GHM hs-cTnI US Test Kit (FIA) – Quantitative High-Sensitive Cardiac Troponin I Testing with 15-Minute Results, 10–15,000 ng/L Measuring Range, and Whole Blood/Serum/Plasma Compatibility

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SKU: GHM hs-cTnI US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM hs-cTnI US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of high-sensitive cardiac troponin I (hs-cTnI) 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 management and monitoring of acute myocardial infarction (AMI).

Cardiac troponin I (cTnI) is a regulatory protein found in heart muscle cells that plays a crucial role in muscle contraction. When heart muscle is damaged, cTnI is released into the bloodstream, making it a highly specific biomarker of myocardial injury. High-sensitivity cardiac troponin I assays are capable of detecting very low concentrations of cTnI, enabling earlier assessment of myocardial injury and supporting timely clinical decision-making.

The GHM hs-cTnI US Test Kit delivers quantitative results in just 15 minutes, with a measuring range of 10–15,000 ng/L, supporting efficient clinical decision-making in emergency and point-of-care settings.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including emergency departments, intensive care units, 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 used in the detection of cardiac markers based on fluorescence immunochromatography.

Key Features & Benefits

Fluorescence Immunoassay Technology – High-Sensitivity Quantitative Detection

The GHM hs-cTnI US Test Kit is based on fluorescence immunoassay technology, utilizing a sandwich immunodetection method. Fluorescence-labeled detector antibodies bind to the target protein (cTnI) in the sample. The test device contains a membrane coated with cTnI-specific monoclonal antibodies, enabling reliable and consistent quantitative detection at low concentrations.

Feature	Benefit
Fluorescence immunoassay (FIA)	High-sensitivity quantitative detection
Sandwich immunodetection method	Reliable and consistent signal generation
cTnI-specific monoclonal antibodies	Targeted and accurate measurement
High-sensitivity design	Detects low concentrations of cTnI
Quantitative determination	Precise cTnI concentration results

High-Sensitive Detection – Early Assessment of Myocardial Injury

High-sensitivity cardiac troponin I (hs-cTnI) assays are designed to detect very low concentrations of cTnI in the bloodstream, supporting earlier assessment of myocardial injury than conventional troponin assays. This enhanced sensitivity supports timely clinical evaluation of patients presenting with symptoms suggestive of acute coronary syndrome.

Feature	Benefit
High-sensitivity detection	Detects low concentrations of cTnI
Early assessment support	Supports timely evaluation of myocardial injury
Improved diagnostic window	Elevated levels persist for extended period after onset
Clinical utility	Useful as an aid in management and monitoring of AMI

Fast Results – 15 Minutes

The GHM hs-cTnI US Test Kit provides quantitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in emergency and point-of-care settings.

Feature	Benefit
15-minute test time	Rapid turnaround for timely clinical decisions
Point-of-care compatibility	Suitable for emergency departments, ICUs, and clinical laboratories
Efficient workflow	Enables immediate patient assessment
Supports clinical pathways	Compatible with rapid rule-out and rule-in protocols

Wide Measuring Range – 10–15,000 ng/L

The GHM hs-cTnI US Test Kit supports a broad measuring range of 10–15,000 ng/L, accommodating a wide variety of cTnI concentrations for comprehensive cardiac marker assessment.

Parameter	Specification
Measuring Range	10–15,000 ng/L
Specimen	Whole blood (fingerstick or venous) / Serum / Plasma
Test Time	15 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 hs-cTnI 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

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
Cardiac marker scope	Certified for IVD test kits detecting cardiac markers
Quality assurance	Meets high standards of quality and safety
Professional-grade	Designed for healthcare professional use

Product Specifications

Specification	Detail
Model / SKU	GHM hs-cTnI US
Product Type	High Sensitive Cardiac Troponin I Test Kit (FIA)
Catalog Number	VID113-03-011
Intended Use	Quantitative determination of High Sensitive Cardiac Troponin I (hs-cTnI) in human whole blood, serum, or plasma
Detection Principle	Fluorescence immunoassay (FIA); sandwich immunodetection
Specimen	Whole blood (fingerstick or venous) / Serum / Plasma
Test Time	15 minutes
Measuring Range	10–15,000 ng/L
Operating Temperature	18–25°C
Storage Temperature	2–30°C
Shelf Life	24 months
Application Scenario	Emergency department, ICU, 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 hs-cTnI US
Fluorescence immunoassay technology	High-sensitivity quantitative detection
High-sensitive detection	Detects low concentrations of cTnI
15-minute test time	Rapid turnaround for timely decisions
Wide measuring range	10–15,000 ng/L for comprehensive cTnI monitoring
Flexible sample types	Whole blood, serum, or plasma compatibility
ISO 13485 certified	Quality management system compliance
Point-of-care compatible	Suitable for emergency departments, ICUs, and clinical laboratories
Reliable cardiac marker	hs-cTnI supports assessment of myocardial injury and infarction
Clinical utility	Useful as an aid in management and monitoring of AMI

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 hs-cTnI 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.