The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis

Children, adolescents and young adults 2 to 20 years old.

Inclusion Criteria:

• > 2 years old to < 20 years old (up until the 21st birthday),
• Right lower quadrant or poorly localized abdominal pain, or tenderness that includes the right lower quadrant, with other features including, but not limited to, nausea, vomiting, and/or anorexia, requiring acute appendicitis to be added to the differential,
• Onset of abdominal pain within 72 hours or less,
• Patients of either gender may participate and,
• Patient or accompanying parent or guardian is able to read and understand study documentation and to provide informed consent.

Exclusion Criteria:

• History includes prior appendectomy,
• Subjects whose presentation history and physical examination place them at such high risk of acute appendicitis that it would be clinically reasonable to proceed with exploratory laparotomy and/or appendectomy without advanced imaging,
• Treatment with any immunosuppressive medication or chemotherapeutic agents within 28 days, or systemic steroids (oral or intravenous) within 14 days,
• History of end-stage, metastatic cancer or an active immune disorder,
• History includes abdominal trauma or invasive abdominal procedures/surgery within the previous two weeks,
• Patients who have received diagnostic imaging (CT, MRI, or US) for abdominal pain in the previous two weeks,
• Patients with report of abdominal pain greater than 72 hours,
• History of active bleeding disorder, which may complicate phlebotomy or placement of peripheral IV catheter,
• Participation in a research study within the previous 30 days,
• Vulnerable populations including prisoners of an adult or juvenile detention center, and
• Subject, parent or guardian unable to provide informed consent.