抗-HCV结果分析及灰区范围设置的探讨

Analysis HCV antibody test and explore the necessity of setting gray zone range

目的：分析酶联免疫吸附试验（ELISA ）筛查丙型肝炎病毒抗体（抗‐HCV ）结果，探讨实验室 ELISA中灰区范围设置的必要性。方法回顾性分析34942例患者抗‐HCV筛查结果，比较抗‐HCV与 HCV‐RNA及临床确诊丙型肝炎患者间的关系；以初筛S／CO值在0．4～2．0范围内的标本为灰区样本，进行不同厂家试剂复检及HCV‐RNA检测，探讨设置抗‐HCV检测灰区范围的必要性。结果抗‐HCV筛查阳性率0．61％；31～50岁阳性率最高；男性高于女性，两者比较差异有统计学意义（P＜0．05）。S／CO≥10时抗‐HCV与 HCV‐RNA检测结果符合程度高，S／CO≥3．8时抗‐HCV与临床确诊丙型肝炎符合程度高。灰区样本的阳性率0．38％，双试剂双孔复检后阳性率0．20％和0．05％。结论抗‐HCV筛查阳性率在不同地域、性别及年龄段存在差异；S／CO值越大，HCV‐RNA阳性率越高，与临床丙型肝炎的确诊符合程度越高，而抗‐HCV 筛查落在灰区范围的样本应复检并检测RN A ，以减少实验室漏检或假阳性结果的产生。

Objective Analyse the results of hepatitis C virus antibody （HCV‐Ab）screening by ELISA ,and discuss the necessity of setting gray zone range of ELISA .Methods A retrospective analysis was made on HCV‐Ab screening results of 34 942 cases ,and then compared the relationship between HCV‐Ab and HCV‐RNA ,clinical con‐firmed hepatitis C .Finally ,in order to explore the necessity of setting laboratory gray zone range by ELISA ,we col‐lected the samples whose S/CO value was in the range of 0 .4 to 2 .0 ,retested by different manufacturers reagents and detected its HCV‐RNA .Results HCV‐Ab positive screening rate was 0 .61% and the highest rate was in the group of 31 to 50 years old;the rate of men was higher than women′s and the difference was statistically significant（P〈0 .05） .When the sample′s S/CO≥10 .0 ,there was high degree of compliance between HCV‐Ab and HCV‐RNA de‐tection ,simultaneously ;the same results arose between HCV‐Ab and clinical confirmed hepatitis C when the sample′s S/CO≥3 .8 .Gray zone sample detection rate was 0 .38% ,and the retested rate was still 0 .20% and 0 .05% by two reagents and double holes detection .Conclusion In different regions ,gender and age ,there are differences HCV‐Ab positive screening rate;when they use ELISA method to test sample′s S/CO value is greater ,the detection rate of HCV‐RNA is higher ,HCV‐Ab positive result and clinical confirmed hepatitis C are more conform .When the samples of HCV‐Ab screening result falls in the gray zone range ,we should retest them and detect their RNA ,in order to re‐duce laboratory missed or false positive generation .