摘要
目的:对血站Panther系统的无效结果进行分析,以找到应对措施。方法:使用Panther系统对标本进行病毒核酸检测,统计无效结果并分析。结果:Panther系统的无效测试率为3.57%。①不同标本类型(常规标本、IQC、Calibrator)的无效测试率:IQC显著高于常规标本和Calibrator(P<0.01);②不同无效模式(散发、五联、成批)的无效发生频率相近,但其中成批无效的测试数占比最高(82.4%);③主要无效信息(样本问题、硬件和软件问题)在不同标本类型中的分布不同(P<0.01),IQC无效以样本问题多见;④主要无效信息在不同无效模式中的分布不同(P<0.01),成批无效以硬件和软件问题多见,而散发无效以样品问题为主;⑤无效列表率在Panther系统运行初期较高,但其无效信息在不同无效模式中的分布情况与后期相似。结论:只有通过NAT实验室的质量监控和风险管理,采取针对样品问题和仪器问题的措施,才能减少无效结果的发生,降低质量风险。
Objective:To analyze the invalid result of Panther system in blood station and find out the countermeasures.Method:The virus nucleic acid was detected by Panther system,and the invalid results were statistically analyzed.Result:The invalid test rate of Panther system was 3.57%.①Invalid test rate of different sample types(routine sample,IQC,Calibrator):IQC was significantly higher than that of routine sample and Calibrator(P<0.01).②Invalid frequency of different invalid patterns(sporadic,quintuple,batch)was similar,but the proportion of invalid tests in batches was the highest(82.4%).③The distribution of major invalid information(sample problems,hardware and software problems)was different in different sample types(P<0.01),and IQC invalidity was more common in sample problems.④The distribution of main invalid information in different invalid patterns was different(P<0.01),and the invalidity in batches was more common in hardware and software problems,while the invalidity in sporadic pattern was mainly in sample problems.⑤Invalid worklist rate was higher at the beginning of Panther system operation,but the distribution of invalid information in different invalid modes was similar to that in later period.Conclusion:Only through the quality control and risk management of NAT laboratory and taking measures aimed at sample and instrument problems can reduce the occurrence of invalid results and the quality risk.
作者
黄敏
黄金昌
柯苑
马成平
李燕
张立波
HUANG Min;HUANG Jinchang;KE Yuan;MA Chengping;LI Yan;ZHANG Libo(Laboratory Department,Nanjing Red Cross Blood Centre,Nanjing,210003,China;NanjingLiuhe District Voluntary Blood Donation Workstation)
出处
《临床血液学杂志（输血与检验）》
CAS
2019年第4期625-628,共4页
Journal of Clinical Hematology(Blood Transfusion & Laboratory Medicine)
