GHM Vibrio Cholerae O1 Antigen Rapid Test US – Qualitative Detection of Vibrio cholerae O1 Antigen with 10–15 Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Vibrio Cholerae O1 Antigen Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Vibrio Cholerae O1 Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Vibrio cholerae O1 antigen in human feces specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of cholera caused by Vibrio cholerae O1 infection.

Cholera is an acute diarrheal infection caused by ingestion of food or water contaminated with toxigenic strains of Vibrio cholerae. While more than 200 serogroups of V. cholerae exist, only two serogroups—O1 and O139—cause outbreaks, and recent outbreaks are almost exclusively due to V. cholerae O1, which is responsible for the current seventh cholera pandemic. The World Health Organization (WHO) reported 804,721 cholera cases and 5,805 deaths across 33 countries spanning five WHO regions in a recent reporting period, marking a disturbing increase over previous years. The disease remains endemic in Africa, Asia, and Central and South America, with the WHO estimating that fewer than 10% of cholera cases are actually reported despite it being a notifiable disease.

Cholera is characterized by acute onset of profuse watery diarrhea, often described as "rice-water stools," which can rapidly lead to severe dehydration and death if untreated. Early and accurate detection of V. cholerae O1 is critical for timely clinical intervention, outbreak confirmation, and implementation of appropriate infection control measures. While culture and polymerase chain reaction (PCR) remain the gold standard for confirmation, these methods require specialized laboratory infrastructure and can take several days to yield results. Rapid diagnostic tests (RDTs) based on the detection of the O-antigen of bacterial lipopolysaccharide are recommended by the WHO Global Task Force for Cholera Control (GTFCC) for surveillance of cholera directly from stool or rectal swabs. The GHM Vibrio Cholerae O1 Antigen Rapid Test US provides a practical, point-of-care solution for the rapid detection of V. cholerae O1 antigen, enabling timely clinical decision-making and supporting outbreak response efforts.

The GHM Vibrio Cholerae O1 Antigen Rapid Test US delivers qualitative results in 10–15 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 primary care clinics, hospital laboratories, and field-based outbreak response programs.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, hospital laboratories, emergency departments, public health outbreak response programs, and clinical laboratories in cholera-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

Colloidal Gold Immunochromatography – Reliable Qualitative Detection

The GHM Vibrio Cholerae O1 Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test uses monoclonal antibodies specifically against Vibrio cholerae O1 lipopolysaccharide (LPS) antigen, which are conjugated with colloidal gold and deposited on the conjugate pad, and also immobilized on the test line of the nitrocellulose membrane. During testing, the extracted fecal 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 Vibrio cholerae O1 antigen is present in the specimen. The test detects both O1-Inaba and O1-Ogawa serotypes of Vibrio cholerae O1.

Fast Results – 10–15 Minutes

The GHM Vibrio Cholerae O1 Antigen Rapid Test US provides qualitative results in 10–15 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 outbreak response measures, which is critical in cholera-endemic settings where rapid case identification is essential for effective disease control.

Feces Sample Compatibility – Simple and Non-Invasive Collection

The GHM Vibrio Cholerae O1 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. For solid specimens, collect approximately 50 mg total from across 3 points along the sample using a swab. For liquid specimens, transfer approximately 80 µl into the collection tube containing the extraction buffer. Test for up to one hour after preparation if stored at room temperature, or store at -20°C for up to 6 months.

Clinical Utility – Aid for Diagnosis of Vibrio cholerae O1 Infection

The GHM Vibrio Cholerae O1 Antigen Rapid Test US is intended for use as an aid in the diagnosis of Vibrio cholerae O1 infection in symptomatic patients. The test provides rapid antigen detection, enabling timely clinical decision-making and supporting patient management. Early and accurate identification of cholera is essential for reducing cholera-related morbidity and mortality through prompt initiation of appropriate rehydration therapy and antimicrobial treatment where indicated.

The test is particularly valuable in settings where rapid identification of cholera supports outbreak confirmation and public health intervention. Cholera RDTs may be used for early outbreak detection, for an initial alert, and for monitoring outbreaks and seasonal peaks in highly endemic areas. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.

High Accuracy – Trusted Clinical Performance

The GHM Vibrio Cholerae O1 Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid cholera diagnostic tests have demonstrated strong performance, with a systematic review and meta-analysis reporting pooled sensitivity and specificity of 0.95 (95% CI: 0.93–0.97) and 0.95 (95% CI: 0.91–0.97), respectively, both exceeding the 2024 GTFCC TPP requirements. A large clinical evaluation using slide agglutination as the reference method reported sensitivity of RDT kits ranging from 99.3% to 99.6% and specificity ranging from 99.3% to 99.7%.

Performance characteristics based on product specifications and published evaluations of rapid cholera diagnostic tests. Pooled sensitivity and specificity from a systematic review and meta-analysis were 0.95 (95% CI: 0.93–0.97) and 0.95 (95% CI: 0.91–0.97), respectively, both exceeding the 2024 GTFCC TPP requirements. Using slide agglutination as the reference, sensitivity of RDT kits ranged from 99.3% to 99.6% and specificity from 99.3% to 99.7% in a large clinical evaluation. Independent evaluations of rapid cholera antigen tests have reported sensitivities ranging from 88% to 100% and specificities ranging from 72% to 100%, depending on the product, population, and reference method used. Detection is optimal in specimens collected during the acute phase of infection, and the test is best suited for use as an aid in the diagnosis of cholera in symptomatic patients. The test provides a preliminary result; culture remains the gold standard for definitive diagnosis.

WHO Guideline-Aligned Testing

The GHM Vibrio Cholerae O1 Antigen Rapid Test US is designed for use in alignment with WHO and GTFCC recommendations for cholera surveillance. Cholera RDTs based on the detection of the O-antigen of bacterial lipopolysaccharide are recommended by the WHO Global Task Force for Cholera Control for surveillance of cholera directly from stool or rectal swabs. The WHO minimum recommended performance for a cholera RDT is a sensitivity of at least 90% and specificity of at least 85%. The test is designed to support early outbreak detection, initial alert, and monitoring of outbreaks and seasonal peaks in highly endemic areas.

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 Vibrio Cholerae O1 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:

• Collect a sufficient quantity of feces in a clean, dry specimen collection container; for solid specimens, collect approximately 50 mg total from across 3 points along the sample; for liquid specimens, transfer approximately 80 µl into the collection tube containing the extraction buffer.

• Bring all kit components and samples to room temperature prior to assay; the test cassette should be used within 1 hour after removing from the sealed pouch.

• Test for up to one hour after preparation if stored at room temperature, or store at -20°C for up to 6 months.

• 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 Vibrio cholerae infection; culture remains the gold standard for definitive diagnosis.

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 Vibrio Cholerae O1 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.