Evaluation of second-international-standard-based reagent kit Lumipulse Presto HBsAb-III

• Published in: Japanese Journal of Medical Technology Vol. 70; no. 4; pp. 691 - 696
• Main Authors: KIMURA, Chihiro, OKUBO, Manabu, KOHGUCHI, Yutaka, UESUGI, Satoe, MAEDA, Hitomi, TOHYAMA, Kaoru, FURUKAWA, Satoko
• Format: Journal Article
• Language: Japanese
• Published: Japanese Association of Medical Technologists 25.10.2021; 一般社団法人 日本臨床衛生検査技師会
• Subjects: CLEIA; HBs抗体; hepatitis B virus surface antibody; Lumipulse Presto HBsAb-III; Second International Standard; ルミパルスプレストHBsAb-III; 化学発光酵素免疫測定法; 第2次国際標準品
• ISSN: 0915-8669; 2188-5346
• DOI: 10.14932/jamt.20-135

The hepatitis B virus (HBV) surface antibody (HBsAb) is used for the diagnosis of HBV infections and is a marker that appears after vaccination. We evaluated the second-international-standard-based reagent kit for anti-hepatitis B surface antigen (anti-HBs) immunoglobulin (NIBSCcode: 07/164), Lumipulse Presto HBsAb-III (Lumipulse 2nd reagent) and compared it with Lumipulse Presto HBsAb-N (Lumipulse 1st reagent). Within-run and between-run reproducibility precisions were 1.6–3.0% and 1.7–3.8%, respectively. The obtained diluted linearity and lower limit of detection were 1,000.0 and 0.9 mIU/mL, respectively. The correlation coefficient (r) between Lumipulse 2nd reagent and Lumipulse 1st reagent was 0.997. The cutoff value (10.0 mIU/mL) for the concordance rate of the Lumipulse 2nd and 1st reagents was 100%. The basal performance of the Lumipulse 2nd reagent was satisfactory, and it could be used for measurement with high sensitivity.