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Sodium citrate vacuum tubes validation: preventing preanalytical variability in routine coagulation testing
Gabriel Lima-Oliveira1, Giuseppe Lippi, Gian Luca Salvagno
1Department of Life and Reproduction Sciences, Laboratory of Clinical Biochemistry, University of Verona, Italy. dr.g.lima.oliveira@gmail.com
Summary
Different brands of sodium citrate vacuum tubes significantly impact coagulation test results, except for fibrinogen. Laboratories must validate and standardize these essential in-vitro diagnostic devices to ensure accurate patient testing.
Area of Science:
- Clinical Chemistry
- Hematology
- In-vitro Diagnostics
Background:
- In-vitro diagnostic devices, such as blood collection tubes, require validation before use.
- Changing tube brands necessitates re-validation to ensure consistent diagnostic accuracy.
- Sodium citrate vacuum tubes are critical for coagulation testing.
Purpose of the Study:
- To validate five different brands of sodium citrate vacuum tubes for routine coagulation tests.
- To assess the impact of tube brand variation on prothrombin time (PT), activated partial thromboplastin time (aPTT), and fibrinogen (FIB) measurements.
Main Methods:
- Blood specimens from 50 volunteers were collected in five distinct tube brands.
- Routine coagulation tests (PT, aPTT, FIB) were performed using an ACL TOP instrument and HemosIL reagents.
- Paired Student's t-test was employed to analyze the significance of differences between tube brands (P < 0.005).
Main Results:
- Significant differences were observed in PT and aPTT results across multiple tube brand comparisons.
- No significant differences were found among the tested brands for fibrinogen determination.
- Specific brand comparisons revealed statistically significant variations in PT and aPTT.
Conclusions:
- The brand of sodium citrate vacuum tube can significantly affect PT and aPTT results.
- Fibrinogen levels appear unaffected by the brand of sodium citrate vacuum tubes used.
- Laboratories should standardize procedures and regularly evaluate the quality of in-vitro diagnostic devices to ensure reliable testing.
