化学发光微粒子免疫分析法检测 HBsAg 的定性 Cutoff 值。
Cutoff Value of Qualitative HBsAg for Confirmatory HBsAg Using the Chemiluminescence Microparticle Immunoassay Method.
机构信息
Department of Clinical Pathology, Faculty of Medicine University of Indonesia/ National General Hospital Dr Cipto Mangunkusumo, Jakarta, Indonesia.
出版信息
Lab Med. 2022 Sep 1;53(5):475-478. doi: 10.1093/labmed/lmac021.
BACKGROUND
Confirmatory hepatitis B surface antigen (HBsAg) is an assay used to distinguish weakly reactive from false-positive HBsAg results.
OBJECTIVE
To determine the signal to cutoff (S/CO) value of chemiluminescence microparticle immunoassay (CMIA) HBsAg assay that should trigger follow-up confirmatory HBsAg testing.
METHODS
All specimens with an initial S/CO value of 0.90-100.00 were subjected to repeat HBsAg testing after high-speed centrifugation. The specimens with an initial S/CO value in that range remained in the same range and were then followed up with confirmatory HBsAg testing.
RESULT
In total, 132 specimens had an S/CO value between 0.90 and 100.00 after high-speed centrifugation, followed by confirmatory HBsAg retesting. The S/CO value of HBsAg specimens for which the results required verification with confirmatory HBsAg was 0.98 (100% sensitivity, 3.3% specificity) through 9.32 (47.1% sensitivity, 100% specificity).
CONCLUSION
The HBsAg S/CO values (as determined by the chemiluminescent microparticle immunoassay [CMIA] method) that should trigger confirmatory HBsAg testing are 0.98-9.32.
背景
确认乙型肝炎表面抗原（HBsAg）是一种用于区分弱阳性和假阳性 HBsAg 结果的检测方法。
目的
确定化学发光微粒子免疫分析（CMIA）HBsAg 检测的信号与临界值（S/CO）值，该值应触发后续确认性 HBsAg 检测。
方法
所有初始 S/CO 值为 0.90-100.00 的标本均进行高速离心后重复 HBsAg 检测。该范围内的初始 S/CO 值仍在该范围内的标本随后进行确认性 HBsAg 检测。
结果
总共 132 份标本经高速离心后 S/CO 值在 0.90-100.00 之间，随后进行确认性 HBsAg 复测。需要用确认性 HBsAg 进行验证的 HBsAg 标本的 S/CO 值为 0.98（100%灵敏度，3.3%特异性），通过 9.32（47.1%灵敏度，100%特异性）。
结论
应触发确认性 HBsAg 检测的 HBsAg S/CO 值（由化学发光微粒子免疫分析[CMIA]方法确定）为 0.98-9.32。
Zotero 插件