Abstract
Recovery of Neisseria gonorrhoeae isolates exposed to a range of transport times and temperatures was quantitatively assessed for two transport devices, BioMed Diagnostics' InTray GC® and Copan Diagnostics' Liquid Amies Elution Swab (ESwab®) Collection and Transport System. Respective devices were inoculated with N. gonorrhoeae, exposed to simulated transport conditions and spread-plated from serial dilutions in duplicates onto chocolate agar in order to count CFU (colony-forming units) in the range of 25-250. Baseline CFU/mL averages of time-zero transport for each device was compared to either 24 hour (Eswab) or 72 hour (InTray GC) CFU/mL average to assess recovery of six clinical isolates of N. gonorrhoeae, and differences showing no greater than a 3 log10 (± 10%) decline between comparative time points qualified as acceptable. Our findings suggest that the InTray GC system has the potential to transport clinical isolates for ≤72 hours with acceptable N. gonorrhoeae recovery.
Highlights
Neisseria gonorrhoeae is a gram-negative obligate human pathogen and the etiological agent of gonorrhea
The purpose of this study was to receive approval from the U.S Food and Drug Administration (FDA) to modify the intended use to extend the allowable times that the InTray GC device could be used to transport specimens; the methods were chosen to demonstrate viability based on FDA standards
The experimental groups consisted of N. gonorrhoeae inoculated onto the InTray GC transport devices (BioMed Diagnostics, Inc., OR, USA), and onto the Liquid Amies Elution Swab (ESwab) Collection and Transport System (Copan Diagnostics, CA, USA)
Summary
Neisseria gonorrhoeae is a gram-negative obligate human pathogen and the etiological agent of gonorrhea. Gonorrhea is the second most commonly reported notifiable infection in the U.S and has experienced a 63% increase in cases since 2014, including a 5.0% increase in incidence in 2018 alone [2]. As of 2016, the global incidence of infection with N. gonorrhoeae was 87 million cases per year [3]. A single 500 mg dose of intramuscular ceftriaxone is the CDC-recommended first-line drug therapy for uncomplicated anogenital and pharyngeal gonorrhea in adults [4]. In the United States, antibiotic resistance trends are monitored by the CDC’s Gonococcal Isolate Surveillance Program (GISP), which has used resistance surveillance data since the 1980s to stop recommending penicillin, tetracycline, fluoroquinolones, cefixime, and other oral cephalosporins to treat gonorrhea [5].
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