ImmunoCard Toxins A&B

The First Rapid Enzyme Immunoassay for the Detection of Clostridium difficile Toxins A and B

Clostridium difficile–associated disease (CDAD)
C. difficile, a sporigen gram positive bacterium, is the major cause of antibiotic-associated and pseudomembranous colitis. Most patients acquire this organism as nosocomial infections, after prophylactic antibiotic treatments which alter the normal gut flora. Pathogenic C. difficile strains overgrow and produce two toxins: toxin A, an enterotoxin causing diarrhea and mucosal injury, and toxin B, a potent cytotoxin.
Since the C. difficile-associated disease (CDAD) is life-threatening, the diagnosis should be performed as soon as possible in order to start the appropriate therapy, based on Vancomycin or Metronidazole.
An empirical treatment should be avoided since the inappropriate use of antibiotics is costly and can produce side effects and antibiotic resistance.
A rapid diagnosis is also important to prevent the spore diffusion, patient-to-patient infection and nosocomial outbreaks.

CDAD diagnosis: importance of detecting both toxin A and toxin B
The cytotoxicity assay, detecting the toxin B and considered the “gold standard” because its high sensitivity, suffers from lack of standardisation and is expensive and time consuming. A number of commercial immunoassays are available for the detection of toxin A, as microtiter or rapid assays.
Several outbreaks produced by toxin A negative / toxin B positive strains are now supporting the importance of detecting both toxins for an increased sensitivity and the use of “toxin A only” tests is therefore discouraged.
While some microtiter enzyme immunoassays are able to detect both toxins, so far only Toxin A tests are available as rapid single tests.

ImmunoCard Toxins A&B
The new ImmunoCard Toxins A&B is a single test enzyme immunoassay for the rapid detection of C. difficile toxin A and toxin B. The EIA technique provides high accuracy with sensitivity and specificity values comparable to the microtiter based EIA Premier Toxins A&B. The new test allows the detection of all toxigenic strains of C. difficile, toxin A negative/toxin B positive included, in 15 minutes.
The test can be performed on demand providing immediate indications to the clinician for proper therapy of the patients. No sample pre-treatment is required, the reagents are ready-to-use and an internal procedure control is integrated in each card. The new ImmunoCard can also be used as culture confirmation for toxins from broth enrichments.
The ImmunoCard Toxins A&B is the convenient choice when testing a limited number of specimens and a rapid result is desired without compromising the sensitivity of the results.

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