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Analytical performance of time-resolved fluorometry-based Innotrac Aio! cardiac marker immunoassays
Summary
The Innotrac Aio! system offers precise, rapid measurement of cardiac troponin I (cTnI), CK-MB, and myoglobin. This dry-chemistry platform is suitable for critical care settings, providing reliable cardiac marker results within 18 minutes.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Diagnostic Technology Evaluation
Background:
- Cardiac markers like troponin I (cTnI), CK-MB, and myoglobin are crucial for diagnosing myocardial infarction.
- Existing diagnostic systems require evaluation for efficiency and accuracy in clinical settings.
Purpose of the Study:
- To evaluate the performance of the Innotrac Aio! system for quantitative measurement of cardiac markers.
- Assess precision, linearity, correlation, detection limits, and stability of the Innotrac Aio! system.
Main Methods:
- The Innotrac Aio! system, based on dry-chemistry and time-resolved fluorometry, was evaluated.
- Assays for cTnI, CK-MB, and myoglobin were tested for precision, linearity, and correlation with the AxSYM system.
- Comparative studies used various sample types (EDTA whole blood, lithium heparin plasma).
Main Results:
- Acceptable precision was achieved for cTnI and CK-MB; myoglobin showed higher CV (5.6-9.5%).
- Linearity was confirmed across tested ranges for all markers.
- High correlation coefficients (>0.96) were observed between Aio! and AxSYM assays, with minor concentration differences.
- Analytical detection limits were established, and analyte stability in lithium heparin samples was assessed.
Conclusions:
- The Innotrac Aio! system demonstrates good performance for cTnI, CK-MB, and myoglobin quantification.
- The system's speed (<18 min) and ease of use make it suitable for emergency departments and critical care units.