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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, Specificity, Negative and Positive Predictive Value | 95% confidence intervals on Sensitivity and Specificity | Upon 3rd party review of data |
| Measure | Description | Time Frame |
|---|---|---|
| CT utilization | CT utilization behaviors based on questions posed to the physicians about their current imaging intentions and those intentions were an APPY1 Test result available | Upon 3rd party review of data |
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Inclusion Criteria:
Exclusion Criteria:
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Children, adolescents and young adults 2 to 20 years old.
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| Name | Affiliation | Role |
|---|---|---|
| Dave Huckins, MD | Newton-Wellesley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hosptial | Phoenix | Arizona | 85016 | United States | ||
| Arkansas Children's Hospital |
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Surplus plasma samples will be retrieved by the Sponsor for future development of protein biomarkers.
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| UC Davis | Sacramento | California | 95817 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida, College of Medicine | Jacksonville | Florida | 32209 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Emory-Egleston (CHOA) | Atlanta | Georgia | 30322 | United States |
| Scottish Rite (CHOA) | Atlanta | Georgia | 30342 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| South Shore Hospital | Weymouth | Massachusetts | 02190 | United States |
| University of Michigan, Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Spectrum Health System | Grand Rapids | Michigan | 49503 | United States |
| The Children's Mercy Hosptial | Kansas City | Missouri | 64108 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27175 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44495 | United States |
| Nationwide Children's | Columbus | Ohio | 43205 | United States |
| OHSU | Portland | Oregon | 97239 | United States |
| Children's Hospital of Pittsburg | Pittsburgh | Pennsylvania | 15224 | United States |
| Rhode Island Hospital - Hasbro | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232 | United States |
| Dell Children's Medical Center | Austin | Texas | 78723 | United States |
| St. Joseph's Regional Health Center | Bryan | Texas | 77802 | United States |
| St. Joseph's Emergency Center | College Station | Texas | 77845 | United States |
| Dallas Children's Hospital | Dallas | Texas | 75235 | United States |
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
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