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Global Healthcare Medical
GHM CysC US Test Kit (FIA) – Quantitative Cystatin C Testing with 3-Minute Results, 0.50–10.00 mg/L Measuring Range, and Whole Blood/Serum/Plasma Compatibility
GHM CysC US Test Kit (FIA) – Quantitative Cystatin C Testing with 3-Minute Results, 0.50–10.00 mg/L Measuring Range, and Whole Blood/Serum/Plasma Compatibility
SKU: GHM CysC US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM CysC US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Cystatin C (Cys C) 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.
Cystatin C (Cys C) is a 13-kDa cysteine protease inhibitor that is freely filtered by the glomeruli and fully catabolized in the kidneys. Unlike creatinine, Cystatin C is less affected by non-GFR determinants such as muscle mass, age, and sex, and may respond more rapidly to changes in glomerular filtration, which can improve recognition of kidney dysfunction and help refine chronic kidney disease (CKD) staging in hospitalized patients. Professional practice guidelines have recommended the expanded use of Cys C as an alternative or adjunctive marker to creatinine.
The GHM CysC US Test Kit delivers quantitative results in just 3 minutes, with a measuring range of 0.50–10.00 mg/L, supporting efficient clinical decision-making at the point of care. The kit is useful as an aid in the management and monitoring of renal disease.
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 CysC US Test Kit is based on fluorescence immunoassay technology. Fluorescence-labeled detector antibodies bind to the target protein (Cys C) in the sample. The test device contains a membrane coated with Cys C-specific antibodies, enabling reliable and consistent quantitative detection.
| Feature | Benefit |
|---|---|
| Fluorescence immunoassay (FIA) | High-sensitivity quantitative detection |
| Cys C-specific antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise Cys C concentration results |
| 3-minute test time | Rapid turnaround for timely clinical decisions |
Fast Results – 3 Minutes
The GHM CysC 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 – 0.50–10.00 mg/L
The GHM CysC US Test Kit supports a measuring range of 0.50–10.00 mg/L, accommodating a wide variety of Cys C concentrations for comprehensive renal function assessment. The typical reference range in adults is approximately 0.6–1.0 mg/L, with values above this range suggesting reduced kidney function.
| Parameter | Specification |
|---|---|
| Measuring Range | 0.50–10.00 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 | 24 months |
Flexible Sample Compatibility – Whole Blood, Serum, and Plasma
The GHM CysC 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 Management
The GHM CysC US Test Kit is intended for use as an aid in the management and monitoring of renal disease. Cys C 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 reduced kidney function, including chronic kidney disease and acute kidney injury.
| Feature | Benefit |
|---|---|
| Renal disease management aid | Supports evaluation and monitoring of kidney function |
| Glomerular filtration marker | Reflects renal clearance capacity |
| Less affected by muscle mass | Particularly reliable in situations where creatinine is less accurate |
| 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 CysC US |
| Product Type | Cystatin C Test Kit (FIA) |
| Catalog Number | VID03-02-011 |
| Intended Use | Quantitative determination of Cystatin C (Cys C) in human whole blood, serum, or plasma; used as an aid in management and monitoring of renal disease |
| Detection Principle | Fluorescence immunoassay (FIA) |
| Specimen | Whole blood (fingerstick or venous) / Serum / Plasma |
| Test Time | 3 minutes |
| Measuring Range | 0.50–10.00 mg/L |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Shelf Life | 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; 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 CysC US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| 3-minute test time | Rapid turnaround for timely decisions |
| Wide measuring range | 0.50–10.00 mg/L for comprehensive Cys C monitoring |
| Flexible sample types | Whole blood, serum, or plasma compatibility |
| Renal disease management aid | Supports evaluation and monitoring of kidney function |
| Less affected by muscle mass | Reliable marker where creatinine is less accurate |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for nephrology clinics and clinical laboratories |
| Reliable renal marker | Cys C 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 CysC 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.
