TY - JOUR
T1 - Prospective validation of a biomarker panel to identify pediatric ED patients with abdominal pain who are at low risk for acute appendicitis
AU - Huckins, David S.
AU - Simon, Harold K.
AU - Copeland, Karen
AU - Milling, Truman J.
AU - Spandorfer, Philip R.
AU - Hennes, Halim
AU - Allen, Coburn
AU - Gogain, Joseph
N1 - Funding Information:
Funding: This research was funded by Venaxis, Inc, Castle Rock, CO.
Funding Information:
This study was a prospective observational industry sponsored investigation to validate a previously described biomarker panel in pediatric and adolescent patients presenting to the ED with abdominal pain and/or other signs and symptoms suggesting acute appendicitis as part of the differential diagnosis. All sites obtained institutional review board approval before study initiation, and all participating patients provided written consent if older than 18 years or written parental consent and patient assent for those younger than the age of 18 years per hospital specific institutional review board requirements. This study was sponsored by Venaxis, Inc, Castle Rock, CO.
Publisher Copyright:
© 2016 Elsevier Inc.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2016/8/1
Y1 - 2016/8/1
N2 - Objectives The objective of the study is to prospectively validate the diagnostic accuracy of a biomarker panel consisting of white blood cell, C-reactive protein, and myeloid-related protein 8/14 levels in identifying pediatric patients with abdominal pain who are at low risk for appendicitis. Methods This prospective observational study enrolled subjects aged 2 to 20 years presenting to 29 US emergency departments with abdominal pain suggesting possible acute appendicitis. Blood samples were analyzed for white blood cell, C-reactive protein, and myeloid-related protein 8/14 levels from which the composite biomarker panel results were calculated, then correlated with the final diagnosis either positive or negative for acute appendicitis. Results A total of 2201 patients were enrolled, with 1887 completing all aspects of the study. Prevalence of appendicitis in this cohort was 25.3%. The biomarker panel exhibited a sensitivity of 97.1% (95% confidence interval [CI], 95.1%-98.2%), negative predictive value of 97.4% (95% CI, 95.8%-98.5%), negative likelihood ratio of 0.08 (95% CI, 0.05-0.13), with a specificity of 37.9% (95% CI, 35.4%-40.4%) for appendicitis. The panel correctly identified 534 (37.8%) of 1410 patients who did not have appendicitis with 14 false negatives (2.9%). Overall, 23.7% (132/557) of computed tomographic (CT) scans were done for patients with negative biomarker panel results, including 31.2% (131/420) of patients who had CT but did not have appendicitis. Conclusion This biomarker panel exhibited high sensitivity and negative predictive value for acute appendicitis in this large prospective cohort. This panel may be useful in identifying pediatric patients who are at low risk for appendicitis and might be followed clinically, potentially reducing the dependence on CT in the evaluation for acute appendicitis.
AB - Objectives The objective of the study is to prospectively validate the diagnostic accuracy of a biomarker panel consisting of white blood cell, C-reactive protein, and myeloid-related protein 8/14 levels in identifying pediatric patients with abdominal pain who are at low risk for appendicitis. Methods This prospective observational study enrolled subjects aged 2 to 20 years presenting to 29 US emergency departments with abdominal pain suggesting possible acute appendicitis. Blood samples were analyzed for white blood cell, C-reactive protein, and myeloid-related protein 8/14 levels from which the composite biomarker panel results were calculated, then correlated with the final diagnosis either positive or negative for acute appendicitis. Results A total of 2201 patients were enrolled, with 1887 completing all aspects of the study. Prevalence of appendicitis in this cohort was 25.3%. The biomarker panel exhibited a sensitivity of 97.1% (95% confidence interval [CI], 95.1%-98.2%), negative predictive value of 97.4% (95% CI, 95.8%-98.5%), negative likelihood ratio of 0.08 (95% CI, 0.05-0.13), with a specificity of 37.9% (95% CI, 35.4%-40.4%) for appendicitis. The panel correctly identified 534 (37.8%) of 1410 patients who did not have appendicitis with 14 false negatives (2.9%). Overall, 23.7% (132/557) of computed tomographic (CT) scans were done for patients with negative biomarker panel results, including 31.2% (131/420) of patients who had CT but did not have appendicitis. Conclusion This biomarker panel exhibited high sensitivity and negative predictive value for acute appendicitis in this large prospective cohort. This panel may be useful in identifying pediatric patients who are at low risk for appendicitis and might be followed clinically, potentially reducing the dependence on CT in the evaluation for acute appendicitis.
UR - http://www.scopus.com/inward/record.url?scp=84964291948&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84964291948&partnerID=8YFLogxK
U2 - 10.1016/j.ajem.2016.03.066
DO - 10.1016/j.ajem.2016.03.066
M3 - Article
C2 - 27133536
AN - SCOPUS:84964291948
SN - 0735-6757
VL - 34
SP - 1373
EP - 1382
JO - American Journal of Emergency Medicine
JF - American Journal of Emergency Medicine
IS - 8
ER -