Innovative C. Difficile Diagnostic Test Provides Both GDH and Toxin Results within 30 Minutes

Clostridium difficile is a leading cause of hospital-acquired diarrhea and pseudomembranous colitis. Infections typically occur when antibiotics disrupt the normal gut flora. Toxigenic strains of C. difficile produce toxins A and B, which are responsible for the symptoms of the infection. Diagnosing C. difficile can be complex because it is possible to carry the bacteria without it producing disease-causing toxins. All strains of C. difficile produce glutamate dehydrogenase (GDH), making GDH testing a useful initial screen for the infection. However, additional tests are necessary since a GDH-positive result does not confirm if the strain is toxin-producing, which is necessary to determine if the patient has an active infection or is just a carrier. Now, a new test that provides results for both GDH and the toxins within approximately 30 minutes can help healthcare professionals accurately distinguish between active infection and colonization in a cost-effective and clinically relevant way.

The C. DIFF QUIK CHEK COMPLETE test from TECHLAB, Inc. (Blacksburg, VA, USA), a part of the SSI Diagnostica Group (Hillerød, Denmark), is a rapid membrane enzyme immunoassay that detects both the C. difficile GDH antigen and toxins A and B in a single reaction well. This test combines the screening and toxin detection steps of the traditional two-step algorithm into one, enhancing workflow efficiency, reducing turnaround time, and offering cost savings compared to the PCR-first algorithm.

Image: The C. DIFF QUIK CHEK COMPLETE test has received the first European IVDR Certification for combined GDH plus Toxin A/B test (Photo courtesy of TECHLAB)

The ability to make rapid clinical decisions is crucial for the effective treatment of patients with C. difficile infections, making it essential to obtain both screening and toxin results quickly. The C. DIFF QUIK CHEK COMPLETE test delivers both GDH and toxin results in about 30 minutes, effectively distinguishing between active infections and colonization with a single test that is both cost-effective and clinically relevant. Furthermore, the C. DIFF QUIK CHEK COMPLETE test is the first combined GDH and toxin A/B test to receive certification under the European In Vitro Diagnostic Medical Device Regulation (IVDR), affirming its compliance with stringent quality and safety standards. This certification ensures the test’s reliability and effectiveness for clinical use across Europe and represents a significant step forward in SSI Diagnostica’s efforts to improve diagnostic tools for C. difficile infections.

“We are proud to achieve IVDR certification for our C. DIFF QUIK CHEK COMPLETE test,” said Christina Lindved, CEO of SSI Diagnostica Group, “This achievement underscores SSI Diagnostica’s commitment to delivering high-quality diagnostic tools that meet the stringent regulatory requirements and fulfill the needs of healthcare providers and patients worldwide.”

Related Links:
TECHLAB, Inc. 
SSI Diagnostica Group