We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
PURITAN MEDICAL

Download Mobile App




CE Marking for Dual-Detection Test for Clostridium difficile

By LabMedica International staff writers
Posted on 20 Apr 2015
CE-IVD approval has been given for a new multiplex test to detection C. More...
difficile infection (CDI) and simultaneous differentiation of the hypervirulence-associated 027 ribotype.

Mobidiag Ltd. (Espoo, Finland) has launched Amplidiag C. difficile+027, a qualitative qPCR-based test performed from DNA extracted from stool in suspected cases of CDI. The CE-marked test, now available throughout Europe, is both economical and well suited to high-volume screening.

In a single reaction, the test offers highly sensitive and specific detection of pathogenic C. difficile by detecting the tcdB (toxin B) gene, and highly accurate differentiation of the hypervirulence-associated 027 ribotype, which has been linked with more severe disease, hospital outbreaks, increased mortality rates, and recurrent infections. The 027 ribotype identification is based on two novel gene markers, whose combination produces very high accuracy in differentiating 027 from other ribotypes. The novel gene markers were identified based on whole-genome sequencing of 88 C. difficile strains.

Performance was evaluated with 309 prospective and 35 spiked samples against toxigenic stool culture findings (the “gold standard”) and through independent molecular methods. Amplidiag C. difficile+027 demonstrated 100% specificity for both tcdB and 027 ribotype, and sensitivities of 97.8% and 94.4% for tcdB and 027 ribotype, respectively.

“Early identification is important for guiding patient management and infection control measures. It is important not only for patient outcome, but also in lowering the overall healthcare costs of CDI. That is why we are very excited to bring this new product to the market,” said Tuomas Tenkanen, CEO of Mobidiag.

Related Links:

Mobidiag



Gold Member
Flocked Fiber Swabs
Puritan® Patented HydraFlock®
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Staining Management Software
DakoLink
New
Automatic Hematology Analyzer
LABAS F9000
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








DIASOURCE (A Biovendor Company)

Channels

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: CellLENS enables the potential precision therapy strategies against specific immune cell populations in the tissue environment (Photo courtesy of MIT)

New AI System Uncovers Hidden Cell Subtypes to Advance Cancer Immunotherapy

To produce effective targeted therapies for cancer, scientists need to isolate the genetic and phenotypic characteristics of cancer cells, both within and across different tumors. These differences significantly... Read more

Technology

view channel
Image: Researchers Dr. Lee Eun Sook and Dr. Lee Jinhyung examine the imprinting equipment used for nanodisk synthesis (Photo courtesy of KRISS)

Multifunctional Nanomaterial Simultaneously Performs Cancer Diagnosis, Treatment, and Immune Activation

Cancer treatments, including surgery, radiation therapy, and chemotherapy, have significant limitations. These treatments not only target cancerous areas but also damage healthy tissues, causing side effects... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.