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研究抗体血清学检测与高敏核酸检测在病毒性丙型肝炎筛查中的价值。对本院住院患者的化学发光免疫分析试验(CLIA)、荧光定量PCR检测结果进行分析。行CLIA的有11221人次，阳性率为0.68%(76/11221)，抗体阳性COI在1～165之间，中位数为38.4。行荧光定量PCR检测的有17314人次，阳性率为0.29%(51/17314)，病毒载量区间为3.5×10IU/mL～4.0×107IU/mL，中位数为1.0×106IU/mL。两种方法检测的阳性率均有年龄分布差异特点，41岁～60岁年龄段阳性率达到最大值。同时进行高敏核酸检测和抗体血清学检测的有8892人次，抗体血清学检测阳性率为0.70%(62/8892)，高敏核酸检测阳性率为0.22%(20/8892)。若将高敏核酸检测结果视为丙型肝炎现症感染诊断的金标准，则抗体血清学检测的敏感度100.00%，特异性为99.53%，准确度为99.53%，阳性预测值(PPV)为32.26%，阴性预测值(NPV)为100.00%,Kappa为0.48。抗体血清学检测COI值与高敏核酸检测病毒载量无明显线性关系，COI值在11～50时，高敏核酸检测阳性率达到最大值。在筛查丙型肝炎中，高敏核酸检测、抗体血清学检测有较高的价值，应重视高危人群的HCV感染管理。
Abstract：The diagnostic value of antibody serological testing and high-sensitivity nucleic acid testing in screening for viral hepatitis C was evaluated. Chemiluminescence immunoassay(CLIA) and real-time fluorescence quantitative PCR(qPCR) results from inpatients at a tertiary hospital were retrospectively analyzed. Among 11,221 individuals tested by CLIA, the positivity rate was 0.68%(76/11,221), with antibody COI values ranging from 1 to 165(median: 38.4). Among 17,314 individuals tested by qPCR, the positivity rate was 0.29%(51/17,314), with viral loads ranging from 3.5×10 IU/mL to 4.0×107 IU/mL(median: 1.0 × 106 IU/mL). For both methods, positivity rates varied by age group, peaking in individuals aged 41-60 years. A total of 8,892 individuals underwent both high-sensitivity nucleic acid testing and antibody testing, with positivity rates of 0.70%(62/8,892) and 0.22%(20/8,892), respectively. Using highsensitivity nucleic acid testing as the reference standard for current HCV infection, antibody testing demonstrated a sensitivity of 100.00%, specificity of 99.53%, accuracy of 99.53%, positive predictive value(PPV) of 32.26%, negative predictive value(NPV) of 100.00%, and a Kappa coefficient of 0.48. No significant linear correlation was observed between antibody COI values and viral load. When the COI value was between 11 and 50, the positivity rate of high-sensitivity nucleic acid testing was highest. Both high-sensitivity nucleic acid testing and antibody serological testing are of substantial value in hepatitis C screening, and HCV infection management in high-risk populations warrants particular attention.
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基本信息:
DOI：10.13242/j.cnki.bingduxuebao.250119
中图分类号:R512.63;R446.6
引用信息:
[1]青清,何丽华,邓蓉,等.病毒性丙型肝炎筛查中丙型肝炎病毒高敏核酸检测及抗体检测的价值研究[J].病毒学报,2025,41(05):1451-1457.DOI:10.13242/j.cnki.bingduxuebao.250119.
基金信息: