Mashali, M., Norris, N., McDowell, G. & Body, R. (2016) The inter-observer reliability of a novel qualitative point of care assay for heart-type fatty acid binding protein. Clin Biochem 49 pp. 1199-1201
Background
Heart-type fatty acid–binding protein (h-FABP) may help to improve the early diagnosis of acute coronary syndromes in patients presenting to the Emergency Department (ED) with chest pain. A novel qualitative point of care h-FABP lateral flow immunoassay (True Rapid, FABPulous BV) could provide results to clinicians within just 5 minutes. Given the qualitative nature of this test and prior to evaluation in a large diagnostic study, we aimed to determine inter-observer reliability when interpreted contemporaneously by staff in the ED.
Methods
In a nested prospective cohort study including adult patients with suspected cardiac chest pain, venous blood samples were tested for h-FABP (FABPulous BV) on arrival and 3 hours later. Each test result was independently interpreted by two different investigators after 5 minutes. The investigators were blinded to each other’s interpretation and recorded their findings on separate case report forms. We determined interobserver reliability by calculating the Cohen’s kappa score and 95% confidence intervals.
Results
A total of 43 test results (from 31 patients) were each interpreted by two independent investigators. Absolute agreement between investigators was 93.0%, with a Cohen’s kappa of 0.81 (95% CI 0.6 – 1.0), indicating near perfect agreement. In total there were three (7.0%) disagreements. In each case one investigator reported a ‘weak positive’ result while the other interpreted the result as ‘negative’.
Conclusions
These findings demonstrate the interobserver reliability of a qualitative point of care h-FABP assay. Further work must evaluate diagnostic accuracy and determine the clinical implications of the small rate of disagreement.
Link to Journal
You must be logged in to post a comment.