb is 10 mIU/mL for protective immunity to HBV. HBsAb ≥ 10mIU/mL indicates successful vaccination and immunity against the hepatitis B virus. Unfortunately, approximately 5-15% of healthy immune competent individuals either does not exhibit an antibody response to the existing recombinant vaccination or respond poorly.
This study evaluates the performance of the HBsAb rapid test, developed by Hangzhou AllTest Biotech Co., Ltd, in comparison to the Radio-Immuno Assay (RIA) method. Clinical trials, employing human whole blood, serum, plasma samples, aimed to ascertain the sensitivity, specificity, and accuracy of the HBsAb rapid test. The HBsAb Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of HBsAb in whole blood, serum or plasma specimen. The test utilizes a double antigen sandwich system to detect as low as 10
mIU/ml of HBsAb in whole blood, serum or plasma. The HBsAb Rapid Test Cassette (Whole Blood/Serum/Plasma) demonstrated ultra-high sensitivity of 99.9% and a specificity of 99.4%, underscoring its accuracy and reliability in identifying HBsAb. Such performance metrics
highlight the viability as a supplementary diagnostic tool in HBsAb detection and management.