title: Fingertip rapid point-of-care test in adult case-finding in coeliac disease.
abstract: BACKGROUND
  Coeliac disease (CD), due to its protean clinical manifestation, is still very under diagnosed in adults and delays in diagnosis may take years and even decades. Simple tools to find cases in primary care may help to identify patients for further diagnostic tests. We have evaluated the usefulness of an on site rapid fingertip whole blood point-of-care test (POCT) for such a purpose.
  
  
  METHODS
  As CD is known to run within families, we tested 148 healthy relatives of 70 Romanian index cases with biopsy-proven CD (87% of all first-degree family members, median age 36 years) for the presence of circulating autoantibodies. In addition to performing the POCT (which measures blood erythrocyte self-TG2-autoantibody complexes) on site, blood was drawn for later evaluations of serum IgA-class endomysial antibodies (EMA). EMA-positive sera were further tested for transglutaminase 2 antibodies (TG2-IgA). All serological parameters were analyzed blindly in a centralized laboratory that had no knowledge of the on site POCT result. Endoscopic small intestinal biopsies was recommended for all POCT- or EMA-test positive subjects.
  
  
  RESULTS
  In on site testing the POCT was positive in 12/148 first-degree relatives (8%) and all these subjects were also serum EMA-positive. A positive EMA test was found only in one other subject. All remaining 135 healthy first-degree relatives were negative for both POCT and EMA. Four subjects positive for both POCT and EMA were negative for TG2-IgA. Ten out of thirteen of the antibody-positive subjects agreed to undergo endoscopy. The POCT was found to be positive in 8/9 first-degree relatives having coeliac-type mucosal lesions of grade Marsh 2 (n = 3) or Marsh 3 (n = 6). The three POCT-positive subjects not agreeing to undergo endoscopy were also both EMA- and TG2-IgA-positive.
  
  
  CONCLUSIONS
  The fingertip whole blood rapid POCT might fulfill the unmet need for a simple and cheap case-finding biomarker for early detection and presumptive diagnosis of CD. Confirmatory studies are warranted in adult case-finding in specialized outpatient clinics and in primary care.
authors.forename: Alina
authors.initials: A
authors.lastname: Popp
authors.forename: Mariana
authors.initials: M
authors.lastname: Jinga
authors.forename: Ciprian
authors.initials: C
authors.lastname: Jurcut
authors.forename: Vasile
authors.initials: V
authors.lastname: Balaban
authors.forename: Catalina
authors.initials: C
authors.lastname: Bardas
authors.forename: Kaija
authors.initials: K
authors.lastname: Laurila
authors.forename: Florina
authors.initials: F
authors.lastname: Vasilescu
authors.forename: Adina
authors.initials: A
authors.lastname: Ene
authors.forename: Ioana
authors.initials: I
authors.lastname: Anca
authors.forename: Markku
authors.initials: M
authors.lastname: Mäki
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001323:Autoantibodies / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D002446:Celiac Disease / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D004912:Erythrocytes / Q000201:enzymology; D019204:GTP-Binding Proteins / Q000276:immunology*; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D007413:Intestinal Mucosa / Q000276:immunology / Q000473:pathology; D008875:Middle Aged; D019095:Point-of-Care Systems; D000091345:Protein Glutamine gamma Glutamyltransferase 2; D011503:Transglutaminases / Q000276:immunology*; D055815:Young Adult
chemical_list: D001323:Autoantibodies; D015415:Biomarkers; D007070:Immunoglobulin A; D000091345:Protein Glutamine gamma Glutamyltransferase 2; D011503:Transglutaminases; D019204:GTP-Binding Proteins