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Global Healthcare Medical
GHM Myoglobin US Test Kit (FIA) – Quantitative Myoglobin Testing with 15-Minute Results, 2–400 ng/mL Measuring Range, and Whole Blood/Serum/Plasma Compatibility
GHM Myoglobin US Test Kit (FIA) – Quantitative Myoglobin Testing with 15-Minute Results, 2–400 ng/mL Measuring Range, and Whole Blood/Serum/Plasma Compatibility
SKU: GHM Myoglobin US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Myoglobin US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Myoglobin (MYO) 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 markers and skeletal muscle injury.
Myoglobin (MYO) is a small heme-containing protein found in cardiac and skeletal muscle tissue. Following myocardial injury, myoglobin is released into the bloodstream rapidly, with elevated levels detectable as early as 1 hour after symptom onset and peaking at approximately 4–8 hours. Its rapid release kinetics make myoglobin a valuable early biomarker for the assessment of acute myocardial infarction (AMI), particularly in combination with other cardiac markers such as troponin I and CK-MB.
The GHM Myoglobin US Test Kit delivers quantitative results in just 15 minutes, with a measuring range of 2–400 ng/mL, 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 Myoglobin US Test Kit is based on fluorescence immunoassay technology, utilizing a sandwich immunoreaction method. Fluorescence-labeled detector antibodies bind to the target protein (myoglobin) in the sample. The test device contains a membrane coated with myoglobin-specific monoclonal antibodies, enabling reliable and consistent quantitative detection.
Fast Results – 15 Minutes
The GHM Myoglobin US Test Kit provides quantitative results 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 |
| Early biomarker detection | Myoglobin elevates as early as 1 hour after myocardial injury onset |
Wide Measuring Range – 2–400 ng/mL
The GHM Myoglobin US Test Kit supports a broad measuring range of 2–400 ng/mL, accommodating a wide variety of myoglobin concentrations for comprehensive cardiac marker assessment.
| Parameter | Specification |
|---|---|
| Measuring Range | 2–400 ng/mL |
| Specimen | Whole blood (fingerstick or venous), serum, or 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 Myoglobin 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 Myoglobin Test Kit demonstrates excellent clinical performance characteristics, with sensitivity of 99.9%, specificity of 97.7%, and accuracy of 98.1%.
| Performance Metric | Result |
|---|---|
| Sensitivity | 99.9% |
| Specificity | 97.7% |
| Accuracy | 98.1% |
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 Myoglobin US |
| Product Type | Myoglobin Test Kit (FIA) |
| Catalog Number | VID15-03-011 (cardiac combo reference) |
| Intended Use | Quantitative determination of Myoglobin (MYO) in human whole blood, serum, or plasma |
| Detection Principle | Fluorescence immunoassay (FIA); sandwich immunoreaction |
| Specimen | Whole blood (fingerstick or venous) / serum / plasma |
| Test Time | 15 minutes |
| Measuring Range | 2–400 ng/mL |
| Sensitivity | 99.9% |
| Specificity | 97.7% |
| Accuracy | 98.1% |
| 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 Myoglobin US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| 15-minute test time | Rapid turnaround for timely decisions |
| Wide measuring range | 2–400 ng/mL for comprehensive myoglobin monitoring |
| Flexible sample types | Whole blood, serum, or plasma compatibility |
| High sensitivity | 99.9% sensitivity for early detection |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for emergency departments, ICUs, and clinical laboratories |
| Early biomarker detection | Myoglobin elevates as early as 1 hour after myocardial injury onset |
| Reliable cardiac marker | Myoglobin supports assessment of myocardial injury and skeletal muscle damage |
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 Myoglobin 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.
