CAJ | 학술논문

目的：研究乙型肝炎病毒表面抗原阴性高值样本的漏检状况并探讨减少漏检的方法。方法参照临床与实验室标准化协会（CLSI）颁布的EP15-A2文件验证ARCHITECT I2000定量乙型肝炎病毒表面抗原（HBsAg）的检测精密度和准确度，保证仪器条件符合实验要求。研究期间内收集ELISA法定性 HBsAg结果的样本吸光度值/临界值之比（S/CO ）值为0．30～0．99范围的1130例样本进行复检，复检后S/CO值仍为0．30～0．99的387例样本，采用雅培I2000进行 HBsAg定量检测的结果作为参考，研究HBsAg阴性高值样本的漏检状况，并采用ROC曲线对ELISA法定性判定乙型肝炎病毒核心抗体（HBcAb）阳性人群的HBsAg阳性结果判断值的确定，寻找更好的诊断性能。结果 i2000SR检测 HBsAg的结果具有良好的重复性，总不精密度小于9．88％，与定值校准品的偏差小于3．91％，符合临床检测要求。该研究发现S/CO值为0．30～0．99 HBsAg的样本在不同的批次检验中分布差异有统计学意义（P＜0．05），且该研究期内有261例出现 HBsAg漏检；HBcAb阳性组的样本利用ROC曲线对ELISA定性 HBsAg结果重新进行临界值的再确定为0．51后，其中239例重新判断为阳性。结论提高ELISA法定性检测HBsAg的重复性和HBcAb阳性人群建立新的ELISA法定性HBsAg阳性判断值0．51，HBsAg对于S/CO值为0．30～0．99的样本具有更好的诊断性能。
목적：연구을형간염병독표면항원음성고치양본적루검상황병탐토감소루검적방법。방법삼조림상여실험실표준화협회（CLSI）반포적EP15-A2문건험증ARCHITECT I2000정량을형간염병독표면항원（HBsAg）적검측정밀도화준학도，보증의기조건부합실험요구。연구기간내수집ELISA법정성 HBsAg결과적양본흡광도치/림계치지비（S/CO ）치위0．30～0．99범위적1130례양본진행복검，복검후S/CO치잉위0．30～0．99적387례양본，채용아배I2000진행 HBsAg정량검측적결과작위삼고，연구HBsAg음성고치양본적루검상황，병채용ROC곡선대ELISA법정성판정을형간염병독핵심항체（HBcAb）양성인군적HBsAg양성결과판단치적학정，심조경호적진단성능。결과 i2000SR검측 HBsAg적결과구유량호적중복성，총불정밀도소우9．88％，여정치교준품적편차소우3．91％，부합림상검측요구。해연구발현S/CO치위0．30～0．99 HBsAg적양본재불동적비차검험중분포차이유통계학의의（P＜0．05），차해연구기내유261례출현 HBsAg루검；HBcAb양성조적양본이용ROC곡선대ELISA정성 HBsAg결과중신진행림계치적재학정위0．51후，기중239례중신판단위양성。결론제고ELISA법정성검측HBsAg적중복성화HBcAb양성인군건립신적ELISA법정성HBsAg양성판단치0．51，HBsAg대우S/CO치위0．30～0．99적양본구유경호적진단성능。
Objective To study the situation of missing detection of HBsAg negative samples with high value and to explore the ways for reducing the missing detection .Methods According to the document EP15-A2 issued by the Clinical and Laboratory Standards Institute(CLSI) ,the precision and accuracy of the HBsAg quantitative detection by the ARCHITECT I 2000 were verified for ensuring the instrument conditions conforming to the test requirements .The 1 130 samples with the ratio of the sample absor-bance value to critical value(S/CO) in the range 0 .30-0 .99 in the HBsAg qualitative results by ELISA were collected during the study period and re-tested .After re-testing ,the quantitative HbsAg of 387 samples ,in which the ratio of S/CO was still in the range 0 .30-0 .99 ,were detected by the ARCHITECT I2000 and the detection results were taken as the reference .The missing detection situation of HBsAg negative samples with high value was researched .The ROC curve was adopted to reassess the cutoff value of negative HBsAg with positive HbcAb for searching better diagnostic performance .Results The HBsAg detection results by the i2000SR had good repeatability with total imprecision of less than 9 .88% and the deviation value with calibrator was less than 3 .91% ,which conformed to the clinical testing requirements .This study found that the HBsAg samples with the S/CO ratio of 0 .30-0 .99 had the significant distribution differences in the different batches of test (P<0 .05) .In the study period ,261 cases of HBsAg missing detection occurred ;then the critical value of HBsAg qualitative results detected by ELISA in the HbcAb positive group was re-determined as 0 .51 by using the ROC curve ,among them 239 cases were rejudged as positive .Conclusion Increasing the repeatability of HBsAg qualitative detection by ELISA and establishing the new positive judgement value of ELISA for qualita-tive HBsAg in the HbcAb positive population as 0 .51 possesses better diagnostic performance for detection the HBsAg samples with the S/CO ratio of 0 .30-0 .99 .