Analytical Performance and 99th Percentile Upper Reference Limit of the Novel SPINCHIP High-Sensitivity Cardiac Troponin I Point-of-Care Assay
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BACKGROUND
In line with International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommendations for high-sensitivity cardiac troponin assays, analytical validation and reference limit assessments are required to confirm that an assay meets performance criteria. This study evaluated the analytical performance and established the 99 th percentile upper reference limit (URL) for the SPINCHIP ® High-Sensitivity Cardiac Troponin I (“SPINCHIP hs-cTnI”) point-of-care assay.
METHODS
Analytical performance characteristics, including the limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ), were assessed. Additionally, 1053 plasma samples and 1055 whole-blood samples were used to determine the URL. Imprecision around the 99 th percentile URL was evaluated as part of the analytical validation. High-sensitivity criteria were assessed by confirming measurable cTnI in ≥50% of healthy individuals (n=432 plasma; n=431 whole blood) and achieving imprecision <10% at the 99th percentile (plasma, n=960; whole blood, n=480).
RESULTS
SPINCHIP hs-cTnI demonstrated a LoB of 0.3 ng/L; LoDs of 0.8 ng/L (plasma) and 0.9 ng/L (whole blood); and LoQs of 1.1 ng/L (plasma) and 1.4 ng/L (whole blood). The analytical measuring range was 1.1–9000 ng/L. Imprecision at the common 99th percentile URL (14 ng/L) was 5.8%; for men (URL=16 ng/L) 5.6% and for women (URL=10 ng/L) 6.3%. Greater than 85.2% (94.0% and 76.1% in men and women, respectively) of healthy individuals showed measurable cTnI above the LoD.
CONCLUSIONS
The SPINCHIP hs-cTnI assay meets the IFCC high-sensitivity requirements, demonstrating <10% imprecision at the 99th percentile, reliable low-concentration precision. and cTnI detection in more than half of healthy individuals.
IMPACT STATEMENT
High-sensitivity cardiac troponin assays must demonstrate exceptional analytical rigor to ensure clinicians can rely on them for timely and accurate detection of myocardial injury. This study provides a comprehensive analytical validation of the SPINCHIP ® hs-cTnI point-of-care assay to confirm that it meets key International Federation of Clinical Chemistry and Laboratory Medicine high-sensitivity criteria, including precise quantification at the 99th percentile and detection of measurable cardiac troponin concentrations in the majority of healthy individuals. These findings establish the assay’s analytical robustness and support its potential to deliver rapid, trustworthy cardiac troponin results at the point-of-care, helping streamline clinical decision making where speed and accuracy are critical.
