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

Amelia Shoemark, Erin Cant, Luis Carreto, Alexandria Smith, Martina Oriano, Holly R. Keir, Lidia Perea, Elisabet Canto, Leonardo Terranova, Silvia Vidal, Kelly Moffitt, Stefano Aliberti, Oriol Sibila, James D. Chalmers (Lead / Corresponding author)

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Abstract

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.

Original languageEnglish
Article number1900303
JournalEuropean Respiratory Journal
Volume53
Issue number6
Early online date31 May 2019
DOIs
Publication statusPublished - 1 Jun 2019

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Point-of-Care Systems
Leukocyte Elastase
Bronchiectasis
Sputum
Infection
Forced Expiratory Volume
Equipment and Supplies
Pancreatic Elastase
Spain
Italy
Biomarkers

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Shoemark, Amelia ; Cant, Erin ; Carreto, Luis ; Smith, Alexandria ; Oriano, Martina ; Keir, Holly R. ; Perea, Lidia ; Canto, Elisabet ; Terranova, Leonardo ; Vidal, Silvia ; Moffitt, Kelly ; Aliberti, Stefano ; Sibila, Oriol ; Chalmers, James D. / A point of care neutrophil elastase activity assay identifies bronchiectasis severity, airway infection and risk of exacerbation. In: European Respiratory Journal. 2019 ; Vol. 53, No. 6.
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title = "A point of care neutrophil elastase activity assay identifies bronchiectasis severity, airway infection and risk of exacerbation",
abstract = "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{\circledR}) 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{\circledR}, 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{\circledR} 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{\circledR} 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{\circledR} 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.",
author = "Amelia Shoemark and Erin Cant and Luis Carreto and Alexandria Smith and Martina Oriano and Keir, {Holly R.} and Lidia Perea and Elisabet Canto and Leonardo Terranova and Silvia Vidal and Kelly Moffitt and Stefano Aliberti and Oriol Sibila and Chalmers, {James D.}",
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Shoemark, A, Cant, E, Carreto, L, Smith, A, Oriano, M, Keir, HR, Perea, L, Canto, E, Terranova, L, Vidal, S, Moffitt, K, Aliberti, S, Sibila, O & Chalmers, JD 2019, 'A point of care neutrophil elastase activity assay identifies bronchiectasis severity, airway infection and risk of exacerbation', European Respiratory Journal, vol. 53, no. 6, 1900303. https://doi.org/10.1183/13993003.00303-2019

A point of care neutrophil elastase activity assay identifies bronchiectasis severity, airway infection and risk of exacerbation. / Shoemark, Amelia; Cant, Erin; Carreto, Luis; Smith, Alexandria; Oriano, Martina; Keir, Holly R.; Perea, Lidia; Canto, Elisabet; Terranova, Leonardo; Vidal, Silvia; Moffitt, Kelly; Aliberti, Stefano; Sibila, Oriol; Chalmers, James D. (Lead / Corresponding author).

In: European Respiratory Journal, Vol. 53, No. 6, 1900303, 01.06.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A point of care neutrophil elastase activity assay identifies bronchiectasis severity, airway infection and risk of exacerbation

AU - Shoemark, Amelia

AU - Cant, Erin

AU - Carreto, Luis

AU - Smith, Alexandria

AU - Oriano, Martina

AU - Keir, Holly R.

AU - Perea, Lidia

AU - Canto, Elisabet

AU - Terranova, Leonardo

AU - Vidal, Silvia

AU - Moffitt, Kelly

AU - Aliberti, Stefano

AU - Sibila, Oriol

AU - Chalmers, James D.

N1 - Copyright ©ERS 2019.

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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.

AB - 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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U2 - 10.1183/13993003.00303-2019

DO - 10.1183/13993003.00303-2019

M3 - Article

C2 - 31151955

VL - 53

JO - European Respiratory Journal

JF - European Respiratory Journal

SN - 0903-1936

IS - 6

M1 - 1900303

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