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

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

Product Overview

Global Healthcare Medical GHM Typhoid IgG/IgM Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of IgG and IgM antibodies to Salmonella typhi (S. typhi) 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 typhoid infection and in the determination of recent and past infection.

Typhoid fever, caused by Salmonella enterica serovar Typhi (S. Typhi), remains a significant global health burden, infecting an estimated 9–11 million people per year and causing approximately 110,000 deaths, predominantly in South and Southeast Asia and sub-Saharan Africa where access to safe water and sanitation is inadequate. The emergence of extensively drug-resistant (XDR) typhoid, resistant to all oral antibiotics, has created a near-untreatable public health emergency in some regions, underscoring the critical need for rapid and accurate diagnostic tools to guide appropriate treatment and minimize selective pressure for antimicrobial resistance.

The symptoms of typhoid are non-specific and indistinguishable from other febrile illnesses, including fever, fatigue, rash, headache, and nausea, making accurate diagnosis challenging without a confirmatory test. While blood culture remains the gold standard, it can be expensive, has low sensitivity, and can take several days to obtain results, requiring infrastructure and skilled staff that may not always be available in endemic regions. The GHM Typhoid IgG/IgM Rapid Test US provides a rapid, point-of-care solution for the differential detection of recent and past typhoid infection, enabling timely clinical decision-making and supporting appropriate patient management.

The GHM Typhoid IgG/IgM Rapid Test US delivers qualitative results in 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.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, hospital laboratories, travel medicine clinics, and clinical laboratories in typhoid-endemic regions. 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 Typhoid IgG/IgM Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating S. typhi IgG and IgM antibodies from a single patient sample. The test incorporates two separate test lines: M for IgM and G for IgG, enabling clear differentiation between recent/acute infection (IgM positive) and past infection or secondary response (IgG positive) 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 Typhoid IgG/IgM Rapid Test US provides qualitative results in 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid antibody testing enables faster case identification and supports timely initiation of appropriate antimicrobial therapy.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM Typhoid 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 Early Diagnosis of Typhoid Infection

The GHM Typhoid IgG/IgM Rapid Test US is intended for use as an aid in the early diagnosis of typhoid infection and in the determination of recent and past infection. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management.

The dual-target design provides comprehensive diagnostic value. IgM antibodies typically appear early in infection and indicate recent or acute typhoid infection, while IgG antibodies generally appear later and persist for years, indicating past infection or a secondary immune response. The differential detection of IgM and IgG supports the determination of recent versus past infection, enabling appropriate clinical management and supporting antimicrobial stewardship efforts.

The test is particularly valuable in settings where rapid identification of typhoid infection supports timely initiation of appropriate antimicrobial therapy. Rapid antibody tests have demonstrated high sensitivity and specificity for S. Typhi infection, lending themselves to diagnosis and treatment of acute typhoid fever in high-burden, resource-limited settings. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.

High Accuracy – Trusted Clinical Performance

The GHM Typhoid 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 in-house evaluation of 210 samples (including 200 S. typhi antibody negative and 10 S. typhi antibody positive samples) compared with a licensed commercially available test. Cross-reactivity testing included samples positive for HIV, HCV, HBV, Dengue, Chikungunya, Leptospira, RA, ASO, and CRP, with no false-positive results observed. Published studies of rapid typhoid antibody tests have reported sensitivities ranging from 59% to 94.9% and specificities ranging from 32.7% to 96%, depending on the product, population, and reference method used. The test is best suited for use as an aid in the diagnosis of typhoid in symptomatic patients, and results should be interpreted in conjunction with other clinical and laboratory findings.

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 Typhoid 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 Typhoid 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.