Journal of Clinical Microbiology
Journal of Clinical Microbiology
5 years ago

Evaluation of the Copan FecalSwab™ as Specimen Type for use in Xpert® C. difficile Assay.

Ledeboer NA, Buchan BW, Faron ML, Mashock MJ
Liquid based microbiology (LBM) devices incorporating flocked swabs and preservation medium eases transport of specimens and improves specimen yield compared to traditional fiber wound swabs; however, the performance of LBM collection devices has not been evaluated in many molecular assays. It is unclear how the differences in matrix and specimen loading with an LBM device will affect test performance compared to traditional collection devices. The purpose of this study was to evaluate the performance of specimens collected in FecalSwab™ transport medium (Copan Diagnostics, Murrieta CA) compared to unpreserved stool using the Cepheid Xpert C. difficile assay (Cepheid, Sunnyvale, CA). Results equivalent to unpreserved stool samples were obtained when 400uL of FecalSwab™ preserved stool was employed in the Xpert assay. The positive and negative percent agreement of specimens inoculated with FecalSwab™ media (n = 281) was 97.0% (95% CI 90.9 to 96.4%) and 99.4% (95% CI 96.4 to 99.9%), respectively, compared to reference results obtained using unpreserved stool. Throughout this study only four discrepant results occurred when comparing preserved specimens to unpreserved stool specimens in the Xpert C. difficile PCR assay. After post discrepant analysis, using the BD MAX Cdiff assay, the specificity and sensitivity both increased to 100%. The high positive and negative percent agreement observed in this study suggests that stool preserved media in FecalSwab™ yields equivalent results to using unpreserved stool when tested on the Xpert C. difficile assay, allowing laboratories to adopt this liquid based microbiology collection device.

Publisher URL: https://www.ncbi.nlm.nih.gov/pubmed/28794179

DOI: PubMed:28794179

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