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Filling accuracy and precision of Na-citrate coagulation tubes for three major blood tube manufacturers

BACKGROUND-AIM: CLSI H21-A5 guideline (Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays) recommends 90% fill volume for Na-citrate tubes. Tube underfilling or overfilling, greater than ±10%, may lead to false results for some coagulation assays. The aim of this study was to examine the filling accuracy and precision for Greiner, Kima and BD, 3.2% Na-citrate coagulation tubes. METHODS: To asses between-lot variations, 3 different lots (20 tubes per lot) of citrate blood tubes from three major manufacturers (Becton, Dickinson and Company (BD), USA ; Greiner Bio-One GmbH, Germany ; Vacutest KIMA, Italy) were examined. One additional lot from each manufacturer was measured in triplicate (three series of 20 tubes), to assess within-lot variations. All tubes were first weighed empty and then filled with water using 50 mL syringe and 19G straight needle (ideal filling conditions). Filled tubes were weighed again, in duplicate. For each series of 20 tubes, mean bias (deviation from the ideal tube filling volume) and CV(%) was calculated. RESULTS: All biases were within ±10%. Within-lot and between-lots variations in filling volume for all three tube manufacturers was acceptable (0.4 to 2.4%). Greiner tubes were most accurate with biases ranging from -1.0 to -2.4%. KIMA tubes were least accurate, with a negative bias across all tested lots, ranging from -6.0 to -7.9%. CONCLUSIONS: Although the coagulation test tubes filling accuracy was within ±10%, for all three tested manufacturers, it should be noted that tube filling accuracy may differ between tube manufacturers. Our experiment shows that tube filling may not be ideal even under ideal filling conditions. This leaves little room for patient related tube filling problems.

preanalytical phase, coagulation, blood tubes, filling accuracy

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