Kaivon Pakzad-Vaezi1, Steve D Levasseur1, Steven Schendel1, Sean Mark2, Richard Mathias2, Diane Roscoe3, Simon P Holland4. 1. Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, Canada. 2. School of Population and Public Health, University of British Columbia, Vancouver, Canada. 3. Division of Medical Microbiology and Infection Control, Vancouver General Hospital and Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada. 4. Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, Canada. Electronic address: drsimonholland@gmail.com.
Abstract
PURPOSE: To determine if a new, single-sample device (ESwab; Copan Diagnostics, Inc) can simplify the traditional multi-sample approach to specimen collection in infectious keratitis. DESIGN: Prospective, diagnostic test evaluation. METHODS: In this institutional study, patients with suspected infectious keratitis meeting traditional criteria for diagnostic corneal specimen collection and culture were randomized to the order of first specimen collection method: ESwab or a sample directly plated for growth on chocolate agar. This was followed by standard samples for blood agar, Gram stain, Sabouraud agar, thioglycolate broth, and brain heart infusion broth in all cases. The specimens collected using the 2 approaches were analyzed separately by the laboratory in a masked fashion. The main outcome measure was positive growth on cultured media. RESULTS:Eighty-one eyes from 80 consecutive patients were sampled. Culture positivity rate for the multi-sample method and ESwab was 70% and 69%, respectively, with a 75% agreement rate. ESwab sensitivity was 84% (95% confidence interval [CI]: 72%-93%), with a specificity of 67% (95% CI: 45%-84%). Positive and negative predictive values of the ESwab were 86% (95% CI: 74%-94%) and 64% (95% CI: 43%-82%), respectively. There was no difference in positive culture reports with respect to the order of specimen collection technique used. CONCLUSIONS: The single-sample ESwab method is a more accessible and less cumbersome approach to corneal culturing for ophthalmologists, particularly those in the community setting who do not have access to the full set of traditional culture materials. Culture results using this single-sample approach were comparable to the multi-sample method.
RCT Entities:
PURPOSE: To determine if a new, single-sample device (ESwab; Copan Diagnostics, Inc) can simplify the traditional multi-sample approach to specimen collection in infectious keratitis. DESIGN: Prospective, diagnostic test evaluation. METHODS: In this institutional study, patients with suspected infectious keratitis meeting traditional criteria for diagnostic corneal specimen collection and culture were randomized to the order of first specimen collection method: ESwab or a sample directly plated for growth on chocolateagar. This was followed by standard samples for blood agar, Gram stain, Sabouraud agar, thioglycolate broth, and brain heart infusion broth in all cases. The specimens collected using the 2 approaches were analyzed separately by the laboratory in a masked fashion. The main outcome measure was positive growth on cultured media. RESULTS: Eighty-one eyes from 80 consecutive patients were sampled. Culture positivity rate for the multi-sample method and ESwab was 70% and 69%, respectively, with a 75% agreement rate. ESwab sensitivity was 84% (95% confidence interval [CI]: 72%-93%), with a specificity of 67% (95% CI: 45%-84%). Positive and negative predictive values of the ESwab were 86% (95% CI: 74%-94%) and 64% (95% CI: 43%-82%), respectively. There was no difference in positive culture reports with respect to the order of specimen collection technique used. CONCLUSIONS: The single-sample ESwab method is a more accessible and less cumbersome approach to corneal culturing for ophthalmologists, particularly those in the community setting who do not have access to the full set of traditional culture materials. Culture results using this single-sample approach were comparable to the multi-sample method.