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Global Healthcare Medical
GHM cTnI/CK-MB US Test Kit (FIA) – Quantitative Cardiac Combo Testing with 15-Minute Results, Dual Biomarker Detection, and Whole Blood/Serum/Plasma Compatibility
GHM cTnI/CK-MB US Test Kit (FIA) – Quantitative Cardiac Combo Testing with 15-Minute Results, Dual Biomarker Detection, and Whole Blood/Serum/Plasma Compatibility
SKU: GHM cTnI/CK-MB US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM cTnI/CK-MB US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Cardiac Troponin I (cTnI) and Creatine Kinase-MB (CK-MB) in human whole blood, serum, or plasma samples. The kit is intended for use with compatible POCT Analyzers, providing healthcare professionals with a reliable tool for the assessment of cardiac biomarkers in a single test.
Measurements of these blood cardiac biomarkers may serve as indicators for the assessment of myocardial injury. Cardiac troponin I is a highly specific marker of myocardial injury, while CK-MB is an isoenzyme predominantly found in cardiac muscle tissue. Together, these biomarkers provide complementary clinical value in the evaluation of patients with suspected acute coronary syndrome. The GHM cTnI/CK-MB US Test Kit delivers quantitative results for both biomarkers in just 15 minutes, supporting efficient clinical decision-making in emergency and point-of-care settings.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including emergency departments, intensive care units, clinical laboratories, and point-of-care environments. The product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers used in the detection of cardiac markers based on fluorescence immunochromatography.
Key Features & Benefits
Fluorescence Immunoassay Technology – High-Sensitivity Quantitative Detection
The GHM cTnI/CK-MB US Test Kit is based on fluorescence immunoassay technology, utilizing a sandwich immunodetection method. Fluorescence-labeled detector antibodies bind to the target proteins (cTnI and CK-MB) in the sample. The test device contains a membrane coated with specific monoclonal antibodies for each biomarker, enabling reliable and consistent quantitative detection.
| Feature | Benefit |
|---|---|
| Fluorescence immunoassay (FIA) | High-sensitivity quantitative detection |
| Sandwich immunodetection method | Reliable and consistent signal generation |
| Dual biomarker detection | cTnI and CK-MB from a single sample |
| Quantitative determination | Precise concentration results for both biomarkers |
Dual Cardiac Biomarkers – cTnI and CK-MB in a Single Test
The GHM cTnI/CK-MB US Test Kit simultaneously measures two cardiac biomarkers, providing a focused cardiac panel in a single test. Cardiac troponin I is a highly specific marker of myocardial injury; CK-MB is an isoenzyme predominantly found in cardiac muscle tissue. Measurements of these blood cardiac biomarkers may serve as indicators for the assessment of myocardial injury.
| Biomarker | Clinical Utility | Measuring Range |
|---|---|---|
| Cardiac Troponin I (cTnI) | Highly specific marker of myocardial injury | 0.1–50 ng/mL |
| Creatine Kinase-MB (CK-MB) | Cardiac muscle isoenzyme assessment | 0.3–100 ng/mL |
Fast Results – 15 Minutes
The GHM cTnI/CK-MB US Test Kit provides quantitative results for both cardiac biomarkers in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in emergency and point-of-care settings.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for emergency departments, ICUs, and clinical laboratories |
| Efficient workflow | Enables immediate patient assessment |
| Dual results in one test | Focused cardiac panel from a single sample |
Wide Measuring Range – cTnI and CK-MB
The GHM cTnI/CK-MB US Test Kit supports broad measuring ranges for each biomarker, accommodating a wide variety of concentrations for comprehensive cardiac marker assessment.
| Parameter | Specification |
|---|---|
| Measuring Range (cTnI) | 0.1–50 ng/mL |
| Measuring Range (CK-MB) | 0.3–100 ng/mL |
| Specimen | Whole blood (fingerstick or venous) / Serum / Plasma |
| Test Time | 15 minutes |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
Flexible Sample Compatibility – Whole Blood, Serum, and Plasma
The GHM cTnI/CK-MB US Test Kit is compatible with whole blood samples obtained from fingerstick or venous collection, as well as serum and plasma samples, providing flexibility for different clinical workflows and patient sample collection preferences.
| Feature | Benefit |
|---|---|
| Fingerstick whole blood | Convenient point-of-care sample collection |
| Venous whole blood | Standard laboratory sample compatibility |
| Serum samples | Standard laboratory sample compatibility |
| Plasma samples | Alternative sample type for flexible workflows |
| Flexible sample collection | Adaptable to different clinical settings |
Clinical Performance – High Sensitivity and Specificity
The cardiac combo test kit demonstrates excellent clinical performance characteristics across both biomarkers, with high sensitivity, specificity, and accuracy.
| Biomarker | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| CK-MB | 99.9% | 99.6% | 99.6% |
| Troponin I (cTnI) | 98.8% | 98.9% | 98.8% |
ISO 13485 Certified – Quality and Safety Compliance
The 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.
| Feature | Benefit |
|---|---|
| EN ISO 13485 certification | Quality management system compliance |
| Cardiac marker scope | Certified for IVD test kits detecting cardiac markers |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM cTnI/CK-MB US |
| Product Type | Cardiac Combo Test Kit (FIA) |
| Catalog Number | VID15-03-011 (cardiac combo reference) |
| Intended Use | Quantitative determination of Cardiac Troponin I (cTnI) and Creatine Kinase-MB (CK-MB) in human whole blood, serum, or plasma |
| Detection Principle | Fluorescence immunoassay (FIA); sandwich immunodetection |
| Specimen | Whole blood (fingerstick or venous) / Serum / Plasma |
| Test Time | 15 minutes |
| Measuring Range (cTnI) | 0.1–50 ng/mL |
| Measuring Range (CK-MB) | 0.3–100 ng/mL |
| Sensitivity (cTnI) | 98.8% |
| Specificity (cTnI) | 98.9% |
| Accuracy (cTnI) | 98.8% |
| Sensitivity (CK-MB) | 99.9% |
| Specificity (CK-MB) | 99.6% |
| Accuracy (CK-MB) | 99.6% |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Application Scenario | Emergency department, ICU, clinical laboratory, point-of-care |
| Compatible Analyzers | POCT Analyzers (VIM series) |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system |
| Intended User | Professional healthcare use only |
| Package Options | 25 tests/kit |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM cTnI/CK-MB US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| Dual biomarker detection | cTnI and CK-MB from a single sample |
| 15-minute test time | Rapid turnaround for timely decisions |
| Wide measuring ranges | cTnI: 0.1–50 ng/mL; CK-MB: 0.3–100 ng/mL |
| Flexible sample types | Whole blood, serum, or plasma compatibility |
| High clinical performance | Sensitivity up to 99.9% across both biomarkers |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for emergency departments, ICUs, and clinical laboratories |
| Focused cardiac panel | Supports assessment of myocardial injury |
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 cTnI/CK-MB US is part of our professional diagnostic line, developed to support accurate, efficient, and connected point-of-care testing in clinical environments.
Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.
