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

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

Product Overview

Global Healthcare Medical GHM Clostridium Difficile GDH & Toxin A & Toxin B Combo Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Clostridium difficile Glutamate Dehydrogenase (GDH), 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-forming 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.

Current guidelines from the European Society for Clinical Microbiology and Infectious Diseases (ESCMID), the Infectious Diseases Society of America (IDSA), and the American College of Gastroenterology (ACG) recommend multistep testing algorithms for the laboratory diagnosis of CDI. These algorithms typically begin with a highly sensitive screening test—either a GDH enzyme immunoassay (EIA) or a nucleic acid amplification test (NAAT)—followed by a confirmatory toxin assay. An immunochromatographic assay that detects both GDH and free toxins simultaneously but separately on the same device can be used for both steps of the diagnostic algorithm, facilitating rapid laboratory confirmation of CDI.

The GHM Clostridium Difficile GDH & 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

Triple-Target Detection – GDH, Toxin A, and Toxin B in One Test

The GHM Clostridium Difficile GDH & Toxin A & Toxin B Combo Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting Clostridium difficile GDH antigen, Toxin A, and Toxin B from a single patient sample. The test device incorporates separate test lines for each target, enabling clear differentiation of results in a single assay. This triple-target design supports a multistep diagnostic algorithm within a single device, streamlining the testing workflow and reducing the need for separate specimen collections and testing procedures.

Fast Results – 10 Minutes

The GHM Clostridium Difficile GDH & 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 results facilitate rapid laboratory confirmation of CDI, which is important for clinical decision-making and infection control measures.

Feces Sample Compatibility – Simple and Non-Invasive Collection

The GHM Clostridium Difficile GDH & 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 buffer 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. C. difficile toxin is very unstable and degrades at room temperature, potentially becoming undetectable within two hours of stool specimen collection.

Clinical Utility – Aid for Diagnosis of Clostridium Difficile Infection

The GHM Clostridium Difficile GDH & 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 antigen and 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 whenever feasible.

The triple-target design provides comprehensive diagnostic value and supports the recommended multistep testing algorithm within a single device. The GDH component serves as a sensitive screening test, as GDH is produced by all C. difficile strains regardless of toxigenicity, while the toxin A and B components confirm the presence of toxin-mediated disease. An immunochromatographic assay that detects both GDH and free toxins simultaneously allows for the interpretation of results: in case of a negative result for both targets, CDI is likely to be absent; if both targets are positive, CDI is likely to be present; if the toxins are positive and the GDH is negative, the sample must be re-tested as this result is considered invalid; and a GDH positive and toxin negative result may be resolved with an additional NAAT test.

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 Accuracy – Trusted Clinical Performance

The GHM Clostridium Difficile GDH & Toxin A & Toxin B Combo Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity across all three targets. The product specifications report GDH sensitivity of 96.36%, Toxin A sensitivity of 96.67%, and Toxin B sensitivity of 100%, with specificities of 98.68%, 98.99%, and 98.86%, respectively.

Performance characteristics based on product specifications. Published evaluations of rapid C. difficile GDH/toxin combo immunoassays have demonstrated that the positive percent agreement between GDH detection and detection of tcdA by NAAT was 100% with multiple immunoassays, while the positive percent agreement for toxin A/B detection was considerably lower (ranging from 50.0% to 71.4% depending on the product). A separate evaluation of a rapid GDH/toxin A/B combo test reported 100% positive concordance rate and 97.1% negative concordance rate for GDH, with 94.1% positive concordance rate and 97.9% negative concordance rate for toxin detection against a comparative immunochromatographic method. The clinical sensitivity of toxin detection is believed to correlate better with clinical disease than molecular methods alone, 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 GDH & 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.

• C. difficile toxin degrades at room temperature and may be undetectable within two hours of specimen collection; specimens should be tested promptly or refrigerated until testing.

• 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 GDH & 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.