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Global Healthcare Medical
GHM NGAL US Test Kit (FIA) – Quantitative NGAL Testing with 3-Minute Results, 0.5–20 mg/L Measuring Range, and Urine/Serum/Plasma Compatibility
GHM NGAL US Test Kit (FIA) – Quantitative NGAL Testing with 3-Minute Results, 0.5–20 mg/L Measuring Range, and Urine/Serum/Plasma Compatibility
SKU: GHM NGAL US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM NGAL US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in human urine, 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.
Neutrophil Gelatinase-Associated Lipocalin (NGAL) is a 25 kDa protein belonging to the lipocalin superfamily, covalently bound to neutrophil gelatinase. As a novel biomarker for acute kidney injury (AKI), NGAL is induced and released from injured distal nephron within minutes to a few hours after renal insult. Clinical studies comprising more than 3,500 cardiac surgery or critically ill patients have demonstrated promising data for NGAL as one of the most intensively investigated renal biomarkers. NGAL measurement is mainly used as an aid to diagnosis of renal impairment and kidney injury.
The GHM NGAL 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, emergency departments, 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 NGAL US Test Kit is based on fluorescence immunoassay technology, utilizing a sandwich immunodetection method. Fluorescence-labeled detector antibodies bind to the target protein (NGAL) in the sample. The test device contains a membrane coated with NGAL-specific monoclonal antibodies, enabling reliable and consistent quantitative detection.
| Feature | Benefit |
|---|---|
| Fluorescence immunoassay (FIA) | High-sensitivity quantitative detection |
| Sandwich immunodetection method | Reliable and consistent signal generation |
| NGAL-specific monoclonal antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise NGAL concentration results |
Fast Results – 3 Minutes
The GHM NGAL US Test Kit provides quantitative results in just 3 minutes, supporting rapid clinical decision-making and efficient patient workflow in emergency and point-of-care settings.
| Feature | Benefit |
|---|---|
| 3-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for nephrology clinics, emergency departments, 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 NGAL US Test Kit supports a measuring range of 0.5–20 mg/L, accommodating a wide variety of NGAL concentrations for comprehensive renal function assessment.
| Parameter | Specification |
|---|---|
| Measuring Range | 0.5–20 mg/L |
| Specimen | Urine / Serum / Plasma |
| Test Time | 3 minutes |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Shelf Life | 18–24 months |
Flexible Sample Compatibility – Urine, Serum, and Plasma
The GHM NGAL US Test Kit is compatible with urine, serum, and plasma samples, providing flexibility for different clinical workflows and patient sample collection preferences.
| Feature | Benefit |
|---|---|
| Urine samples | Non-invasive sample collection for renal assessment |
| 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 Function Injury Assessment
The GHM NGAL US Test Kit is intended for use as an aid for the diagnosis of renal function injury. NGAL measurement supports the early assessment of acute kidney injury (AKI), with NGAL being one of the earliest and most significantly elevated biomarkers following renal insult. The test is useful for monitoring patients at risk of AKI, including those undergoing cardiac surgery or in critical care settings.
| Feature | Benefit |
|---|---|
| Renal injury assessment aid | Supports early evaluation of kidney function |
| Early biomarker detection | NGAL elevates within minutes to hours after renal insult |
| Monitoring utility | Supports longitudinal monitoring of renal function |
| Clinical versatility | Useful across nephrology, emergency, and critical 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 NGAL US |
| Product Type | NGAL Test Kit (FIA) |
| Catalog Number | VID08-02-011 |
| Intended Use | Quantitative determination of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in human urine, serum, or plasma; used as an aid for the diagnosis of renal function injury |
| Detection Principle | Fluorescence immunoassay (FIA); sandwich immunodetection |
| Specimen | Urine / 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, emergency department, clinical laboratory, point-of-care |
| Compatible Analyzers | POCT Analyzers (VIM series) |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; registered as a medical device in multiple international markets |
| Intended User | Professional healthcare use only |
| Package Options | 25 tests/kit |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM NGAL 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 NGAL monitoring |
| Flexible sample types | Urine, serum, or plasma compatibility |
| Renal injury assessment aid | Supports early evaluation of kidney function |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for nephrology clinics, emergency departments, and clinical laboratories |
| Early biomarker detection | NGAL elevates within minutes to hours after renal insult |
| Reliable renal marker | NGAL supports early assessment of acute kidney injury |
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 NGAL 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.
