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目的评估电化学发光法HBsAg检测用于献血者HBsAg阳性确认的可行性,探索HBsAg ELISA的灰区设定条件和HBsAg阳性确认的替代方法,简化献血者归队的判定流程。方法以HBsAg电化学发光检测(Electrochemiluminescence assay,ECL)作为血液HBsAg常规筛查ELISA反应性的补充试验,并对HBsAg ECL反应性的标本进行中和试验(ECL)确证。联合核酸检测(Nucleic acid test,NAT)、ECL、ELISA检测技术以及献血者的跟踪检测进行HBsAg的阳性确认。比较电化学发光中和试验和HBsAg ECL对HBsAg ELISA双试剂反应性(S/CO≥1)中的HBV DNA阳性的检出能力;比较不同检测流程在补充HBsAg ECL检测前后以及不同灰区界值的设定对HBsAg确认阳性检出的效果影响,以敏感度(Sensitivity,SEN)和阳性预期值(Positive Predictive Value,PPV)表示;比较ELISA假反应性与确认阳性检出时S/CO值的分布差异。结果 2013年1月1日-2015年6月30日间,在本中心采集的192065份血液标本中检出HBsAg反应性821份,其中通过联合检测和献血者的跟踪检测估算出HBsAg确认阳性有160份。ECL对HBsAg ELISA双试剂反应性(S/CO≥1)标本的核酸检出显著高于电化学中和试验(P<0.05);以HBsAg ECL作为HBsAg反应性的补充试验能够将各筛查流程的HBsAg确认阳性检出的PPV提高至92.6%-99.2%(P=0);2种HBsAg ELISA试剂各自假反应性与确认阳性检出时S/CO值的分布存在着明显的差异,S/CO≤2可作为假反应性的简化判定标准;随着灰区界值的降低,2种ELISA试剂对HBsAg确认阳性检出的SEN和PPV变化均存在1个平台区,S/CO≤1时ELISA1的此2个指标即处于其平台区,ELISA2则为S/CO≤0.8。结论 HBsAg ECL能够作为血液HBsAg筛查的阳性确认试验。以该方法得到的HBsAg阳性确认数据为依据可以简化ELISA假反应性献血者归队的判定流程、合理地设定灰区。本研究采用的2种ELISA检测试剂其假反应性献血者的判定标准均可设定为S/CO≤2.0;ELISA1不宜设置灰区,ELISA2的灰区界值宜设为S/CO=0.8。
Objective To evaluate the feasibility of using electrochemiluminescence (HBsAg) detection for the positive identification of HBsAg in blood donors, to explore the setting conditions of HBsAg ELISA and the alternative methods of HBsAg positive identification, and to simplify the judgment process of blood donors reversion. Methods HBsAg Electrochemiluminescence assay (ECL) was used as a supplementary test to routinely screen ELISA for blood HBsAg screening, and the neutralization assay (ECL) was performed on HBsAg-ECL-responsive samples. The combined detection of nucleic acid (NAT), ECL, ELISA detection and tracking of blood donors for HBsAg positive confirmation. To compare the positive detection of HBV DNA in HBsAg ELISA double reagent reactivity (S / CO≥1) by electrochemical neutralization test and HBsAg ECL; compare the different detection processes before and after HBsAg ECL test and different gray threshold The results of sensitivity test (Sensitivity, SEN) and positive predictive value (PPV) showed that the positive effect of HBsAg was positive. Distribution differences. Results From January 1, 2013 to June 30, 2015, 821 copies of HBsAg-reactive were detected in 192065 blood samples collected from our center, of which HBsAg positive was estimated by joint testing and follow-up testing by blood donors 160 copies. The detection of nucleic acid of ECL for HBsAg ELISA double reagent reactivity (S / CO≥1) was significantly higher than that of electrochemical neutralization test (P <0.05). Using HBsAg ECL as a supplementary test of HBsAg reactivity, (P = 0). The differences of S / CO values between the two kinds of HBsAg ELISA reagents and the positive ones were significant. The S / CO≤2 can be used as a simplified criterion for the determination of false reactivity. As the cutoff value of gray zone decreases, there are 1 plateau zone for SEN and PPV detected by HBsAg positive for the two ELISA reagents. When S / CO≤1 ELISA1 of these two indicators that is in its platform area, ELISA2 S / CO ≤ 0.8. Conclusion HBsAg ECL can be used as a positive confirmation test for blood HBsAg screening. Based on the positive confirmation data of HBsAg obtained by this method, the determination procedure of rejointing ELISA false-reactivated blood donors can be simplified, and the gray area can be reasonably set. The two kinds of ELISA test reagents used in this study can be set to S / CO≤2.0 for the determination of the false-reactive blood donors. The ELISA1 should not be used to set the gray zone, and the ELISA2 should be set as S / CO = 0.8.