title: False-Positive Clostridium difficile in Negative-Control Reactions Peak and Then Decrease with Repetitive Refrigeration of Immunoassay.
abstract: Aberrant false-positive reactions in negative-controls during ELISA testing for Clostridium difficile indicated the potential for false-diagnoses. Experiments with 96-well products showed a maximum peak of false-positive immunoassay reactions with the provided negative-control reagents after 5 refrigeration-to-room temperature cycles (P < 0.001), decreasing thereafter with additional refrigeration cycles. Because repetitive refrigeration causes a peak of false-positives, the use of single negative-controls per ELISA run might be insufficient to monitor aberrant preanalytical false-positives if immunoassays are subject to repetitive refrigeration.
authors.affiliation: Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, NY 14580, USA; Division of Gastroenterology and Liver Disease, Case Western Reserve University, Cleveland, OH 44106, USA.
authors.forename: Alexander
authors.initials: A
authors.lastname: Rodriguez-Palacios
authors.affiliation: Department of Clinical Studies, University of Guelph, Guelph, ON, Canada N1G 2W1.
authors.forename: Henry R
authors.initials: HR
authors.lastname: Stämpfli
authors.affiliation: Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, NY 14580, USA.
authors.forename: Yung-Fu
authors.identifier: 0000-0001-8902-3089
authors.initials: YF
authors.lastname: Chang