GHM Norovirus Antigen Rapid Test US – Qualitative Detection of Norovirus Genogroups I & II Antigens with 10-Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Norovirus Antigen Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Norovirus Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of norovirus genogroup I (GI) and genogroup II (GII) antigens in human feces specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of norovirus infection in symptomatic patients.

Norovirus is the most common viral cause of epidemic gastroenteritis worldwide and a leading cause of sporadic cases and outbreaks of acute gastroenteritis across all age groups. Noroviruses account for 16% to 18% of acute gastroenteritis cases globally, resulting in an estimated 685 million illnesses and 210,000 deaths annually, including approximately 200 million cases among children under 5 years and 50,000 child deaths. The clinical presentation of norovirus infection—including acute onset of vomiting, watery diarrhea, nausea, and abdominal cramps—overlaps significantly with other viral and bacterial causes of gastroenteritis, making laboratory confirmation essential for accurate diagnosis, timely infection control, and outbreak management.

Norovirus is highly infectious and rapidly transmissible, with a low infectious dose and environmental stability that facilitate person-to-person spread in closed settings such as hospitals, long-term care facilities, schools, and cruise ships. While reverse transcription quantitative polymerase chain reaction (RT-qPCR) is recognized as the gold standard for molecular diagnostics, it is constrained by complex operational procedures, the need for specialized equipment, and limited suitability for rapid point-of-care applications. Rapid immunochromatographic assays provide a practical solution for preliminary screening in community and clinical settings, enabling faster case identification and supporting timely implementation of infection control measures.

The GHM Norovirus Antigen Rapid Test US delivers qualitative results in just 10 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with human feces specimens, providing a simple and non-invasive sample collection method suitable for a wide range of clinical settings, including hospital laboratories, long-term care facilities, and outbreak response programs.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including hospital laboratories, long-term care facilities, physician office laboratories, emergency departments, and public health outbreak response programs. 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

Dual-Genogroup Detection – Norovirus GI and GII in One Test

The GHM Norovirus Antigen Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting norovirus genogroup I (GI) and genogroup II (GII) antigens from a single patient sample. While only viruses from genogroups I, II, and IV are widely infectious in humans, GII is the most prevalent genogroup in outbreaks and sporadic cases worldwide. The test incorporates monoclonal antibodies specific for both GI and GII antigens, enabling comprehensive detection of circulating norovirus strains.

Fast Results – 10 Minutes

The GHM Norovirus Antigen Rapid Test US provides qualitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid results enable immediate clinical assessment and timely implementation of infection control measures, which is critical in outbreak settings where norovirus spreads rapidly through closed populations.

Feces Sample Compatibility – Simple and Non-Invasive Collection

The GHM Norovirus Antigen Rapid Test US is compatible with human feces specimens, providing a simple and non-invasive sample collection method. The test uses collection tubes with extraction buffer for convenient specimen processing. Collect a sufficient quantity of feces (1–2 mL or 1–2 g) in a clean, dry specimen collection container to obtain maximum antigens. The specimen collection applicator should be randomly stabbed into the fecal specimen in at least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Fresh stool specimens are recommended for optimal results; specimens may be stored at 2–8°C for up to 3 days if not tested within 6 hours.

Clinical Utility – Aid for Diagnosis of Norovirus Infection

The GHM Norovirus Antigen Rapid Test US is intended for use as an aid in the diagnosis of norovirus infection in symptomatic patients. The test provides rapid antigen detection, enabling timely clinical decision-making and supporting patient management. Early and accurate identification of norovirus infection is essential for reducing norovirus-related morbidity and preventing outbreaks in healthcare and community settings.

The test is particularly valuable in settings where rapid identification of norovirus supports infection control measures and outbreak management. Rapid antigen tests for norovirus are used for preliminary screening in community settings, enabling timely patient management and infection control interventions. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.

High Accuracy – Trusted Clinical Performance

The GHM Norovirus Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid norovirus antigen tests have demonstrated strong performance, with immunochromatographic assays achieving sensitivity and specificity suitable for routine clinical screening.

Performance characteristics based on published evaluations of rapid norovirus immunochromatographic tests. An evaluation of norovirus immunochromatographic assay performance reported sensitivity, specificity, and overall agreement of 95.9%, 100.0%, and 97.0%, respectively, compared with RT-qPCR. Genotype-specific sensitivity was 100.0% for norovirus GI.5, GII.3, and GII.7, with sensitivities of 94.4% for GII.4 and 87.5% for GII.17. Independent evaluations of rapid norovirus antigen tests have reported relative sensitivity and specificity of 92.0% and 98.0% compared with RT-PCR, and specificities exceeding 97%. Detection is optimal in fresh stool specimens collected during the acute phase of infection, and the test is best suited for use as an aid in the diagnosis of norovirus infection in symptomatic patients. The test provides a preliminary result; RT-qPCR remains the gold standard for definitive diagnosis.

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 Norovirus Antigen 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:

• Diagnostic testing should be performed only in symptomatic patients with acute onset of diarrhea and/or vomiting.

• Collect a sufficient quantity of feces (1–2 mL or 1–2 g) in a clean, dry specimen collection container; well-formed stools are not suitable for this test.

• Fresh stool specimens are recommended for optimal results; if not tested within 6 hours, store at 2–8°C for up to 3 days.

• Any visible colored line in the Test line (T) indicates a positive result, as intensity varies with antigen concentration.

• A negative result does not rule out norovirus infection; RT-qPCR remains the gold standard for definitive diagnosis.

• The test provides a preliminary result and should be interpreted in conjunction with clinical findings and other laboratory results.

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 Norovirus Antigen 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.