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Poor comparability of plasma renin activity measurement in determining patient samples: the status quo and recommendations for harmonization

  • Zhenni Liu ORCID logo , Lizi Jin ORCID logo , Jie Zeng , Tianjiao Zhang , Jiangtao Zhang , Weiyan Zhou EMAIL logo and Chuanbao Zhang EMAIL logo
Published/Copyright: April 14, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 61 Issue 10

Abstract

Objectives

This study aims to investigate and update the consistency and comparability of plasma renin activity (PRA) assays in measuring clinical samples. The contributions of recalibration, blank subtraction, and incubation strategies to interchangeability were also explored.

Methods

Five different laboratories were evaluated using forty-six individual plasma samples, including four liquid chromatography-tandem mass spectrometry (LC‒MS/MS) assays and one chemiluminescence immunoassay (CLIA). Spearman correlation coefficient (R), Passing–Bablok regression, and Bland‒Altman plot analyses were used to evaluate the consistency among assays. Consistency before and after recalibration, blank subtraction, and incubation strategy unification was compared.

Results

A good correlation was observed among all assays (R>0.93). None of the samples measured by all assays showed coefficient variation (CV) <10 %, and 37 % of samples showed overall CVs >20 %. The 95 % confidence intervals (CIs) for slopes did not contain 1 for most assay pairs. Large relative biases (−85.1–104.2 %) were found, and 76 % (52–93 %) of samples had unacceptable biases. Recalibration reduced the calibration bias. Ignoring blank subtraction improved the comparability across all assays while unifying incubation did not.

Conclusions

The interchangeability of PRA measurement was unsatisfying. Harmonization on calibrator and ignoring blank were recommended. Unifying incubation strategy was unnecessary.

Keywords: immunoassay; liquid chromatography-tandem mass spectrometry; method comparison; primary aldosteronism; recalibration; 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: Beijing Natural Science Foundation

Award Identifier / Grant number: 7212087

Funding source: National Key Research and Development Program of China

Award Identifier / Grant number: 2022YFF0710301

Acknowledgments

We would like to thank our colleagues from Beijing Hospital and Hangzhou CALIBRA TECHNOLOGIES Co., Ltd., for their kind help in sample collection. We sincerely thank the Shanghai Biotree BIOTECH Co., Ltd., Hangzhou CALIBRA TECHNOLOGIES Co., Ltd., Peking Union Medical College Hospital Department of Clinical Laboratory, and Shenzhen New Industries (Snibe) Biomedical Engineering Co., Ltd. for the sample testing and technical support in the comparison study. We are also grateful for the help of Dr. Xueyan Han from Peking Union Medical College on language editing.

  1. Research funding: This work was supported by the Beijing Natural Science Foundation (grant no. 7212087) and the National Key Research and Development Program of China (grant no. 2022YFF0710301).

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

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

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The collection of plasma was approved by the Ethics Committee of Beijing Hospital.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2023-0117).

Received: 2023-01-05
Accepted: 2023-04-04
Published Online: 2023-04-14
Published in Print: 2023-09-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2023-0117
Keywords for this article
immunoassay; liquid chromatography-tandem mass spectrometry; method comparison; primary aldosteronism; recalibration; renin activity

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Laboratory Medicine: from just testing to saving lives
  4. Reviews
  5. Serum biomarkers of remodeling in severe asthma with fixed airway obstruction and the potential role of KL-6
  6. Safety monitoring of drug-induced muscle injury and rhabdomyolysis: a biomarker-guided approach for clinical practice and drug trials
  7. Mini Review
  8. Concise review on the combined use of immunocapture, mass spectrometry and liquid chromatography for clinical applications
  9. Opinion Paper
  10. Recommendation for the design of stability studies on clinical specimens
  11. General Clinical Chemistry and Laboratory Medicine
  12. Assessment of WHO 07/202 reference material and human serum pools for commutability and for the potential to reduce variability among soluble transferrin receptor assays
  13. veRification: an R Shiny application for laboratory method verification and validation
  14. Impact of storage temperature and time before analysis on electrolytes (Na+, K+, Ca2+), lactate, glucose, blood gases (pH, pO2, pCO2), tHb, O2Hb, COHb and MetHb results
  15. The stability of blood gases and CO-oximetry under slushed ice and room temperature conditions
  16. Elevated levels of renal function tests conferred increased risks of developing various pregnancy complications and adverse perinatal outcomes: insights from a population-based cohort study
  17. Poor comparability of plasma renin activity measurement in determining patient samples: the status quo and recommendations for harmonization
  18. Salivary cortisol and cortisone in diagnosis of Cushing’s syndrome – a comparison of six different analytical methods
  19. Improved diagnostics of purine and pyrimidine metabolism disorders using LC-MS/MS and its clinical application
  20. Analytical evaluation of a GAD65 antibodies chemiluminescence immunoassay for CSF in neurological syndromes
  21. Reference Values and Biological Variations
  22. Evaluation of low-density lipoprotein cholesterol equations by cross-platform assessment of accuracy-based EQA data against SI-traceable reference value
  23. Highly sensitive tandem mass spectrometric measurement of serum estradiol without derivatization and pediatric reference intervals in children and adolescents
  24. Cancer Diagnostics
  25. Practical delta check limits for tumour markers in different clinical settings
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  27. Hematology and Coagulation
  28. Value of monocyte distribution width for predicting severe cholecystitis: a retrospective cohort study
  29. Performance of digital morphology analyzer Medica EasyCell assistant
  30. Validation of non-invasive point of care blood content analysis using the TensorTip™ MTX device: a method comparison study
  31. Infectious Diseases
  32. Kinetics and ability of binding antibody and surrogate virus neutralization tests to predict neutralizing antibodies against the SARS-CoV-2 Omicron variant following BNT162b2 booster administration
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