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Global Healthcare Medical
GHM Beta2MG US Test Kit (FIA) – Quantitative Beta-2 Microglobulin Testing with 3-Minute Results, 0.5–20 mg/L Measuring Range, and Whole Blood/Serum/Plasma Compatibility
GHM Beta2MG US Test Kit (FIA) – Quantitative Beta-2 Microglobulin Testing with 3-Minute Results, 0.5–20 mg/L Measuring Range, and Whole Blood/Serum/Plasma Compatibility
SKU: GHM Beta2MG US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Beta2MG US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Beta-2 Microglobulin (β2-MG) 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 assessment of renal function.
Beta-2 Microglobulin (β2-MG) is a low-molecular-weight protein (approximately 11.8 kDa) that forms the light chain of Class I MHC molecules and is present on the surface of nearly all nucleated cells. Circulating β2-MG is generated during normal HLA turnover and is primarily eliminated by glomerular filtration, with approximately 95% reabsorbed and degraded in the proximal tubules. Serum β2-MG has been noted to be elevated in inflammatory diseases, some viral infections, renal dysfunction, and autoimmune diseases. Its measurement serves as a valuable aid in the assessment of renal disease.
The GHM Beta2MG US Test Kit delivers quantitative results in just 3 minutes, with a measuring range of 0.5–20 mg/L, supporting efficient clinical decision-making at the point of care.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including nephrology clinics, 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 based on fluorescence immunochromatography.
Key Features & Benefits
Fluorescence Immunoassay Technology – High-Sensitivity Quantitative Detection
The GHM Beta2MG US Test Kit is based on fluorescence immunoassay technology, utilizing a complete immune detection method. Fluorescence-labeled detector antibodies bind to the target protein (β2-MG) in the sample. The test device contains a membrane coated with β2-MG-specific antibodies, enabling reliable and consistent quantitative detection.
| Feature | Benefit |
|---|---|
| Fluorescence immunoassay (FIA) | High-sensitivity quantitative detection |
| Complete immune detection method | Reliable and consistent signal generation |
| β2-MG-specific antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise β2-MG concentration results |
Fast Results – 3 Minutes
The GHM Beta2MG US Test Kit provides quantitative results in just 3 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.
| Feature | Benefit |
|---|---|
| 3-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for nephrology clinics and clinical laboratories |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Wide Measuring Range – 0.5–20 mg/L
The GHM Beta2MG US Test Kit supports a measuring range of 0.5–20 mg/L, accommodating a wide variety of β2-MG concentrations for comprehensive renal function assessment.
| Parameter | Specification |
|---|---|
| Measuring Range | 0.5–20 mg/L |
| Specimen | Whole blood (fingerstick or venous) / Serum / Plasma |
| Test Time | 3 minutes |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Shelf Life | 18–24 months |
Flexible Sample Compatibility – Whole Blood, Serum, and Plasma
The GHM Beta2MG 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 |
Clinical Utility – Aid for Renal Disease Assessment
The GHM Beta2MG US Test Kit is intended for use as an aid for the diagnosis of renal disease. β2-MG measurement supports the assessment of glomerular filtration function, and elevated levels may indicate compromised renal function. The test is also useful for monitoring patients with conditions associated with increased β2-MG levels, including inflammatory diseases, viral infections, and autoimmune diseases.
| Feature | Benefit |
|---|---|
| Renal disease assessment aid | Supports evaluation of kidney function |
| Glomerular filtration marker | Reflects renal clearance capacity |
| Monitoring utility | Supports longitudinal monitoring of renal function |
| Clinical versatility | Useful across nephrology, laboratory, and point-of-care settings |
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 |
| IVD scope | Certified for in vitro diagnostic test kits and analyzers |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM Beta2MG US |
| Product Type | Beta-2 Microglobulin Test Kit (FIA) |
| Catalog Number | VID07-02-011 |
| Intended Use | Quantitative determination of Beta-2 Microglobulin (β2-MG) in human whole blood, serum, or plasma; used as an aid for the diagnosis of renal disease |
| Detection Principle | Fluorescence immunoassay (FIA); complete immune detection method |
| Specimen | Whole blood (fingerstick or venous) / Serum / Plasma |
| Test Time | 3 minutes |
| Measuring Range | 0.5–20 mg/L |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Shelf Life | 18–24 months |
| Application Scenario | Nephrology clinic, clinical laboratory, point-of-care |
| Compatible Analyzers | POCT Analyzers (VIM series) |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system |
| Intended User | Professional healthcare use only |
| Package Options | 25 tests/kit |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Beta2MG US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| 3-minute test time | Rapid turnaround for timely decisions |
| Wide measuring range | 0.5–20 mg/L for comprehensive β2-MG monitoring |
| Flexible sample types | Whole blood, serum, or plasma compatibility |
| Renal disease assessment aid | Supports evaluation of kidney function |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for nephrology clinics and clinical laboratories |
| Reliable renal marker | β2-MG supports assessment of glomerular filtration function |
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 Beta2MG 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.
