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Global Healthcare Medical
GHM Testosterone US Testosterone Test Kit (FIA) – Quantitative, 10-Minute, Serum/Plasma
GHM Testosterone US Testosterone Test Kit (FIA) – Quantitative, 10-Minute, Serum/Plasma
SKU: GHM Testosterone US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Testosterone US Testosterone Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of total Testosterone in human serum and plasma samples. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and, in females, hirsutism and virilization due to tumors, polycystic ovaries, and adrenogenital syndromes.
The GHM Testosterone 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. Not for use in point-of-care settings.
Key Features & Benefits
Quantitative Testosterone Measurement – Aid in Androgen Disorder Assessment
The GHM Testosterone US delivers quantitative testosterone results, providing measurable concentration values that can be used as an aid in the diagnosis and treatment of disorders involving the male sex hormones (androgens).
| Feature | Benefit |
|---|---|
| Quantitative result | Provides measurable testosterone concentration values |
| Specimen types | Serum, plasma |
| Intended use | Aid in the diagnosis and treatment of androgen-related disorders |
| Analyzer test time | 10 ± 5 seconds for analyzer reading |
Analytical Performance – Sensitivity and Linear Range
The GHM Testosterone US demonstrates reliable analytical performance with a low limit of detection and a wide linear range.
| Parameter | Specification |
|---|---|
| Analytical Sensitivity (LoD) | ≤ 0.2 ng/mL |
| Linear Range | 0.2–15 ng/mL |
| Correlation Coefficient | r ≥ 0.99 |
FIA Analyzer – Advanced Technical Platform
The GHM Testosterone 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 |
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 for the kit and -10 ~ 40°C for the analyzer, 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 Testosterone US |
| Product Type | Testosterone Test Kit (FIA) |
| Specimen | Serum, Plasma |
| Intended Use | Aid in the diagnosis and treatment of disorders involving the male sex hormones (androgens) |
| Analytical Sensitivity (LoD) | ≤ 0.2 ng/mL |
| Linear Range | 0.2–15 ng/mL |
| Correlation Coefficient | r ≥ 0.99 |
| Reference Value (Male) | 1.72–8.53 ng/mL |
| Reference Value (Female) | 0.2–0.81 ng/mL |
| 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 |
| Kit Storage Temperature | 2 ~ 30°C |
| Relative Humidity | 20 – 90% |
| Intended Use Setting | In vitro diagnostic use; professional use only; not for point-of-care settings |
| Package Options | Kit format |
Why Clinical Laboratories Choose Global Healthcare Medical
| Consideration | GHM Testosterone US |
|---|---|
| Quantitative results | Measurable testosterone concentration values |
| Reliable analytical performance | LoD ≤ 0.2 ng/mL; linear range 0.2–15 ng/mL |
| Flexible specimen types | 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 Testosterone US is part of our fluorescence immunoassay product line, developed to support efficient androgen disorder assessment in professional settings.
Our focus is on dependable performance, clear documentation, and responsive support for clinical and laboratory environments.
