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A point-of-care neutrophil elastase activity assay identifies bronchiectasis severity, airway infection and risk of exacerbation

医学 支气管扩张 恶化 中性粒细胞弹性蛋白酶 内科学 弹性蛋白酶 气道 胃肠病学 痰培养 危险系数 免疫学 外科 置信区间 病理 炎症 肺结核 化学 生物化学
作者
Amelia Shoemark,Erin Cant,Luís Carreto,Alexandria Smith,Martina Oriano,Holly R. Keir,Lídia Perea,Elisabet Cantó,Leonardo Terranova,Sílvia Vidal,Kelly Moffitt,Stefano Aliberti,Oriol Sibila,James D. Chalmers
出处
期刊:The European respiratory journal [European Respiratory Society]
卷期号:53 (6): 1900303-1900303 被引量:64
标识
DOI:10.1183/13993003.00303-2019
摘要

Introduction Neutrophil elastase 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 stick – 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 neutrophil elastase concentration from 0 (<8 µg·mL −1 elastase activity) to 10 (maximum detectable neutrophil elastase activity). High neutrophil elastase 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 forced expiratory volume in 1 s (FEV 1 ) 69%. High neutrophil elastase activity was associated with worse bronchiectasis severity using the bronchiectasis severity index (p=0.0007) and FEV 1 (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 neutrophil elastase activity from sputum in minutes and identifies patients at increasing risk of airway infection and future exacerbations.
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