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Validation of the minimal citrate tube fill volume for routine coagulation tests on ACL TOP 500 CTS®
K Ver Elst1, S Vermeiren, S Schouwers
1Clinical Laboratory, Department of Hematology, GZA Hospitals, Antwerp, Belgium.
Introduction:
CLSI recommends a minimal citrate tube fill volume of 90%. A validation protocol with clinical and analytical components was set up to determine the tube fill threshold for international normalized ratio of prothrombin time (PT-INR), activated partial thromboplastin time (aPTT) and fibrinogen.
Methods:
Citrated coagulation samples from 16 healthy donors and eight patients receiving vitamin K antagonists (VKA) were evaluated. Eighty-nine tubes were filled to varying volumes of >50%. Coagulation tests were performed on ACL TOP 500 CTS(®) . Receiver Operating Characteristic (ROC) plot, with Total error (TE) and critical difference (CD) as possible acceptance criteria, was used to determine the fill threshold.
Results:
Receiving Operating Characteristic was the most accurate with CD for PT-INR and TE for aPTT resulting in thresholds of 63% for PT and 80% for aPTT. By adapted ROC, based on threshold setting at a point of 100% sensitivity at a maximum specificity, CD was best for PT and TE for aPTT resulting in thresholds of 73% for PT and 90% for aPTT. For fibrinogen, the method was only valid with the TE criterion at a 63% fill volume.
Conclusion:
In our study, we validated the minimal citrate tube fill volumes of 73%, 90% and 63% for PT-INR, aPTT and fibrinogen, respectively.
