TY - JOUR
T1 - Evaluation of 4 molecular assays as part of a 2-step algorithm for the detection of Clostridium difficile in stool specimens
AU - Caulfield, Adam J.
AU - Bolster LaSalle, Catherine M.
AU - Chang, Yu Hui H.
AU - Grys, Thomas E.
N1 - Publisher Copyright:
© 2018
PY - 2018/5
Y1 - 2018/5
N2 - Detection of Clostridium difficile infection is important for clinical laboratories, owing to debilitating disease, severe outcomes, patient awareness, and public reporting of hospital data. This study evaluated the performance of 4 nucleic acid amplification test (NAAT) assays as part of a 2-step algorithm that involves reflexive NAAT following enzyme immunoassay (EIA) testing that is indeterminate for glutamate dehydrogenase (GDH) antigen and toxin A/B (GDH+/toxin− or GDH−/toxin+). A total of 500 stool specimens from consecutive patients were tested by each of the 5 methods and also evaluated as part of a 2-step algorithm. A specimen was considered positive for presence of C. difficile if it tested positive by 3 of 4 molecular methods or toxigenic culture. The sensitivity and specificity of the GDH-EIA method were each 93%. The toxin EIA had only 48% sensitivity, but it had 99% specificity. Sensitivity and specificity of 2-step algorithmic testing ranged from 88% to 93% and 99% to 100%, respectively, offering similar performance to stand-alone NAAT testing.
AB - Detection of Clostridium difficile infection is important for clinical laboratories, owing to debilitating disease, severe outcomes, patient awareness, and public reporting of hospital data. This study evaluated the performance of 4 nucleic acid amplification test (NAAT) assays as part of a 2-step algorithm that involves reflexive NAAT following enzyme immunoassay (EIA) testing that is indeterminate for glutamate dehydrogenase (GDH) antigen and toxin A/B (GDH+/toxin− or GDH−/toxin+). A total of 500 stool specimens from consecutive patients were tested by each of the 5 methods and also evaluated as part of a 2-step algorithm. A specimen was considered positive for presence of C. difficile if it tested positive by 3 of 4 molecular methods or toxigenic culture. The sensitivity and specificity of the GDH-EIA method were each 93%. The toxin EIA had only 48% sensitivity, but it had 99% specificity. Sensitivity and specificity of 2-step algorithmic testing ranged from 88% to 93% and 99% to 100%, respectively, offering similar performance to stand-alone NAAT testing.
KW - Clostridium difficile
KW - Diagnostic assay
KW - GDH
KW - Glutamate dehydrogenase
KW - NAAT
KW - Nucleic acid amplification test
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U2 - 10.1016/j.diagmicrobio.2017.12.018
DO - 10.1016/j.diagmicrobio.2017.12.018
M3 - Article
C2 - 29428547
AN - SCOPUS:85044717569
SN - 0732-8893
VL - 91
SP - 1
EP - 5
JO - Diagnostic Microbiology and Infectious Disease
JF - Diagnostic Microbiology and Infectious Disease
IS - 1
ER -