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Global Healthcare Medical
GHM MAU US Test Kit (FIA) – Quantitative Micro Albuminuria Testing with 3-Minute Results, 10–200 mg/L Measuring Range, and Urine Sample Compatibility
GHM MAU US Test Kit (FIA) – Quantitative Micro Albuminuria Testing with 3-Minute Results, 10–200 mg/L Measuring Range, and Urine Sample Compatibility
SKU: GHM MAU US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM MAU US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Micro Albuminuria (MAU) in human urine samples. The kit is intended for use with compatible POCT Analyzers, providing healthcare professionals with a reliable tool for the early assessment of kidney damage.
Microalbuminuria (MAU) refers to the presence of small amounts of albumin in urine, which may indicate early kidney damage. The relative molecular weight of albumin is 66 kDa, and under normal conditions, very low concentrations are present in urine. When the kidneys are damaged, small amounts of albumin leak into the urine, a condition known as microalbuminuria. The clinical increase of microalbuminuria excretion is most commonly caused by diabetes-induced kidney damage. However, many other conditions can also lead to kidney damage, such as hypertension, heart failure, cirrhosis, or systemic lupus erythematosus (SLE). If early kidney damage is not treated, larger amounts of albumin and protein may leak into the urine, potentially indicating serious kidney damage that can lead to end-stage renal disease.
The GHM MAU US Test Kit delivers quantitative results in just 3 minutes, with a measuring range of 10–200 mg/L, supporting efficient clinical decision-making at the point of care. Microalbuminuria testing can be performed on random (e.g., after the first morning urination), 24-hour, or timed urine collections, such as a 4-hour or overnight collection.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including diabetes clinics, 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 MAU US Test Kit is based on fluorescence immunoassay technology, utilizing a competitive immunodetection method. The microalbumin in the urine sample binds to the fluorescence-labeled microalbumin antibody, forming a fluorescent complex. When the fluorescent complex flows through the membrane where the albumin antigen is coated on the TEST line, the more microalbumin present in the urine, the less fluorescent antibody accumulates, resulting in a lower fluorescent signal. The fluorescence signal intensity reflects the amount of microalbumin.
| Feature | Benefit |
|---|---|
| Fluorescence immunoassay (FIA) | High-sensitivity quantitative detection |
| Competitive immunodetection method | Reliable and consistent signal generation |
| MAU-specific antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise MAU concentration results |
Fast Results – 3 Minutes
The GHM MAU 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 diabetes clinics and clinical laboratories |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Wide Measuring Range – 10–200 mg/L
The GHM MAU US Test Kit supports a measuring range of 10–200 mg/L, accommodating a wide variety of MAU concentrations for comprehensive renal function assessment.
| Parameter | Specification |
|---|---|
| Measuring Range | 10–200 mg/L |
| Specimen | Urine |
| Test Time | 3 minutes |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Shelf Life | 18–24 months |
Urine Sample Compatibility – Non-Invasive Collection
The GHM MAU US Test Kit is compatible with urine samples, providing a non-invasive and convenient sample collection method for patients. The test can be performed on random urine samples, making it suitable for routine screening in diabetes clinics and primary care settings.
| Feature | Benefit |
|---|---|
| Urine samples | Non-invasive sample collection |
| Random urine collection | Convenient for routine screening |
| No special preparation | Simple and efficient workflow |
| Patient-friendly | Comfortable sample collection experience |
Clinical Utility – Aid for Early Detection of Kidney Damage
The GHM MAU US Test Kit is intended for use as an aid for the diagnosis of diabetic nephropathy and other kidney damage. Microalbuminuria testing is a complementary method for the early detection of kidney damage associated with diabetes and other conditions. The test is useful for monitoring patients at risk of kidney damage, including those with diabetes, hypertension, or heart failure.
| Feature | Benefit |
|---|---|
| Early kidney damage detection aid | Supports early identification of kidney impairment |
| Diabetic nephropathy assessment | Useful for monitoring patients with diabetes |
| Monitoring utility | Supports longitudinal monitoring of renal function |
| Clinical versatility | Useful across diabetes, nephrology, and primary 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 MAU US |
| Product Type | Micro Albuminuria Test Kit (FIA) |
| Catalog Number | VID06-02-011 |
| Intended Use | Quantitative determination of Micro Albuminuria (MAU) in human urine; used as an aid for the diagnosis of diabetic nephropathy and other kidney damage |
| Detection Principle | Fluorescence immunoassay (FIA); competitive immunodetection method |
| Specimen | Urine |
| Sample Volume | 75 µL / 100 µL |
| Test Time | 3 minutes |
| Measuring Range | 10–200 mg/L |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Shelf Life | 18–24 months |
| Application Scenario | Diabetes clinic, nephrology clinic, clinical laboratory, point-of-care |
| Compatible Analyzers | POCT Analyzers (VIM series) |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; CE marked |
| Intended User | Professional healthcare use only |
| Package Options | 25 tests/kit |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM MAU US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| 3-minute test time | Rapid turnaround for timely decisions |
| Wide measuring range | 10–200 mg/L for comprehensive MAU monitoring |
| Urine sample compatibility | Non-invasive and convenient sample collection |
| Early kidney damage detection aid | Supports early identification of kidney impairment |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for diabetes clinics, nephrology clinics, and clinical laboratories |
| Reliable renal marker | MAU supports early assessment of diabetic nephropathy and other kidney damage |
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 MAU 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.
