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Global Healthcare Medical
GHM Cardiac US Cardiac Markers Rapid Test (FIA) – Quantitative, 15-Minute, Whole Blood/Serum/Plasma
GHM Cardiac US Cardiac Markers Rapid Test (FIA) – Quantitative, 15-Minute, Whole Blood/Serum/Plasma
SKU: GHM Cardiac US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Cardiac US Cardiac Markers Rapid Test (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of cardiac biomarkers, including Cardiac Troponin I (cTnI), Creatine Kinase-MB (CK-MB), Myoglobin (MYO), Heart-type Fatty Acid Binding Protein (H-FABP), and N-terminal pro-B-type Natriuretic Peptide (NT-proBNP), in human whole blood, serum, or plasma samples. Measurements of these blood cardiac biomarkers may serve as indicators for diagnosis of myocardial injury secondary to cTnI and CK-MB, and can help assess the prognosis of patients. The system is also useful as an aid in the management and monitoring of acute myocardial infarction (AMI) and heart failure.
Cardiovascular disease (CVD) stands as the primary cause of global mortality, necessitating early diagnosis for mitigating death rates and improving quality of life. Point-of-care testing (POCT) enables immediate diagnosis at the patient's bedside, reducing hospital stays and improving early intervention. The cardiac biomarkers diagnostics industry is set for transformative growth, fueled by innovation in high-sensitivity assays, multiplex biomarker panels, and POCT advancements.
The GHM Cardiac US is intended for use with the FIA Analyzer (VIM01), a compact benchtop analyzer that utilizes fluorescence immunochromatography technology. The analyzer features auto calibration, barcode identification, and a built-in memory capacity of 50,000 results. The analyzer delivers reliable results in 10 ± 5 seconds after the test device is inserted.
The system is designed for professional use in clinical laboratories, hospitals, and clinics. The FIA analyzer operates with a small sample volume and provides fast, reliable results with simple operation.
This product is for in vitro diagnostic use only. For professional use only.
Key Features & Benefits
Quantitative Cardiac Biomarker Measurement – Aid in Myocardial Injury Assessment
The GHM Cardiac US delivers quantitative cardiac biomarker results, providing measurable concentration values that can be used as an aid in the diagnosis and management of acute myocardial infarction and other cardiac conditions. Cardiac troponin I and CK-MB are well-established biomarkers for myocardial injury, and their measurement supports timely clinical decision-making in acute care settings. The International Federation of Clinical Chemistry and Laboratory Medicine Committee on Clinical Application of Cardiac Bio-Markers (IFCC C-CB) has developed educational guidance on how high-sensitivity cardiac troponin point-of-care assays may be implemented in acute healthcare settings and networks.
| Feature | Benefit |
|---|---|
| Quantitative result | Provides measurable cardiac biomarker concentration values |
| Specimen types | Whole blood (fingerstick or venous), serum, plasma |
| Intended use | Aid in diagnosis and management of myocardial injury |
| Test time | 15 minutes |
| Clinical utility | Supports early detection of acute myocardial infarction and cardiac risk assessment |
| Flexible combination | Multiple test items can be combined for customized panels |
Comprehensive Test Menu – Broad Cardiac Marker Coverage
The GHM Cardiac US supports detection of a comprehensive panel of cardiac biomarkers, providing broad coverage for clinical cardiovascular testing needs.
| Biomarker Category | Test Items |
|---|---|
| Cardiac Injury Markers | High-Sensitive Cardiac Troponin I (hs-cTnI), Cardiac Troponin I (cTnI), Cardiac Troponin T (TnT), Creatine Kinase-MB (CK-MB), Myoglobin (MYO), Heart-type Fatty Acid Binding Protein (H-FABP) |
| Heart Failure Markers | B-type Natriuretic Peptide (BNP), N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) |
| Combination Panels | CK-MB/cTnI Combo, CK-MB/cTnI/Myo Combo, NT-proBNP/cTnI Combo |
Clinical Applications by Marker:
| Marker | Clinical Utility |
|---|---|
| hs-cTnI | Used as an aid in management and monitoring of acute myocardial infarction (AMI); highest sensitivity for early detection of myocardial injury |
| cTnI | Used as an aid in diagnosis of myocardial injury secondary to acute myocardial infarction and other diseases |
| CK-MB | Used as an aid in diagnosis of myocardial injury secondary to acute myocardial infarction; supports assessment of patient prognosis |
| Myoglobin (MYO) | Early marker of myocardial injury; useful in combination with cTnI and CK-MB for acute myocardial infarction assessment |
| NT-proBNP / BNP | Used as an aid in the management and monitoring of heart failure |
| H-FABP | Early marker of myocardial injury; supports rapid risk assessment |
Multiple panel configurations available. Contact Global Healthcare Medical for the complete test menu and panel customization options.
Sandwich Immunodetection Method – Fluorescence Immunoassay Principle
The GHM Cardiac US uses a sandwich immunodetection method. When the sample is added to the sample well of the test device, fluorescence-labeled detector antibodies bind to cardiac biomarker antigens in the sample. As the sample mixture migrates on the nitrocellulose matrix of the test strip by capillary action, the complexes of detector antibody and cardiac biomarker antigen are captured by immobilized capture antibodies at specific test lines on the strip. Thus, the more cardiac biomarker antigen in the specimen, the more complexes accumulate on the test strip. The signal intensity of the fluorescent signal reflects the amount of cardiac biomarker captured, and the FIA Analyzer displays the cardiac biomarker concentration in the specimen.
| Feature | Benefit |
|---|---|
| Sandwich immunodetection | Reliable quantitative measurement principle |
| Fluorescence signal | Measurable concentration values |
| Test strip technology | Cardiac biomarker-specific antibodies at test line; control line verification |
| Objective results | Results interpreted automatically by analyzer |
VivaDiag FIA Analyzer – Advanced Technical Platform
The GHM Cardiac US is used with the FIA Analyzer (VIM01), a compact fluorescence immunoassay analyzer featuring auto calibration, barcode identification, and a large memory capacity. The analyzer can detect 30+ parameters by auto-scanning the code chip.
| Feature | Benefit |
|---|---|
| Auto calibration | Reduces manual calibration steps |
| Barcode identification | 2D barcode scanning for test device identification |
| Code chip coding | Automatic parameter recognition |
| Memory capacity | 50,000 results storage |
| Connectivity | Direct LIS/HIS connection |
| Display | 3.5-inch LCD screen |
| Dimensions | 173 × 210 × 75.8 mm |
| Weight | 1.5 kg |
| Printer | Built-in printer |
| Multi-parameter detection | Analyzer can detect 30+ parameters |
Wide Storage Temperature – No Cold Chain Required
The test kit is designed for convenient storage and transport, with a storage temperature range of 2 ~ 30°C, eliminating the need for cold chain logistics.
| Specification | Detail |
|---|---|
| Kit storage temperature | 2 ~ 30°C |
| Operating temperature | 18 ~ 25°C |
| Relative humidity | 20 – 90% |
Simple Operation – Professional Laboratory Testing
The test procedure involves three simple steps: mix the sample with buffer, add the mixed specimen, and insert the device into the analyzer.
| Step | Action |
|---|---|
| 1 | Mix the sample with buffer |
| 2 | Add the mixed specimen |
| 3 | Insert device into the analyzer |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM Cardiac US |
| Product Type | Cardiac Markers Rapid Test (FIA) |
| Specimen | Whole blood (fingerstick or venous), Serum, Plasma |
| Sample Volume | 100 μL |
| Test Time | 15 minutes |
| Measuring Range (cTnI) | 0.1 ~ 50 ng/mL |
| Measuring Range (hs-cTnI) | 10 ~ 15,000 ng/L |
| Measuring Range (CK-MB) | 0.3 ~ 100 ng/mL |
| Measuring Range | Quantitative |
| Operating Temperature | 18 ~ 25°C |
| Storage Temperature | 2 ~ 30°C |
| Analyzer Compatibility | FIA Analyzer (VIM01) |
| Analyzer Display | 3.5-inch LCD |
| Analyzer Dimensions | 173 × 210 × 75.8 mm |
| Analyzer Weight | 1.5 kg |
| Analyzer Memory | 50,000 results |
| Analyzer Connectivity | Direct LIS/HIS |
| Analyzer Test Time | 10 ± 5 seconds |
| Analyzer Operation Temperature | 5 ~ 40°C |
| Analyzer Storage Temperature | -10 ~ 40°C |
| Relative Humidity | 20 – 90% |
| Intended Use | In vitro diagnostic use; professional use only |
| Package Options | Kit format |
Why Clinical Laboratories Choose Global Healthcare Medical
| Consideration | GHM Cardiac US |
|---|---|
| Quantitative results | Measurable cardiac biomarker concentration values |
| Flexible specimen types | Whole blood, serum, or plasma |
| Comprehensive cardiac panel | cTnI, hs-cTnI, CK-MB, MYO, H-FABP, NT-proBNP, and more |
| Fast test time | 15 minutes per test |
| Fast analyzer reading | 10 ± 5 seconds per test |
| Auto calibration | Reduces manual steps |
| Large memory | 50,000 results storage |
| LIS/HIS connectivity | Direct data integration |
| Convenient storage | 2 ~ 30°C, no cold chain required |
| Simple operation | Three-step test procedure |
| Multi-parameter platform | Analyzer supports 30+ parameters |
