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Clostridium difficile infection diagnostics: evaluation of the C. DIFF Quik Chek Complete assay, a rapid enzyme immunoassay for detection of toxigenic C. difficile in clinical stool samples
Department of Laboratory Medicine, Molecular Diagnostics, Örebro University Hospital, Örebro.
Department of Laboratory Medicine, Molecular Diagnostics, Örebro University Hospital, Örebro.
Örebro University, School of Medical Sciences. Department of Laboratory Medicine, Clinical Microbiology.
2016 (English)In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), ISSN 0903-4641, E-ISSN 1600-0463, Vol. 124, no 11, 1016-1020 p.Article in journal (Refereed) Published
Abstract [en]

Diagnostic testing for Clostridium difficile infection (CDI) has, in recent years, seen the introduction of rapid dual-EIA (enzyme immunoassay) tests combining species-specific glutamate dehydrogenase (GDH) with toxin A/B. In a prospective study, we compared the C. DIFF Quik Chek Complete test to a combination of selective culture (SC) and loop-mediated isothermal amplification (LAMP) of the toxin A gene. Of 419 specimens, 68 were positive in SC including 62 positive in LAMP (14.7%). The combined EIA yielded 82 GDH positives of which 47 were confirmed toxin A/B positive (11%) corresponding to a sensitivity and specificity of 94% for GDH EIA compared to SC and for toxin A/B EIA a sensitivity of 71% and a specificity of 99% compared to LAMP. Twenty different PCR ribotypes were evenly distributed except for UK 081 where only 25% were toxin A/B positive compared to LAMP. We propose a primary use of a combined GDH toxin A/B EIA permitting a sensitive 1-h result of 379 of 419 (90%, all negatives plus GDH and toxin EIA positives) referred specimens. The remaining 10% being GDH positive should be tested for toxin A/B gene on the same day and positive results left to a final decision by the physician.

Place, publisher, year, edition, pages
Hoboken, NJ, USA: Wiley-Blackwell Publishing Inc., 2016. Vol. 124, no 11, 1016-1020 p.
Keyword [en]
Clostridium difficile, diagnostics, glutamate dehydrogenase, toxin A/B EIA
National Category
Clinical Laboratory Medicine Immunology in the medical area Microbiology in the medical area
Identifiers
URN: urn:nbn:se:oru:diva-52522DOI: 10.1111/apm.12595ISI: 000388264900014PubMedID: 27651167Scopus ID: 2-s2.0-84992088607OAI: oai:DiVA.org:oru-52522DiVA: diva2:974329
Available from: 2016-09-26 Created: 2016-09-26 Last updated: 2016-12-19Bibliographically approved

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