Aim: The quality of quantitative analytical measurements is dependent on the quality of the sample collected, and dried blood spots (DBS) are no exception. As the use of DBS has matured into late-stage clinical drug-development studies, it has become apparent that a simple and straightforward approach in a controlled single-site, first-time-into-human clinic, does not always translate into multicenter clinical studies. Using synthetic blood, a method of training and assessing clinical laboratory staff has been developed to ensure the quality of sampling. Methods: A test kit comprising of synthetic blood, a pipetting aid, blank blood spot card, drying rack and training manual was sent to each clinical site for each technician to assess and approve prior to spotting PK samples. Results: The development of a DBS training kit along with a step-by-step guide has been successfully implemented. Conclusion: The training kit has been 100% successful across three large multisite clinical studies.
Keywords:
- clinical bioanalysis
- data quality
- dried blood spot samples
- training