糖化血红蛋白分析仪基于风险的多级室内质量控制方案的设计
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国家自然科学基金(81560552);广西壮族自治区本级财政科技计划项目(2018AB58018);广西自然科学基金(2018GXNSFAA138120)


Risk-based multistage internal quality control schemes designed for HbA1c analyzers
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    摘要:

    摘要:目的:为2种糖化血红蛋白(HbA1c)分析仪设计基于风险的多级室内质量控制(IQC)方案,帮助不同标本量的检测系统更经济地维持质量。 方法:通过参加国家卫生健康委临床检验中心组织的正确度验证计划获得Sebia Capilarys 2FP和Premier Hb 9210两种HbA1c检测系统的偏倚,并从日常IQC数据获得变异系数,然后根据偏倚和变异系数计算西格玛度量。最后根据西格玛度量、每日最大工作量以及期望2次结果报告之间间隔的标本数,并结合西格玛度量批长度列线图和西格玛功效函数图来分别确定不同西格玛水平下相应IQC程序的批长度、误差检出率和假失控率,最终制定适当的IQC方案。 结果:Premier Hb 9210和Sebia Capilarys 2FP检测系统的西格玛度量分别为4.96σ和5.35σ,最大工作量是200个患者标本。Premier Hb 9210和Sebia Capilarys 2FP检测系统起始IQC两水平质控品均只检测1次,使用的质控程序分别为:“13s/22s/R4s,N2”,和“13s N2”;接下来每50个患者标本的夹心IQC中均只需交替检测1个水平质控品(13s N1)。对于5σ水平,工作量为1 000个患者标本的检测系统,起始IQC需检测2个水平质控品,每个水平检测2次(13s/22s/R4s/41s N4),每200个患者标本的夹心IQC只需对2个水平质控品检测1次(13s N2)。对于5σ水平,工作量为500个患者标本的检测系统,起始IQC需检测2个水平质控品1次(13s/22s/R4s N2),每125个患者标本的夹心IQC只需交替检测1个水平质控品(12.5s N1)。 结论:由起始和夹心IQC组成的多级IQC方案可有效维持连续检测的HbA1c分析仪的质量,是最小化患者风险的有效方案。

    Abstract:

    Abatract:Objective: To design a risk-based multi-stage internal quality control (IQC) scheme for two kinds of HbA1c analyzers to facilitate the detection systems with different sample sizes maintaining quality more economically. Methods: The biases of two HbA1c analyzers(Sebia Capilarys 2FP and Premier Hb 9210)were obtained by participating in the Trueness Verification Program organized by National Center for Clinical Laboratories of National Health Commission, and the coefficient of variation was derived from routine IQC data. Then, the Sigma metric was calculated using the bias and coefficient of variation. According to Sigma metric level, the daily maximum number of patient samples and the desired number of specimen between two result reports, combined with Sigma-metric run size nomogram and power function graph, the run size, probability of error detection and probability of false rejection of QC schedules were determined for the corresponding IQC schedule of different sigma performances respectively. Finally, an appropriate IQC scheme was developed. Results: The Sigma metrics of Premier Hb 9210 and Sebia Capilarys 2FP analyzers were 4.96σ and 5.35σ respectively, and the maximum workload of the these two analyzers were 200 patient samples. For Premier Hb 9210 and Sebia Capilarys 2FP analyzers, two levels of controls were analyzed once in the startup IQC event; the IQC procedures were 13s/22s/R4s N=2 and 13s N=2 respectively. Then, only one level of control was analyzed alternatively in each subsequent bracketing event (13s N=1) for every 50 patient samples. For the analyzers with 5σ performance and the maximum workload of 1000 patient samples, two levels of controls were analyzed twice in the startup QC event (13s/22s/R4s/41s N=4) but only once in each subsequent bracketing QC event (13s N=2) for every 200 patient samples. For analyzers with 5σ performance and the maximum workload of 500 patient samples, the two levels of controls were analyzed only once in the startup QC event (13s/22s/R4s N=2) and only one level control was analyzed once in each subsequent bracketing event (12.5s N=1) every 125 patient samples. Conclusion: The multistage IQC scheme which enploy a startup IQC event followed by periodic bracketing IQC events can effectively control the quality of the HbA1c analyzer for continuous production, and could be optimized to minimize the risk of harm to patients.

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李婷婷,柯培锋,曹顺旺,黄宪章.糖化血红蛋白分析仪基于风险的多级室内质量控制方案的设计[J].临床检验杂志,2020,(2):145-149

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  • 收稿日期:2019-01-24
  • 最后修改日期:2020-03-05
  • 录用日期:2020-01-09
  • 在线发布日期: 2020-07-23
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