Epitope Diagnostics Expands Infectious Disease Product Line with Clostridium Difficile Family of Tests

Epitope Diagnostics, Inc. developed and produced a new ELISA Kit and rapid test with accessories for the detection of Clostridium difficile specific glutamate dehydrogenase (GDH).

San Diego, CA, May 10, 2015 --(PR.com)-- Clostridium difficile colitis is one of the most common diseases related to healthcare-associated infections (HAIs). The opportunistic bacteria C. difficile infects the human gut and releases enterotoxins and cytotoxins, causing severe diarrhea and inflammation. According to the CDC, C. difficile caused almost half a million infections in the U.S. in 2011; 29,000 deaths occurred within a month of diagnosis.

Modern diagnosis of infection involve immunoassay to detect specific C. difficile antigens, such as glutamate dehydrogenase (GDH). According to peer reviewed literature, measurement of C. difficile GDH gives satisfactory clinical diagnostic sensitivity and specificity, 100% and 99.6% respectively.

Epitope Diagnostics, Inc. has launched the EDI™ Fecal C. difficile GDH ELISA (Cat. no. KT-828), which is CE marked for in vitro diagnostic use.

This monoclonal antibody-based sandwich ELISA uniquely allows for both quantitative and qualitative detection of C. difficile GDH. Therefore, the clinical laboratory has the flexibility to perform either of these to suit patient needs. The assay has 2 hour incubation period. In-house validation study showed a 100% clinical sensitivity and specificity, with an LLOD of approximate 0.5 ng/ml.

To supplement ease of use, Epitope Diagnostics has a simple and cost effective collection tube (Cat. no. KT-889) available to handle stool samples, which can be used in conjunction with the ELISA kit.

For more information, please visit www.epitopediagnostics.com.

Products in this family include:

KT-828: Fecal C. Difficile GDH ELISA Kit, 96 tests/kit

KT-889: C. difficile Sample Collection & Extraction Kit, 48 tubes/kit

KT-935: Fecal C. difficile GDH Rapid Test Kit, 30 tests/kit

KT-935.10: Fecal C. difficile GDH Rapid Test Kit, 10 tests/kit

Related Literature

Simon D. Goldenberg,* Penny R. Cliff, and Gary L. French, Glutamate Dehydrogenase for Laboratory Diagnosis of Clostridium difficileInfection. J Clin Microbiol. 2010 Aug; 48(8): 3050–3051.

Kawada M1, Annaka M, Kato H, Shibasaki S, Hikosaka K, Mizuno H, Masuda Y, Inamatsu T. Evaluation of a simultaneous detection kit for the glutamate dehydrogenase antigen and toxin A/B in feces for diagnosis of Clostridium difficile infection. J Infect Chemother. 2011 Dec; 17(6):807-11.

About Epitope Diagnostics, Inc.

Established since 2003, Epitope Diagnostics, Inc. is an ISO 13845 certified medical device manufacturing company located in the Sorrento Valley biotech hub of San Diego, California. They specialize in development and manufacture of products for the global medical device and diagnostics industry. Their areas of interest include gastrointestinal, cardiovascular, infectious and autoimmune disease, as well as tumors/cancers and calcium/bone metabolism.
Epitope Diagnostics, Inc.
Lily Atebekyan