摘要
目的评价本实验室乙肝表面抗原(HBsAg)酶免试剂灰区设置0.8倍临界值(CO值)的必要性及合理性。方法 1)采用2种HBsAg的ELISA试剂分别检测卫生部临检中心"化学发光多中心合作项目"血清盘标本792份,计算2种试剂真阳性检出率、灰区标本确证阳性率;绘制ROC曲线确定2种试剂最佳CO值,比较不同CO值下(最佳CO值、厂商推荐CO值、实验室灰区设置的工作CO值)灵敏度与特异性的变化。2)通过实验室既往数据,分析HBsAg酶免灰区标本HBV DNA检出率,对比HBV DNA单阳性标本ELISA结果分布(S/CO值)与灰区的关系。结果血清盘确认结果:587份阳性,197份阴性,8例不确定。真阳性检出率,试剂A、B分别为82.45%、71.89%。灰区标本确认阳性率:试剂A、B分别为94.74%(18/19)、93.10%(27/29)。ROC曲线确定最佳CO值,试剂A、B分别为0.49、0.27,均低于所设灰区值0.8,2种试剂最佳CO值对应的特异性小幅下降,但灵敏度提升较大。2015年1月~2019年1月检测标本183 551份, HBsAg灰区总数13份,试剂A 7份,有1份核酸阳性;试剂B 6份,核酸均阴性。HBV DNA单阳标本134份,96.27%(129/134)的标本S/CO值低于0.4,与阴性标本重叠,距离灰区0.8较远。结论本实验室2种HBsAg ELISA试剂有必要设置灰区,所设灰区值0.8 CO对应的试剂灵敏度不佳,结合ROC曲线选取最佳临界值:试剂A 0.49 CO,试剂B 0.27 CO。灰区设置对核酸单阳标本的筛查无明显效果。
Objective To evaluate the necessity and rationality of setting 0.8 CO of the gray area of hepatitis B surface antigen(ELISA) reagent in our laboratory. Methods 1) 792 samples of serum plates from the Clinical Laboratory Centre,Ministry of Health(NCCL) were tested by two HBsAg ELISA reagents. The true positive rate, and confirmed positive rate of gray area samples revealed by 2 reagents were calculated. ROC curve was drawn to determine the best CO value of 2 reagents. The changes in sensitivity and specificity under different CO values were compared. 2) Based on previous data, the HBV-DNA-yield rate among HBsAg gray area samples was analyzed, and the relationship between the distribution of ELISA results of solo HBV-DNA positive samples and gray area was analyzed. Results Of the 792 samples that form NCCL,587 were positive,197 negative and 8 indeterminate. The true positive detection rates of reagents A and B were 82.45% and 71.89%. The confirmed positive rate of gray area samples given by 2 reagents were 94.74%(18/19)and 93.10%(27/29). The best CO values of reagents A and B are 0.49 and 0.27, which are both lower than the 0.8. The specificity corresponding to the best CO values of the two reagents decreased slightly, but the sensitivity increased greatly. From January 2015 to January 2019, 183 551 samples were tested. Of the 13 cases of HBsAg gray area samples, 7 were revealed by reagent A and 1 was positive for NAT;6 were revealed byreagent B and all negative for NAT. Out of 134 cases of solo HBV-DNA positive samples, 96.27%(129/134) samples had S/CO values below 0.4, overlapped with negative samples, and were far from 0.8. Conclusion It is necessary to set gray area for these two HBsAg ELISA reagents. The gray area value setting to 0.8 CO corresponds to poor reagent sensitivity. The best cutoff value would be selected according to the ROC curve: 0.49 CO in Reagent A and 0.27 CO in Reagent B. Gray area has no obvious effect on screening of single-virus NAT-yield sample.
作者
金建怀
许友山
蒋瑞馨
宋晓菲
JIN Jianhuai;XU Youshan;JIANG Ruixing;SONG Xiaofei(Wuxi Red Cross Central Blood Station,Wuxi 214000,China)
出处
《中国输血杂志》
CAS
2021年第1期74-77,共4页
Chinese Journal of Blood Transfusion
