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Commutability assessment of candidate reference materials for plasma renin activity measurement: current challenges

  • Zhenni Liu ORCID logo , Lizi Jin ORCID logo , Zijia Ma , Xiaerbanu Nizhamuding , Jie Zeng , Tianjiao Zhang , Jiangtao Zhang , Weiyan Zhou EMAIL logo and Chuanbao Zhang EMAIL logo
Published/Copyright: July 21, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 62 Issue 1

Abstract

Objectives

This study aims to evaluate the commutability of external quality assessment (EQA) materials and candidate reference materials (RMs) for plasma renin activity (PRA) assay.

Methods

Commutabilities of 16 candidate RMs were measured along with 40 clinical samples by the four different routine PRA assays, including three LC‒MS/MS assays and one chemiluminescence immunoassay. Sixteen candidate RMs included native/spiked human plasma pools (small-scale pools with <50 individuals) and current EQA materials (large-scale pools with >1,000 individuals). Difference in bias approach and linear regression with prediction interval approach were adopted to determine the commutability. Two-way variance analysis was used to estimate the effects of spiked and pool size on the commutability. Stability and homogeneity studies were performed.

Results

Precision and correlation performance of all assays was acceptable. In the difference in bias approach, the commutability results were not satisfactory (noncommutability: 14/16) and significant sample-specific effects were detected in assay pairs using different incubation buffers. For the prediction interval approach, no commutability was observed in the spiked small-scale pools; EQA materials (4/9) had more satisfactory commutability among all assays than the small-scale pools (2/7); RMs of large-scale pools tend to have better commutability no matter spiked or not.

Conclusions

Commutable RMs were obtainable but challenging. Current EQA materials with relatively good commutability, stability, and homogeneity were appropriate RMs. Large-scale pools are tending to be commutable. Spiking in small-scale pools was not suggested to prepare RMs. MPs adopting a uniform incubation buffer would be preferable for further commutability research.

Keywords: blank subtraction; commutability; external quality assessment; harmonization; reference materials; renin activity
Corresponding authors: Weiyan Zhou, PhD, National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, P.R. China, E-mail: ; and Chuanbao Zhang, PhD, National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, P.R. China; and Chinese Academy of Medical Sciences and Peking Union Medical College, No. 1 Dahua Road, Dongcheng District, Beijing 100730, P.R. China, Phone: +86 010 58115059, Fax: +86 010 65132968, E-mail:

Funding source: National High Level Hospital Clinical Research Funding

Award Identifier / Grant number: BJ-2023-094

Funding source: Beijing Natural Science Foundation

Award Identifier / Grant number: 7212087

Acknowledgments

We would like to thank our colleagues in Beijing Hospital for their kind help in sample collection. We sincerely thank the Zhejiang Disigns Diagnostics Technology Co., Ltd., Shanghai Biotree Biomedical Technology Co., Ltd, (Shanghai, China), and Shenzhen New Industries Biomedical Engineering Co., Ltd, (Shenzhen, China) for the sample testing and technical support.

  1. Research ethics: The collection of plasma was approved by the Ethics Committee of Beijing Hospital.

  2. Informed consent: This study was approved an exemption from informed consent.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: The authors state no conflict of interest.

  5. Research funding: This work was supported by the Beijing Natural Science Foundation (grant no. 7212087) and the National High Level Hospital Clinical Research Funding (grant no. BJ-2023-094).

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2023-0698).

Received: 2023-07-04
Accepted: 2023-07-12
Published Online: 2023-07-21
Published in Print: 2024-01-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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  2. Editorial
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  4. Reviews
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https://doi.org/10.1515/cclm-2023-0698
Keywords for this article
blank subtraction; commutability; external quality assessment; harmonization; reference materials; renin activity

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Biological management of diabetes mellitus, the laboratory medicine specialist and the patient
  4. Reviews
  5. Remote HbA1c testing via microsampling: fit for purpose?
  6. The effect of hormonal contraceptive therapy on clinical laboratory parameters: a literature review
  7. Opinion Paper
  8. Continuous glucose monitoring has an increasing role in pre-symptomatic type 1 diabetes: advantages, limitations, and comparisons with laboratory-based testing
  9. IFCC Paper
  10. Comparison and commutability study among four faecal immunochemical tests (FIT) systems
  11. Guidelines and Recommendations
  12. Evidence-based procedures to improve the reliability of circulating miRNA biomarker assays
  13. General Clinical Chemistry and Laboratory Medicine
  14. Commutability assessment of candidate reference materials for plasma renin activity measurement: current challenges
  15. Aggregated data from the same laboratories participating in two glucose external quality assessment schemes show that commutability and transfers of values to control materials are decisive for the biases found
  16. Methodological considerations in determining sex steroids in children: comparison of conventional immunoassays with liquid chromatography-tandem mass spectrometry
  17. From “wet” matrices to “dry” blood spot sampling strategy: a versatile LC-MS/MS assay for simultaneous monitoring caffeine and its three primary metabolites in preterm infants
  18. A sensitive LC-MS/MS methotrexate assay capable of assessing adherence to methotrexate therapy in rheumatoid arthritis
  19. Determination of cortisone and cortisol in human scalp hair using an improved LC-MS/MS-based method
  20. Mild hypophosphatasia may be twice as prevalent as previously estimated: an effective clinical algorithm to detect undiagnosed cases
  21. Combined deficient response to polysaccharide-based and protein-based vaccines predicts a severe clinical phenotype
  22. Reference Values and Biological Variations
  23. A sex-specific association of leukocyte telomere length with thigh muscle mass
  24. Cancer Diagnostics
  25. Optimized procedure for high-throughput transcriptome profiling of small extracellular vesicles isolated from low volume serum samples
  26. Ultra-short cell-free DNA fragments enhance cancer early detection in a multi-analyte blood test combining mutation, protein and fragmentomics
  27. Clinical relevance of clonal hematopoiesis and its interference in cell-free DNA profiling of patients with gastric cancer
  28. Development and analytical validation of a novel nasopharynx swab-based Epstein-Barr virus C promoter methylation quantitative assay for nasopharyngeal carcinoma detection
  29. Infectious Diseases
  30. (Pre)analytical considerations concerning the analysis of synovial calprotectin
  31. Corrigendum
  32. Thermal and chronological stability of monocyte distribution width (MDW), the new biomarker for sepsis
  33. Acknowledgment
  34. Acknowledgment
  35. Letters to the Editor
  36. In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency
  37. Use of thyroid function tests in urine: a position statement of the Belgian Thyroid Club
  38. State of the art of measurement uncertainty of serum ferritin
  39. Analytical performance evaluation and consumable waste reduction strategies using a tube-based quality control material
  40. Stability of fecal calprotectin extracts using the Diasorin® kit
  41. Reverse cascade testing from newborn screening: the opportunity to improve family healthcare outcomes
  42. An indirect data-mining approach to standardise paediatric serum phosphate reference intervals in Wales
  43. Sodium and risk assessment of osmotic demyelination syndrome: the method matters!
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