郑州地区核酸检测结果无效的原因分析及对策

Analysis of invalidated detections in the nucleic acid test among blood screening samples in Zhengzhou area

目的通过分析华益美血液筛查核酸检测系统结果无效的原因,制定应对策略。方法采用华益美血液筛查核酸检测系统对2017年03月—2018年02月的152 076例献血者标本(酶免检测双试剂阳性除外)进行HBV DNA/HCV RNA/HIV-1RNA核酸检测,并统计分析华益美核酸检测结果无效数据。结果共计检测核酸标本19 266 pools,总的pools结果无效率为1.29%(249/19 266);结果无效率以2017年4月份最高(7.52%),2017年8月份和12月份最低(均是0.20%),不同月份的结果无效率之间比较,其差异具有统计学意义(P<0.05);仪器故障引起无效类型占比最大50.20%(125/249),扩增曲线异常引起无效类型占比次之48.60%(121/249);不同批号试剂之间的结果无效率差异有统计学意义(P<0.05),其中试剂批号4(29/3 349,0.87%)导致结果无效率最高。对扩增曲线异常的标本再次混检之后,有2个pools混检为HBV DNA反应性,拆分后各有1份标本为HBVDNA+。结论结果的无效与仪器故障以及不同批次之间有一定关系。重新检测由于扩增曲线异常造成无效结果的标本对保障血液检测质量十分必要。实验结果无效率的统计和分析,有助于监控核酸检测性能。

Objective To analyze the cause of the invalid results for BACME NAT(nucleic acid test, NAT) blood screening system and formulate corrective countermeasure. Methods After simultaneously tested by two different ELISA reagents for HBsAg, anti-HCV and anti-HIV1/2, 152 076 blood samples(except double ELISA positive samples) from March 2017 to February 2018 were also analyzed with HBV DNA/HCV RNA/HIV-1 RNA NAT. The invalid results were identified and calculated in line with BACME NAT blood screening system according to detection time, regents Lots, the amplification curve and test alarm information. Results Among 19 266 pools tested by BACME NAT blood screening system, the total invalid pools rate was 1.29%(249/19 266). The invalid detection rate were the highest in April 2017(7.52%) and the lowest in August and December 2017(both 0.20%).There was statistical difference among the invalidation rates in different months(P<0.05). As to the cause of invalidation, the invalid detection rate due to machine operation failure was the highest( 50.20%,125/249), followed by abnormal amplification curve(48.60%,121/249). The NAT invalid detection rates among different NAT reagent Lots had statistical differences(P<0.05), and the reagent Lot 4 contributed to the highest invalid detection rate(0.87%, 29/3 349). Two reactive pools were rescreened in the invalidated samples with abnormal amplification curves, and each pool had a HBV DNA+ confirmed sample.Conclusion The invalidation was associated with machine operation failure and different regents Lots. It was necessary to rescreen invalidated samples showing abnormal amplification curves in order to ensure blood screening quality. Counting and analyzing the invalid rates for NAT results contribute to monitor the NAT testing performance.