{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T21:11:58Z","timestamp":1761513118564,"version":"3.44.0"},"reference-count":0,"publisher":"SMW Supporting Association","issue":"1314","license":[{"start":{"date-parts":[[2012,3,25]],"date-time":"2012-03-25T00:00:00Z","timestamp":1332633600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Swiss Med Wkly"],"abstract":"<jats:p>QUESTIONS:  Is the novel in-vitro diagnostic device U-Test\u00ae reliable and secure  for urine collection in diaper-wearing children and simultaneous evaluation of  the urine collected for the presence of leucocytes and nitrite?\n        METHODS:  The qualitative and functional performance of U-Test\u00ae was evaluated  in a multicentre prospective clinical trial. The diagnostic performance of the  novel in-vitro diagnostic device was determined in reference to the established  procedure involving urine sampling by urine-bag, clean-catch, catheterisation  and suprapubic aspiration followed by dipstick analysis and urine culture, and  in an in-vitro study.\n        RESULTS:  U-Test\u00ae proved to be comfortable and secure for the child and well  accepted by the persons responsible for the participating children. No  undesired side-effects were seen and in 75.8% (95% CI \u00b1 10.5%; n = 66) of the  tests used, enough urine was collected within the permitted time for immediate  and successful urine analysis by the integrated test card. Diagnostic  performance was found to be comparable to the established procedure using  dipstick analysis (leucocytes: \u03ba-coefficient 0.86; nitrite: \u03ba-coefficient 0.74;  n = 150). Sensitivity of the U-Test\u00ae for leucocyte detection was  found to be 96.7% and specificity 100.0%. For nitrite detection sensitivity of  90.0% and specificity of 98.3% were found.\n        CONCLUSIONS:  The evaluation shows that U-Test\u00ae is a safe and reliable device of  high functionality and diagnostic performance for the detection of leucocytes  and nitrite directly and without time delay in a child\u2019s diaper. This statement  is based on a comprehensive comparison of the novel device with accepted  diagnostic test systems and procedures based on the same dry chemistry  technology. Due to its simplicity of use, U-Test\u00ae can be considered  an alternative to the cumbersome procedures of urine collection by the  bag-method or clean-catch followed by dipstick analysis for the presence of  leucocytes and nitrite.<\/jats:p>","DOI":"10.4414\/smw.2012.13560","type":"journal-article","created":{"date-parts":[[2012,4,12]],"date-time":"2012-04-12T05:57:14Z","timestamp":1334210234000},"page":"w13560","source":"Crossref","is-referenced-by-count":2,"title":["Evaluation  of a novel in-vitro diagnostic device for the detection of urinary tract  infections in diaper-wearing children"],"prefix":"10.57187","volume":"142","author":[{"given":"Jean-Daniel","family":"Kr\u00e4henb\u00fchl","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chantal","family":"Beaulieu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mario","family":"Gehri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"36756","published-online":{"date-parts":[[2012,3,25]]},"container-title":["Swiss Medical Weekly"],"original-title":[],"link":[{"URL":"https:\/\/smw.ch\/index.php\/smw\/article\/download\/1464\/1812","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/smw.ch\/index.php\/smw\/article\/download\/1464\/1813","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/smw.ch\/index.php\/smw\/article\/download\/1464\/1812","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,15]],"date-time":"2025-08-15T03:42:11Z","timestamp":1755229331000},"score":1,"resource":{"primary":{"URL":"https:\/\/smw.ch\/index.php\/smw\/article\/view\/1464"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,3,25]]},"references-count":0,"journal-issue":{"issue":"1314","published-online":{"date-parts":[[2012,3,26]]}},"URL":"https:\/\/doi.org\/10.4414\/smw.2012.13560","relation":{},"ISSN":["1424-3997"],"issn-type":[{"type":"electronic","value":"1424-3997"}],"subject":[],"published":{"date-parts":[[2012,3,25]]}}}