Validation of a New Portable Exhaled Nitric Oxide Analyzer, NIOX VERO®: Randomized Studies in Asthma
Tóm tắt
Fractional exhaled nitric oxide (FeNO) is a non-invasive marker of airway inflammation, and a new portable analyzer (NIOX VERO®) is now available. Our studies aimed to assess the agreement of measurements between NIOX VERO® and a reference device (NIOX MINO®) and assess the reproducibility of NIOX VERO®. Paired FeNO readings were obtained from 112 subjects from both devices to assess agreement and reproducibility. FeNO readings were obtained from 122 subjects using NIOX VERO® to assess inter-operator repeatability. All subjects had a diagnosis of asthma and were aged ≥7 years. Agreement was shown with 90.8% of subjects within tolerance limits for the first valid FeNO measurement. Mean observed paired difference for the first valid FeNO measurement on each device was −4.6 ppb [95% confidence interval (CI) −5.825 to −3.377; < 0.0001]. Weighted Deming Regression Analysis showed a slope of 0.842 (95% CI 0.757, 0.927) and a y-intercept of −0.472 (95% CI −1.999, 1.055). Paired differences were centered close to 0. Intra-subject repeatability of NIOX VERO® was significantly better than NIOX MINO® (p = 0.0112). Further, inter-operator repeatability was achieved with NIOX VERO® with a mean intra-subject variance of 6.61 ± 17.954 ppb (upper 95% CI 9.41) and an estimated standard deviation of 2.57 (upper 95% CI 3.07). The coefficient of variance was 0.066 ± 0.054 (upper 95% CI 0.074). Our findings show that the portable instrument NIOX VERO® is clinically equivalent to NIOX MINO® when used in an asthma population. The NIOX VERO® analyzer gives reproducible, consistent measurements that are well within the technical specifications of the device, showing no observable pattern of a training effect or operator-order effect on FeNO results. Thus, our findings validate the NIOX VERO®. Aerocrine AB, Solna, Sweden.
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