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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 To compare the serum anti-HCV and HCV RNA in patients with chronic hepatitis C virus infection by enzyme-linked immunosorbent assay (ELISA) and reverse transcription-polymerase chain reaction (RT-nPCR). Methods In May 2005, a total of 185 HCV infected patients and 52 healthy controls were collected from rural Hebei Zhaoxian County in Hebei Province. Fasting venous blood was collected from 185 individuals. The infected population was infected with apheresis plasma even before 1990 when blood transfusion cells were infected. In 1993, it was confirmed by on-site investigation, serum biochemical indexes and etiological markers for HCV infection. The follow-up survey in 2002 still confirmed the diagnosis. Anti-HCV was detected by ELISA and HCV RNA by RT-nPCR. Results ① Among the 185 serum samples, 92 were positive for anti-HCV and HCV RNA, accounting for 49.73%; 18 were anti-HCV negative and HCV-RNA positive were 9.73%; those with anti-HCV positive and HCV-RNA negative were 22 Share, accounting for 11.89%, both negative 53, accounting for 28.65%. The coincidence rate of the two methods was 78.38% [(92 + 53) / 185], and there was no significant difference between the two methods (χ2 = 0.40, P> 0.05); ② The sensitivity of ELISA for detecting chronic HCV infection was 82.71 %, The specificity was 92.31% and the rate of misdiagnosis was 17.29%. The sensitivity of RT-nPCR was 81.20%, the specificity was 96.15% and the misdiagnosis rate was 18.80%. There was no significant difference between the two methods (χ2 = 0.102, P> 0.05). ③ The sensitivity of parallel assay was 96.75% and the specificity was 88.76%. The sensitivity was significantly higher than that of single ELISA (χ2 = 9.62, P <0.01). Conclusion The detection rate of anti-HCV by ELISA was about 17%, while the detection of HCV RNA by RT-nPCR could significantly increase the positive rate of HCV infection.