Rapid DNA Test to Detect Clostridium difficile Infection Approved by FDA Today

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Published at: www.medscape.com

Rapid DNA Tests to Detect Clostridium difficile needed in Veterinary Medicine

August 10, 2010

Analysis by: GLG Expert Contributor

Clostridium difficile is a common bacterial intestinal resident in most animals and can serve as a source for transmission to man. Rapid and efficient testing for C. difficile toxins in veterinary medicine would be assistance to infectious disease specialists and public health specialists.

A useful advance

July 28, 2009

Analysis by: GLG Expert Contributor

This test will enable quicker diagnosis of C. difficile colitis in suspicious cases, thus allowing more timely and appropriate therapy

Clostridium difficile PCR-based test may gain quick adoption

July 26, 2009

Analysis by: GLG Expert Contributor

 The FDA has approved a new assay which utilizes the GeneXpert platform and detects Toxin B DNA in less then an hour. The test is very sensitive and specific, and allows precise use of appropriate anti-C. diff. antibiotics early in care. 

A GREAT STEP FORWARD IN RX OF C.DIFFICILE

July 25, 2009

Analysis by: GLG Expert Contributor

A new test was approved by the FDA for the B toxin of C. difficile which caused severe diarrhea and dehydration. The test is 93% sensitive and 94% specific and only takes 45 minutes to complete versus the gold standard culture which takes 3 days.

A Difficult Pathogen Meets its Match

July 23, 2009

Analysis by: GLG Expert Contributor

C. difficile is one of the most pervasive hospital-acquired pathogens. Existing techniques for detecting C. difficile are fraught with problems, including a high incidence of false negatives and false positives. PCR-based testing is a game-changer because it practically eliminates false negatives. Thus, the added cost of PCR testing is recouped many times over.

Rapid DNA Clostridium difficile test useful for public health laboratories.

July 22, 2009

Analysis by: GLG Expert Contributor

Clostridium difficile is a bacterium that infects dogs, cats and other animals and is transmissible from animals to man. It is important for veterinary diagnostic laboratories and public health laboratories to monitor infections of C. difficile as preventative measures and control of zoonotic infections.

Importance of the rapid C.Difficile DNA test

July 22, 2009

Analysis by: GLG Expert Contributor

Availability of this test is an important advance.C.Difficile colitis has drammatically increased in frequency and severity and results in major health care costs.Early diagnosis of the infection with early treatment will improve prognosis.I would expect that the test should be rapidly introduced into clinical practice

New PCR test--statistical improvement, but clinical question mark

July 20, 2009

Analysis by: GLG Expert Contributor

The new Cepheid test that provides improved sensitivity over EIA and faster turnaround time compared to cytotoxicity assays. But acceptance of the new test in hospital laboratories will depend upon demonstration of clinical improvement of diagnosis and a beneficial impact on the cost per episode of care.

Are the New Molecular Assays for CDAD Worth the Cost?

July 20, 2009

Analysis by: GLG Expert Contributor

The new molecular tests detect of genes of Clustridium difficile. They use primers to amplify the toxin(s) gene and the bacterium. The data that justify their sensitivity versus the current antigen detection assays are based on identification of the bacterium and potential for toxin expression. Since normal people can carry C. difficile, some are gene carriers of the toxins, the molecular tests may lead to more false positive results. The newer molecular assays may not be worth the cost.

New Rapid Test for C. Difficile

July 19, 2009

Analysis by: GLG Expert Contributor

C. difficile disease has been spreading throughout hospitals during the last decade. It causes serious diarrhea, dehydration and requires isolation of patients to prevent its spread. Part of the problem is the fact that up until now it took 3 days to make a definitive diagnosis. This new test has both rapid turn around time(45 minutes) and excellent sensitivity(93%) and specificity(94%). It should help to limit the proliferation of Clostridia difficile in the hospital setting.

Will the new rapid test for C difficile be an important advance?

July 19, 2009

Analysis by: GLG Expert Contributor

In patients with C difficile colitis, the usual situation is that when the diarrhea stops during or after treatment, isolation can stop. The biggest benefit of this new test is in validating preliminary identification of newly infected or relapsing patients so that isolation will be used appropriately.

Peter BornsteinEpidemiologist HEALTHEAST CARE SYSTEM

Potential game changer for patients and hospitals regarding C. difficile colitis

July 18, 2009

Clostridium difficile-associated colitis is a disabling, and potentially life-threatening infection.  Moreover, hospitals spend great resources in isolating patients with this disease to prevent infection within the hospital. This new technology from Cepheid offers faster, and more accurate diagnosis, leading to potentially quicker treatment for patients, but potentially huge savings for hospitals, that can shorten isolation periods for these patients.