Study to assess the effect of age of control human and animal blood on its suitability for use in quantitative bioanalytical DBS methods

Abstract

Background: A study was performed to evaluate the suitability of stored EDTA-treated control whole blood for use in the preparation of calibration standards and quality control samples for quantitative bioanalytical methods employing dried blood spot (DBS) samples to support pharmaceutical exposure studies. Results: It has been demonstrated that a storage time of 14 days for control human and animal blood is suitable for producing quantitative analytical results within internationally recognised acceptance criteria for two analytes. Furthermore, blood hemolysis and chill–thaw cycles have been evaluated and shown not to affect bioanalytical results notably. Aggressive mixing techniques can result in rat blood coagulation; however, this does not occur with other species tested and can be affected by the method of blood collection. Conclusion: Control whole blood handled and stored using the recommendations generated from this study will not notably affect quantitative bioanalytical results when used for the preparation of calibration standards and quality control samples for DBS assays. It was demonstrated that control human and animal blood can be stored for periods long enough to effectively eliminate wastage.