ELISA联合RT-nPCR检测慢性丙型肝炎病毒感染者结果分析

Analyses of anti-HCV detected by ELISA and HCV RNA detected by RT-nPCR in chronic hepatitis C virus infectors

目的对比酶联免疫吸附试验(ELISA)和逆转录套式聚合酶链反应(RT-nPCR)检测慢性丙型肝炎病毒感染者血清抗-HCV和HCVRNA结果。方法2005年5月对河北赵县某农村单采血浆还输血细胞HCV感染者133人及健康对照52人共185人采集空腹静脉血。该感染人群于1990年前单采血浆还输血细胞时感染、1993年被现场调查、血清生化指标及病原学标志检查确诊为HCV感染者、2002年追踪调查仍明确诊断者。用ELISA法检测抗-HCV,用RT-nPCR检测HCVRNA。结果①185份血清标本中,抗-HCV和HCVRNA均阳性者92份,占49.73%;抗-HCV阴性、HCV-RNA阳性者18份,占9.73%;抗-HCV阳性、HCV-RNA阴性者22份,占11.89%,两者均阴性53份,占28.65%。两种方法检测结果一致符合率为78.38%[(92+53)/185],检测不一致率差异无显著性(配对χ2=0.40,P>0.05);②ELISA法检测慢性HCV感染者的灵敏度为82.71%,特异度为92.31%,漏诊率为17.29%;RT-nPCR检测的灵敏度为81.20%,特异度为96.15%,漏诊率为18.80%,两种方法检测灵敏度差异无显著性(χ2=0.102,P>0.05);③并联试验检测其灵敏度为96.75%,特异度为88.76%,其灵敏度明显高于单一ELISA法82.71%(χ2=9.62,P<0.01)。结论单独用ELISA法检测抗-HCV约有17%的漏检率,同时用RT-nPCR检测HCVRNA,可明显提高HCV感染者的阳性检出率。

Objective In order to provide the basis for the clinical test and the blood station screening the health donator, the results of anti-HCV tested by ELISA （enzyme-linked-immuno-absorbed assay ） and HCV RNA tested by RT-nPCR （ reverse-transcript-nested-polymerase-chain-reaction ） were compared in the chronic hepatitis C virus infectors. Methods Venous blood samples of 133 chronic hepatitis C virus infectors, 52 health controls were collected in May 2005. These infectors were infected with HCV nearly in 1990 through plasma donator and diagnosed in 1993 in a rural area of Zhao County in Hebei Province, which remained the same diagnosis as HCV infectors in 2002 Hebei Province. The anti-HCV was tested by ELISA and HCV RNA was tested by RT-nPCR,Results （1）In 185 cases, the positive rates of both anti-HCV and HCV RNA were 49.73% （92/185）. The rate of anti-HCV negative but HCV RNA positive was 9.73% （18/185）. The rate of anti-HCV positive but HCV RNA negative was 11.89% （22/185）. The negative rate of both antiHCV and HCV RNA tested was 28.65% （53/185）. The result-agreement rate of ELISA and RT-nPCR methods were 78.38%[（92 ＋ 53）/185]. The disagreement rate between ELISA and RT-nPCR methods was not obviously different （paired 2 = 0.40, P 〉 0.05）. （2）In the chronic HCV infectors, the sensitivity of anti-HCV tested by ELISA was 82.71%, the specificity was 92.31%, and the omitting rate was 17.29%. The sensitivity of HCV RNA tested by RT-nPCR was 81.20%, the specificity was 96.15%, and the omitting rate was 18.80%. The sensitivitv between EIJSA and RT-nPCR was not obviously different （ χ^2 = 0. 102, P 〉 0.05）. （3）The sensitivity tested by ELISA combined with RT-nPCR was 96.75%, which was evidently higher than that of single ELISA （82.71%） （χ^2 = 9.62, P 〈 0.01）. Conclusion The false negative rate was nearly 17% when anti-HCV was tested with single EEISA in HCV infectors. The positive testing rate of HCV infection was increased remarkably when ELISA and RT-nPCR were tested simultaneously.