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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
Author(s) -
Johansson Karin,
Karlsson Hanna,
Norén Torbjörn
Publication year - 2016
Publication title -
apmis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 88
eISSN - 1600-0463
pISSN - 0903-4641
DOI - 10.1111/apm.12595
Subject(s) - clostridium difficile , immunoassay , microbiology and biotechnology , clinical microbiology , clostridium infections , c difficile , clostridiaceae , enzyme , clostridium , medicine , virology , biology , bacteria , antibiotics , immunology , antibody , toxin , biochemistry , genetics
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.