Implementation of new Westgard rules suggested by the Westgard Advisor software for five immunological parameters.

Biochemia medica Pub Date : 2025-02-15 Epub Date: 2024-12-15 DOI:10.11613/BM.2025.010701
Lisa Cristelli, Francesca Occhipinti, Daniel Tumiatti, De Luisi Antonia, Erika Jani, Massimo Daves
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Abstract

Introduction: Knowledge and systematic evaluation of analytical errors is the task of internal analytical quality control management. The aim of this study was to assess whether the Westgard rules proposed by Bio-Rad's Westgard Advisor software are more efficient in the monitoring of analytical performance than those previously in use.

Materials and methods: The study was carried out on the nephelometer Atellica NEPH630 (Siemens Healthineers, Erlangen, Germany). Five parameters were chosen: serum immunoglobulin A (IgA), alpha 1 - antitrypsin (AAT), prealbumin, lipoprotein (a) (Lp(a)) and ceruloplasmin. The study was divided into 4 phases (A, B, C, D): phase A - old rules used (13s, R4s and 22s); phase B - first introduction of new rules (30 days), (13s/22s for IgA; 13s/22s/R4s/41s/10x for the remaining parameters); Phase C - second intervention (after 60 days) 13s/22s/R4s/41s for IgA and Lp(a), 13s/22s/R4s/41s/8x for prealbumin and ceruloplasmin and 13s/22s/R4s/41s/10x for AAT; and Phase D - values at the end of the study (13s for IgA, 13s/22s/32s/R4s/31s/12x for AAT and ceruloplasmin, 13s/22s/R4s/41s/8x for prealbumin and 13s/22s/R4s/41s/10x for Lp(a).

Results: At the end of the study the coefficient of variation (CV%), bias (%) and sigma for IgA were 2.55%, - 1.09% and 5.33, respectively; for AAT 3.88, - 2.21 and 3.25; for prealbumin 3.99, - 0.14 and 2.95; for Lp(a) 8.02, - 0.34 and 3.81; for ceruloplasmin 2.48, - 3.65 and 3.49.

Conclusions: By using newly suggested rejection rules, we did not observe an improvement in monitoring of analytical performance.

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实施 Westgard Advisor 软件针对五项免疫参数提出的新 Westgard 规则。
对分析误差的认识和系统评价是内部分析质量控制管理的任务。本研究的目的是评估由Bio-Rad的Westgard Advisor软件提出的Westgard规则是否比以前使用的规则在监测分析性能方面更有效。材料与方法:采用Atellica NEPH630浊度计(Siemens Healthineers, Erlangen, Germany)。选取血清免疫球蛋白A (IgA)、α - 1 -抗胰蛋白酶(AAT)、前白蛋白、脂蛋白(A) (Lp(A))和铜蓝蛋白5个参数。研究分为4个阶段(A, B, C, D): A阶段-使用旧规则(13s, R4s和22s);阶段B -首次引入新规则(30天),IgA为13秒/22秒;其余参数为13s/22s/R4s/41s/10x);C期-第二次干预(60天后)IgA和Lp的13s/22s/R4s/41s (a),白蛋白和铜蓝蛋白的13s/22s/R4s/41s/8x, AAT的13s/22s/R4s/41s/10x;研究结束时的D期值(IgA为13s, AAT和铜蓝蛋白为13s/22s/32s/R4s/31s/12x,白蛋白前为13s/22s/R4s/41s/8x, Lp为13s/22s/R4s/41s/10x) (a)。结果:研究结束时,IgA的变异系数(CV%)、偏倚(%)和sigma分别为2.55%、- 1.09%和5.33;AAT为3.88、- 2.21和3.25;白蛋白前蛋白为3.99,- 0.14和2.95;Lp(a)为8.02,- 0.34和3.81;对于铜蓝蛋白2.48,- 3.65和3.49。结论:通过使用新建议的拒绝规则,我们没有观察到分析性能监测的改善。
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