Abstract
Objectives
The European Kidney Function Consortium (EKFC) developed two novel equations in 2023 for estimating glomerular filtration rate (GFR): one sex-free cystatin C-based equation (EKFCCys) and one creatinine-cystatin C combined equation (EKFCCr-Cys). This study compared their performance with the previous creatinine-based EKFC equation (EKFCCr) and commonly used Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Berlin Initiative Study (BIS) equations in Chinese adults.
Methods
A total of 2,438 Chinese adults (mean age=53.04 years) who underwent the 99mTc-DTPA renal dynamic imaging for reference GFR (rGFR) were included. Diagnostic value was evaluated using correlation coefficients, sensitivity, specificity, and area under the receiver operating characteristic curve (ROCAUC). Performance was assessed in terms of bias, precision (interquartile range of the median difference [IQR]), accuracy (percentage of estimates ±30 % of rGFR [P30], and root-mean-square error [RMSE]) across age, sex, and rGFR subgroups. Gender differences in bias and P30 were also analyzed.
Results
Average rGFR was 73.37 mL/min/1.73 m2. EKFC equations showed stronger correlations and larger AUCs compared to the parallel CKD-EPI equations, with EKFCCr-Cys demonstrating the greatest improvement (R=0.771, ROCAUC=0.913). Concerning bias, precision, and accuracy, EKFC equations consistently outperformed CKD-EPI equations. EKFCCr-Cys and EKFCCr performed acceptably well in the entire population and were equivalent to BIS equations in the elderly. All equations, including EKFCCys, showed similar P30 accuracy across sexes.
Conclusions
EKFC equations provided a reasonable alternative for estimating GFR in the Chinese adult population. While EKFCCys did not outperform EKFCCr, EKFCCr-Cys improved the accuracy of single-marker equations.
Funding source: National Key Research and Development Program of China - Key Special Project on Science and Technology
Award Identifier / Grant number: (2023YFC3605500)
Funding source: National Key Research and Development Program of China
Award Identifier / Grant number: (2018YFC2002100, 2018YFC2002102)
Funding source: National Natural Science Foundation of China
Award Identifier / Grant number: (82171585, 81971320)
Funding source: Jiangsu Province Older Adults Health Introduction New Technique Project
Award Identifier / Grant number: (LX2021003)
Funding source: Jiangsu Province Hospital Clinical Ability Improvement Project
Award Identifier / Grant number: (JSPH-MC-2022-22)
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Research ethics: This study was approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University and conducted in accordance with the Declaration of Helsinki, registration number 2021-SR-508.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Research funding: This study was supported by the grants from the National Key Research and Development Program of China - Key Special Project on Science and Technology Responses to Proactive Health and Population Aging (2023YFC3605500), the National Key Research and Development Program of China (2018YFC2002100, 2018YFC2002102), National Natural Science Foundation of China (82171585, 81971320), Jiangsu Province Older Adults Health Introduction New Technique Project (LX2021003), Jiangsu Province Hospital Clinical Ability Improvement Project (JSPH-MC-2022-22).
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Data availability: The data underlying this article will be shared on reasonable request to the corresponding author.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0080).
© 2024 Walter de Gruyter GmbH, Berlin/Boston
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- Frontmatter
- Editorial
- Analytical performance specifications – moving from models to practical recommendations
- Opinion Papers
- What the Milan conference has taught us about analytical performance specification model definition and measurand allocation
- The role of analytical performance specifications in international guidelines and standards dealing with metrological traceability in laboratory medicine
- How clinical laboratories select and use Analytical Performance Specifications (APS) in Italy
- Outcome-based analytical performance specifications: current status and future challenges
- Analytical performance specifications based on biological variation data – considerations, strengths and limitations
- State-of-the-art model for derivation of analytical performance specifications: how to define the highest level of analytical performance technically achievable
- Analytical performance specifications for combined uncertainty budget in the implementation of metrological traceability
- When bias becomes part of imprecision: how to use analytical performance specifications to determine acceptability of lot-lot variation and other sources of possibly unacceptable bias
- Using analytical performance specifications in a medical laboratory
- Issues in assessing analytical performance specifications in healthcare systems assembling multiple laboratories and measuring systems
- Applying the Milan models to setting analytical performance specifications – considering all the information
- Guidelines and Recommendations
- Recommendations for blood sampling in emergency departments from the European Society for Emergency Medicine (EUSEM), European Society for Emergency Nursing (EuSEN), and European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase. Executive summary
- General Clinical Chemistry and Laboratory Medicine
- Assessment of accuracy of laboratory testing results, relative to peer group consensus values in external quality control, by bivariate z-score analysis: the example of D-Dimer
- The stability of 65 biochemistry analytes in plasma, serum, and whole blood
- Assessment of the 2023 European Kidney Function Consortium (EKFC) equations in a Chinese adult population
- In vitro, in vivo metabolism and quantification of the novel synthetic opioid N-piperidinyl etonitazene (etonitazepipne)
- Quantification of blood glial fibrillary acidic protein using a second-generation microfluidic assay. Validation and comparative analysis with two established assays
- Association of prehospital lactate levels with base excess in various emergencies – a retrospective study
- Reference Values and Biological Variations
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- Variations in tumor growth, intra-individual biological variability, and the interpretation of changes
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- Infectious Diseases
- Fetal chronic hypoxia does not affect urinary presepsin levels in newborns at birth
- Letters to the Editor
- AWMF statement on medical services in laboratory diagnostics and pathology with regard to the IVDR
- An outline of measurement uncertainty of total protein in urine estimated according to the ISO Technical Specification 20914
- Early diagnosis of severe illness in an outpatient – the Sysmex XN’s neutrophil reactivity parameter
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