GHM C-Reactive Protein (CRP) Semi-Quantitative Rapid Test US – Semi-Quantitative Detection of C-Reactive Protein with 10-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM C-Reactive Protein (CRP) Semi-Quantitative Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM C-Reactive Protein (CRP) Semi-Quantitative Rapid Test US is a lateral flow chromatographic immunoassay designed for the semi-quantitative detection of C-Reactive Protein (CRP) in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as an aid in the assessment of inflammatory conditions and in the clinical evaluation of infections.

C-Reactive Protein (CRP) is an acute-phase protein produced by the liver in response to inflammation, infection, and tissue injury. Its serum concentration rises significantly during inflammatory processes, making it a crucial indicator for assessing the presence and severity of infection or systemic inflammation. CRP testing is widely utilized in clinical settings to support the diagnosis and management of bacterial infections, guide antibiotic prescribing decisions, and monitor treatment response. The World Health Organization has identified CRP as a valuable biomarker for antibiotic stewardship in primary care, and point-of-care CRP testing has been shown to reduce inappropriate antibiotic use when implemented correctly in routine practice.

The GHM CRP Semi-Quantitative Rapid Test US provides a practical, point-of-care solution for the rapid assessment of CRP levels, enabling timely clinical decision-making and supporting antimicrobial stewardship efforts. The test delivers semi-quantitative results in just 10 minutes, supporting rapid clinical assessment at the point of care. The test is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, emergency departments, hospital laboratories, and clinical laboratories. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on immunochromatography.

Key Features & Benefits

Colloidal Gold Immunochromatography – Reliable Semi-Quantitative Detection

The GHM CRP Semi-Quantitative Rapid Test US is based on lateral flow chromatographic immunoassay technology. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to CRP, along with immobilized capture antibodies on the test line. The test provides semi-quantitative results by comparing the intensity of the test line against a reference scale, enabling healthcare professionals to classify CRP levels into clinically meaningful ranges: <10 mg/L (normal), 10–40 mg/L (mild inflammation), 40–80 mg/L (moderate inflammation), and >80 mg/L (severe inflammation).

Fast Results – 10 Minutes

The GHM CRP Semi-Quantitative Rapid Test US provides semi-quantitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Point-of-care CRP testing enables clinicians to make informed decisions about antibiotic prescribing at the time of patient assessment, which is particularly valuable in primary care settings where immediate test results can guide treatment decisions.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM CRP Semi-Quantitative Rapid Test US is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. Fingerstick whole blood collection enables minimally invasive testing in primary care and community settings. The test requires only a small sample volume, making it suitable for both clinic-based and field-based testing scenarios.

Clinical Utility – Aid for Assessment of Inflammatory Conditions

The GHM CRP Semi-Quantitative Rapid Test US is intended for use as an aid in the assessment of inflammatory conditions and in the clinical evaluation of infections. The test provides rapid semi-quantitative detection of CRP, enabling timely clinical decision-making and supporting patient management.

CRP testing is a valuable tool for guiding antibiotic prescribing decisions in patients presenting with respiratory tract infections and other inflammatory conditions. The test is particularly valuable in primary care settings where rapid identification of elevated CRP levels supports appropriate antibiotic stewardship and reduces unnecessary antibiotic prescriptions. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited. Point-of-care CRP testing has been increasingly adopted in community healthcare settings to support clinical decision-making on antibiotic prescribing at the time of patient assessment.

High Accuracy – Trusted Clinical Performance

The GHM CRP Semi-Quantitative Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid CRP tests have demonstrated strong performance across multiple clinical settings. A systematic review and meta-analysis of point-of-care CRP devices for acute respiratory tract infections reported overall pooled sensitivity of 70% (95% CI 52–83%) and specificity of 86% (95% CI 80–91%). At a threshold of 10 mg/L, the sensitivity of semi-quantitative rapid tests has been reported to range from 87–98% and specificity from 91–98%.

Performance characteristics based on published evaluations of rapid CRP tests. A systematic review and meta-analysis of point-of-care CRP devices for acute respiratory tract infections reported pooled sensitivity of 70% (95% CI 52–83%) and specificity of 86% (95% CI 80–91%). At a threshold of 10 mg/L, the sensitivity of semi-quantitative rapid tests has been reported to range from 87–98% and specificity from 91–98%. Detection is optimal when specimens are collected and processed according to the manufacturer's instructions, and the test is best suited for use as an aid in the assessment of inflammatory conditions. The test provides a preliminary result; laboratory-based quantitative testing may be required for confirmation and monitoring.

ISO 13485 Certified – Quality and Safety Compliance

The VivaDiag 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.

CE Marked – European Conformity

The GHM CRP Semi-Quantitative Rapid Test US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.

Product Specifications

Important Testing Notes:

• Allow the test kit and sample to reach room temperature (15–30°C) prior to testing.

• For fingerstick whole blood, clean the fingertip with an alcohol swab and allow it to dry; collect blood using a sterile lancet.

• Add the specimen to the sample buffer tube according to the instructions, mix well, and apply to the test cassette.

• Results should be interpreted at 10 minutes. Do not interpret results after 15 minutes.

• The test provides semi-quantitative results by comparing test line intensity against the reference scale.

• The test is intended for screening and preliminary assessment. Laboratory-based quantitative testing may be required for confirmation and monitoring of CRP levels.

• CRP levels may be elevated in various inflammatory conditions, including infections, autoimmune disorders, and tissue injury. Results should be interpreted in conjunction with clinical findings and other laboratory results.

• A normal CRP level does not exclude the possibility of localized infection or inflammation.

• Healthcare professionals should exercise clinical consideration and professional judgment with any test result.

Why Clinical Professionals Choose Global Healthcare Medical

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-Reactive Protein (CRP) Semi-Quantitative Rapid Test US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.

Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.