两种巨细胞病毒IgG抗体ELISA诊断试剂性能评价

Evaluation of two commercial cytomegalovirus IgG ELISA diagnostic kits

目的对国内两种巨细胞病毒IgG抗体ELISA诊断试剂进行评价。方法用两种试剂对BBI公司的质控盘QTC711，血清转化盘PTC901，BIOMEX公司血清转化盘SCP—CMV-001（RP-003）、SCP—CMV-002（RP-019），儿童、孕妇和门诊患者2163份标本进行检测，对不一致的样本用DiasorinELISA试剂盒和Mikrogen重组免疫印迹试剂盒进行复测，比较两种试剂的灵敏度、特异性和对不同人群的检测差异。结果A试剂对3个血清转化盘的检出时间均早于B试剂，平均提前25d，与AbbottImxCMVIgG检测灵敏度一致。两种试剂检测孕妇样本607份，8份不一致，总符合率98．68％；门诊样本512份，7份不一致，总符合率98．63％；儿童样本1044份，74份不一致，总符合率92．91％，两试剂对儿童人群的符合率低于孕妇和门诊人群。两试剂对三个人群检测均为阴性的161份样本，和A试剂检测为阳性B试剂检测为阴性的89份样本，用意大利Diasorin公司CMV—IgGELISA试剂复测，A试剂与Diasorin的阳性符合率为100％，阴性符合率为93．06％，总符合率为95．22％；B试剂与Diasorin的阴性符合率为100％，78份阳性未检出，总符合率为68．92％。选择A试剂与Diasorin结果不一致的样本12份，一致的样本6份，用重组免疫印迹复测，其中14份阳性，4份阴性。结论国内A试剂对血清转化盘的检测窗口期较B试剂显著提前。两试剂对孕妇和门诊人群的符合率高于儿童人群。两试剂不符合的样本用进口试剂盒复测，A试剂与进口试剂盒的符合率高于B试剂，显示了较高的灵敏度。

Objective To evaluate the two commercial cytomegalovirus IgG ELISA diagnostic kits. Methods Anti-CMV quality control panel QTC711 and seroconversion Panel PTC901 from BBI, seroconversion panel SCP-CMV-001 （ RP-O03 ） and SCP-CMV-002 （ RP-019 ） from BIOMEX, and 2163 samples from three population groups were detect by the two kits. The inconsistent sample were retest by Diasorin CMV-IgG ELISA kit and Mikrogen recomblot CMV-IgG kit. Results Three seroconversion panel result show that the average detected positive time of A kit is 25 days earlier than B kit, the sensitivity of A kit is same as Abbott Imx CMV. The two kits detect 607 pregnant woman samples, 8 were inconsistent, the coincidence rate is 98.68%; 512 outpatients samples, 7 were inconsistent, the coincidence rate is 98.63% ; 1044 Pediatric population samples, 74 were inconsistent, the coincidence rate is 92. 91% ; the coincidence rate of Pediatric group is lower than other two groups. 161 negative samples detect by A and B kits, and 89 samples positive by A kit but negative by B kit, were retest by Diasorin CMV-IgG ELISA kit, the positive coincidence rate of A and Diasorin kit is 100% , negative coincidence rate is 93.64% , total coincidence is 95.62% ; the negative coincidence rate of B and Diasorin kit is 100% , total coincidence is 68.92%, 78 samples were negative by B kit. 12 A and Diasorin kit detect inconsistent samples and 6 consistent samples were retest by recomblot CMV-IgG, 14 resuhs were positive, 4 results were negative. Conclusion The detection window period of A kit is shoter than B kit. The coincidence rate of A and B kit for pregnant women and outpatient population is higher than pediatric population. The inconsistent samples were retest by imported kits, A kit show high consistent with imported kit than B kit.