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目的比较一种新的国产风疹病毒(rubella virus,RV)免疫球蛋白M(immunoglobulin M,Ig M)抗体化学发光检测试剂和进口化学发光检测试剂的检测性能。方法 2014年1月—3月收集临床血液样本356例,同时用国产试剂(评价试剂)和进口试剂(比对试剂)的RV Ig M抗体化学发光检测试剂,检测血清中RV Ig M抗体水平,按各自的操作说明书进行测定,检测结果不一致者以第三方试剂Trinity Biotech Plc的RV IgM抗体检测试剂盒(酶联免疫吸附测定法)验证,对临床样本进行等效性评价。结果评价试剂和比对试剂同时检测了356例RV IgM样本,312例为阴性,38例为阳性。评价试剂和比对试剂测定结果阳性符合率为100.00%[95%CI(90.82%,100.00%)],阴性符合率为98.11%[95%CI(95.95%,99.13%)],总符合率为98.31%[95%CI(87.59%,100.00%)],不一致的6例以第三方试剂验证后可得灵敏度为100.00%[95%CI(90.82%,100.00%)],特异度为98.11%[95%CI(95.95%,99.13%)],阳性预测值为86.36%[95%CI(72.65%,94.83%)],阴性预测值为100.00%[95%CI(98.82%,100.00%)]。评价试剂和比对试剂的受试者工作特征曲线下面积分别为0.991和1.000,诊断效能比较差异无统计学意义(P>0.05)。结论该国产RV Ig M抗体化学发光检测试剂盒具有较好的敏感性和特异性,能为临床RV IgM抗体的检测提供可靠的实验室诊断依据。
Objective To compare the detection performance of a new rubella virus (RV) immunoglobulin M (Ig M) antibody chemiluminescence detection reagent and imported chemiluminescence detection reagent. Methods A total of 356 clinical blood samples were collected from January to March 2014. RV Ig M antibody levels in serum were detected by using RV Ig M chemiluminescence detection reagent with domestic reagent (evaluation reagent) and imported reagent (comparison reagent) According to the respective operating instructions, the test results were inconsistent with the third-party reagent Trinity Biotech Plc’s RV IgM antibody test kit (ELISA) validation, clinical samples for equivalent evaluation. Results A total of 356 RV IgM samples were simultaneously detected by the evaluation reagents and the comparison reagents, 312 were negative and 38 were positive. The positive coincidence rate was 100.00% [95% CI (90.82%, 100.00%)] and the negative coincidence rate was 98.11% [95% CI (95.95%, 99.13%)]. The total coincidence rate was 98.31% [95% CI (87.59%, 100.00%]]. The inconsistency of the 6 cases with the third-party reagents showed 100.00% [95% CI (90.82%, 100.00% (95.95%, 99.13%)]. The positive predictive value was 86.36% [95% CI (72.65%, 94.83%]] and the negative predictive value was 100.00% [95% CI 98.82%, 100.00%]. The area under the working characteristic curve of the evaluation reagent and the comparison reagent were 0.991 and 1.000, respectively, with no significant difference in diagnostic efficacy (P> 0.05). CONCLUSION: The domestic kit for detection of RV Ig M antibodies has good sensitivity and specificity, which can provide a reliable laboratory diagnosis basis for the detection of clinical RV IgM antibodies.