Quantitative bedside assay for cardiac troponin T: a complementary method to centralized laboratory testing.

Area of Science:

• Cardiology
• Biomedical Engineering
• Clinical Diagnostics

Background:

• Centralized clinical chemistry testing for chest pain patients can be time-consuming.
• Whole blood bedside assays offer a potential alternative for rapid cardiac marker analysis.
• Cardiac troponin T (cTnT) is a highly specific biomarker for myocardial injury.

Purpose of the Study:

• To report on an optimized test strip device for quantitative cardiac troponin T (cTnT) analysis.
• To evaluate the performance of a bedside cTnT assay using a cardiac reader.
• To assess the utility of rapid cTnT measurement in diagnosing acute coronary syndromes.

Main Methods:

• Development of an optimized cTnT test strip device for bedside use.
• Quantitative analysis using a cardiac reader with CCD camera for reflectance measurement.
• Method comparison with cTnT ELISA and ROC curve analysis in patients with suspected myocardial infarction.

Main Results:

• Quantitative results from the cTnT test strip reader showed close correlation with cTnT ELISA (r=0.98).
• Within-run and day-to-day coefficients of variation (CVs) were between 11% and 16%.
• Detection rates for myocardial infarction were 45% on admission and 91% at 4-8 hours; ROC analysis showed comparable efficiency to laboratory ELISA.

Conclusions:

• Quantitative determination of cTnT at the bedside is now feasible with a rapid test device.
• The test strip device facilitates the diagnostic workup of patients with suspected myocardial cell necrosis.
• This bedside assay offers a convenient and efficient alternative for cardiac troponin T measurement.