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Appendicitis: Tests
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Appendicitis’ apparently idiopathic nature has led to many different theories explaining its occurrence. One theory regarding the cause of appendicitis, sometimes facetiously referred to as "the porcelain throne theory”, was proposed by Dr. Denis Burkitt, who developed the theory after observing low rates of appendicitis in Uganda. He proposed two causes for this: one, the Africans ate a diet high in fiber, and two, they used squat toilets rather than seat toilets. Most health practitioners accept Dr. Burkitt's first cause as a contributing factor, but are unfamiliar with the second one, which has never been tested.
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AspenBio has created and optimized a specialized assay test to detect a marker in the blood associated with appendicitis and has tested this assay in several on-going research trials involving hundreds of human patients. Positive results from preliminary clinical trials were announced on February 22, 2007. These include three studies which were conducted during the past 30 months, with one 400 patient study still ongoing.
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This large pre-FDA study was designed to provide a statistically significant confirmation of the performance, including utility and accuracy, of the AppyScore appendicitis screen / triage test in an emergency room setting. A secondary purpose of the study was to optimize sampling and testing methodologies in preparation for clinical studies to be conducted with the final In Vitro Diagnostic ("IVD") device that will be submitted for FDA review. The study was conducted at multiple hospital sites under appropriate Institutional Review Board Approvals, which included patient consent.
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AppyScore Screen Test is designed to screen patients suspected of having appendicitis. Emergency room physicians are expected to use the device as part of a complete clinical workup. The key metric for the clinical study is the device's Negative Predictive Value, which has been shown consistently in pre-FDA clinical studies to be approximately 98%.
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Continued improvements in helical CT technology may allow nonenhanced helical CT to be the imaging test of choice for adults with suspected appendicitis. Additional studies are needed to identify subgroups that derive the most benefit from diagnostic imaging.
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Based on the data obtained to-date, the company's AppyScore(TM) blood test has been able to identify patients with appendicitis at a very high sensitivity level of 94% to 97%. This compares to significantly lower diagnostic success rates for expensive CT scans, which are generally considered the best diagnostic method available for appendicitis.
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