Impact of water temperature on reconstitution of quality controls for routine hemostasis testing

Simone De Nitto; Gian Luca Salvagno; Emmanuel J. Favaloro; Robert C. Gosselin; Giuseppe Lippi

doi:10.1515/dx-2019-0111

Article

Impact of water temperature on reconstitution of quality controls for routine hemostasis testing

Simone De Nitto , Gian Luca Salvagno , Emmanuel J. Favaloro , Robert C. Gosselin and Giuseppe Lippi

Published/Copyright: February 28, 2020

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From the journal Diagnosis Volume 8 Issue 2

Abstract

Background

This study aimed to investigate whether the temperature of distilled water used for reconstituting lyophilized routine internal quality control (IQC) material may influence the process of validation of analytical sessions of routine hemostasis testing.

Methods

Routine hemostasis testing was performed for 10 consecutive days using two levels of IQC materials dissolved using distilled water at three different temperatures (2–4°C, 22–24°C and 36–38°C). The tests assayed comprised prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FBG), antithrombin (AT), protein C (PC), protein S (PS) and D-dimer (D-Dimer HS 500), using the same ACL TOP 700 hemostasis instrument.

Results

Overall, 50% (i.e. 7/14) IQC measurements displayed statistically significant bias when lyophilized material was dissolved with distilled water at 3–5°C compared to 22–24°C, and in two instances (level I for both PT and D-dimer) the bias was higher than the quality specifications. Concerning lyophilized material dissolved with distilled water at 36–38°C, 21% (3/14) IQC values displayed a statistically significant bias compared to 22–24°C, and in one instance (level 2 for PT) the bias was higher than the quality specifications.

Conclusions

The results of this study show that water temperature, as used to dissolve lyophilized IQC material, may represent an important pre-analytical variable in routine hemostasis testing, especially cold temperatures. Laboratory professionals are encouraged to standardize water temperature, preferably between 22 and 24°C, before reconstituting lyophilized IQC materials used to validate routine hemostasis testing.

Keywords: coagulation; hemostasis; laboratory medicine; quality; quality controls

Corresponding author: Prof. Giuseppe Lippi, Section of Clinical Biochemistry, University of Verona, Piazzale LA Scuro, 37134 Verona, Italy

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2019-12-27

Accepted: 2020-02-15

Published Online: 2020-02-28

Published in Print: 2021-05-26

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Articles in the same Issue

https://doi.org/10.1515/dx-2019-0111

Keywords for this article

coagulation; hemostasis; laboratory medicine; quality; quality controls