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Urine Biomarkers of COPD Exacerbation; A Feasibility Study
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A4753 - Urine Biomarkers of COPD Exacerbation; A Feasibility Study
Author Block: A. Yousuf1, L. Watson1, G. Parekh2, V. Mistry3, J. Finch1, S. Parker1, L. Beadle1, S. Glover1, L. George1, C. E. Brightling4; 1Infection, Immunity and Inflammation, University of Leicester, Leicester, United Kingdom, 2Mologic Ltd, Thurleigh, United Kingdom, 3Clinical Sciences, University of Leicester, Leicester, United Kingdom, 4Infection, Immunity, Inflammation, University of Leicester, Maurice Shock Medical School, Leicester, United Kingdom.
Introduction: COPD exacerbations cause considerable morbidity and mortality. Early identification and appropriate treatment might improve patient outcomes. We sought to determine whether urinary biomarkers are associated with a COPD exacerbation and undertook a pilot feasibility study of usability and acceptability of a new urine test kit (HEADSTART®). Method: Urine samples from paired stable and exacerbation visits from 55 subjects were available from the COPD-BEAT study. 50 biomarkers were analysed in each sample at Mologic (Mologic LTD). Biomarkers that fulfilled the criteria i) a significant parametric pairwise t-test (p≤0.05) and ii) area under the receiver-operator characteristic curve (AUROC ≥0.59 ) were selected for inclusion in a logistic regression model. We also recruited 10 patients who were admitted to hospital with a diagnosis of COPD exacerbation. They were trained to use the test device, which consists of disposable test cassettes (similar in form and operation to pregnancy test) allowing simultaneous measurement of up to 5 biomarkers, and a compact opto-electronic reader (‘cube’) capable of quantifying and interpreting the test results. The participants used the cube as inpatients while being treated for exacerbation and continued using it for 1 month post discharge. Subjects completed an acceptability questionnaire at the end of the study. Results: Of the biomarkers that met criteria and were taken forward for further analysis CC16, CRP, MMP8 and NGAL combined had an AUROC 0.82 (95% confidence interval 0.74 to 0.90). The Youden’s index gave a sensitivity and specificity of 78% and 82% respectively. The device usability success rate was very high 92% (273 planned tests, 3 missed, 19 incorrectly run). The acceptability questionnaire at the end of study revealed 100% of patients found the device easy to use and 90% would be willing to use it again in future. Conclusion: COPD exacerbations can be identified by urinary biomarkers using a user friendly opto-electronic reader. The biomarker panel requires further validation in a prospective longitudinal study.
Author Block: A. Yousuf1, L. Watson1, G. Parekh2, V. Mistry3, J. Finch1, S. Parker1, L. Beadle1, S. Glover1, L. George1, C. E. Brightling4; 1Infection, Immunity and Inflammation, University of Leicester, Leicester, United Kingdom, 2Mologic Ltd, Thurleigh, United Kingdom, 3Clinical Sciences, University of Leicester, Leicester, United Kingdom, 4Infection, Immunity, Inflammation, University of Leicester, Maurice Shock Medical School, Leicester, United Kingdom.
Introduction: COPD exacerbations cause considerable morbidity and mortality. Early identification and appropriate treatment might improve patient outcomes. We sought to determine whether urinary biomarkers are associated with a COPD exacerbation and undertook a pilot feasibility study of usability and acceptability of a new urine test kit (HEADSTART®). Method: Urine samples from paired stable and exacerbation visits from 55 subjects were available from the COPD-BEAT study. 50 biomarkers were analysed in each sample at Mologic (Mologic LTD). Biomarkers that fulfilled the criteria i) a significant parametric pairwise t-test (p≤0.05) and ii) area under the receiver-operator characteristic curve (AUROC ≥0.59 ) were selected for inclusion in a logistic regression model. We also recruited 10 patients who were admitted to hospital with a diagnosis of COPD exacerbation. They were trained to use the test device, which consists of disposable test cassettes (similar in form and operation to pregnancy test) allowing simultaneous measurement of up to 5 biomarkers, and a compact opto-electronic reader (‘cube’) capable of quantifying and interpreting the test results. The participants used the cube as inpatients while being treated for exacerbation and continued using it for 1 month post discharge. Subjects completed an acceptability questionnaire at the end of the study. Results: Of the biomarkers that met criteria and were taken forward for further analysis CC16, CRP, MMP8 and NGAL combined had an AUROC 0.82 (95% confidence interval 0.74 to 0.90). The Youden’s index gave a sensitivity and specificity of 78% and 82% respectively. The device usability success rate was very high 92% (273 planned tests, 3 missed, 19 incorrectly run). The acceptability questionnaire at the end of study revealed 100% of patients found the device easy to use and 90% would be willing to use it again in future. Conclusion: COPD exacerbations can be identified by urinary biomarkers using a user friendly opto-electronic reader. The biomarker panel requires further validation in a prospective longitudinal study.
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