GHM Campylobacter Antigen Rapid Test US – Qualitative Detection of Campylobacter jejuni & coli Antigens with 15-Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Campylobacter Antigen Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Campylobacter Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Campylobacter jejuni and Campylobacter coli antigens in human feces specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of campylobacteriosis in patients with signs and symptoms of gastroenteritis.

Campylobacter is one of the four leading global causes of diarrheal disease and the most commonly reported bacterial cause of foodborne gastroenteritis worldwide. The species most frequently causing campylobacteriosis are C. jejuni and C. coli, followed by C. fetus, C. upsaliensis, and C. lari. A meta-analysis of studies conducted between 2000 and 2025 revealed an overall pooled prevalence of Campylobacter-associated gastroenteritis of 8.0% (95% CI: 6.0–10.0%). The infection is typically transmitted through the consumption of contaminated poultry, unpasteurized milk, or contaminated water, and it presents with clinical symptoms including diarrhea (often bloody), abdominal pain, fever, headache, and nausea. These symptoms overlap significantly with other bacterial and viral causes of gastroenteritis, making laboratory confirmation essential for accurate diagnosis and appropriate patient management.

While culture and polymerase chain reaction (PCR) remain the gold standard for confirmation, stool culture to detect Campylobacter requires a minimum of 48 hours and has a sensitivity ranging from 60% to 76%. PCR assays are often validated for C. jejuni and C. coli only, and access to PCR technology may be limited in many clinical settings. For laboratories that do not have access to PCR technology, rapid antigen tests can be of the utmost importance for early diagnosis of the disease. The GHM Campylobacter Antigen Rapid Test US provides a practical, point-of-care solution for the rapid detection of Campylobacter antigens, enabling timely clinical decision-making and supporting antibiotic stewardship efforts.

The GHM Campylobacter 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, emergency departments, and clinical laboratories.

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, 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 Campylobacter Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test uses monoclonal antibodies specifically against Campylobacter-specific antigens, 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 Campylobacter antigen is present in the specimen. The test detects both Campylobacter jejuni and Campylobacter coli.

Fast Results – 15 Minutes

The GHM Campylobacter 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. The assay has a rapid turnaround time of approximately 15 minutes after sample collection. Rapid results enable immediate clinical assessment and support antibiotic stewardship efforts by reducing the need for empirical therapy in patients presenting with acute gastroenteritis.

Feces Sample Compatibility – Simple and Non-Invasive Collection

The GHM Campylobacter 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. Fresh stool specimens are recommended for optimal results; specimens may be stored at 2–8°C for up to 3 days if not tested within 6 hours.

Clinical Utility – Aid for Diagnosis of Campylobacter Gastroenteritis

The GHM Campylobacter Antigen Rapid Test US is intended for use as an aid in the diagnosis of Campylobacter infection in symptomatic patients. The test provides rapid antigen detection, enabling timely clinical decision-making and supporting patient management. Early and accurate identification of Campylobacter infection is essential for reducing unnecessary antibiotic use, supporting antimicrobial stewardship, and preventing complications such as Guillain-Barré syndrome and reactive arthritis.

The test is particularly valuable in settings where rapid identification of Campylobacter supports timely clinical decision-making and appropriate use of antibiotics. Given its high specificity for the detection of Campylobacter spp., this assay may serve as a useful adjunct to clinical judgment and may contribute to improved diagnostic accuracy. The test may also have potential utility as a rapid diagnostic tool in patients with diarrheal illness for whom diagnostic testing and antimicrobial treatment are recommended according to antimicrobial stewardship guidelines. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.

High Accuracy – Trusted Clinical Performance

The GHM Campylobacter Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. A rapid fluorescence immunoassay evaluated for Campylobacter antigen detection achieved sensitivity of 97.87% and 96.88% in retrospective and prospective evaluations, respectively, with specificity of 98.84%. The reported sensitivities for rapid Campylobacter assays generally range from approximately 70% to 90%, whereas the specificities often exceed 95%.

Performance characteristics based on published evaluations of rapid Campylobacter antigen tests. A rapid fluorescence immunoassay for detecting Campylobacter antigens in stool samples demonstrated sensitivity of 97.87% and 96.88% in retrospective and prospective evaluations, respectively, with specificity of 98.84%. A prospective multicenter evaluation of a rapid Campylobacter antigen test reported positive concordance of 78.8%, negative concordance of 99.0%, and total concordance of 93.4% compared with the FilmArray Gastrointestinal Panel. The test showed no cross-reactivity with phylogenetically related species including Aliarcobacter butzleri, Helicobacter cinaedi, or Helicobacter pullorum. Detection is optimal in fresh stool specimens collected during the early phase of illness, and the test is best suited for use as an aid in the diagnosis of campylobacteriosis in symptomatic patients. The test provides a preliminary result; culture remains the gold standard for definitive diagnosis and antimicrobial susceptibility testing.

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 Campylobacter 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; well-formed stools are not suitable for this test.

• Fresh stool specimens are recommended for optimal results; if not tested within 6 hours, store at 2–8°C for up to 3 days.

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

• The test provides a preliminary result and should be interpreted in conjunction with clinical findings and other laboratory results.

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 Campylobacter 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.