血源肝炎病毒筛查试验结果的分析

The analysis on the results of blood screening tests in blood bank

目的探讨血筛酶免疫试剂的质量以及2次化验试剂的合理搭配,最大限度地避免漏检和减少假阳性。方法对随机抽取的73份HBsAg和99份抗-HCV检测不合格的献血标本分别采用与常规筛查相同的2种进口试剂和另1种国产酶免试剂进行复检,并对复检中至少1种试剂为反应性的标本进行HBsAg中和试验或抗-HCV重组免疫印迹试验确证。结果73份HBsAg不合格标本中,20份确证阳性,11份可疑,42份阴性;99份抗-HCV不合格标本中,29份确证阳性,70份阴性。针对研究范围内特定的标本,进口试剂的漏检率可达13.79%～27.59%,且也存在不同程度的假阳性。2种进口试剂间检测结果互补,而国产试剂无法查出进口试剂的漏检。结论无论是进口还是国产血筛酶免试剂,都存在不同程度的漏检和假阳性情况,应选择2种检测结果互补的试剂对血液进行筛查,以保障血液安全。

Objective To assess the quality of reagents for blood screening tests and to select suitable reagents for an EIA-based blood screening protocol which will increase signal detection and reduce false positive results. Methods Disqualified donor blood samples during routine screenings, 73 based on HBsAg and 99 based anti-HCV antibody analyses, were randomly selected and re-tested with two imported EIA reagents and one domestic EIA reagent. The two imported EIA reagents were the same reagents used for the routine sereening assay. The samples that were reactive to at least one reagent were selected for confirmation tests using either an HBsAg neutralization assay or an HCV antibody Western blot assay. Results Out of the 73 disqualified samples related to HBsAg test, 20 were confirmed positive, 11 were indetemlinate, and 42 were negative. Out of the 99 disqualified samples due to anti-HCV antibody screening test, 29 were confimed positive, and 70 were negative. With the above tested samples, the rate of missing the detection of positive samples for the imported reagents was 13.79 - 27.59%. False positive results were also present. The use of two imported reagents was complementary to each other, but those positive samples that were not detected with the imported reagents were also not detected with the domestic reagents. Conclusion Different levels of failure to detect positive samples and false positive results were found with both imported and domestic reagents. Two complementary EIA reagents should be used for blood screening to ensure the safety of the blood.