Background: In order to minimize the influence of glycolysis on diabetes mellitus (DM) diagnostic tests, we have compared the behavior of citric/citrate, fluoride additives and gel-serum with plasma-heparin under careful preanalytical conditions. Subsequently, we compared the effectiveness of both fluoride and citric additives at different pre-centrifugation times. Finally, the influence of citric/citrate collection tube on diagnostic tests results was evaluated.
Methods: The first study of 80 voluntary patients assessed the glucose bias of citric/citrate, fluoride additive tubes and gel-serum tubes versus plasma-heparin tubes at several medical decision cut-offs (MDC). The second study performed with 72 volunteers evaluated additives, simulating transport times to the laboratory and centrifugation delay periods. Final evaluation compares the proportion of positive tests in total tests carried out in two different periods.
Results: When citric/citrate (n=79) and fluoride tubes (n=60) were compared with plasma-heparin under controlled preanalytical conditions, both met the bias specification for plasma glucose (±1.8%) at seven MDC. On the contrary, serum samples (n=15) did not meet it at five MDC. In the second study, differences in glucose values at distinct pre-centrifugation times were not statistically significant for citric/citrate tubes, but significant for fluoride tubes and also for comparison of fluoride and citric/citrate tubes. Hemolysis in fluoride tubes was higher. Citric/citrate tube implementation in our laboratory caused an increase in positive diagnostic tests that were only statistically significant for gestational diabetes mellitus (GDM) screening.
Conclusions: Citric/citrate additive tube is equivalent to plasma-heparin avoiding glycolysis completely and immediately under careful preanalytical conditions even with a 3-h delay in plasma separation. According to used MDC we have not statistically significantly increased the diagnoses of DM cases.
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