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Comparative Study
. 2006 Apr 20;7(1):67.
doi: 10.1186/1465-9921-7-67.

Performance of a new hand-held device for exhaled nitric oxide measurement in adults and children

K Alving  1 , C Janson, L Nordvall
Affiliations
Comparative Study

Performance of a new hand-held device for exhaled nitric oxide measurement in adults and children

K Alving et al. Respir Res. .

Abstract

Background: Exhaled nitric oxide (NO) measurement has been shown to be a valuable tool in the management of patients with asthma. Up to now, most measurements have been done with stationary, chemiluminescence-based NO analysers, which are not suitable for the primary health care setting. A hand-held NO analyser which simplifies the measurement would be of value both in specialized and primary health care. In this study, the performance of a new electrochemical hand-held device for exhaled NO measurements (NIOX MINO) was compared with a standard stationary chemiluminescence unit (NIOX).

Methods: A total of 71 subjects (6-60 years; 36 males), both healthy controls and atopic patients with and without asthma were included. The mean of three approved exhalations (50 ml/s) in each device, and the first approved measurement in the hand-held device, were compared with regard to NO readings (Bland-Altman plots), measurement feasibility (success rate with 6 attempts) and repeatability (intrasubject SD).

Results: Success rate was high (> or = 84%) in both devices for both adults and children. The subjects represented a FENO range of 8-147 parts per billion (ppb). When comparing the mean of three measurements (n = 61), the median of the intrasubject difference in exhaled NO for the two devices was -1.2 ppb; thus generally the hand-held device gave slightly higher readings. The Bland-Altman plot shows that the 95% limits of agreement were -9.8 and 8.0 ppb. The intrasubject median difference between the NIOX and the first approved measurement in the NIOX MINO was -2.0 ppb, and limits of agreement were -13.2 and 10.2 ppb. The median repeatability for NIOX and NIOX MINO were 1.1 and 1.2 ppb, respectively.

Conclusion: The hand-held device (NIOX MINO) and the stationary system (NIOX) are in clinically acceptable agreement both when the mean of three measurements and the first approved measurement (NIOX MINO) is used. The hand-held device shows good repeatability, and it can be used successfully on adults and most children. The new hand-held device will enable the introduction of exhaled NO measurements into the primary health care.

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Figures

Figure 1
Figure 1
Appearance of devices. Illustrations of (A) the NIOX and (B) the NIOX MINO. Note that the relative size is not proportional (see Table 1 for device dimensions).
Figure 2
Figure 2
Device agreement. Scatter plots of the mean of three valid FENO measurements using the NIOX vs (A) the mean of three valid FENO measurements, or vs (B) the first valid FENO measurement using the NIOX MINO (n = 61). Repeatability coefficients (ICCs) were (A) 0.97 and (B) 0.98, respectively (p < 0.001 for both).
Figure 3
Figure 3
Device agreement. Bland-Altman plots of the mean of three valid FENO measurements using the NIOX vs (A) the mean of three valid FENO measurements, or vs (B) the first valid FENO measurements using the NIOX MINO (n = 61).
Figure 4
Figure 4
Repeatability. Histograms of the intra-subject SD of three valid FENO measurements using (A) the NIOX (n = 63) and (B) the NIOX MINO (n = 62). The estimated distribution of SD is indicated with the line.
See this image and copyright information in PMC

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