Analytical validation of the Mindray CL1200i analyzer high sensitivity cardiac troponin I assay: MERITnI study

• Published in: Clinical chemistry and laboratory medicine Vol. 62; no. 12; pp. 2519 - 2525
• Main Authors: Fabre-Estremera, Blanca, Schulz, Karen, Ladd, Alanna, Sexter, Anne, Apple, Fred S.
• Format: Journal Article
• Language: English
• Published: Germany De Gruyter 26.11.2024; Walter De Gruyter & Company
• Subjects: Actin; Adult; analytical performance; Assaying; Biomarkers; Biotin; Blood Chemical Analysis - methods; Blood Chemical Analysis - standards; Coefficient of variation; Creatine; Creatine kinase; Cross-reactivity; Female; Females; Freeze thaw cycles; Freeze-thawing; Health care; Heart; Heart attacks; Heparin; high sensitivity cardiac troponin assay; Humans; imprecision; Kinases; Laboratories; Limit of Detection; Linearity; Lithium; Male; Males; Middle Aged; Myoglobins; Myosin; Preventive medicine; Reagents; Reference Values; Reproducibility of Results; Research centers; Sensitivity analysis; sex specific 99th percentile upper reference limits; Tropomyosin; Troponin C; Troponin I; Troponin I - analysis; Troponin I - blood; Troponin T; Validation studies; Young Adult; sex specific 99th percentile upper reference limits; imprecision; analytical performance; high sensitivity cardiac troponin assay
• ISSN: 1434-6621; 1437-4331; 1437-4331
• DOI: 10.1515/cclm-2024-0352

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. 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. 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. 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.