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The effect of ratios upon improving patient-based real-time quality control (PBRTQC) performance

  • Yuanyuan Li , Xiaoling Chen and Ying Zhao EMAIL logo
Published/Copyright: October 23, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 62 Issue 4

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.

Keywords: patient based real time quality control (PBRTQC); internal quality control (IQC); moving average (MA); moving median (MM); exponentially weighted moving average (EWMA)
Corresponding author: Ying Zhao, Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, P.R. China; Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, P.R. China; and Institute of Laboratory Medicine, Zhejiang University, Hangzhou, P.R. China, E-mail:

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.

  1. 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).

  2. Informed consent: Not applicable.

  3. 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.

  4. Competing interests: Authors state no conflict of interest.

  5. 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).

  6. 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).

Received: 2023-08-07
Accepted: 2023-10-05
Published Online: 2023-10-23
Published in Print: 2024-03-25

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2023-0865
Keywords for this article
patient based real time quality control (PBRTQC); internal quality control (IQC); moving average (MA); moving median (MM); exponentially weighted moving average (EWMA)

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Value-based laboratory medicine: the time is now
  4. Review
  5. Cardiovascular risk evaluation in pregnancy: focus on cardiac specific biomarkers
  6. Opinion Papers
  7. From volume to value: a watershed moment for the clinical laboratory
  8. APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
  9. Guidelines and Recommendations
  10. Analytical interference of intravascular contrast agents with clinical laboratory tests: a joint guideline by the ESUR Contrast Media Safety Committee and the Preanalytical Phase Working Group of the EFLM Science Committee
  11. Genetics and Molecular Diagnostics
  12. Specifications of qPCR based epigenetic immune cell quantification
  13. General Clinical Chemistry and Laboratory Medicine
  14. An appraisal of the practice of duplicate testing for the detection of irregular analytical errors
  15. Machine learning-based nonlinear regression-adjusted real-time quality control modeling: a multi-center study
  16. The effect of ratios upon improving patient-based real-time quality control (PBRTQC) performance
  17. Diagnostic sample transport via pneumatic tube systems: data logger and their algorithms are sensitive to transport effects
  18. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices
  19. Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays
  20. Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection
  21. Performance evaluation of a novel platelet count parameter, hybrid platelet count, on the BC-780 automated hematology analyzer
  22. Reference Values and Biological Variations
  23. Pediatric reference intervals for serum neurofilament light and glial fibrillary acidic protein using the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort
  24. Biological variation of serum neopterin concentrations in apparently healthy individuals
  25. Short-term biological variation of serum tryptase
  26. Cancer Diagnostics
  27. Quantification of the lung cancer tumor marker CYFRA 21-1 using protein precipitation, immunoaffinity bottom-up LC-MS/MS
  28. Cardiovascular Diseases
  29. Prognostic significance of chronic myocardial injury diagnosed by three different cardiac troponin assays in patients admitted with suspected acute coronary syndrome
  30. Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community
  31. Diabetes
  32. Innovations in HbA1c analysis: finding the balance between speed and accuracy. An investigation of a potential new Secondary Reference Measurement Procedure for the IFCC
  33. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes
  34. Infectious Diseases
  35. Urinary phenotyping of SARS-CoV-2 infection connects clinical diagnostics with metabolomics and uncovers impaired NAD+ pathway and SIRT1 activation
  36. Letters to the Editor
  37. Analytical performance specifications for measurement uncertainty in therapeutic monitoring of immunosuppressive drugs
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  40. A comparison of cannabidiol (CBD) concentrations in venous vs. fingertip-capillary blood
  41. Identification of sulfamethoxazole’s residues in sulfamethoxazole induced kidney stones by mass spectrometry
  42. Impact of different preservation methods on urinary red blood cell counts
  43. Diagnosis of IRAK-4-deficiency by flow cytometric measurement of IκB-α degradation
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