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
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
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.
Clostridium difficile, diagnostics, glutamate dehydrogenase, toxin A/B EIA
Clinical Laboratory Medicine Immunology in the medical area Microbiology in the medical area
IdentifiersURN: urn:nbn:se:oru:diva-52522DOI: 10.1111/apm.12595ISI: 000388264900014PubMedID: 27651167ScopusID: 2-s2.0-84992088607OAI: oai:DiVA.org:oru-52522DiVA: diva2:974329