丙型肝炎病毒不同标志物检测结果的相关性分析

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丙型肝炎病毒不同标志物检测结果的相关性分析
Analysis of correlation to detected results for different hepatitis C virus markers

摘要：
目的：分析丙型肝炎病毒（ Hepatitis C virus，HCV）抗原、抗体及核酸标志物实验室检测结果之间的关联性，评价适合血源筛查与早期临床确诊联合检测HCV感染的实验室诊断技术。方法用HCV RNA定量试剂、HCV核心抗原试剂及HCV抗体试剂分别检测304份血浆样本中HCV RNA载量、HCV Ag和抗-HCV指标，并对HCV RNA阳性样本进行基因分型。结果在304份血浆样本中，检出HCV RNA阳性样本87份，其HCV RNA载量≥500 IU／mL、500～30 IU／mL之间和＜30 IU／mL时，血清学标志物HCV Ag浓度≥3 fmol／L及抗-HCV信号值／判断值≥1的阳性率分别为92．0％（23／25）：96．0％（24／25）、58．8％（10／17）：82．3％（14／17）及11．1％（5／45）：75．6％（34／45）， HCV RNA载量低于基因分型试剂盒LOD要求为500 IU／mL时，基因分型检测率为24．2％（15／62）。 HCV RNA阴性样本217份中，HCV Ag浓度≥3 fmol／L和抗-HCV信号值／判断值≥1的样本阳性率分别为3．2％（7／217）和32．7％（71／217）。血清学指标在不同HCV RNA载量的阳性率差异具有统计学意义（χ2＝197．4，P＜0．01），HCV RNA载量与HCV Ag和抗-HCV水平成正相关。结论在中国人群中存在低HCV RNA水平携带者，HCV Ag和基因分型检测能力需要进一步提高。

Abstract：
Objective To analyze correlation to the laboratory detected results for hepatitis C virus ( HCV) antigen, antibod-y, and RNA markers, and evaluate the detection methods for blood screening and joint detection of HCV infection in early clinical diagnosis.Methods HCV RNA loads, HCV Ag and anti-HCV index of plasma samples from 304 cases were detec-ted by HCV RNA quantitative reagents, HCV core antigen reagents, and HCV antibody reagents from Abbott, and the genetic typing of HCV RNA positive samples was conducted.Results Among the 304 plasma samples, 87 were detected HCV RNA positive.While the HCV RNA loads were≥500 IU/mL, between 500 and 30 IU/mL, and <30 IU/mL, samples with the positive rate of HCV Ag concentration≥3 fmol/L and anti-HCV signal value/judgment value ≥1 were 92.0% (23/25):96.0%(24/25);58.8%(10/17):82.3%(14/17);11.1%(5/45):75.6%(34/45), respectively.The genetic typing rate was 24.2%(15/62)when the HCV RNA loads were lower than the 500 IU/mL LOD standard of genetic typing reagent. Among the 217 HCV RNA negative samples, the positive rate of HCV Ag concentration≥3 fmol/L and anti-HCV signal val-ue/judgment value≥1 samples were 3.2%(7/217), 32.7%(71/217), respectively.The difference for positive rates of serological indicators in different HCV RNA loads is statistically significant (χ2=197.4, P<0.01).There is positive correla-tion to HCV RNA loads and HCVAg, anti-HCV.Conclusion There are HCV carriers with low HCV RNA loads in popula-tion of China.The detectability of HCVAg and genetic typing need to be improved.

作者：谷金莲 于洋 梁争论   Author：GU Jin-lian YU Yang LIANG Zheng-lun
作者单位： 中国食品药品检定研究院,北京,100050
刊 名：微生物学免疫学进展