Improved infrared spectrophotometer for point-of-care patient 13C-urea breath testing in the primary care setting.
The 13C-urea breath test provides non-invasive testing for Helicobacter pylori infection with the possibility of analysis at the point of care. Point of care tests require accurate and efficient desktop instrumentation.


OBJECTIVE
To compare results obtained from a new infrared spectrophotometer (10 kg, 2 min sample measurement) to the previously approved UBiT-IR300 (22.5 kg, 5-6 min sample measurement).


METHODS
Adults underwent urea breath testing; breath samples were analyzed using the new and the predicate instruments.


RESULTS
There were 220 adults enrolled (age range 18-74 years; M/F = 35:65); with 86 UBT positive and 134 negative cases. The overall agreement between instruments was 99.6% (95% C.I. = 97.6 to 99.9); the positive agreement was 100%.


CONCLUSIONS
Technical performance of the new instrument was excellent.
Opekun
Antone R
AR
Baylor College of Medicine, Department of Medicine, Family and Community Medicine, 6550 Fannin Street (SM-1122), Houston, TX 77030-2399, USA. aopekun@bcm.tmc.edu
Gotschall
Ann B
AB
Abdalla
Nageeb
N
Agent
Cornelia
C
Torres
Elizabeth
E
Sutton
Fred M
FM
Graham
David Y
DY
Tsuchiya
Kyoko
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D001944:Breath Tests / Q000295:instrumentation* / Q000379:methods; D002247:Carbon Isotopes; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D011320:Primary Health Care; D011446:Prospective Studies; D013055:Spectrophotometry, Infrared / Q000295:instrumentation*; D014508:Urea
D002247:Carbon Isotopes; D014508:Urea