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C. difficile Testing
How often should we repeat C. difficile toxin EIA testing for the same patient?

Physicians may order a second C. difficile toxin test on a patient to confirm that the patient no longer has C. difficile. No EIA toxin test has been cleared for use as a test of cure. On some occasions, the physician may order repeat tests on patients with previously negative C. difficile toxin tests, but who may continue to display symptoms of CDI. It has been reported that repeat testing should be performed 48 hours after the original negative test.1 Each hospital’s pathology staff should determine whether repeat testing is efficacious.

Does Meridian have a pediatric claim for the ImmunoCard® Toxin AB assays?

The age of the patients included in the clinical trial ranged from 1 to 99 years. Males and females were equally represented. Less than 2% of the 591 samples tested were from pediatric patients less than 16 years of age; therefore, the product’s package insert carries the limitation that the performance of specimens from pediatric patients has not been evaluated.

Are Cary-Blair or C&S approved transport media for the collection of samples for Premier and ImmunoCard® Toxin A&B and ImmunoCard® C. difficile assays?

Meridian Bioscience has not validated use of specimens in Cary-Blair or C&S on the Premier or ImmunoCard® C. difficile assays. Specimens should be collected in clean, airtight containers with no preservative, and processed as soon as possible.

Reference

1. Cardona DM, Rand KH. Evaluation of repeat Clostridium difficile enzyme immunoassay testing. J Clin Microbiol. 2008;46:3686–3689.