Agreement and Repeatability of Three Fractional Exhaled Nitric Oxide Analyzers in Patients with Chronic Obstructive Pulmonary Disease: A Prospective Comparative Study
- 1Istituti Clinici Scientifici Maugeri IRCCS, Pulmonary Rehabilitation Unit of Telese Terme Institute, 82037 Telese Terme, Italy
- 2Department of Advanced Biomedical Sciences, University of Naples “Federico II”, 80126 Naples, Italy
Abstract
Background and aim: Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of airway inflammation that may provide complementary information on inflammatory phenotypes in chronic obstructive pulmonary disease (COPD). The increasing availability of portable FeNO analyzers requires assessment of their reproducibility and agreement before measurements obtained with different devices can be considered interchangeable. In this study, we aimed to compare the performance of three FeNO analyzers in patients with COPD. Methods: In this prospective study, consecutive patients with COPD underwent FeNO assessment using three analyzers: Medisoft Hyp’Air FeNO, Sunvou CA2122, and Sunvou TM2120. Two consecutive valid measurements were obtained with each device. Both within-device repeatability and between-device agreement were evaluated, while the number of measurement attempts recorded for each analyzer was investigated as an exploratory analysis of feasibility. Results: In total, 56 participants (69.6% male), with a mean age of 70.8 ± 4.3 years and a mean FEV1 of 42.3 ± 13.1% predicted, were enrolled. All analyzers showed excellent within-device repeatability, with ICCs of 0.976 for Hyp’Air, 0.967 for CA2122, and 0.992 for TM2120. Between-device absolute agreement was highest for Hyp’Air versus TM2120 (ICC 0.989), followed by CA2122 versus TM2120 (ICC 0.943) and Hyp’Air versus CA2122 (ICC 0.931). The median number of attempts was 4.5 [3.8–5.0] with Hyp’Air, 3.0 [2.0–3.0] with CA2122, and 2.0 [2.0–3.0] with TM2120 (overall p < 0.001). Conclusions: All three FeNO analyzers demonstrated excellent within-device repeatability in patients with COPD. TM2120 showed closer agreement with Hyp’Air than CA2122, although the limited representation of elevated FeNO values prevents firm conclusions regarding inter-device agreement at higher concentrations.
Related
- Repeatability of Swan600 and Its Agreement with Lenstar LS900 for Ocular Biometry in Children
- Assessing body composition via a smartphone computer vision application: High repeatability but method-dependent agreement compared with BODPOD and Inbody
- Real-Time AI-Based ACR TI-RADS Classification of Thyroid Nodules on the Ultrasound Console: A Prospective Agreement Study in a Region with Historical Iodine Deficiency
- Exploratory Agreement of 3D Body Surface Analysis with Expert Manual Assessment of Pelvic Malalignment in Patients with Non-Acute Low Back Pain: A Prospective Pilot Study with Linked Post-Hoc Analyses
- Electrocardiographic Changes Following Pediatric Adenotonsillectomy for Obstructive Sleep-Disordered Breathing: A Pilot Prospective Study
BibTeX
@article{candia2026agreement,
title = {{Agreement and Repeatability of Three Fractional Exhaled Nitric Oxide Analyzers in Patients with Chronic Obstructive Pulmonary Disease: A Prospective Comparative Study}},
author = {Claudio Candia and Silvestro Ennio D’Anna and Antonio Iovine and Carmen Lombardi and Claudia Merola and Mauro Maniscalco},
journal = {Journal of Clinical Medicine},
year = {2026},
month = nov,
doi = {10.3390/jcm15218744},
url = {https://www.mdpi.com/2077-0383/15/21/8744},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Agreement and Repeatability of Three Fractional Exhaled Nitric Oxide Analyzers in Patients with Chronic Obstructive Pulmonary Disease: A Prospective Comparative Study
AU - Claudio Candia
AU - Silvestro Ennio D’Anna
AU - Antonio Iovine
AU - Carmen Lombardi
AU - Claudia Merola
AU - Mauro Maniscalco
PY - 2026
DA - 2026/11/09
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15218744
UR - https://www.mdpi.com/2077-0383/15/21/8744
AB - Background and aim: Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of airway inflammation that may provide complementary information on inflammatory phenotypes in chronic obstructive pulmonary disease (COPD). The increasing availability of portable FeNO analyzers requires assessment of their reproducibility and agreement before measurements obtained with different devices can be considered interchangeable. In this study, we aimed to compare the performance of three FeNO analyzers in patients with COPD. Methods: In this prospective study, consecutive patients with COPD underwent FeNO assessment using three analyzers: Medisoft Hyp’Air FeNO, Sunvou CA2122, and Sunvou TM2120. Two consecutive valid measurements were obtained with each device. Both within-device repeatability and between-device agreement were evaluated, while the number of measurement attempts recorded for each analyzer was investigated as an exploratory analysis of feasibility. Results: In total, 56 participants (69.6% male), with a mean age of 70.8 ± 4.3 years and a mean FEV1 of 42.3 ± 13.1% predicted, were enrolled. All analyzers showed excellent within-device repeatability, with ICCs of 0.976 for Hyp’Air, 0.967 for CA2122, and 0.992 for TM2120. Between-device absolute agreement was highest for Hyp’Air versus TM2120 (ICC 0.989), followed by CA2122 versus TM2120 (ICC 0.943) and Hyp’Air versus CA2122 (ICC 0.931). The median number of attempts was 4.5 [3.8–5.0] with Hyp’Air, 3.0 [2.0–3.0] with CA2122, and 2.0 [2.0–3.0] with TM2120 (overall p < 0.001). Conclusions: All three FeNO analyzers demonstrated excellent within-device repeatability in patients with COPD. TM2120 showed closer agreement with Hyp’Air than CA2122, although the limited representation of elevated FeNO values prevents firm conclusions regarding inter-device agreement at higher concentrations.
SN - 2077-0383
ER -