An inter- and intra-laboratory comparison of breath ¹³CO₂analysis.
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.
Perri
F
F
Department of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy. perrisgr@tin.it
Zagari
R M
RM
Uebersax
J S
JS
Quitadamo
M
M
Bazzoli
F
F
Amarri
Sergio
S
Armuzzi
Alessandro
A
Cantoni
Franco
F
Colombo
Roberto
R
De Berardinis
Franco
F
De Pretis
Giovanni
G
Dell'Anna
Lucio
L
Festi
Davide
D
Neri
Matteo
M
Geypens
Benny
B
Ierardi
Enzo
E
Johnson
Phil
P
Marchi
Santino
S
Masoero
Guya
G
Micunco
Claudio
C
Palli
Domenico
D
Russo
Antonio
A
Palmas
Franco
F
Realdi
Giuseppe
G
Sangaletti
Ornella
O
Savarino
Vincenzo
V
Stellaard
Frans
F
Vigneri
Sergio
S
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
D002245:Carbon Dioxide