Additional info: |
Millions of Americans ingest daily 'mini-dose' (80 mg) aspirin(TM) as a means of selectively inhibiting platelet cyclooxygenase-1 (COX-1) and subsequent production of Thromboxane A2 (TXA2). Recent studies indicate that a subpopulation of these users do not achieve the desired level of inhibition of TXA2, as determined by its more stable metabolites. The Cayman Aspirin(TM) Effect-Detection Kit is a 510K, clinically approved diagnostic kit for the measurement of 11-dehydro TXB2. It is intended to help physicians assess the effectiveness of their patients' aspirin(TM) regime, and to help identify the high-risk group who are inadequately controlled on an 80 mg aspirin(TM) dose. Current methods for detecting aspirin(TM) resistance include a number of blood-based assays that measure in vitro platelet aggregation. However, these methods are not quantitative and can be affected by factors that are unrelated to aspirin(TM) sensitivity. In order to more quickly and accurately detect aspirin(TM) resistance in at-risk patients, we have developed a rapid, quantitative competitive immunoassay for 11-dehydro TXB2 using a monoclonal antibody. This new assay can be completed in three hours and utilizes urine as the sample matrix. The assay exhibits intra-assay %CV values of <11% with sensitivity sufficient to detect the lower levels of 11-dehydro TXB2 in patients that respond well to aspirin(TM). Thus, this sensitive, urine-based monoclonal ELISA for 11-dehydro TXB2 detection combines the speed of the blood-based assays with the sensitivity and quantitation of the ELISA. |