使用重组DNA衍生的乙肝表面抗原（HBsAg）检测抗HBsAg抗体的第二代检测方法。

Second generation assays for the detection of antibody to HBsAg using recombinant DNA-derived HBsAg.

作者信息

Mimms L, Goetze A, Swanson S, Floreani M, Edwards B, Macioszek J, Okasinski G, Kiang W

机构信息

Hepatitis/AIDS Research, Abbott Laboratories, Abbott Park, IL 60064.

出版信息

J Virol Methods. 1989 Aug;25(2):211-31. doi: 10.1016/0166-0934(89)90034-7.

DOI:10.1016/0166-0934(89)90034-7

PMID:2476461

Abstract

A second generation radioimmunoassay (RIA) and enzyme-linked immunoassay (EIA) for the detection and quantitation of the antibody to hepatitis B surface antigen (anti-HBs) was developed which utilizes recombinant DNA-derived HBsAg (rHBsAg) in place of human plasma derived HBsAg. In these sandwich assays, rHBsAg immobilized on a solid phase was used to capture anti-HBs from the specimen and rHBsAg conjugated to horseradish peroxidase or radiolabeled with 125I was used as a detecting reagent. These rHBsAg-based assays were compared to a commercial radioimmunoassay for anti-HBs detection (AUSAB RIA). For a population of 1711 sera and plasma specimens, 99.2% overall agreement was demonstrated between the recombinant RIA and EIA and 98.6% agreement was observed between the recombinant assays and AUSAB-RIA. The recombinant assays demonstrated equivalent sensitivity and detectability to AUSAB RIA. Most discrepant samples were low-level reactive by AUSAB-RIA, generally less than 10 mIU/ml, and likely represent nonspecific reactivity since no other marker for hepatitis B infection was detected in these samples.

摘要

开发了一种第二代放射免疫测定法（RIA）和酶联免疫测定法（EIA），用于检测和定量乙型肝炎表面抗原抗体（抗-HBs），该方法使用重组DNA衍生的HBsAg（rHBsAg）代替人血浆衍生的HBsAg。在这些夹心测定法中，固定在固相上的rHBsAg用于从标本中捕获抗-HBs，与辣根过氧化物酶缀合或用125I放射性标记的rHBsAg用作检测试剂。将这些基于rHBsAg的测定法与用于抗-HBs检测的商业放射免疫测定法（AUSAB RIA）进行比较。对于1711份血清和血浆标本，重组RIA和EIA之间的总体一致性为99.2%，重组测定法与AUSAB-RIA之间的一致性为98.6%。重组测定法显示出与AUSAB RIA相当的灵敏度和可检测性。大多数差异样本通过AUSAB-RIA呈低水平反应性，通常低于10 mIU/ml，并且由于在这些样本中未检测到其他乙型肝炎感染标志物，可能代表非特异性反应性。