The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in order to compute the APPY1 Test result, which is based on a combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for those subjects that were discharged from the ED without an appendectomy or diagnosis of acute appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing radiation in children, adolescents, and young adults.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis in Children, Adolescents, and Young Adults Presenting to the Emergency Department|
- Sensitivity, Specificity, Negative and Positive Predictive Value [ Time Frame: Upon 3rd party review of data ] [ Designated as safety issue: No ]95% confidence intervals on Sensitivity and Specificity
- CT utilization [ Time Frame: Upon 3rd party review of data ] [ Designated as safety issue: No ]CT utilization behaviors based on questions posed to the physicians about their current imaging intentions and those intentions were an APPY1 Test result available
Biospecimen Retention: Samples Without DNA
Surplus plasma samples will be retrieved by the Sponsor for future development of protein biomarkers.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
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|Principal Investigator:||Dave Huckins, MD||Newton-Wellesley Hospital|