血液筛查实验室HBsAg检测的室间质量评价  

External quality assessment of HBsAg detection among blood screening laboratories

作　　者：姬慧敏 常乐[1] 闫颖[1] 王露楠[1] Ji Huimin;Chang Le;Yan Ying;Wang Lunan(National Center for Clinical Laboratories,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Hospital/National Center of Gerontology,Beijing 100730,China)

机构地区：[1]北京医院国家老年医学研究中心、国家卫生健康委临床检验中心血液安全与免疫血液学实验室、北京市临床检验工程技术研究中心,100730

出　　处：《国际病毒学杂志》2023年第2期120-125,共6页International Journal of Virology

基　　金：北京医院临床研究"启航"专项(BJ-2022-182)。

摘　　要：目的评价我国采供血机构ELISA检测乙型肝炎表面抗原(hepatitis B surface antigen,HBsAg)的检测能力以及所使用的不同试剂盒的检测性能。方法统计分析2018—2021年国家卫生健康委临床检验中心对全国采供血机构实验室开展的HBsAg室间质量评价数据,评估参评实验室检测能力,分析和比较各检测试剂的检测精密度以及检测灵敏度等。结果2018—2021年参与室间质评的单位数量有稳步的增加,4种国产试剂和2种进口试剂的使用单位数在每年度均超过10家,两种进口试剂检测adw血清型样本时,批内CV<7%的实验室比例相对较高(>75%),而三种国产试剂的批内CV<7%的实验室比例均在50%左右,说明国产试剂的批内精密度有待提高。3种国产试剂检测0.2 IU/mL的adw2型样本时,S/CO值≥2的实验室为小于50%,表明这些试剂检测HBsAg弱阳性标本时存在漏检风险;当检测血清型为ayw1时,两种进口试剂均100%实验室检测正确,但B试剂和C试剂正确率相对较低(84.4%和60.9%)。结论我国采供血机构实验室ELISA检测HBsAg的整体水平较高,实验室所用的6种主流检测试剂盒的整体性能较好,国产试剂的检测精密度尚需进一步提高,此外,国产试剂需进一步提高其检测效能以及检测灵敏度,以保证检测结果的准确性,确保血液安全。Objective To evaluate the detection ability of hepatitis B surface antigen(HBsAg)by enzyme-linked immunosorbent assay(ELISA)and the performance of different kits used in blood collection and supply institutions in China.Methods The data of HBsAg external quality assessment(EQA)conducted by National Center for Clinical Laboratories(NCCL)of the National Health Commission for blood collection and supply institutions nationwide from 2018 to 2021 were collected and statistically analyzed to evaluate the testing capacities of participating laboratories,The detection precision and sensitivities of different kits were then analyzed and compared.Results The number of laboratories participating in EQA increased steadily from 2018 to 2021.Over 10 laboratories used 4 domestic and 2 imported reagent kits annually.For testing of adw serotype samples,the proportion of laboratories with intra-assay CV<7%using the 2 imported reagent kits was relatively high(75.6%and 84.6%),while the proportion of laboratories using the 3 domestic kits(B,C and D)was about 50%,indicating that the domestic reagents should improve the intra-assay precision.When three domestic kits were used in detecting the adw2 sample of 0.2 IU/mL,less than 50%of the laboratories reported S/CO value≥2,indicating the risks of missed detection by the kits for weak positive HBsAg samples.As for the adw1 samples of 0.1 IU/mL,the two imported kits obtained 100%of correct laboratory detection results,but the rate of correct detection for domestic kits B and C were relatively low(84.4%and 60.9%).Conclusions The overall detection ability of HBsAg by ELISA for blood collection and supply institutions in China is relative good.The 6 regent kits used in these laboratories showed good performance.However,the detection precision,as well as the detection efficiency and sensitivity of the domestic reagents still need to be improved to ensure the correct detection and blood safety.

关 键 词：乙型肝炎表面抗原 酶联免疫吸附试验(ELISA) 室间质量评价 

分 类 号：R446.5[医药卫生—诊断学]