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

Abstract

AbstractObjectiveDetermine the feasibility 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 in children with pharyngitis and their caregivers.MethodsChildren (aged 5-17 years) with pharyngitis who tested positive for GAS via rapid antigen detection test from a pharyngeal swab were included in the study at an ambulatory care clinic in Madison, WI. Caregiver-child dyads were enrolled in the study so that both could provide user feedback regarding the experience. Immediately after the clinical visit, children were asked to suck on two mouth swabs and two CandyCollect devices. GAS presence was confirmed and measured with qPCR.ResultsAll 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 like to use the CandyCollect if another test was needed. All caregivers (30/30) and most children (28/30) would be willing to use the CandyCollect device at home.ConclusionAll participants (30/30) 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 extending the capabilities of CandyCollect to additional pathogens and shortening collection time while maintaining the attractive form of the device.Article SummaryThis paper reports qPCR data and user feedback from pediatric patients with streptococcal pharyngitis, using a lollipop-inspired sampling device instead of pharyngeal swabs.What’s Known on This SubjectObtaining 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.What This Study AddsCandyCollect devices, a child-preferred lollipop-inspired salivary pathogen collection tool, had 100% concordance with the positive results from traditional pharyngeal swabs processed with a rapid antigen detection test from pediatric patients. CandyCollect could potentially become an alternative sampling tool for diagnosis of streptococcal pharyngitis.Contributors Statement PageWan-chen Tu designed the sample processing protocol, carried out the sample analysis, performed data analysis, made figures for the manuscript, drafted the initial manuscript, and critically reviewed and revised the manuscript.Ingrid Jeacopello fabricated the CandyCollect devices and prepared devices for human subject research, interpreted the data, drafted the initial manuscript, and critically reviewed and revised the manuscript.Andrea Blom advised on study design and execution, enrolled and interacted with the participants, collected the samples and user surveys, accessioned and shipped the samples, interpreted the data, and critically reviewed and revised the manuscript.Elena Alfaro advised on study design and execution, advised on all regulatory aspects, drafted the study protocol and survey instruments, obtained Institutional Review Board (IRB) approval, interpreted the data, and critically reviewed and revised the manuscript.Victoria A. M. Shinkawa, Daniel B. Hatchett, and Juan C. Sanchez fabricated the CandyCollect devices and prepared devices for human subject research and revised the manuscript.Anika M. McManamen and Xiaojing Su designed the sample processing protocol and drafted and revised the manuscript.Erwin Berthier conceptualized the research, advised on study design, and revised the manuscript.Ashleigh B. Theberge, Gregory P. DeMuri, Ellen R. Wald, and Sanitta Thongpang conceptualized the research, designed the study, oversaw study execution, interpreted the data, critically reviewed the manuscript, and revised the manuscript.All authors reviewed and approved the final manuscript as submitted.