Effects of different tube types on patient classification using current diabetes decision limits

Abstract Management of diabetes is a challenge starting in the pre-analytical phase with selecting the most appropriate glycolysis inhibitor. Study goal was to calculate the impact of tubes with different glycolysis inhibitors on the classification of the glycemic control of 157,415 consecutive hospital patients according to current WHO diabetes criteria. Methods Glucose and lactate were measured in parallel in samples from 68 healthy subjects collected and stored in different sample tubes from Sarstedt and Greiner. Bias to baseline conditions (fluoride heparin (FH) tubes, centrifugation within 1 hr) was determined. Results In baseline samples, glucose concentration in fluoride/EDTA/citrate (FC) plasma was ∼13% higher and lactate concentration ∼20% lower compared to FH, fluoride oxalate, and fluoride EDTA plasma, and in serum. Glucose recovery after storage up to 48 hrs was 99 -101% in the different tubes, but the effectiveness of glycolysis inhibition by FC was inconsistent. Based on the observed mean bias of 12% when FC tubes are used, we estimate an increase of 48.4 - 55.8% in the frequency of patients with impaired glucose levels using current WHO criteria. Conclusion Using current established decision limits, the number of patients with impaired glucose levels in the hospital would increase substantially with a strong impact on patient treatment and consumption of resources. The unpredictable failure of glycolysis inhibition in FC tubes does not allow to adjust the decision limits by a fixed factor. In the absence of prospective outcome studies with FC tubes, we recommend to measure glucose in samples containing FH.