Capture of Group A Streptococcus by Open-Microfluidic CandyCollect Device in Pediatric Patients

Abstract Importance Obtaining high-quality samples to diagnose streptococcal pharyngitis in pediatric patients is challenging due to discomfort associated with traditional pharyngeal swabs. This may cause reluctance to go to the clinic, inaccurate diagnosis, or inappropriate treatment for children with sore throat.Objective Determine the efficacy of using CandyCollect, a lollipop-inspired open-microfluidic pathogen collection device, to capture Group A Streptococcus (GAS) and compare user preference for CandyCollect, conventional pharyngeal swabs, or mouth swabs among children with pharyngitis and their caregivers.Design Participants of this cohort study were recruited over a 7-month period in 2022 – 2023.Setting This study was conducted at an ambulatory care clinic that serves pediatric patients in the Madison, Wisconsin, metropolitan area.Participants Study participants were diagnosed with GAS pharyngitis using a traditional pharyngeal swab via rapid antigen detection test (RADT); those testing positive were approached or reached out to about participation in the study. A total of 74 caregiver/children dyads were contacted about the study: 23 declined to participate; 21 were not eligible; and 30 willing and eligible participants were admitted into the study. A caregiver provided verbal consent and parental permission, and all children provided verbal assent. Immediately after the standard of care visit in which the throat swab was obtained, a research nurse guided participants through collecting oral samples: CandyCollect device and mouth swab (ESwabTM). CandyCollect and mouth swab samples were analyzed for GAS by quantitative polymerase chain reaction (qPCR) at the University of Washington.Exposure Detection of salivary GAS using qPCR analysis of samples obtained from CandyCollect devices and mouth swabs.Main Outcome(s) and Measure(s) The proportion of pediatric patients with GAS pharyngitis, as determined by a positive pharyngeal swab tested via a RADT, who were also positive using a CandyCollect and mouth swab analyzed by qPCR.Results All child participants (30/30) were positive for GAS by qPCR on both the mouth swab and CandyCollect. Caregivers ranked CandyCollect as a good sampling method overall (27/30), and all caregivers (30/30) would recommend the CandyCollect for children 5 years and older. Twenty-three of 30 children “really like” the taste and 24/30 would prefer to use the CandyCollect if a future test was needed. All caregivers (30/30) and most children (28/30) would be willing to use the CandyCollect device at home.Conclusion and relevance All participants tested positive for GAS on all three collection methods (pharyngeal swab, mouth swab, and CandyCollect). While both caregivers and children like the CandyCollect device, some caregivers would prefer a shorter collection time. Future work includes additional studies with larger cohorts presenting with pharyngitis of unknown etiology and shortening collection time, while maintaining the attractive form of the device.Trial Registration Registry name:<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link>Identifier:<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT05175196">NCT05175196</jats:ext-link>Weblink:<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://classic.clinicaltrials.gov/ct2/show/NCT05175196">https://classic.clinicaltrials.gov/ct2/show/NCT05175196</jats:ext-link>Key Points Question In pediatric patients with Group A Streptococcus pharyngitis, how do test results and user experience compare across three sampling methods—CandyCollect devices, mouth swabs, and pharyngeal swabs?Findings In this cohort study of 30 children, aged 5-14 years, saliva samples were collected with CandyCollect devices and mouth swabs and analyzed via qPCR. The results show CandyCollect, a pathogen collection tool preferred by children, had 100% concordance with the results from pharyngeal swabs positive with a rapid antigen detection test performed as part of their clinical care.Meaning With further development and testing, the CandyCollect device may potentially become an alternative sampling tool for the diagnosis of streptococcal pharyngitis..

Medienart:	Preprint

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	bioRxiv.org - (2024) vom: 22. Apr. Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Beteiligte Personen:

Tu, Wan-chen [VerfasserIn] Jeacopello, Ingrid [VerfasserIn] Blom, Andrea [VerfasserIn] Alfaro, Elena [VerfasserIn] Shinkawa, Victoria A. M. [VerfasserIn] Hatchett, Daniel B. [VerfasserIn] Sanchez, Juan C. [VerfasserIn] McManamen, Anika M. [VerfasserIn] Su, Xiaojing [VerfasserIn] Berthier, Erwin [VerfasserIn] Thongpang, Sanitta [VerfasserIn] Wald, Ellen R. [VerfasserIn] DeMuri, Gregory P. [VerfasserIn] Theberge, Ashleigh B. [VerfasserIn]

Links:	Volltext [kostenfrei]

Themen:	570 Biology

doi:	10.1101/2023.12.14.23299923

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	XBI041899466