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Global Healthcare Medical
GHM Hepatitis US Hepatitis Virus Rapid Test (FIA) – Qualitative, 15-Minute, Whole Blood/Serum/Plasma
GHM Hepatitis US Hepatitis Virus Rapid Test (FIA) – Qualitative, 15-Minute, Whole Blood/Serum/Plasma
SKU: GHM Hepatitis US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Hepatitis US Hepatitis Virus Rapid Test (FIA) is a fluorescence immunoassay (FIA) designed for the qualitative detection of hepatitis virus markers in human whole blood, serum, or plasma samples. The test is used as an aid in the diagnosis of hepatitis virus infection and supports the screening of individuals for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
The GHM Hepatitis 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
Qualitative Hepatitis Virus Detection – Aid in Hepatitis Infection Assessment
The GHM Hepatitis US delivers qualitative hepatitis virus marker results, providing a clear positive or negative determination that can be used as an aid in the diagnosis of hepatitis virus infection. Hepatitis B and hepatitis C are bloodborne viral infections that can lead to chronic liver disease, cirrhosis, and hepatocellular carcinoma if left undiagnosed and untreated. Accurate, rapid, and cost-effective screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection may be useful in clinical settings.
| Feature | Benefit |
|---|---|
| Qualitative result | Provides positive/negative determination |
| Specimen types | Whole blood, serum, plasma |
| Intended use | Aid in diagnosis of hepatitis virus infection |
| Test time | 15 minutes |
| Clinical utility | Supports screening and diagnosis of HBV and HCV infection |
Comprehensive Test Menu – Broad Hepatitis Marker Coverage
The GHM Hepatitis US supports detection of a comprehensive panel of hepatitis virus markers, providing broad coverage for clinical hepatitis testing needs.
| Marker Category | Test Items |
|---|---|
| Hepatitis B Virus (HBV) | HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc, HBcAb |
| Hepatitis C Virus (HCV) | Anti-HCV |
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 Hepatitis US uses a sandwich immunodetection method. Detector antibodies in buffer bind to hepatitis virus antigens or antibodies in the sample, forming antigen-antibody complexes, and migrate onto a nitrocellulose matrix to be captured by immobilized antibodies on the test strip. If target antigens or antibodies are present, they are captured on the surface of fluorescent microbeads coated with specific antibodies or antigens. Microbeads that carry bound target are then captured by secondary antibodies at specific locations on the test strip, where they are detected by the analyzer. If no target antigens or antibodies are present, the microbeads are not captured and are not detected. The fluorescent lateral flow immunoassay system uses a small bench-top fluorescence reader for qualitative measurement of HBsAg, anti-HBs, and anti-HCV in serum or whole blood samples, demonstrating diagnostic performance equivalent to current automated chemiluminescent immunoassays (CLIAs).
| Feature | Benefit |
|---|---|
| Sandwich immunodetection | Reliable qualitative measurement principle |
| Fluorescence signal | Clear positive/negative determination |
| Test strip technology | Specific antibodies or antigens at test lines; control line verification |
| Objective results | Results interpreted automatically by analyzer |
FIA Analyzer – Advanced Technical Platform
The GHM Hepatitis 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 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 Hepatitis US |
| Product Type | Hepatitis Virus Rapid Test (FIA) |
| Specimen | Whole blood, Serum, Plasma |
| Specimen Volume | 100 μL |
| Test Time | 15 minutes |
| Measuring Range | Negative / Positive |
| 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 Hepatitis US |
|---|---|
| Qualitative results | Positive/negative determination |
| Flexible specimen types | Whole blood, serum, or plasma |
| Comprehensive marker coverage | HBV and HCV markers available |
| 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 |
