Analytical validation of the Mindray CL1200i analyzer high sensitivity cardiac troponin I assay: MERITnI study
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Abstract
Objectives
This study performed an analytical validation study of the Mindray high-sensitivity cardiac troponin I (hs-cTnI) assay addressing limit of blank (LoB), limit of detection (LoD), precision, linearity, analytical specificity and sex-specific 99th percentile upper reference limits.
Methods
LoB, LoD, precision, linearity and analytical specificity were studied according to Clinical and Laboratory Standards Institute. We used one reagent lot and one CL1200i analyzer. Skeletal troponin I and T, cardiac troponin T, troponin C, actin, tropomyosin, myosin light chain, myoglobin and creatine kinase (CK-MB) were studied for cross-reactivity. Interference with biotin was examined. Lithium heparin samples (one freeze thaw cycle) from healthy males and females were measured to determine the 99th percentiles by using the non-parametric method. Analyses were performed before and after excluding subjects with clinical conditions and/or increased surrogate biomarkers.
Results
The Mindray hs-cTnI assay met criteria to be considered as a hs-cTn assay. LoB and LoD was <0.1 ng/L and 0.1 ng/L, respectively. Repeatability had a coefficient of variation 1.2–3.8 %, and within-laboratory imprecision 1.7–5.0 %. The measuring interval ranged from 1.1 to 28,180 ng/L. The analytical specificity was clinically acceptable for the interferents studied. After exclusions, the 99th percentile URLs obtained were 10 ng/L overall, 5 ng/L for females and 12 ng/L for males.
Conclusions
Analytical observations of the Mindray hs-cTnI assay demonstrated excellent LoB, LoD, precision, linearity and analytical specificity, that were in alignment with the manufacturer’s claims and regulatory guidelines for hs-cTnI. The assay is suitable for clinical investigation for patient-oriented studies.
Funding source: Funded as investigator initiated trial in part by Mindray.
Award Identifier / Grant number: none
Acknowledgments
We acknowledge the numerous technologists that performed all cTn testing.
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Research ethics: The clinicaltrials.gov MERITnI (Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon, NCT05853042), was approved by the Institutional Review Committee of Hennepin Healthcare/Hennepin County Medical Center (HCMC) (Minneapolis, MN, USA).
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Informed consent: Not applicable.
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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: FSA: Consultant: Mindray; Associate Editor: Clinical Chemistry; Advisory Boards: Werfen, Abbott Vascular; PI on Industry Funded Grants (non-salaried) on cardiac biomarkers through Hennepin Healthcare Research Institute: Abbott Diagnostics, Abbott POC, BD, Beckman Coulter, Ortho-Clinical Diagnostics, Roche Diagnostics, Siemens Healthineers. KS, BFE, AS: These authors state not conflict of interests.
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Research funding: This study was supported in part by Mindray as an investigator initiated study (FSA). We thank the International Federation of Clinical Chemistry (IFCC) for the support with the Professional Scientific Exchange Programme (PSEP) to BFE.
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Data availability: Not applicable.
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Trial registration: Clinicaltrials.gov number NCT05853042.
References
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0352).
© 2024 Walter de Gruyter GmbH, Berlin/Boston
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- Molecular allergology: a clinical laboratory tool for precision diagnosis, stratification and follow-up of allergic patients
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