血液混样HCV/HIV-1 RNA全自动提取方法的应用评价

目的：建立献血者全自动核酸检测方法，探讨在我国血液筛查中引进全自动核酸筛查的可行性。方法：选用STAR2000加样仪进行血样汇集(24人份)，在COBAS AMPLICOR进行扩增和检测分析结果，从灵敏度及抗干扰能力方面进行评价。结果：用国际标准核酸质控品考评及常规应用，表明全自动汇集、全自动核酸提取及扩增和检测95％的检出限量HCV RNA和HIV-1 RNA分别为17．4IU／ml和20．6cp／ml，20mg／ml胆红素、1g／dl血色素及中等程度的脂血对结果无影响。通过对16512个样本共688汇集池分析，HCVRNA阳性1例(ELISA亦阳性)，HIV-1 RNA未检出阳性。结论：血液混样MPLC全自动核酸提取方法可应用于血液HCV RNA和HIV-1 RNA的筛查工作。

EVALUATION OF NUCLEIC ACID ENTIRELY AUTOMATED EXTRACTION METHOD ON HCV RNA/HIV-1 RNA IN BLOOD SCRENING

Objective:To investigate and study Roche nucleic acid entirely automated extraction method on HCV RNA/HIV-1 RNA in blood sample pooled(24 samples) by sampling processor.Method:Entirely automated extraction method was used to extract nucleic acid simultaneously,the samples were amplicated and detected by Roche COBUS AMPLICOR system,the sensitivity,efficacy and anti-interference were evaluated.Result:The 95 percent cutoff HCV RNA/HIV-1 RNA tests by MPLC were 17.4 IU/ml and 20.6 cp/ml,20 mg/dl bilirubin,1 g/dl hemoglobin and medium lipid blood did not interfere with the results.1 of 16 512 donations was HCV RNA positive( positive for ELISA),none of HIV-1 RNA was detected.Conclusion:Entirely automated extraction method of HCV/HIV-1 RNA by MPLC can be applied in the blood screening.