Abstract
Objectives
Large biological variation hinders application of patient-based real-time quality control (PBRTQC). The effect of analyte ratios on the ability of PBRTQC to improve error detection was investigated.
Methods
Four single analyte-ratio pairs (alanine aminotransferase [ALT] vs. ALT to aspartate aminotransferase ratio [RALT]; creatinine [Cr] vs. Cr to cystatin C ratio [RCr]; lactate dehydrogenase [LDH] vs. LDH to hydroxybutyrate dehydrogenase ratio [RLDH]; total bilirubin [TB] vs. TB to direct bilirubin ratio [RTB]) were chosen for comparison. Various procedures, including four conventional algorithms (moving average [MA], moving median [MM], exponentially weighted moving average [EWMA] and moving standard deviation [MSD]) were assessed. A new algorithm that monitors the number of defect reports per analytical run (NDR) was also evaluated.
Results
When a single analyte and calculated ratio used the same PBRTQC parameters, fewer samples were needed to detect systematic errors (SE) by taking ratios (p<0.05). Application of ratios in MA, MM and EWMA significantly enhanced their ability to detect SE. The influence of ratio on random error (RE) detection depended upon the analytes and PBRTQC parameters, as consistent advantage was not demonstrated. The NDR method performed well when appropriate parameters were used, but was only effective for unilateral SE. Rearrangement of sample order led to a significant deterioration of conventional algorithms’ performance, while NDR remained almost unaffected.
Conclusions
For analytes with large variation and poor PBRTQC performance, using ratios as PBRTQC indexes may significantly improve performance and achieve better anti-interference ability, providing a new class of monitoring indicators for PBRTQC.
Funding source: Natural Science Foundation of China of Zhejiang Province
Award Identifier / Grant number: LGC22H200001
Funding source: National Key Technologies R&D Program, Ministry of Science and Technology of the People's Republic of China
Award Identifier / Grant number: grant numbers 2022YFC3602300, 2022YFC3602301
Acknowledgments
We thank Elixigen Corporation (Huntington Beach, California, USA) for helping in proofreading and editing the English of final manuscript.
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Research ethics: This study was approved by the Ethics Committee of the First Affiliated Hospital, Zhejiang University School of Medicine (Ethics Approval Ref: 2022-460). The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013).
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Informed consent: Not applicable.
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Author contributions: Yuanyuan Li designed the study and wrote the manuscript; Yuanyuan Li and Xiaoling Chen analyzed data; Xiaoling Chen collected data; Ying Zhao supervised the study and reviewed the manuscript. All the authors have accepted responsibility for the entire content of this submitted manuscript and have approved the submission.
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Competing interests: Authors state no conflict of interest.
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Research funding: This work was supported by Natural Science Foundation of China of Zhejiang Province (LGC22H200001) and National Key Technologies R&D Program provided by Ministry of Science and Technology of the People’s Republic of China (Project Grant: 2022YFC3602300, Sub-project Grant: 2022YFC3602301).
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Data availability: The raw data can be obtained on request from the corresponding author.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2023-0865).
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