title: An inter- and intra-laboratory comparison of breath ¹³CO₂analysis.
abstract: BACKGROUND
  ¹³C breath test analysis requires accurate ¹³CO₂measurements.
  
  
  OBJECTIVE
  To perform a multicentre study to evaluate the repeatability and reproducibility of breath ¹³CO₂analysis.
  
  
  METHODS
  Two series of 25 paired randomly coded tubes (each consisting of 23 ¹³CO₂-enriched breath samples and two samples of standard reference pure CO₂with certified δ ¹³C(PDB)) were sent to participating centres for ¹³CO₂measurement. Each series of tubes was analysed 10 days apart. The repeatability and reproducibility of ¹³C measurements was assessed by Mandel's k and h statistics.
  
  
  RESULTS
  Twenty-two centres participated in the study: 18 showed good inter- and intra-laboratory variability, whilst four showed abnormally high inter- or intra-laboratory variability. Breath test results were also significantly affected by the accuracy of the ¹³C analytical procedures.
  
  
  CONCLUSIONS
  A low accuracy of ¹³C measurements may significantly affect the results of breath tests, leading to inappropriate clinical decisions. Standardization of ¹³C analysis is required to guarantee optimal ¹³C measurements and accurate ¹³C breath test results.
authors.affiliation: Department of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy. perrisgr@tin.it
authors.forename: F
authors.initials: F
authors.lastname: Perri
authors.forename: R M
authors.initials: RM
authors.lastname: Zagari
authors.forename: J S
authors.initials: JS
authors.lastname: Uebersax
authors.forename: M
authors.initials: M
authors.lastname: Quitadamo
authors.forename: F
authors.initials: F
authors.lastname: Bazzoli
authors.forename: Sergio
authors.initials: S
authors.lastname: Amarri
authors.forename: Alessandro
authors.initials: A
authors.lastname: Armuzzi
authors.forename: Franco
authors.initials: F
authors.lastname: Cantoni
authors.forename: Roberto
authors.initials: R
authors.lastname: Colombo
authors.forename: Franco
authors.initials: F
authors.lastname: De Berardinis
authors.forename: Giovanni
authors.initials: G
authors.lastname: De Pretis
authors.forename: Lucio
authors.initials: L
authors.lastname: Dell'Anna
authors.forename: Davide
authors.initials: D
authors.lastname: Festi
authors.forename: Matteo
authors.initials: M
authors.lastname: Neri
authors.forename: Benny
authors.initials: B
authors.lastname: Geypens
authors.forename: Enzo
authors.initials: E
authors.lastname: Ierardi
authors.forename: Phil
authors.initials: P
authors.lastname: Johnson
authors.forename: Santino
authors.initials: S
authors.lastname: Marchi
authors.forename: Guya
authors.initials: G
authors.lastname: Masoero
authors.forename: Claudio
authors.initials: C
authors.lastname: Micunco
authors.forename: Domenico
authors.initials: D
authors.lastname: Palli
authors.forename: Antonio
authors.initials: A
authors.lastname: Russo
authors.forename: Franco
authors.initials: F
authors.lastname: Palmas
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Realdi
authors.forename: Ornella
authors.initials: O
authors.lastname: Sangaletti
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Savarino
authors.forename: Frans
authors.initials: F
authors.lastname: Stellaard
authors.forename: Sergio
authors.initials: S
authors.lastname: Vigneri
mesh_terms: D001944:Breath Tests / Q000295:instrumentation*; D002245:Carbon Dioxide / Q000032:analysis*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D015203:Reproducibility of Results
chemical_list: D002245:Carbon Dioxide