GHM Zika IgG/IgM Rapid Test US – Dual-Target Qualitative Detection of Zika Virus IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Zika IgG/IgM Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Zika IgG/IgM Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of IgG and IgM antibodies to Zika virus (ZIKV) in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of 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).

The clinical presentation of Zika overlaps significantly with other arboviral diseases such as dengue, chikungunya, and yellow fever, making laboratory confirmation essential for accurate diagnosis. According to CDC guidelines, Zika virus immunoglobulin (Ig) M antibody testing is recommended in certain situations, particularly when molecular testing is negative or unavailable. IgM generally is detectable starting in the first week after onset of symptoms and persists for months to years, while IgG antibodies appear shortly after IgM and persist for years, indicating past infection or immunity.

The GHM Zika IgG/IgM 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

2-in-1 Detection – IgG and IgM in One Test

The GHM Zika IgG/IgM Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating Zika virus IgG and IgM antibodies from a single patient sample. The test incorporates two separate test lines: T1 for IgG and T2 for IgM, enabling clear differentiation between acute/recent infection and past infection or immunity in a single assay. This dual-target design provides a comprehensive diagnostic picture that supports appropriate clinical decision-making and effective patient management.

Fast Results – 15 Minutes

The GHM Zika IgG/IgM Rapid Test US provides qualitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid diagnostic tests for Zika enable faster case identification and support timely clinical management, particularly in pregnant women and individuals with neurological symptoms.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM Zika IgG/IgM 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 Zika Virus Infection

The GHM Zika IgG/IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of infection with Zika virus. The test provides rapid serological diagnosis, 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 dual-target design provides comprehensive diagnostic value. IgM antibodies are typically detectable starting in the first week after symptom onset and persist for months to years, indicating acute or recent infection. IgG antibodies generally appear shortly after IgM and persist for years, indicating past infection or immunity. The presence of both IgM and IgG may indicate a recent infection in a later stage or a secondary flavivirus infection.

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 IgG/IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity for both IgG and IgM targets. Clinical evaluation against reference methods has 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 antibody tests. Published evaluations of rapid Zika antibody tests have reported sensitivities ranging from 50% to over 94% and specificities exceeding 98% depending on the product, population, and timing of specimen collection. Detection is optimal when specimens are collected at appropriate time points during infection. Cross-reactivity may occur with other flaviviruses, particularly dengue virus, which can affect test interpretation. The WHO target product profile for Zika diagnostic tests recommends high specificity to minimize false-positive results, particularly in areas where dengue co-circulates.

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 IgG/IgM 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 IgG/IgM 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.