摘要
目的对丙型肝炎病毒抗体试剂检测结果的可信度进行分析探讨。方法留取无偿献血筛查中因HCV项目报废的血浆样本400份样本,用国内2家和国外2家公司生产的4种抗HCV试剂进行检测。若4种试剂检测结果不一致,需做进一步验证,所使用的试剂为HCV RIBA和HCV RNAPCR。验证后对总体分析结果进行综合性地分析探讨。结果 2种经国家批准合格的国产LZ、GBI试剂与国际上第三代主流试剂及国外进口试剂检测阴性符合率及总符合率大于96%,差异无统计学意义。4种抗HCV检测试剂阳性符合率大于97%。有5份样品经4种抗HCV试剂检测结果不一致,用HCV RIBAHCV3.0和HCV RNAPCR试剂做进一步验证。结论国产抗HCVEIA试剂检测灵敏度和特异性较好,在阳性样品的筛查检测上优于国外的检测试剂。
Objective To explore the reliability of test result on anti-HCV diagnostic kits. Methods Four hundred plasma samples scrapped because of HCV screening were collected in volunteer blood donor. The samples were detected by 4 kinds of anti-HCV kits manufactured by 2 domestic companies and 2 abroad ones. The test was used HCV RIBA and HCV RNA PCR. If the test results were different from each other among 4 kinds of kits, it should be further verified and the total results were analyzed and explored comprehensively after verification. Results Negative coincidence rate and total coincidence rate were more than 96% of which 2 kinds of domestic LZ and GBI kits approved by state and international the 3rd generation of kits and imported reagent, and it had no significance among them, and the results were correspond with the report of literatures. Positive coincidence rate of 4 kinds of anti-HCV kits were higher than 97%. 5 samples had different test results detected by 4 kinds of anti-HCV diagnostic kits and HCV RIBA HCV3.0and HCV RNA PCR was used for further verification. Conclusion Domestic anti-HCV EIA kits have good sensitivity and specificity and it superior to abroad kits on screening of positive samples.
出处
《中国当代医药》
2013年第2期100-101,共2页
China Modern Medicine
