GHM Hantavirus Antigen Rapid Test US – Qualitative Detection of Hantavirus Nucleocapsid Antigen with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use

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

Product Overview

Global Healthcare Medical GHM Hantavirus Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of hantavirus nucleocapsid antigen in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as an aid in the early diagnosis of hantavirus infection in symptomatic individuals.

Hantaviruses are a group of rodent-borne zoonotic viruses that pose a serious health risk to humans, causing severe and often fatal diseases. These viruses are maintained in nature through chronic infection in rodent reservoirs and transmitted primarily via inhalation of aerosolized particles contaminated with rodent excreta such as urine, saliva, or feces. The clinical syndromes caused by hantaviruses differ by region: in the Americas, they cause hantavirus cardiopulmonary syndrome (HCPS), a fast-progressing disease marked by pulmonary edema and respiratory failure, while in Europe and Asia, they typically cause hemorrhagic fever with renal syndrome (HFRS), which affects kidney function and blood vessels.

Annually, it is estimated that between 100,000 and 200,000 clinical hantavirus cases occur worldwide, though these numbers are likely underreported due to limited surveillance and diagnostic capacities. HCPS caused by viruses such as Sin Nombre and Andes virus has a high case fatality rate of 35–40%. Early symptoms are nonspecific—fever, headache, muscle pain, nausea—making early clinical recognition challenging. Accurate diagnosis is complicated by symptom overlap with diseases like malaria, dengue, COVID-19, and Ebola. Given the fast progression of disease manifestations, rapid and accurate diagnostic tools are crucial for patient management.

The GHM Hantavirus Antigen Rapid Test US delivers qualitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with whole blood, serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including remote and resource-limited environments where laboratory infrastructure may be limited.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including emergency departments, infectious disease clinics, primary care settings, and field diagnostic programs in endemic areas. 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 Qualitative Detection

The GHM Hantavirus Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to the hantavirus nucleocapsid antigen, along with immobilized capture antibodies on the test line. During testing, the specimen reacts with the antibody-coated particles and migrates up the membrane to react with the antibodies on the membrane. A colored line is generated at the test line region if hantavirus antigen is present in the specimen. The test detects the highly conserved hantavirus nucleocapsid (N) protein, a major viral protein that contains three epitopes at the amino-terminal portion capable of triggering robust humoral immune responses.

Fast Results – 15 Minutes

The GHM Hantavirus Antigen Rapid Test US provides qualitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. HCPS can rapidly progress to severe respiratory distress and cardiovascular shock within 24–48 hours, making rapid diagnostic tools essential for timely patient management. A rapid test that can be performed at the point of care with results available in a short timeframe is fundamental to guiding patient management and saving lives.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM Hantavirus Antigen Rapid Test US is compatible with whole blood, serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. The test requires only a small sample volume, making it suitable for both clinic-based and field-based testing scenarios. Rapid tests designed for field use with flexibility for sample types are highly recommended for epidemiological surveys and remote diagnostic programs.

Clinical Utility – Aid for Early Diagnosis of Hantavirus Infection

The GHM Hantavirus Antigen Rapid Test US is intended for use as an aid in the early diagnosis of hantavirus infection. The test provides rapid etiological diagnosis, enabling timely clinical decision-making and supporting patient management. Early and accurate identification of hantavirus infection is essential for reducing hantavirus-related mortality through prompt and appropriate clinical management.

The test is particularly valuable in settings where rapid identification of hantavirus infection supports timely clinical intervention. Rapid antigen detection can guide initial patient care while confirmatory analyses are performed by reference services. The test is also suitable for use in decentralized testing environments and field diagnostic programs where laboratory infrastructure may be limited. Hantavirus infection prevalence studies in wild rodents and humans have been done mainly by serological detection using ELISA and immunofluorescent antibody assays, but more rapid, simple, and safer diagnostic methods are required, and rapid tests are of great potential for this purpose.

High Accuracy – Trusted Clinical Performance

The GHM Hantavirus Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of hantavirus lateral flow immunoassay prototypes have demonstrated promising diagnostic performance, with one study reporting 100% sensitivity and 97.5% to 99.3% specificity across multiple prototype configurations.

Performance characteristics based on published evaluations of hantavirus lateral flow immunoassay prototypes. Studies of point-of-care hantavirus tests have reported sensitivities ranging from 88–100% and specificities ranging from 97–100% across multiple sample groups. A separate evaluation of lateral flow immunoassay prototypes reported 100% sensitivity and 97.5% to 99.3% specificity. The test has demonstrated cross-reactivity with multiple hantavirus genotypes, enabling broad detection coverage.

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 Hantavirus 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

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 Hantavirus 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.