Acetaminophen and salicylate are contained in over 200 prescription and non-prescription formulations. Of all intentional and unintentional overdose ingestions of pharmaceutical and non-pharmaceutical compounds, those of acetaminophen and salicylate are the most frequent, both in number of exposures and fatalities. Many exposures are co-intoxications of both drugs. One half of all patients are children. The need for rapid estimation of acetaminophen and salicylate in acute intoxication and therapeutic monitoring is well documented. Rapid test methods for use by non-laboratory personnel in point-of-care environments are lacking. Some laboratory spot-tests for urine exist but they lack specificity, and timely specimen acquisition, transfer and analysis can be problematic. Methods on existing laboratory equipment are scarce and cost-intensive. Subject of this Phase II proposal is the development of a novel non- instrumented dual-analyte teststrip method for the simultaneous rapid estimation of acetaminophen and salicylate levels in micro-specimens of whole blood and saliva. The method is specific for each of the two compounds as enzymic-colorimetric detection principles are employed. Dry- reagent technology enhances method stability and product life time. Contributions of the device are its functionality in a near-patient, non- laboratory environment, early detection, timely institution of treatment, and cost-savings. Product feasibility has been demonstrated by the Phase I work.
Of all toxic exposures involving pharmaceutical and non-pharmaceutical compounds, those to acetaminophen and salicylate are the two most frequent and fatal (US Poison Center Report 1991). A serum acetaminophen level is routinely requested in most toxic or unexplained emergency presentations. By providing an early estimate of the degree of intoxication, the proposed device identifies the need for treatment at the point-of-care and minimizes unnecessary testing and treatment, producing cost-savings in the multi-million dollar range. The combined worldwide reagent market for acetaminophen and salicylate testing is in excess of $25 million. Laboratory billings are estimated at $1 billion.
