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Global Healthcare Medical
GHM C-Peptide US Test Kit (FIA) – Quantitative C-Peptide Testing with 10–15 Minute Results, 0.1–40 ng/mL Detection Range, and Serum/Plasma/Whole Blood Compatibility
GHM C-Peptide US Test Kit (FIA) – Quantitative C-Peptide Testing with 10–15 Minute Results, 0.1–40 ng/mL Detection Range, and Serum/Plasma/Whole Blood Compatibility
SKU: GHM C-Peptide US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM C-Peptide US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of C-peptide in human serum, plasma, or whole blood samples. The kit is intended for use with compatible POCT Analyzers, providing healthcare professionals with a reliable tool for assessing pancreatic beta-cell function and supporting the classification of diabetes subtypes.
C-peptide, also known as connecting peptide, is a byproduct of insulin synthesis that is secreted by pancreatic beta cells in equimolar concentrations with insulin. Unlike insulin, C-peptide is not significantly extracted by the liver, making it a more stable and reliable marker of endogenous insulin secretion. Measurement of C-peptide supports the assessment of residual beta-cell function, aiding in the differentiation of type 1 diabetes, type 2 diabetes, and other diabetes subtypes.
The GHM C-Peptide US Test Kit delivers quantitative results in just 10–15 minutes, with a detection range of 0.1–40 ng/mL, 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 laboratories, clinics, and hospitals. The C-Peptide Test Kit carries ISO 13485, CE, and MHRA certifications, underscoring its compliance with international quality and safety standards.
Key Features & Benefits
Fluorescence Immunoassay Technology – High-Sensitivity Quantitative Detection
The GHM C-Peptide US Test Kit is based on fluorescence immunochromatography technology, utilizing a sandwich immunoreaction method. Fluorescence-labeled detector antibodies bind to the target protein (C-peptide) in the sample. The test device contains a membrane coated with C-peptide-specific monoclonal antibodies, enabling reliable and consistent quantitative detection.
| Feature | Benefit |
|---|---|
| Fluorescence immunoassay (FIA) | High-sensitivity quantitative detection |
| Sandwich immunoreaction method | Reliable and consistent signal generation |
| C-peptide-specific monoclonal antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise C-peptide concentration results |
Fast Results – 10–15 Minutes
The GHM C-Peptide US Test Kit provides quantitative results in just 10–15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.
| Feature | Benefit |
|---|---|
| 10–15 minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for laboratories, clinics, and hospitals |
| Efficient workflow | Enables immediate patient consultation |
Wide Detection Range – 0.1–40 ng/mL
The GHM C-Peptide US Test Kit supports a broad detection range of 0.1–40 ng/mL, accommodating a wide variety of C-peptide levels for comprehensive beta-cell function assessment.
| Parameter | Specification |
|---|---|
| Detection Range | 0.1–40 ng/mL |
| Specimen | Serum, plasma, or whole blood |
| Test Time | 10–15 minutes |
| Sample Volume | 80 µL |
| Storage Temperature | 2–30°C |
| Shelf Life | 24 months |
Flexible Sample Compatibility – Serum, Plasma, and Whole Blood
The GHM C-Peptide US Test Kit is compatible with serum, plasma, or whole blood samples, providing flexibility for different clinical workflows and patient sample collection preferences.
| Feature | Benefit |
|---|---|
| Serum samples | Standard laboratory sample compatibility |
| Plasma samples | Alternative sample type for flexible workflows |
| Whole blood samples | Point-of-care convenience without centrifugation |
| Flexible sample collection | Adaptable to different clinical settings |
ISO 13485, CE, and MHRA Certified – Quality and Safety Compliance
The C-Peptide Test Kit carries ISO 13485 quality management system certification, CE marking, and MHRA registration, demonstrating compliance with stringent international regulatory standards for in vitro diagnostic medical devices.
| Feature | Benefit |
|---|---|
| ISO 13485 certification | Quality management system compliance |
| CE marking | Compliance with European IVD regulations |
| MHRA registration | UK market authorization |
| Quality assurance | Meets high standards of quality and safety |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM C-Peptide US |
| Product Type | C-Peptide Test Kit (FIA) |
| Intended Use | Quantitative determination of C-peptide in human serum, plasma, or whole blood |
| Detection Principle | Fluorescence immunochromatography; sandwich immunoreaction |
| Specimen | Serum / plasma / whole blood |
| Sample Volume | 80 µL |
| Test Time | 10–15 minutes |
| Detection Range | 0.1–40 ng/mL |
| Storage Temperature | 2–30°C (36–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Laboratory, clinic, hospital |
| Compatible Analyzers | POCT Analyzers (VIM series) |
| Regulatory Status | ISO 13485, CE, MHRA certified |
| Intended User | Professional healthcare use only |
| Package Options | 25 tests/kit |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM C-Peptide US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| 10–15 minute test time | Rapid turnaround for timely decisions |
| Wide detection range | 0.1–40 ng/mL for comprehensive C-peptide monitoring |
| Flexible sample types | Serum, plasma, or whole blood compatibility |
| ISO 13485, CE, MHRA certified | Compliance with international quality standards |
| Point-of-care compatible | Suitable for laboratories, clinics, and hospitals |
| Reliable monitoring parameter | C-peptide supports assessment of pancreatic beta-cell 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 C-Peptide 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.
