{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,23]],"date-time":"2025-08-23T00:08:28Z","timestamp":1755907708141,"version":"3.44.0"},"reference-count":25,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T00:00:00Z","timestamp":1755820800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:p>Obtaining a stool specimen for diagnostic testing of enteric conditions (e.g., gastroenteritis) can be a challenging and unpleasant experience. A person is required to obtain a sample pot from a healthcare location, return home and wait until they have a bowel motion, and then deal with the challenges of returning the sample to the clinic or pathology centre. This trial aims to identify whether the simpler approach of obtaining a rectal swab is effective for diagnosing enteric conditions. Recruitment will take place in a variety of settings, including suspected norovirus clusters, Hepatitis A clusters, in both hospital, and community settings. We will compare paired stool and rectal swab sample polymerase chain reaction (PCR) testing to determine whether rectal swabs are a reliable proxy for faecal sampling. Persons who would normally be provided with a faecal specimen container, will also be provided with a rectal swab for self-collection or clinician-collection (within 24 hours of the bulk faeces collection). We will assess the sensitivity, specificity, positive predictive value, negative predictive value using standard confusion matrix. The gold standard reference will be considered the bulk faeces PCR tests. We hypothesise that rectal swab PCR testing will be equally as effective as bulk faeces PCR testing. If successful, rectal swab PCR testing could be implemented as routine practice with several key benefits. Firstly, it would improve the patient experience by conveniently enabling stool collection at the point of care, which is rarely possible currently. Secondly, it would reduce healthcare costs, and streamline collection processes by eliminating the need for persons to return to a clinic to deliver specimen. Thirdly, the ease of testing will likely increase testing rates and compliance, leading to better diagnoses and more accurate clinical care. The protocol described has the potential to revolutionise daily clinical practice.<\/jats:p>\n<jats:p><jats:bold>Trial registration<\/jats:bold>: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12624000095561.<\/jats:p>","DOI":"10.1371\/journal.pone.0329643","type":"journal-article","created":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T17:39:13Z","timestamp":1755884353000},"page":"e0329643","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Rectal swabs vs bulk faeces PCR testing for the diagnosis of enteric conditions (RecSwabFaeces): Protocol for a single group diagnostic accuracy comparative trial"],"prefix":"10.1371","volume":"20","author":[{"given":"Madisen Sadie","family":"Roser","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Megan K.","family":"Young","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dustylee","family":"Williams","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shradha","family":"Subedi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donna","family":"Barnekow","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alyssa","family":"Pyke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacob","family":"Tickner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Glen","family":"Hewitson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8398-8661","authenticated-orcid":true,"given":"Michael","family":"Thomas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gulam","family":"Khandaker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanmarie","family":"Schlebusch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6923-9701","authenticated-orcid":true,"given":"Nicolas Roydon","family":"Smoll","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,8,22]]},"reference":[{"issue":"628","key":"pone.0329643.ref001","doi-asserted-by":"crossref","DOI":"10.3399\/bjgp14X682261","article-title":"Patients\u2019 perspectives on providing a stool sample to their GP: a qualitative study","volume":"64","author":"DM Lecky","year":"2014","journal-title":"Br J Gen Pract"},{"issue":"1","key":"pone.0329643.ref002","doi-asserted-by":"crossref","first-page":"493","DOI":"10.1038\/s41598-022-27131-9","article-title":"Rectal swabs as a viable alternative to faecal sampling for the analysis of gut microbiota functionality and composition","volume":"13","author":"ST Radhakrishnan","year":"2023","journal-title":"Sci Rep"},{"issue":"1","key":"pone.0329643.ref003","doi-asserted-by":"crossref","DOI":"10.1186\/s13756-018-0434-x","article-title":"The acceptability of screening for Carbapenemase Producing Enterobacteriaceae (CPE): cross-sectional survey of nursing staff and the general publics\u2019 perceptions","volume":"7","author":"K Currie","year":"2018","journal-title":"Antimicrob Resist Infect Control"},{"key":"pone.0329643.ref004","volume-title":"National Health and Medical Research Council. Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) [Internet]","year":"2019"},{"issue":"10","key":"pone.0329643.ref005","doi-asserted-by":"crossref","first-page":"2223","DOI":"10.1002\/ijc.27790","article-title":"High-risk HPV testing on self-sampled versus clinician-collected specimens: A review on the clinical accuracy and impact on population attendance in cervical cancer screening","volume":"132","author":"PJF Snijders","year":"2013","journal-title":"Int J Cancer"},{"issue":"4","key":"pone.0329643.ref006","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcv.2011.05.025","article-title":"Rectal swabs can be used for diagnosis of viral gastroenteritis with a multiple real-time PCR assay","volume":"51","author":"L Gustavsson","year":"2011","journal-title":"J Clin Virol"},{"key":"pone.0329643.ref007","doi-asserted-by":"crossref","first-page":"208","DOI":"10.1186\/s40814-021-00928-7","article-title":"Rectal specimen self-collection for chlamydia and gonorrhea screening: a cross-sectional feasibility study at a community health center","volume":"7","author":"MS Haddad","year":"2021","journal-title":"Pilot Feasibility Studies"},{"issue":"6122","key":"pone.0329643.ref008","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1016\/S0140-6736(01)08403-3","article-title":"An outbreak of sonne dysentery","volume":"236","author":"R Cruickshank","year":"1940","journal-title":"The Lancet"},{"issue":"4884","key":"pone.0329643.ref009","article-title":"Disadvantages of the rectal swab in diagnosis of diarrhoea","volume":"2","author":"MEM Thomas","year":"1954","journal-title":"Br Med J"},{"issue":"2","key":"pone.0329643.ref010","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1016\/j.diagmicrobio.2006.04.003","article-title":"Comparison of rectal swabs with fecal cultures for detection of Salmonella typhimurium in adult volunteers","volume":"56","author":"CN Kotton","year":"2006","journal-title":"Diagn Microbiol Infect Dis"},{"issue":"6","key":"pone.0329643.ref011","doi-asserted-by":"crossref","first-page":"733","DOI":"10.1016\/j.cmi.2018.09.026","article-title":"Evaluation of rectal swab use for the determination of enteric pathogens: a prospective study of diarrhoea in adults","volume":"25","author":"T Kotar","year":"2019","journal-title":"Clin Microbiol Infect"},{"key":"pone.0329643.ref012","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1186\/1471-2334-13-447","article-title":"Comparison of rectal swabs and faeces for real-time PCR detection of enteric agents in Rwandan children with gastroenteritis","volume":"13","author":"JC Kabayiza","year":"2013","journal-title":"BMC Infect Dis"},{"issue":"12","key":"pone.0329643.ref013","doi-asserted-by":"crossref","DOI":"10.1111\/1469-0691.12723","article-title":"Rectal swab for detection of norovirus by real-time PCR: similar sensitivity compared to faecal specimens","volume":"20","author":"JA Sidler","year":"2014","journal-title":"Clin Microbiol Infect"},{"key":"pone.0329643.ref014","doi-asserted-by":"crossref","DOI":"10.1017\/S0950268818003515","article-title":"Outbreak of hepatitis A genotype IB in Australia associated with imported frozen pomegranate arils","volume":"147","author":"N Franklin","year":"2019","journal-title":"Epidemiol Infect"},{"issue":"2","key":"pone.0329643.ref015","doi-asserted-by":"crossref","first-page":"248","DOI":"10.3346\/jkms.2014.29.2.248","article-title":"Clinical Characteristics and Outcomes of Acute Hepatitis A in Korea: A Nationwide Multicenter Study","volume":"29","author":"SY Kwon","year":"2014","journal-title":"J Korean Med Sci"},{"key":"pone.0329643.ref016","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1016\/j.jbi.2014.02.013","article-title":"Sample size estimation in diagnostic test studies of biomedical informatics","volume":"48","author":"K Hajian-Tilaki","year":"2014","journal-title":"J Biomed Inform"},{"issue":"1","key":"pone.0329643.ref017","article-title":"Accuracy and comparison of two rapid multiplex PCR tests for gastroenteritis pathogens: a systematic review and meta-analysis","volume":"8","author":"L-J Chang","year":"2021","journal-title":"BMJ Open Gastroenterol"},{"issue":"12","key":"pone.0329643.ref018","doi-asserted-by":"crossref","first-page":"1485","DOI":"10.1097\/CM9.0000000000000841","article-title":"Molecular diagnostic practices for infectious gastroenteritis","volume":"133","author":"N Shen","year":"2020","journal-title":"Chin Med J (Engl)"},{"issue":"7","key":"pone.0329643.ref019","doi-asserted-by":"crossref","DOI":"10.1093\/ofid\/ofae322","article-title":"Multiplex Gastrointestinal Panel Testing in Hospitalized Patients With Acute Diarrhea in Thailand","volume":"11","author":"A Jitmuang","year":"2024","journal-title":"Open Forum Infect Dis"},{"issue":"7","key":"pone.0329643.ref020","doi-asserted-by":"crossref","first-page":"1900","DOI":"10.1007\/s10620-018-5087-3","article-title":"The Distribution of Enteric Infections Utilizing Stool Microbial Polymerase Chain Reaction Testing in Clinical Practice","volume":"63","author":"JE Axelrad","year":"2018","journal-title":"Dig Dis Sci"},{"key":"pone.0329643.ref021","unstructured":"Office for Civil Rights. Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule [Internet]. HHS.gov. 2012 [cited 2023 Jul 13]. Available from: https:\/\/www.hhs.gov\/hipaa\/for-professionals\/privacy\/special-topics\/de-identification\/index.html"},{"key":"pone.0329643.ref022","unstructured":"OAIC. Guide to data analytics and the Australian Privacy Principles [Internet]. OAIC. 2023 [cited 2023 Jul 13]. Available from: https:\/\/www.oaic.gov.au\/privacy\/privacy-guidance-for-organisations-and-government-agencies\/more-guidance\/guide-to-data-analytics-and-the-australian-privacy-principles"},{"key":"pone.0329643.ref023","volume-title":"De-identification and the Privacy Act [Internet]","author":"Office of the Australian Information Commissioner","year":"2018"},{"key":"pone.0329643.ref024","unstructured":"Information and Privacy Commisioner of Ontario. De-identification Guidelines for Structured Data [Internet]. [cited 2023 Jul 13]. Available from: https:\/\/www.ipc.on.ca\/wp-content\/uploads\/2016\/08\/Deidentification-Guidelines-for-Structured-Data.pdf"},{"key":"pone.0329643.ref025","unstructured":"O\u2019Keefe C, Otorepec S, Elliot M, Mackey E, O\u2019Hara K. The De-Identification Decision-Making Framework. CSIRO Rep [Internet]. 2017 Sep 18 [cited 2023 Jul 13];EP173122 and EP175702. Available from: https:\/\/publications.csiro.au\/publications\/publication\/PIcsiro:EP173122"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0329643","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T17:39:18Z","timestamp":1755884358000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0329643"}},"subtitle":[],"editor":[{"given":"Tsegaye","family":"Alemayehu","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,8,22]]},"references-count":25,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2025,8,22]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0329643","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,22]]}}}