GHM Cardiac Troponin I (cTnI) Rapid Test US – Qualitative Detection of Cardiac Troponin I with 10-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Cardiac Troponin I (cTnI) Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Cardiac Troponin I (cTnI) Rapid Test US is a lateral flow chromatographic immunoassay designed for the qualitative detection of human cardiac Troponin I in whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of myocardial infarction (MI).

Cardiac troponin I (cTnI) is a protein found in the contractile apparatus of cardiac muscle cells and is released into the bloodstream when myocardial injury occurs. According to the 2025 ACC/AHA guidelines, cTn is the biomarker of choice for assessing patients for possible cardiac injury, with high-sensitivity assays being preferred because the sensitivity and negative predictive values are greater and the time interval from chest pain onset to detection is shorter. A cTn concentration above the 99th percentile upper reference limit is an indicator of myocardial injury, and monitoring the rise and fall of troponin levels helps distinguish acute coronary syndrome from other conditions that can cause troponin elevation. Troponin levels begin to rise within 2–3 hours of myocardial injury, and early detection is critical for timely clinical intervention.

The GHM Cardiac Troponin I (cTnI) Rapid Test US provides a practical, point-of-care solution for the rapid qualitative detection of cTnI, enabling timely clinical decision-making in emergency and critical care settings where every minute matters. The test delivers results in just 10 minutes, supporting rapid rule-out and rule-in of myocardial infarction. The test is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including emergency departments, cardiac care units, and clinical laboratories.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including emergency departments, cardiac care units, intensive care units, and clinical laboratories. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on immunochromatography.

Key Features & Benefits

Colloidal Gold Immunochromatography – Reliable Qualitative Detection

The GHM Cardiac Troponin I (cTnI) Rapid Test US is based on lateral flow chromatographic immunoassay technology, utilizing a rapid direct binding test format for the visual detection of cardiac Troponin I. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to cTnI, along with immobilized capture antibodies on the test line. During testing, the specimen reacts with the antibody-coated particles and migrates up the membrane to react with the antibodies on the membrane. A colored line is generated at the test line region if cardiac Troponin I is present in the specimen.

Fast Results – 10 Minutes

The GHM Cardiac Troponin I (cTnI) Rapid Test US provides qualitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in emergency and critical care settings. Cardiac troponin levels begin to rise within 2–3 hours of myocardial injury, and early detection is essential for timely clinical intervention. The 2025 ACC/AHA guidelines emphasize that cTn is central to the diagnosis of AMI, and point-of-care testing enables rapid rule-in or rule-out of ischemia.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM Cardiac Troponin I (cTnI) Rapid Test US is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. The test requires only a small sample volume, making it suitable for both emergency and routine clinical settings.

Clinical Utility – Aid for Diagnosis of Myocardial Infarction

The GHM Cardiac Troponin I (cTnI) Rapid Test US is intended for use as an aid in the diagnosis of myocardial infarction. The test provides rapid qualitative detection of cardiac Troponin I, enabling timely clinical decision-making and supporting patient management. A cTn concentration above the 99th percentile upper reference limit is an indicator of myocardial injury, and AMI is characterized by a rising and/or falling pattern of cTn values with at least one value above the 99th percentile upper reference limit believed caused by myocardial ischemia.

The test is particularly valuable in emergency departments, where rapid identification of cardiac troponin I supports timely triage and initiation of appropriate clinical management. Point-of-care cardiac troponin testing has been shown to provide results with a rapid turnaround time, enhancing acute myocardial infarction assessment outside hospital settings. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.

High Accuracy – Trusted Clinical Performance

The GHM Cardiac Troponin I (cTnI) Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. The product specifications report a sensitivity of 99.4%, specificity of 99.0%, and accuracy of 99.1%. High-sensitivity cardiac troponin point-of-care assays have demonstrated strong performance in clinical evaluations, with one study reporting sensitivity and specificity for AMI diagnosis of 100% and 92.3%, respectively, and another reporting sensitivity of 100%, specificity of 81.25%, and negative predictive value of 100% using the 99th percentile upper reference limit as the cut-off. A prospective multisite cohort study of 3,582 patients reported high negative predictive values of 99.8% for initial hs-cTnI measurements below the limit of quantification and below 5.0 ng/L. Point-of-care assays have also demonstrated superior specificity compared to laboratory assays in some clinical settings.

Performance characteristics based on product specifications. High-sensitivity cardiac troponin point-of-care assays have demonstrated sensitivity and specificity for AMI diagnosis ranging from 90.7% to 100% and 81.25% to 92.3%, respectively, depending on the assay, population, and cut-off used. A prospective multisite cohort study of 3,582 patients reported high negative predictive values of 99.8% for initial hs-cTnI measurements below the limit of quantification and below 5.0 ng/L. The clinical performance of cardiac troponin assays is influenced by the timing of specimen collection relative to symptom onset, with serial testing at 1–3 hours recommended when high-sensitivity assays are used. Detection is optimal in specimens collected at appropriate time points after symptom onset, and the test is best suited for use as an aid in the diagnosis of myocardial infarction in symptomatic patients. The test provides a preliminary result; hs-cTn is the biomarker of choice for assessing patients for possible cardiac injury, and additional testing may be required per clinical guidelines.

ISO 13485 Certified – Quality and Safety Compliance

The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.

CE Marked – European Conformity

The GHM Cardiac Troponin I (cTnI) Rapid Test US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.

Product Specifications

Important Testing Notes:

• Allow the test kit and sample to reach room temperature (18–30°C) prior to testing.

• For fingerstick whole blood, clean the fingertip with an alcohol swab and allow it to dry; collect blood using a sterile lancet.

• Any visible shade of color in the Test line (T) indicates a positive result, as intensity varies with antigen concentration.

• A negative result does not rule out myocardial infarction, particularly if the specimen was collected within 2–3 hours of symptom onset before troponin levels rise, or if the troponin concentration is below the detection limit of the test.

• Cardiac troponin levels begin to rise within 2–3 hours of myocardial injury and may remain elevated for 7–10 days after MI.

• When using a diagnostic protocol that incorporates a single hs-cTn value, the troponin should be obtained at least 3 hours after the onset of symptoms.

• The test provides a preliminary result; cTn is the biomarker of choice for assessing patients for possible cardiac injury, and additional testing including serial sampling may be required per clinical guidelines.

• In the setting of electrocardiographic evidence of STEMI, reperfusion therapy should not be delayed pending biomarker results.

Why Clinical Professionals Choose Global Healthcare Medical

About Global Healthcare Medical

Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM Cardiac Troponin I (cTnI) Rapid Test US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.

Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.