Stabilization of glucose concentration in the new VACUETTE® FC Mix blood collection tube for diagnosis of gestational diabetes

Background:

Reliable detection of GDM is required to prevent maternal and fetal complications. The aim of the study was to demonstrate long term stability of initial glucose concentration in specimens centrifuged directly after collection and compared to whole blood specimens stored at room temperatures.

Method:

The study was conducted at ISALA Hospital (Netherlands) using VENOSAFE™ FC Mixture versus VACUETTE FC Mix tubes. Altogether, 43 pregnant donors (healthy (n = 19) or diagnosed with gestational diabetes by 75 g-OGT-Test (n = 24)) were recruited. The study was approved by EC Netherlands. Venous blood was drawn into four tubes. One tube of each type was centrifuged directly after blood collection, the second one after whole blood storage for 48h at RT. Plasma was measured immediately after centrifugation and after 48h for evaluation of glucose stability on a Roche-COBAS-8000. Statistical evaluation was done by STATISTICA 12.

Results:

Evaluation for glucose concentration and any deviations was done on basis of maximal allowed deviation for single values (for glucose 11%) according to RILIBÄK-guideline. The utilization of both tubes did not reveal any clinically nor statistically significant deviations (p < 0.05). The values resulted in an initial highest deviation of 5.5%, and 6.4% after 48h (both healthy). The storage of whole blood specimens for 48h showed no significant deviation (10.5%, healthy).

Conclusion:

The FC Mix tube is suitable for reliable determination of blood glucose, one of the most frequently measured laboratory analytes and of primary importance in diagnosis, monitoring and therapy of GDM.