三种抗-HCV检测试剂盒对无偿献血者筛检价值评价

目的：评价3种抗．HCV筛检试剂对无偿献血者的筛检价值。方法：以卫生部临床检验中心抗-HCV临床科研血清盘标本50份为评价标本，分别用快速试剂法，国产ELISA试剂及进口ELISA试剂对评价标本作盲法检测，以卫生部临床检验中心血清盘标本所提供的阴性和阳性结果为金标准，用四格表法计算出评价真实性及可靠性指标，并对ELISA法的cut-off值的合理性进行评价．结果：快速试剂法，国产英科新创ELISA试剂盒与进口傲拓ELISA试剂盒的灵敏度分别为48％，88％，76％，特异度均为100％，准确度分别为74％，94％，88％．约登指数分别为0．48，0．88，0．76．3种试剂盒的重复符合率均为100％．国产英科新创ELISA试剂盒规定的cut-off值是合理的，而进口傲拓ELISA试剂盒规定的cut-off值太高．结论：3种试剂盒的灵敏度与准确度以国产ELISA试剂盒为最好，3种试剂盒的重复性均好，因此使用2种优选的国产ELISA试剂盒对血液进行联合筛检，既可以保证输血的安全性，又可以减低筛检成本．

Evaluation of three anti-HCV screening reagents in blood donors

AIM: To evaluate three anti HCV screening reagents in blood donors. METHODS: Samples for evaluation were 50 anti HCV serum plates for clinical scientific research from the Clinical Testing Center of the State Ministry of Health. The samples underwent blind screening by fast reagent method, China made ELISA kit and imported ELISA kit, respectively. Using the anti HCV positive and negative serum plates from Clinical Testing Center of the State Ministry of Health as the golden criteria, the validity and reliability were tested with four fold table and the cut off of ELISA was reasonably evaluated. RESULTS: The sensitivity of fast reagent method, China made INTEC ELISA kit and imported ORTHO ELISA kit was 48.0%, 88.0% and 76.0%, respectively. Their specificity was all 100.0% and their accuracy was 74.0%, 94.0% and 88.0%, respectively. Their Youden's index was 0.48, 0.88 and 0.76, respectively and the repetition coincidence rate of all the three reagents was 100.0%. The due cut off value of homemade INTEC ELISA kit was reasonable, while the due cut off value of imported ORTHO ELISA kit was too high. CONCLUSION: Of the three reagents under study, the China made INTEC ELISA kit has the best sensitivity and accuracy .The repetition coincidence rate of all the three reagents is satisfactory. The combined screening of two optimized China made ELISA kits can ensure the safety of blood transfusion and low cost of screening.