GHM Clostridium Difficile Toxin A & Toxin B Combo Rapid Test US – Dual-Toxin Qualitative Detection of C. difficile Toxin A and Toxin B Antigens with 10-Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Clostridium Difficile Toxin A & Toxin B Combo Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Clostridium Difficile Toxin A & Toxin B Combo Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Clostridium difficile Toxin A and Toxin B antigens in human feces specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of Clostridium difficile infection (CDI) in symptomatic patients.

Clostridium difficile is a Gram-positive, spore-bearing anaerobic bacterium and is the leading cause of healthcare-associated diarrhea worldwide. CDI develops when the organism proliferates in the colon, most commonly after antibiotic use has eliminated competing flora. The bacterium produces two major virulence factors—Toxin A (TcdA) and Toxin B (TcdB)—which are directly responsible for the clinical manifestations of disease, ranging from mild, self-limited watery diarrhea to fulminant pseudomembranous colitis, toxic megacolon, and death. Early and accurate detection of toxin-mediated disease is essential for appropriate clinical management, infection control, and antimicrobial stewardship.

Since not all strains of C. difficile produce toxins and approximately 2% of healthy adults as well as up to 50% of children younger than 2 years can be colonized with C. difficile, the detection of toxins in stool samples of patients with diarrhea is more clinically significant than culturing the bacteria. Current guidelines recommend the use of a multistep algorithm combining sensitive screening and specific toxin assays for the laboratory diagnosis of CDI, as the sensitivity of toxin detection correlates better with clinical disease than molecular methods alone. The GHM Clostridium Difficile Toxin A & Toxin B Combo Rapid Test US provides a rapid, point-of-care solution for the simultaneous detection of both toxins, enabling timely clinical decision-making and supporting appropriate patient management.

The GHM Clostridium Difficile Toxin A & Toxin B Combo Rapid Test US delivers qualitative results in just 10 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 hospitals, long-term care facilities, and clinical laboratories.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including hospital laboratories, long-term care facilities, physician office laboratories, 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

Dual-Toxin Detection – Toxin A and Toxin B in One Test

The GHM Clostridium Difficile Toxin A & Toxin B Combo Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting both Clostridium difficile Toxin A and Toxin B antigens from a single patient sample. The test device contains separate test lines for Toxin A and Toxin B, enabling clear differentiation of results for each toxin in a single assay. This dual-toxin design supports comprehensive detection of toxigenic C. difficile strains, as some strains may produce only one of the two toxins.

Fast Results – 10 Minutes

The GHM Clostridium Difficile Toxin A & Toxin B Combo Rapid Test US provides qualitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid toxin detection enables timely clinical decision-making and supports infection control measures.

Feces Sample Compatibility – Simple and Non-Invasive Collection

The GHM Clostridium Difficile Toxin A & Toxin B Combo 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 solution for convenient specimen processing. Fresh stool specimens are recommended for optimal results, as freezing stool samples has been shown to negatively affect the detection of both GDH and toxins. Specimens should be tested immediately if possible.

Clinical Utility – Aid for Diagnosis of Clostridium difficile Infection

The GHM Clostridium Difficile Toxin A & Toxin B Combo Rapid Test US is intended for use as an aid in the diagnosis of Clostridium difficile infection (CDI) in symptomatic patients. The test provides rapid toxin detection, enabling timely clinical decision-making and supporting patient management. Diagnostic testing should be limited to symptomatic patients with acute onset of unexplained diarrhea and performed prior to initiating therapy.

The dual-toxin design provides comprehensive diagnostic value. Detection of Toxin A and/or Toxin B supports the diagnosis of toxin-mediated CDI, which correlates better with clinical disease than molecular detection alone. The test is particularly valuable in hospital and long-term care settings, where CDI is a leading cause of healthcare-associated diarrhea and a major source of nosocomial morbidity and mortality worldwide. Rapid results support timely initiation of appropriate antimicrobial therapy, implementation of infection control measures, and reduction of unnecessary antibiotic exposure.

High Specificity – Trusted Clinical Performance

The GHM Clostridium Difficile Toxin A & Toxin B Combo Rapid Test US is designed to deliver reliable clinical performance with high specificity for both toxin targets. Published evaluations of rapid C. difficile toxin A/B immunoassays have demonstrated strong performance, making this assay a valuable tool for point-of-care diagnostics when correctly used.

Performance characteristics based on published evaluations of rapid C. difficile toxin A/B immunoassays. A systematic review and meta-analysis reported that the sensitivity of Tox A/B enzyme immunoassays is 75% (95% CI: 70–79) and the specificity is 95% (95% CI: 94–96). A separate evaluation of three commercial rapid immunoassays found that the best-performing assay achieved a positive percent agreement of 71.4% for toxin A/B detection compared to NAAT, with GDH detection showing 100% positive percent agreement with NAAT for tcdA detection. The clinical sensitivity of toxin detection is believed to correlate better with clinical disease than molecular methods, as NAAT alone may lead to overdiagnosis of CDI by detecting asymptomatic carriers. Detection is optimal in fresh stool specimens, as freezing has been shown to negatively affect toxin detection sensitivity.

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 Clostridium Difficile Toxin A & Toxin B Combo 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:

• Diagnostic testing should be performed only in symptomatic patients with acute onset of unexplained diarrhea and prior to initiating therapy whenever feasible.

• Collect a small scoop of stool in a screw-capped container; well-formed stools are not suitable for this test.

• Fresh stool specimens are recommended for optimal results; freezing stool samples has been shown to negatively affect toxin detection sensitivity.

• A negative result does not rule out CDI; consider reflex testing with NAAT for GDH-positive but toxin-negative samples.

• Repeat testing should be reserved for recurrence of diarrhea, as patients may continue to shed spores for several weeks after successful treatment.

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 Clostridium Difficile Toxin A & Toxin B Combo 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.