| 樊琳,章媛媛,王洁,等.液相色谱 -串联质谱法检测拉莫三嗪血药浓度的室内质量控制性能评价[J].安徽医药,2026,30(4):696-700. |
| 液相色谱 -串联质谱法检测拉莫三嗪血药浓度的室内质量控制性能评价 |
| Evaluation of the in-house quality control performance for determining plasma lamotrigine concentration via LC-MS/MS method |
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| DOI：10.3969/j.issn.1009-6469.2026.04.012 |
| 中文关键词: 拉莫三嗪 液相色谱 -串联质谱法 质量控制 质控规则 西格玛规则 |
| 英文关键词: Lamotrigine LC-MS/MS Quality control Westgard Sigma rules |
| 基金项目:中华医学会临床药学分会临床药学科研基金项目( Z-2021-46-2101)；南京市卫健委一般性项目( YKK22160) |
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| 中文摘要: |
| 目的运用分析批长度 Westgard-西格玛规则优化液相色谱 -串联质谱( LC/MS-MS)法检测拉莫三嗪血药浓度项目的室内质量控制策略，指导检测方法质量改进。方法采用 2024年国家卫生临床检验中心性能规范中的总允许误差( TEa)作为质量目标，基于 2024年上半年卫生部室间质评实验数据的偏倚值( Bias%)和实验室连续 6个月( 2023年 10月至 2024年 3月)室内质控数据计算的变异系数( CV)，计算 3个水平质控的 σ水平值，并运用分析批长度 Westgard-西格玛规则设计室内质控策略。结果低、中、高水平质控累积 CV分别为 6.17%，5.00%和 4.25%；Bias%分别为 1.45%，2.82%和 2.05%；TEa为 20%；σ水平值分别为 3.01，3.44和 4.22，分析性能分别为临界、临界和良好。建议将 13s/2 of 32s/R4s/31s/6x(N=3，R=2)多规则和 45个样品的批次量用于该实验室拉莫三嗪室内质控方案。质量目标指数( QGI)值低于 0.8，表明精密度需要提高。结论分析批长度 Westgard-西格玛规则可用于优化 LC-MS/MS法检测拉莫三嗪血药浓度的质控策略。 |
| 英文摘要: |
| Objective To optimize the in-house quality control strategy for measuring plasma lamotrigine concentrations using LC-MS/MS by applying the analytical batch length Westgard Sigma rules, thereby guiding the improvement of method quality. Methods The total allowable error (TEa) from the 2024 National Center for Clinical Laboratory (NCCL) performance specifications was used asthe quality target. The sigma levels for three quality control (QC) levels were calculated based on bias values (Bias%) from the inter-lab-oratory quality assessment data from the NCCL in the first half of 2024 and the coefficients of variation (CV) from six months (2023.10to 2024.3) of continuous in-house QC data. An in-house QC strategy was designed using the Westgard-Sigma rules.Results The cumu-lative CV for low, medium, and high levels QCs were 6.17%, 5.00%, and 4.25%, respectively; the Bias% values were 1.45%, 2.82%,and 2.05%, respectively; and the TEa was found to be 20%. The sigma levels were 3.01, 3.44, and 4.22, indicating "critical", "critical",and "good" analytical performance, respectively. It was recommended to use the 13s/2 of 32s/R4s/31s/6x (N=3, R=2) multi-rule along with a batch size of 45 samples for the laboratory's lamotrigine in-house QC scheme. The Quality Goal Index value was below 0.8, indicating that precision needs improvement.Conclusion The analytical batch length Westgard-Sigma rules can be applied to optimize the quali-ty control strategy for measuring plasma lamotrigine concentrations using the LC-MS/MS method. |
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