RT Journal Article
SR Electronic
T1 A point of care neutrophil elastase activity assay identifies bronchiectasis severity, airway infection and risk of exacerbation
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1900303
DO 10.1183/13993003.00303-2019
A1 Amelia Shoemark
A1 Erin Cant
A1 Luis Carreto
A1 Alexandria Smith
A1 Martina Oriano
A1 Holly R Keir
A1 Lidia Perea
A1 Elisabet Canto
A1 Leonardo Terranova
A1 Silvia Vidal
A1 Kelly Moffitt
A1 Stefano Aliberti
A1 Oriol Sibila
A1 James D. Chalmers
YR 2019
UL http://erj.ersjournals.com/content/early/2019/03/15/13993003.00303-2019.abstract
AB Introduction Neutrophil elastase (NE) activity in sputum can identify patients at high risk of airway infection and exacerbations in bronchiectasis. Application of this biomarker in clinical practice is limited because no point of care test is available. We tested whether a novel semi-quantitative lateral flow device (Neutrophil elastase airway test stik–NEATstik®) can stratify bronchiectasis patients according to severity, airway infection and exacerbation risk.Methods Sputum samples from 124 patients with stable bronchiectasis enrolled in the UK and Spain were tested using the NEATstik®, which scores NE concentration from 0 (<8 µg·mL−1 elastase activity) to 10 (maximum detectable NE activity). High NE activity was regarded as a NEATstik® grade>6. Severity of disease, airway infection from sputum culture and exacerbations over the 12-months were recorded. An independent validation was conducted in 50 patients from Milan, Italy.Measurements and main results Patients had a median age of 69 years and FEV1 69%. High NE activity was associated with worse bronchiectasis severity using the bronchiectasis severity index (p=0.0007) and FEV1 (p=0.02). A high NEATstik® grade was associated with a significant increase in exacerbation frequency, incident rate ratio 2.75 95% CI 1.63–4.64, p<0.001. The median time to next exacerbation for patients with a NEATstik® grade >6 was 103 days compared to 278 days. The hazard ratio was 2.59 95% CI 1.71–3.94, p<0.001. Results were confirmed in the independent validation cohort.Conclusions A novel lateral flow device provides assessment of NE activity from sputum in minutes and identifies patients at increasing risk of airway infection and future exacerbations.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Shoemark has nothing to disclose.Conflict of interest: Dr. Cant has nothing to disclose.Conflict of interest: Dr. Carreto has nothing to disclose.Conflict of interest: Dr. Smith has nothing to disclose.Conflict of interest: Dr. Oriano has nothing to disclose.Conflict of interest: Dr. Keir has nothing to disclose.Conflict of interest: Dr. Perea has nothing to disclose.Conflict of interest: Dr. Canto has nothing to disclose.Conflict of interest: Dr. Terranova has nothing to disclose.Conflict of interest: Dr. Vidal has nothing to disclose.Conflict of interest: Dr. Moffitt reports personal fees from Employed by Proaxsis, during the conduct of the study.Conflict of interest: Dr. Aliberti has nothing to disclose.Conflict of interest: Dr. Sibila has nothing to disclose.Conflict of interest: Dr. Chalmers reports grants and personal fees from Glaxosmithkline, grants and personal fees from Boehringer-Ingelheim, grants from Astrazeneca, grants and personal fees from Pfizer, grants and personal fees from Bayer Healthcare, grants and personal fees from Grifols, personal fees from Napp, personal fees from Aradigm corporation, grants and personal fees from Insmed, outside the submitted work.