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Treatment decisions following impact surveys and in post-control surveillance for communities are currently based on the prevalence of clinical signs, which may result in further unnecessary distribution of mass antibiotic treatment and the increased spread of macrolide resistance alleles in \u2018off-target\u2019 bacterial species. We therefore developed a simple, fast, low cost diagnostic assay (DjinniChip) for diagnosis of ocular\n                      <jats:italic>C. trachomatis<\/jats:italic>\n                      for use by trachoma control programmes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study was conducted in the UK, Germany and Tanzania. For clinical testing in Tanzania, specimens from a sample of 350 children between the ages of 7 to 15\u00a0years, which were part of a longitudinal cohort that began in February 2012 were selected. Two ocular swabs were taken from the right eye. The second swab was collected dry, kept cool in the field and archived at \u2013 80\u00a0\u00b0C before sample lysis for DjinniChip detection and parallel nucleic acid purification and detection\/quantification by qPCR assay.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      DjinniChip was able to reliably detect &gt; 10 copies of\n                      <jats:italic>C. trachomatis<\/jats:italic>\n                      per test and correctly identified 7\/10 Quality Control for Molecular Diagnostics\n                      <jats:italic>C. trachomatis<\/jats:italic>\n                      panel samples, failing to detect 3 positive samples with genome equivalent amounts \u2264 10 copies. DjinniChip performed well across a range of typical trachoma field conditions and when used by lay personnel using a series of mock samples. In the laboratory in Tanzania, using clinical samples the sensitivity and specificity of DjinniChip for\n                      <jats:italic>C. trachomatis<\/jats:italic>\n                      was 66% (95% CI 51\u201378) and 94.8 (95% CI 91\u201397%) with an overall accuracy of 90.1 (95% CI 86.4\u201393).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      DjinniChip performance is extremely promising, particularly its ability to detect low concentrations of\n                      <jats:italic>C. trachomatis<\/jats:italic>\n                      and its usability in field conditions. The DjinniChip requires further development to reduce inhibition and advance toward a closed system. DjinniChip results did not vary between local laboratory results and typical trachoma field settings, illustrating its potential for use in low-resource areas to prevent unnecessary rounds of MDA and to monitor for\n                      <jats:italic>C. trachomatis<\/jats:italic>\n                      recrudescence.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13071-020-04414-6","type":"journal-article","created":{"date-parts":[[2020,10,27]],"date-time":"2020-10-27T08:05:57Z","timestamp":1603785957000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["DjinniChip: evaluation of a novel molecular rapid diagnostic device for the detection of Chlamydia trachomatis in trachoma-endemic areas"],"prefix":"10.1186","volume":"13","author":[{"given":"Tamsyn R.","family":"Derrick","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalia","family":"Sandetskaya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harry","family":"Pickering","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"K\u00f6lsch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Athumani","family":"Ramadhani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elias","family":"Mafuru","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Massae","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aiweda","family":"Malisa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tara","family":"Mtuy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J.","family":"Burton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5828-6318","authenticated-orcid":false,"given":"Martin J.","family":"Holland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk","family":"Kuhlmeier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,10,27]]},"reference":[{"key":"4414_CR1","doi-asserted-by":"publisher","first-page":"563","DOI":"10.1136\/bjo.2008.148494","volume":"93","author":"SP Mariotti","year":"2009","unstructured":"Mariotti SP, Pascolini D, Rose-Nussbaumer J. 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The study adhered to the tenets of the Declaration of Helsinki. Study participants were aged between 4 and 11\u00a0years at baseline and 7 and 15\u00a0years at the time-point 14 of sample collection. Clinical signs and swab specimens were collected following written informed consent from a parent or guardian.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"533"}}