三种国产抗-HCV酶联免疫诊断试剂检测结果与电化学发光法比较

目的探讨A、B和C三种不同国产酶联免疫吸附试验（ELISA）试剂检测丙型肝炎病毒抗体（抗-HCV）结果的差异性,并将检测结果与电化学发光法检测结果进行比较。方法随机挑选临床检测样本94例。所有样本再使用B、C和Roche电化学发光法试剂盒进行检测。ELISA试剂都使用各自的试剂盒S/CO值进行阴阳性判断,电化学发光检测结果判断以仪器的COI作为判断标准,结果〉1为检测有反应性。结果 A、B、C和电化学发光检测的阳性率分别为84.04%（79/94）、35.11%（33/94）、25.53%（24/94）和39.36%（37/94）,A试剂显著高于电化学发光法,而C试剂显著低于电化学发光法。A、B、C和电化学发光检测的结果一致性分别为55.32%（52/94）、95.74%（90/94）和86.17%（81/94）。将A试剂盒检测的结果分为阴性组（〈1）、弱阳性组（1~8）、阳性组（〉8）三个组,阴性和阳性组四种试剂检测结果符合率较好,而弱阳性组符合率较低。结论 3种国产试剂对阴性和阳性标本与Roche电化学发光法检测符合率很高,弱阳性标本符合率则存在差异,对于弱阳性标本建议使用确诊试验。

Evaluation and comparison of three different hepatitis C virus antibody tests based on enzyme-linked immunosorbent assay and chemiluminescence methods

Objeetlve To investigate the difference of results based three commercially anti-HCV antibody ELISA kits（A, B and C） used in routine laboratory in China. We also compare the results with the results based chemiluminescence immune assay（CIA） methods. Methods Ninety four samples of sera were collected t~om inpatients. All sera were analysed using three different ELISA kits and Cobas e 601 anti-HCV CIA systems. All of the assays were performed and S/CO or COI were gained according to the manufacturers＇ instructions. If the S/CO or COI〉 1 the results were considered reactive. Results Total anti-HCV positive rate for the 94 serum samples to the three different ELISA tests and CIA systems were 84.04 %（79/94）, 35.11%（33/94）, 25.53%（24/94） and 39.36%（37/94）. The positive rate of A ELISA test kits was statistically higher than the rate of CIA systems, but C ELISA test kits was lower than CIA systems. No difference was between B ELISA test kits and CIA systems. The total coincidence rates between three ELISA kits and CIA systems were 55.32%（52/94）, 95.74%（90/94） and 86.17%（81/94）. According to the results based A ELISA kits, the samples were divided into three groups： negative group（〈 1 ）, weak positive group（I-g） and positive group（ 〉 g）. In the negative group and positive group, the results had good coincidence rate based four reagents, but weakly positive group, the coincidence rate was low. Conclusion In the negative group and positive group, the results have good coincidence rate based three ELISA kits, but weakly positive group, the coincidence rate is low, so the confirm tests is recommended.