GHM Zika NS1 Antigen Rapid Test US – Qualitative Detection of Zika Virus NS1 Antigen with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Zika NS1 Antigen Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Zika NS1 Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Zika virus non-structural protein 1 (NS1) antigen in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of acute Zika virus infection.

Zika virus (ZIKV) is a mosquito-borne flavivirus belonging to the Flaviviridae family, which also includes dengue, West Nile, Japanese encephalitis, and yellow fever viruses. ZIKV is primarily transmitted through the bites of infected Aedes aegypti and Aedes albopictus mosquitoes, and can also be transmitted through blood transfusions, sexual contact, and vertically during pregnancy. While the majority of ZIKV infections are asymptomatic or present with mild symptoms—including fever, rash, joint pain, muscle pain, headache, and conjunctivitis—the virus has been linked to severe neurological complications. In-utero ZIKV infections are associated with microcephaly and other congenital malformations, while adults may develop Guillain-Barré Syndrome. In 2015, Brazil and several South American countries experienced a ZIKV epidemic that was later declared a global public health emergency by the World Health Organization (WHO).

ZIKV infection is characterized by two distinct stages: the acute phase (within the first 5 days of infection) and the convalescence phase (extending 6 days after the acute phase). During the acute phase, the virus genome and antigens can be detected in various body fluids, including blood, serum, urine, saliva, and semen. NS1 is a highly conserved non-structural protein secreted by virus-infected cells into the bloodstream, and it is known to remain detectable in the blood even after the viral genome has disappeared, making it a useful marker for acute-phase infection. Direct detection of viral antigen during the acute phase enables early diagnosis and timely clinical intervention.

The GHM Zika NS1 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 (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including decentralized 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 physician office laboratories, hospital laboratories, public health screening programs in endemic areas, travel medicine clinics, 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 Qualitative Detection

The GHM Zika NS1 Antigen Rapid Test US is based on lateral flow immunochromatography technology, utilizing a double antibody sandwich method. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to the Zika virus NS1 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 Zika virus NS1 antigen is present in the specimen.

Fast Results – 15 Minutes

The GHM Zika NS1 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. NS1 antigen detection is particularly valuable during the acute phase of infection (first 5 days), when the virus genome and antigens are most readily detectable in body fluids.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM Zika NS1 Antigen 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. The test requires only a small sample volume, making it suitable for both clinic-based and field-based testing scenarios in resource-limited settings.

Clinical Utility – Aid for Diagnosis of Acute Zika Virus Infection

The GHM Zika NS1 Antigen Rapid Test US is intended for use as an aid in the diagnosis of acute Zika virus infection. The test provides rapid antigen detection, enabling timely clinical decision-making and supporting patient management. Early and accurate identification of Zika infection is essential for reducing Zika-related complications, particularly in pregnant women and their newborns.

The test is particularly valuable in settings where rapid identification of Zika infection supports public health surveillance and clinical management. The WHO has emphasized that accurate diagnosis is critical for monitoring Zika transmission and guiding public health 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 Zika NS1 Antigen Rapid Test US is designed to deliver reliable clinical performance with high specificity. Published evaluations of Zika NS1 rapid antigen tests have demonstrated strong performance, making this assay a valuable tool for point-of-care diagnostics when correctly used.

Performance characteristics based on evaluations of rapid Zika NS1 antigen tests. Published evaluations of rapid Zika NS1 tests have reported sensitivities ranging from 80% to over 90% and specificities exceeding 94%, with higher detection sensitivity observed when NS1 is detected from urine. Detection sensitivity of immunochromatographic kits has been reported at 125 pg/mL using recombinant NS1. Detection is optimal during the acute phase of infection (first 5 days), when antigen levels are highest. Negative results should be confirmed by molecular testing (RT-PCR) or other reference methods, particularly in patients presenting more than 5 days after symptom onset.

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 Zika NS1 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 Zika NS1 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.