title: Fecal Calprotectin Measured By Patients at Home Using Smartphones--A New Clinical Tool in Monitoring Patients with Inflammatory Bowel Disease.
abstract: BACKGROUND
  Fecal calprotectin is a reliable noninvasive marker for intestinal inflammation usable for monitoring patients with inflammatory bowel disease. Tests are usually performed by enzyme-linked immunosorbent assay (ELISA), which is time consuming and delays results, thus limiting its use in clinical practice. Our aim was to evaluate CalproSmart, a new rapid test for fecal calprotectin performed by patients themselves at home, and compare it to gold standard ELISA.
  
  
  METHODS
  A total of 221 patients with inflammatory bowel disease (115 ulcerative colitis and 106 Crohn's disease) were included. The CalproSmart test involves extraction of feces, application to the lateral flow device, and taking a picture with a smartphone after 10 minutes of incubation. Results appear on the screen within seconds. Patients were instructed at inclusion and had a video guide of the procedure as support. When using CalproSmart at home, patients also sent in 2 fecal samples to be analyzed by ELISA.
  
  
  RESULTS
  Totally, 894 fecal calprotectin results were obtained by ELISA, and 632 of them from CalproSmart. The correlation coefficient was 0.685, higher for academics than nonacademics (0.768 versus 0.637; P = 0.0037). The intra-assay and interassay coefficients of variation of the CalproSmart test were 4.42% and 12.49%, respectively. The sensitivity, specificity, positive predictive value, and negative predictive value were 82%, 85%, 47%, and 97%, respectively, with an optimal cutoff at 150 μg/g.
  
  
  CONCLUSIONS
  The CalproSmart test performed by patients with inflammatory bowel disease for fast assessment of gut inflammation seems a reliable alternative to ELISA and presents a new way of monitoring patients by eHealth.
authors.affiliation: *Gastrounit, Medical Section, Herlev University Hospital, Herlev, Denmark; †Department of Gastroenterology, Slagelse University Hospital, Slagelse, Denmark; ‡Gastrounit, North Zealand Hospital, University of Copenhagen, Frederikssund, Denmark; §Department of Pediatrics, Hvidovre University Hospital, Hvidovre, Denmark; and ‖Gastrounit, Medical section, Hvidovre University Hospital, Hvidovre, Denmark.
authors.forename: Kristoffer Kofod
authors.initials: KK
authors.lastname: Vinding
authors.forename: Henriette
authors.initials: H
authors.lastname: Elsberg
authors.forename: Tine
authors.initials: T
authors.lastname: Thorkilgaard
authors.forename: Erika
authors.initials: E
authors.lastname: Belard
authors.forename: Natalia
authors.initials: N
authors.lastname: Pedersen
authors.forename: Margarita
authors.initials: M
authors.lastname: Elkjaer
authors.forename: Dorte
authors.initials: D
authors.lastname: Marker
authors.forename: Katrine
authors.initials: K
authors.lastname: Carlsen
authors.forename: Johan
authors.initials: J
authors.lastname: Burisch
authors.forename: Pia
authors.initials: P
authors.lastname: Munkholm
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000378:metabolism*; D016022:Case-Control Studies; D003093:Colitis, Ulcerative / Q000175:diagnosis* / Q000378:metabolism; D003424:Crohn Disease / Q000175:diagnosis* / Q000378:metabolism; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation*; D005243:Feces / Q000737:chemistry*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D039841:Leukocyte L1 Antigen Complex / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D011379:Prognosis; D000068997:Smartphone / Q000706:statistics & numerical data*; D055815:Young Adult
chemical_list: D015415:Biomarkers; D039841:Leukocyte L1 Antigen Complex