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Global Healthcare Medical
GHM Total IgE US Total Immunoglobulin E Test Kit (FIA) – Quantitative, 15-Minute, Whole Blood/Serum/Plasma
GHM Total IgE US Total Immunoglobulin E Test Kit (FIA) – Quantitative, 15-Minute, Whole Blood/Serum/Plasma
SKU: GHM Total IgE US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Total IgE US Total Immunoglobulin E Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Total Immunoglobulin E (IgE) in human whole blood, serum, or plasma samples. The measurement of total IgE is used as an aid in the diagnosis of allergic disease. It may also be used to support the assessment of type I hypersensitivity conditions, including allergic asthma, allergic rhinitis, and other atopic disorders.
The GHM Total IgE US is intended for use with the FIA Analyzer (VIM01), a compact benchtop analyzer that utilizes quantitative 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 Total IgE Measurement – Aid in Allergic Disease Assessment
The GHM Total IgE US delivers quantitative total IgE results, providing measurable concentration values that can be used as an aid in the diagnosis of allergic disease. IgE plays a central role in type I hypersensitivity and is associated with allergic responses, including asthma, and to a lesser degree with immunity to parasites.
| Feature | Benefit |
|---|---|
| Quantitative result | Provides measurable total IgE concentration values |
| Specimen types | Whole blood, serum, plasma |
| Intended use | Aid in diagnosis of allergic disease |
| Analyzer test time | 10 ± 5 seconds for analyzer reading |
| Clinical utility | Elevated total IgE may indicate an allergic response is likely present |
Sandwich Immunodetection Method – Fluorescence Immunoassay Principle
The GHM Total IgE US uses a sandwich immunodetection method. Detector antibodies in buffer bind to IgE antigens in the sample, forming antigen-antibody complexes, and migrate onto a nitrocellulose matrix to be captured by immobilized antibodies on the test strip. More IgE antigen in the sample forms more antigen-antibody complexes, leading to a stronger fluorescence signal that is processed by the analyzer to show total IgE concentration in the sample.
| Feature | Benefit |
|---|---|
| Sandwich immunodetection | Reliable quantitative measurement principle |
| Fluorescence signal | Measurable concentration values |
| Test strip technology | Anti-IgE at test line; control line verification |
FIA Analyzer – Advanced Technical Platform
The GHM Total IgE US is used with the FIA Analyzer (VIM01), a compact fluorescence immunoassay analyzer featuring auto calibration, barcode identification, and a large memory capacity.
| 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 and analyzer are 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 |
| Analyzer storage temperature | -10 ~ 40°C |
| Analyzer operation temperature | 5 ~ 40°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 Total IgE US |
| Product Type | Total Immunoglobulin E Test Kit (FIA) |
| Specimen | Whole blood, Serum, Plasma |
| Test Time | 15 minutes |
| Operating Temperature | 18 ~ 25°C |
| Storage Temperature | 2 ~ 30°C |
| Analyzer Compatibility | VivaDiag 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 Total IgE US |
|---|---|
| Quantitative results | Measurable total IgE concentration values |
| Flexible specimen types | Whole blood, serum, or plasma |
| 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 |
About Global Healthcare Medical
Global Healthcare Medical is dedicated to connecting clinical laboratories, hospitals, and healthcare distributors with high-quality in vitro diagnostic devices designed for reliable performance. The GHM Total IgE US is part of our fluorescence immunoassay product line, developed to support efficient allergic disease assessment in professional settings.
Our focus is on dependable performance, clear documentation, and responsive support for clinical and laboratory environments.
