WhatsApp USA: +1 6032769350 | WhatsApp HK: +852 63697831
Global Healthcare Medical
GHM H-FABP US Test Kit (FIA) – Quantitative Heart Fatty Acid Binding Protein Testing with 5-Minute Results, 1–120 ng/mL Measuring Range, and Whole Blood/Serum/Plasma Compatibility
GHM H-FABP US Test Kit (FIA) – Quantitative Heart Fatty Acid Binding Protein Testing with 5-Minute Results, 1–120 ng/mL Measuring Range, and Whole Blood/Serum/Plasma Compatibility
SKU: GHM H-FABP US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM H-FABP US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Heart Fatty Acid Binding Protein (H-FABP) 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 early assessment of myocardial injury.
Heart Fatty Acid Binding Protein (H-FABP) is a small cytoplasmic protein with a molecular weight of approximately 15 kDa found predominantly in myocardium cells. Its primary function is to regulate the transportation of free fatty acids within myocardium cells, supporting energy supply to cardiac muscle tissue. When myocardium is damaged, H-FABP is rapidly released into the bloodstream, making it a valuable early biochemical marker for the assessment of acute myocardial infarction (AMI). H-FABP can be detected in the blood within one to three hours of symptom onset and is 20 times more cardiac specific than myoglobin.
The GHM H-FABP US Test Kit delivers quantitative results in just 5 minutes, with a measuring range of 1–120 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 H-FABP US Test Kit is based on fluorescence immunoassay technology, utilizing a sandwich immunodetection method. Fluorescence-labeled detector antibodies bind to the target protein (H-FABP) in the sample. The test device contains a membrane coated with H-FABP-specific monoclonal antibodies, enabling reliable and consistent quantitative detection.
| Feature | Benefit |
|---|---|
| Fluorescence immunoassay (FIA) | High-sensitivity quantitative detection |
| Sandwich immunodetection method | Reliable and consistent signal generation |
| H-FABP-specific monoclonal antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise H-FABP concentration results |
Fast Results – 5 Minutes
The GHM H-FABP US Test Kit provides quantitative results in just 5 minutes, supporting rapid clinical decision-making and efficient patient workflow in emergency and point-of-care settings.
| Feature | Benefit |
|---|---|
| 5-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 | H-FABP elevates as early as 30 minutes after myocardial injury onset |
Wide Measuring Range – 1–120 ng/mL
The GHM H-FABP US Test Kit supports a broad measuring range of 1–120 ng/mL, accommodating a wide variety of H-FABP concentrations for comprehensive cardiac marker assessment.
| Parameter | Specification |
|---|---|
| Measuring Range | 1–120 ng/mL |
| Specimen | Whole blood (fingerstick or venous), serum, or plasma |
| Test Time | 5 minutes |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
Flexible Sample Compatibility – Whole Blood, Serum, and Plasma
The GHM H-FABP 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 |
High Myocardial Specificity – Superior to Myoglobin
H-FABP is 20 times more cardiac specific than myoglobin, making it a more reliable biomarker for the early assessment of acute myocardial infarction. H-FABP adds significant diagnostic and prognostic value when used in combination with troponin or high-sensitivity troponin.
| Feature | Benefit |
|---|---|
| High myocardial specificity | 20 times more cardiac specific than myoglobin |
| Early detection | Detectable within 1–3 hours of symptom onset |
| Complementary value | Adds diagnostic value when combined with troponin testing |
| Prognostic value | Supports monitoring of congestive heart failure and myocardial injury |
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 H-FABP US |
| Product Type | Heart Fatty Acid Binding Protein Test Kit (FIA) |
| Catalog Number | VID13-03-011 |
| Intended Use | Quantitative determination of Heart Fatty Acid Binding Protein (H-FABP) in human whole blood, serum, or plasma |
| Detection Principle | Fluorescence immunoassay (FIA); sandwich immunodetection |
| Specimen | Whole blood (fingerstick or venous) / serum / plasma |
| Test Time | 5 minutes |
| Measuring Range | 1–120 ng/mL |
| 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; registered as a medical device in multiple international markets |
| Intended User | Professional healthcare use only |
| Package Options | 25 tests/kit |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM H-FABP US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| 5-minute test time | Rapid turnaround for timely decisions |
| Wide measuring range | 1–120 ng/mL for comprehensive H-FABP monitoring |
| Flexible sample types | Whole blood, serum, or plasma compatibility |
| High myocardial specificity | 20 times more cardiac specific than myoglobin |
| Early biomarker detection | H-FABP elevates as early as 30 minutes after myocardial injury onset |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for emergency departments, ICUs, and clinical laboratories |
| Reliable cardiac marker | H-FABP supports early assessment of acute myocardial infarction |
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 H-FABP 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.
