Blood Test for Appendicitis Appears Promising
According to a report on Medical News Today, AspenBio Pharma, Incorporated has announced exciting findings with their serum appendicitis screen/triage test, the AppyScore. The group is simultaneously applying for an IDE from the FDA.
Results are from a clinical trial recently completed to assess the test in the emergency room department. The study was completed to verify accuracy of the test in the emergency room setting. The secondary intent of the trial was to optimize both testing and sampling methods in preparation for FDA data review.
471 people were recruited to participate in the clinical trial, including 100 individuals recruited to serve as normal, healthy controls. Data from the controls was used to confirm AppyScore findings in those without appendicitis. The additional study participants were recruited from the emergency room after presenting with right upper quadrant pain, consistent with acute appendicitis. 311 patients had evaluation with the AppyScore, others were eliminated after laboratory tests ruled out the diagnosis of appendicitis.
Findings from the clinical trial validated both the sensitivity and specificity of the laboratory tool. Data procured with use of the AppyScore was compared to histopathologic analysis of the removed appendices following surgery. Sensitivity was rated at 98 percent, the high rate of sensitivity is that this limits the rate of false negatives. Specificity was rated at 40 percent, which is the balance of higher sensitivity.
Importantly, previous data indicates that almost 20 percent of patients are incorrectly misdiagnosed as not having appendicitis. This can lead to a more serious case of the condition, such as when the appendix bursts.
Additionally, testing with AppyScore could have prevented 58 percent of surgeries which were unnecessary. Twelve of the study patients underwent surgery with a healthy appendix discovered during pathology analysis. The AppyScore test was negative in seven of those patients. Again, previous data indicates that upwards of 15 percent of appendectomies were unnecessary.
Testing can reduce the use of CT scanning to provide information to narrow the differential diagnosis. Findings from the AppyTest indicated that 68 of 142 patients with negative CTs did not have the condition. That can reduce overall costs to treat patients being evaluated with a high suspicion of appendicitis.
Once approved by the FDA, this new test may provide means to change the diagnostic workup for patients that present to the emergency room with the classic signs and symptoms of appendicitis. Ruling out the cases where disease is not present and preventing missed cases can dramatically increase the cost to treat the condition.
October 1, 2007 Related topics: Laboratory, New Technology & Innovation, Laboratory Equipment, Surgery, Emergency