中和确认试验在电化学发光免疫法检测乙型肝炎表面抗原弱反应性中的价值探讨

Significance investigation of neutralization confirmatory test for the weak reactive result of HBsAg determination by electrochemiluminescence immunoassay

目的对电化学发光免疫法(ECLIA)检测乙型肝炎表面抗原(HBsAg)弱反应性的标本进行中和确认试验,并对确认结果进行分析。方法筛选ECLIA检测HBsAg弱反应性(COI值在1.00～50.00之间)的100例标本进行中和确认试验,并对确认结果进行分析。结果 100例HBsAg弱反应性标本经确认试验确认阳性87例(87.0%),阴性10例(10.0%),不确定3例(3.0%)。受试者工作特征(ROC)曲线分析结果显示,当ECLIA检测HBsAg的COI值为1.97时,特异性可达100.0%,敏感性为83.9%。结论中和确认试验可作为HBsAg弱反应性标本进一步确认的手段;ECLIA对弱反应性HBsAg检测敏感性高,特异性好;当ECLIA检测HBsAg的COI值>2.00时,一般可以排除假阳性的可能,无需进一步做确认试验。

Objective To use neutralization confirmatory test to confirm and analyze the results of weak reactive hepatitis B surface antigen （HBsAg） determination by electrochcmiluminescence immunoassay （ECLIA）. Methods A total of 100 weak reactive HBsAg positive samples （1.00 〈COI 〈50.00） were detected by ECLIA,and confirmed by neutralization confirmatory test. The results were analyzed. Results Among the 100 weak reacitve HBsAg positive samples ,87 samples （ 87.0% ） were confirmed, 10 samples （ 10% ） were negative, and 3 samples （ 3.0% ） were uncertain. According to the receiver operating characteristic （ ROC ） curve, when the COI was 1.97, the specificity was 100.0%, and the sensitivity was 83.9%. Conclusions The neutralization confirmatory test can be used as the further means to confirm the samples with weak reactive HBsAg. ECLIA shows high sensitivity and specificity on weak reactive HBsAg positive samples. When COI 〉 2.00, generally it is unnecessary to do the neutralization confirmatory test and could exclude the possibility of false-positivity.