Status of internal quality control for thyroid hormones immunoassays from 2011 to 2016 in China

Zhang, Shishi; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kangping; Yuan, Shuai; Wang, Zhiguo

doi:10.1002/jcla.22154

Cited by 8 publications

(6 citation statements)

References 11 publications

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“…Similar findings for FT4 Immulite 2000 assay were declared by Hendriks et al [7]. A recent Chinese study revealed lower precision rates for several FT4 assays compared to precision performance of TSH assays on different analytical platforms [20].…”

Section: Discussionsupporting

confidence: 85%

Comparison of Thyroid -Stimulating Hormone and Free Thyroxine Immunoassays Performed on Immulite 2000 and Maglumi 800 Automated Analyzers

Kuzmanovska

Miladinova

2020

Open Access Maced J Med Sci

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OBJECTIVE: Our goal was to evaluate the analytical performance of the novel immunoassay platform and to compare the agreement between thyroid-stimulating hormone (TSH) and FT4 results, obtained by novel and currently used platform. MATERIALS AND METHODS: Both immunoassay platforms, current Immulite 2000 and novel Maglumi 800, are based on chemiluminecsence immunoassay method. Analytical performance was evaluated by the use of serum pools and commercial quality control samples. The comparison study was carried out with 80 serum samples. Obtained results were analyzed by descriptive statistics, Mann–Whitney U-test, and Paired t-test. Method comparison was performed with Passing-Bablok regression analysis and Bland-Altman plots. RESULTS: TSH Maglumi 800 showed better within-run precision for both concentration ranges (1.7–2.8 CV%) in comparison to Immulite 2000 (4.4–5.7 CV%). FT4 Maglumi 800 imprecision was higher compared with Immulite 2000 FT4 in both within-run (3.5–3.9 CV% vs. 4.9–6.6 CV%) and between-run (3.6–4.2 CV% vs. 4.6–5.9 CV%) tests. Mann–Whitney U-test for TSH revealed non-significant difference between data (p = 0.9011). Regression analysis showed no systematic (intercept = 0.01), nor proportional (slope = 0.9781) differences. Non-significant bias was observed in Bland-Altman Plots. For FT4, we found significant differences between methods using paired t-test (t39 = 10.5, p < 0.0001) and significant difference (p = 0.00745) with Mann–Whitney U-test. Bland-Altman plot revealed 22.8% average bias. CONCLUSION: TSH evaluation showed good precision and close agreement between Maglumi 800 and Immulite 2000 methods, which assures transferability of results. However, FT4 performance evaluation revealed higher imprecision of Maglumi 800 platform and significant differences of test results.

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Section: Discussionsupporting

confidence: 85%

Comparison of Thyroid -Stimulating Hormone and Free Thyroxine Immunoassays Performed on Immulite 2000 and Maglumi 800 Automated Analyzers

Kuzmanovska

Miladinova

2020

Open Access Maced J Med Sci

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“…Moreover, the Westgard Sigma rule, the total number of control measurements per QC event (N), and the run size of patient samples between two adjacent QC events (R) per day were also introduced in the SQC procedure of all the analytes. The selection of QC procedure is vital in balancing appropriate Pfr and Ped scores for the analytes as well as avoiding economic costs and overwork 29. For instance, based on the re-evaluated sigma values of FT3, TT3, TSH, CROT, E2, LH, and F I G U R E 3 The effects of analytical temperature and humidity on the performance of analytes evaluated with sigma metrics (Level 1 and Level 2) by the same staff.…”

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confidence: 99%

Evaluation of the analytical performance of endocrine analytes using sigma metrics

Yanming

Cao

Liu

et al. 2020

Clinical Laboratory Analysis

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Background (a) To evaluate the clinical performance of endocrine analytes using the sigma metrics (σ) model. (b) To redesign quality control strategies for performance improvement. Methods The sigma values of the analytes were initially evaluated based on the allowable total error (TEa), bias, and coefficient of variation (CV) at QC materials level 1 and 2 in March 2018. And then, the normalized QC performance decision charts, personalized QC rules, quality goal index (QGI) analysis, and root causes analysis (RCA) were performed based on the sigma values of the analytes. Finally, the sigma values were re‐evaluated in September 2018 after a series of targeted corrective actions. Results Based on the initial sigma values, two analytes (FT3 and TSH) with σ > 6, only needed one QC rule (13S) with N2 and R500 for QC management. On the other hand, seven analytes (FT4, TT4, CROT, E2, PRL, TESTO, and INS) with σ < 4 at one QC material level or both needed multiple rules (13S/22S/R4S/41S/10X) with N6 and R10‐500 depending on different sigma values for QC management. Subsequently, detailed and comprehensive RCA and timely corrective actions were performed on all the analytes base on the QGI analysis. Compared with the initial sigma values, the re‐evaluated sigma metrics of all the analytes increased significantly. Conclusions It was demonstrated that the combination of sigma metrics, QGI analysis, and RCA provided a useful evaluation system for the analytical performance of endocrine analytes.

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“…In a study concerning performances of four analytical platforms that use CLIA or ECLIA technology in an external quality assessment program over five years, only 50% of the evaluated laboratories met the desired quality performances. In all cases, CV% values were below the desired value of 9.6% (8).…”

Section: Discussionmentioning

confidence: 68%

Total Errors of TSH results by fluorescent immunoassay technique from dried blood spots in a newborn screening program for congenital hypothyroidism - variations in time

Oprea

Zaharia

Dobreanu

2020

Revista Romana De Medicina De Laborator

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Objective:the aim of this study was to evaluate the imprecision of the method used to determine TSH (Thyroid Stimulating Hormone) levels from dried blood spots in a newborn screening program and how the value of the coefficient of variation influences the total error of the method.Methods:A short-term evaluation of imprecision was compared with the imprecision of the method assessed over five years. The coefficient of variation from the best quality control period and the worst quality control period were used. For Bias assessment mean results from the external quality program were used. Total Error was calculated with Bias and Coefficient of Variation values. A freely available software was used for standard deviation and coefficient of variation profiling.Results:The values of the coefficient of variation for the short-term were lower than values obtained in worst quality control period but higher than in the best quality control period. Total error was higher than the accepted value for low-level control in the worst quality control period. Images obtained with the software showed that for high-level control coefficient of variation is concentration-dependent but this finding is not similar for low-level control.Conclusions:Total Error of the Method may be subject to change in time. Initial evaluation of imprecision must be performed on a short term analysis but a continuous evaluation should be performed as the performance of a method may change in time. The evaluation should be performed on clinically significant levels for each parameter.

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Status of internal quality control for thyroid hormones immunoassays from 2011 to 2016 in China

Abstract: With change of IQC practice, only FT3 had precision performance improved in 6 years. However, precision status of five analytes in China was still unsatisfying. Ongoing investigation and improvement of IQC have yet to be achieved.

Cited by 8 publications

References 11 publications

Comparison of Thyroid -Stimulating Hormone and Free Thyroxine Immunoassays Performed on Immulite 2000 and Maglumi 800 Automated Analyzers

Comparison of Thyroid -Stimulating Hormone and Free Thyroxine Immunoassays Performed on Immulite 2000 and Maglumi 800 Automated Analyzers

Evaluation of the analytical performance of endocrine analytes using sigma metrics

Total Errors of TSH results by fluorescent immunoassay technique from dried blood spots in a newborn screening program for congenital hypothyroidism - variations in time

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