Ultrasensitive Detection of Clostridioides difficile Toxins A and B by Use of Automated Single-Molecule Counting Technology

Journal of Clinical Microbiology
Johanna SandlundNiaz Banaei

Abstract

Current tests for the detection of Clostridioides (formerly Clostridium) difficile free toxins in feces lack sensitivity, while nucleic acid amplification tests lack clinical specificity. We have evaluated the Singulex Clarity C. diff toxins A/B assay (currently in development), an automated and rapid ultrasensitive immunoassay powered by single-molecule counting technology, for detection of C. difficile toxin A (TcdA) and toxin B (TcdB) in stool. The analytical sensitivity, analytical specificity, repeatability, and stability of the assay were determined. In a clinical evaluation, frozen stool samples from 311 patients with suspected C. difficile infection were tested with the Clarity C. diff toxins A/B assay, using an established cutoff value. Samples were tested with the Xpert C. difficile/Epi assay, and PCR-positive samples were tested with an enzyme immunoassay (EIA) (C. Diff Quik Chek Complete). EIA-negative samples were further tested with a cell cytotoxicity neutralization assay. The limits of detection for TcdA and TcdB were 0.8 and 0.3 pg/ml in buffer and 2.0 and 0.7 pg/ml in stool, respectively. The assay demonstrated reactivity to common C. difficile strains, did not show cross-reactivity to common gastrointestinal ...Continue Reading

References

Oct 6, 2005·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Jacques PépinLuc Lanthier
Mar 3, 2009·Nature·Dena LyrasJulian I Rood
Apr 28, 2009·Journal of Microbiological Methods·Xiangyun HeHanping Feng
May 11, 2010·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Vhairi WilsonMartin J Llewelyn
Aug 27, 2010·Indian Journal of Gastroenterology : Official Journal of the Indian Society of Gastroenterology·Chintan ModiGeorge Perez
Sep 17, 2010·Nature·Sarah A KuehneNigel P Minton
Jul 21, 2012·European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology·J L LeslieC R Polage
Feb 27, 2013·The American Journal of Gastroenterology·Christina M SurawiczBrian S Zuckerbraun
Feb 26, 2015·The New England Journal of Medicine·Fernanda C LessaL Clifford McDonald
Sep 9, 2015·JAMA Internal Medicine·Christopher R PolageStuart H Cohen
Oct 30, 2015·Journal of Clinical Microbiology·Larry K Kociolek, Dale N Gerding
Jul 28, 2016·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·M J T CrobachE J Kuijper
Nov 5, 2016·Biochemia Medica·Farrokh HabibzadehMahboobeh Yadollahie
Jan 13, 2017·Journal of Clinical Microbiology·Ferric C FangMark H Wilcox
Jun 16, 2017·Journal of Clinical Microbiology·Fiona SenchynaNiaz Banaei
Feb 20, 2018·Infection Control and Hospital Epidemiology : the Official Journal of the Society of Hospital Epidemiologists of America·Donna M SchoraElena A Usacheva
Feb 21, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·L Clifford McDonaldMark H Wilcox
May 23, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Nira R PollockCiaran P Kelly

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Citations

Jan 8, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Stuart Johnson
Aug 27, 2019·Therapeutic Advances in Infectious Disease·Robert Orenstein, Roberto L Patron
Apr 10, 2020·Journal of Clinical Microbiology·Johanna SandlundMark H Wilcox
Aug 23, 2019·BMJ : British Medical Journal·Benoit GueryFrédéric Barbut
Aug 3, 2020·Current Opinion in Critical Care·Benoit GuerySarah Tschudin-Sutter
Feb 15, 2021·Journal of Immunological Methods·Madhu PrabhakaranAdrian B McDermott
Mar 9, 2021·Expert Review of Molecular Diagnostics·Masako Mizusawa, Karen C Carroll
Mar 26, 2021·Current Infectious Disease Reports·Frances J BolyJennie H Kwon

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