A new high-sensitivity troponin assay developed for the PATHFAST Biomarker Analyzer from Polymedco received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Rapid Myocardial Infarction Diagnosis Test
The new The PATHFAST hs-cTnI-II test will facilitate the accurate, rapid diagnosis of myocardial infarction at the point of care. The PATHFAST point-of-care platform offers a comprehensive menu of tests that bring central lab-quality diagnostic results closer to the clinician and patient, saving time when evaluating patients with potentially life-threatening conditions.
Troponin Test Improves Diagnostic Accuracy
Chest pain remains the second most common reason for adults to seek care at the emergency department (ED) in the United States, accounting for over 7 million annual visits.(1) Timing of troponin test results is a critical factor in helping doctors quickly diagnose and effectively treat patients. When patients enter the ED with a suspected heart attack, doctors typically use a troponin blood test to aid in their diagnosis. Before the introduction of the PATHFAST high-sensitivity troponin assay, the test was only available in the hospital central laboratory where results typically can take an hour or more to get to the physician. The PATHFAST platform delivers results in 17 minutes at the point of care,(2) providing EDs and other acute care facilities the ability to make accurate diagnostic and treatment decisions much faster than previously available.
“Both speed and quality in high-sensitivity cardiac troponin testing are essential in the emergency department for safe and timely disposition of patients. Access to rapid and accurate results can assist clinicians in identifying patients through safe, early rule-out protocols that can decrease length of stay, reduce overcrowding, and improve patient satisfaction, all while assuring that patients with abnormal findings suggestive of acute coronary syndromes and myocardial infarction receive appropriate care,” says Robert H. Christenson, PhD, DABCC, FADLM, FACC.
Use with Polymedco’s PATHFAST Analyzer
With this clearance, the test may be sold in the U.S. for use on Polymedco’s PATHFAST analyzer with whole blood and plasma patient specimens. PATHFAST High Sensitivity Troponin-I results should be used in conjunction with other diagnostic information such as electrocardiogram (ECG), clinical findings and patient symptoms to aid in the diagnosis of heart attacks.
“Polymedco is committed to providing the most accurate and efficient diagnostics to help overburdened Emergency Departments more effectively and efficiently respond and treat patients presenting with symptoms of a heart attack. Having the diagnostic accuracy of high-sensitivity cardiac troponin at the point-of-care represents a significant advancement in cardiac care in the U.S.,” says Polymedco CEO Doug White.
Further reading: Blood Biomarkers Help Predict Cardiovascular Disease Risk in Rheumatoid Arthritis Patients
References:
- Kontos M, de Lemos, J. et al. 2022 ACC Expert consensus decision pathway on the evaluation and disposition of acute chest pain in the emergency department: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022;80(20):1925-1960. doi:10.1016/j.jacc.2022.08.750
- Point of care cardiac troponin I and T assay analytical characteristics. IFCC Committee on Clinical Applications of Cardiac Bio-Markers. Accessed March 13, 2024. https://ifcc.org/ifcc-education-division/emd-committees/committee-on-clinical-applications-of-cardiac-bio-markers-c-cb/biomarkers-reference-tables/
Featured image: The PATHFAST Cardiac Biomarker Analyzer. Photo: Polymedco
