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).
Design and 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%.
Conclusion: Technical performance of the new instrument was excellent.