726-P: Preventing Glycolysis with the VACUETTE FC Mix Tube—An Accurate Diagnosis of Diabetes

Background: Diabetes continues to be one of the most prevalent diseases worldwide. According to the IDF (International Diabetes Federation), 537 million people were diagnosed with diabetes in 2021. This number is estimated to reach 643 million by 2030. Gestational Diabetes, which affects vulnerable populations, increased by 13% from 2019-20. Currently, the process for blood collection and analysis of glucose can require a transport time of up to 48 hours to the laboratory. The current practices used to stabilize glucose are to either place the sample in a centrifuge immediately or in an ice slurry and subsequently spin within 15-30 minutes. These practices are not consistently done across laboratories as it is not always practical. The impact of different storage conditions on glucose stability in the FC Mix tube was studied.

Method: The study took place at a laboratory in Austria. A European ethics committee approved the study. Apparently healthy subjects (n=20) were recruited and consented. Subjects were advised to fast prior to blood collection. Venous blood was drawn from each subject into four tubes. Tubes were inverted 10 times prior to centrifugation (1800 g for 10 minutes). Samples were spun and analyzed at different timepoints (0h, 7h, 24h, and 48h) to assess the stability of glucose. A portion of the samples remained in the original tube and a portion was aliquoted following spinning. The platform used was the Beckman Coulter AU680. Statistical evaluation was done using GLIMS.

Results: The evaluation of all results was based on a Total Change Limit of 3.55% for Glucose. Performance testing revealed no clinically significant differences between timepoints. Storage of whole blood specimens for 48h at RT led to a deviation of 3.34% and in a refrigerator for 48h led to a deviation of 2.36%. The measurement of plasma aliquots after 48h revealed a deviation of 1.45% compared to the plasma at 0h.

Conclusion: The FC Mix tube is suitable for stabilizing blood glucose under a variety of storage conditions up to 48h.