GHM Vibrio Cholerae O1/O139 Antigen Rapid Test US – Dual-Serogroup Qualitative Detection of Vibrio cholerae O1 and O139 Antigens with 15-Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Vibrio Cholerae O1/O139 Antigen Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Vibrio Cholerae O1/O139 Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of Vibrio cholerae O1 and O139 antigens 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 and/or O139 infection.

Cholera is an acute diarrheal infection caused by ingestion of food or water contaminated with toxigenic strains of Vibrio cholerae. Among the more than 200 identified serogroups, V. cholerae O1 and O139 are the sole epidemic-causing serogroups with high pathogenicity. The World Health Organization reported 804,721 cholera cases and 5,805 deaths across 33 countries, underscoring the persistent threat and unmet needs in global cholera control. The disease remains endemic in Africa, Asia, and Central and South America, with the WHO estimating that the real burden of cholera cases may be up to four times what is actually reported.

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 and O139 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/O139 Antigen Rapid Test US provides a practical, point-of-care solution for the rapid detection of both O1 and O139 antigens, enabling timely clinical decision-making and supporting outbreak response efforts.

The GHM Vibrio Cholerae O1/O139 Antigen Rapid Test US delivers qualitative results in 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

Dual-Serogroup Detection – Vibrio cholerae O1 and O139 in One Test

The GHM Vibrio Cholerae O1/O139 Antigen Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating Vibrio cholerae O1 and O139 antigens from a single patient sample. The test device incorporates two separate test lines: T1 for O139 and T2 for O1 (both Inaba and Ogawa serotypes), enabling clear differentiation of results in a single assay. This dual-target design supports comprehensive detection of both epidemic-causing serogroups, which together are responsible for virtually all epidemic cholera cases worldwide.

Fast Results – 15 Minutes

The GHM Vibrio Cholerae O1/O139 Antigen Rapid Test US provides qualitative results in 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. The GTFCC recommends that cholera RDTs provide results in <30 minutes to support same-day triage and public health action.

Feces Sample Compatibility – Simple and Non-Invasive Collection

The GHM Vibrio Cholerae O1/O139 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 of feces using the specimen collection applicator, or use 2 drops of liquid stool into the provided specimen collection tube with 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 and O139 Infection

The GHM Vibrio Cholerae O1/O139 Antigen Rapid Test US is intended for use as an aid in the diagnosis of Vibrio cholerae O1 and/or O139 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. A field evaluation in Cameroon demonstrated that cholera RDTs can be effectively deployed directly on fresh stool samples by non-laboratory staff, with inter-operator agreement high (Cohen's κ 0.81–0.89) and more than 80% of end users reporting that RDTs were easy to use under outbreak conditions.

High Accuracy – Trusted Clinical Performance

The GHM Vibrio Cholerae O1/O139 Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. A systematic review and meta-analysis of 22 studies (46 data points, 20,353 specimens) reported 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 Target Product Profile requirements. Using slide agglutination as the reference method, sensitivity of RDT kits ranged from 99.3% to 99.6% and specificity from 99.3% to 99.7%. In a field evaluation during a cholera outbreak in Cameroon, when performed at the point of care, RDT sensitivity ranged from 88% to 95%, comparable to laboratory-based testing, while specificity ranged from 72% to 85%.

Performance characteristics based on systematic review and meta-analysis of cholera RDTs. Pooled sensitivity and specificity were 0.95 (95% CI: 0.93–0.97) and 0.95 (95% CI: 0.91–0.97), 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%. When performed at the point of care in field settings, RDT sensitivity ranged from 88% to 95% and specificity from 72% to 85%. Detection is optimal in fresh stool specimens collected from patients who have been ill for less than 4 days and who have not been given antibiotics. The test provides a preliminary result; culture remains the gold standard for definitive diagnosis.

WHO Guideline-Aligned Testing

The GHM Vibrio Cholerae O1/O139 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 recommends and distributes Crystal VC Ag O1/O139 and Bioline Cholera Ag O1/O139 for field use. 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/O139 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:

• RDTs should ideally be performed on fresh stool specimens within 2 hours of collection from a patient who has been ill for less than 4 days and who has not been given antibiotics.

• For solid specimens, collect approximately 50 mg of feces using the specimen collection applicator; for liquid specimens, use 2 drops of liquid stool into the provided specimen collection tube with 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 (T1 or T2) 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/O139 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.