Incomplete filling of spray-dried K2EDTA evacuated blood tubes: impact on measuring routine hematological parameters on Sysmex XN-10

Giuseppe Lippi; Francesco Dima; Marco Tosi; Giovanni Carpenè; Giovanni Celegon; Emmanuel J. Favaloro; Gian Luca Salvagno

doi:10.1515/dx-2023-0064

Article

Incomplete filling of spray-dried K₂EDTA evacuated blood tubes: impact on measuring routine hematological parameters on Sysmex XN-10

Giuseppe Lippi , Francesco Dima , Marco Tosi , Giovanni Carpenè , Giovanni Celegon , Emmanuel J. Favaloro and Gian Luca Salvagno

Published/Copyright: July 24, 2023

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From the journal Diagnosis Volume 10 Issue 4

Abstract

Objectives

Because there is little published evidence on the effects of incomplete filling of K₂EDTA evacuated blood tubes on routine hematological testing, this original study aimed to provide updated information on this preanalytical aspect.

Methods

The study population consisted of 17 ostensibly healthy volunteers. Blood was drawn by venipuncture with a 10 mL syringe and dispensed in varying amounts (0.2, 0.5, 1.0, 2.0, and 3.0 mL) into 3.0 mL blood tubes containing spray-dried 5.4 mg K₂EDTA. All tubes were gently mixed and used to perform routine hematology tests on the Sysmex XN-10. Clinically significant variations were defined when the limits of desirable specifications of bias derived from biologic variation were exceeded.

Results

The desirable bias was exceeded in 33 % filled tubes (1.0 mL) for hematocrit and MCV (increased values) and for MCHC (decreased values), while it was exceeded in 17 % filled tubes (0.5 mL) for hemoglobin, hematocrit and MCV (increased values), and for MCHC (decreased values). Finally, the variation of values was higher than the desirable bias for RBC, hemoglobin, hematocrit and MCV (increase), and for MCHC and MPV (decrease) in 7 % filled tubes (0.2 mL). No clinically significant variations were observed in tubes filled up to 67 % of their nominal volume (i.e., 2.0 mL).

Conclusions

Consideration should be given to reject spray-dried K₂EDTA blood tubes that contain a blood volume <67 % of the nominal fill volume, as biased laboratory data in these samples may interfere with clinical decision making and care management.

Keywords: blood tubes; filling; hematological testing; preanalytical variability

Corresponding author: Prof. Giuseppe Lippi, Section of Clinical Biochemistry and School of Medicine, University Hospital of Verona, Piazzale L.A. Scuro, 10, 37134 Verona, Italy, Phone: 0039 045 8122970, Fax: 0039 045 8124308, E-mail: giuseppe.lippi@univr.it

Acknowledgments

The authors are thankful to Mrs. Francesca Juvara and Lorenza Zanardi for the skilled technical assistance provided in performing the hematological measurements.

Research ethics: The study was approved by the Ethical Committee of the University Hospital of Verona (970CESC; July 20, 2016).
Informed consent: All volunteers provided an informed consent for participating to this study.
Author contributions: All authors contributed equally to this study
Competing interests: Not applicable.
Research funding: Not applicable.
Data availability: Data will be available upon reasonable request to the corresponding author

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Received: 2023-06-04

Accepted: 2023-06-21

Published Online: 2023-07-24

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https://doi.org/10.1515/dx-2023-0064

Keywords for this article

blood tubes; filling; hematological testing; preanalytical variability