Evaluation of a novel heparin-iloprost-based antithrombotic formulation blood collection tube for clinical usage.


Journal

Clinica chimica acta; international journal of clinical chemistry
ISSN: 1873-3492
Titre abrégé: Clin Chim Acta
Pays: Netherlands
ID NLM: 1302422

Informations de publication

Date de publication:
01 Dec 2022
Historique:
received: 26 08 2022
revised: 07 10 2022
accepted: 09 10 2022
pubmed: 25 10 2022
medline: 16 11 2022
entrez: 24 10 2022
Statut: ppublish

Résumé

The objective of our study was to evaluate a single blood collection tube with a novel antithrombotic formulation to measure both hematological, biochemical, and d-dimer analytes. Paired samples of gold standard blood tubes (EDTA, lithium heparin, sodium citrate) and a new antithrombotic formulation blood tube were collected from 187 patients. The new antithrombotic tube is a lithium heparin tube preloaded with a liquid form of prostacyclin analog. The novel tube was tested on seventeen hematological parameters and smears against EDTA, on fourteen biochemical parameters against lithium heparin and on d-dimer against sodium citrate. All correlation coefficients were close to 0.99. The Bland-Altman analyses presented a satisfactory correspondence for all analytes. All the hematological examinations demonstrated comparable results between EDTA and the novel formulation, except for platelet counts analyzed by impedance method, but not by fluorescence. We detected lower mean platelet volume with/without outliers (5.06%)/(5.13%) in the novel formulation and increased mean corpuscular hemoglobin concentration (2.55%). All the biochemistry analytes demonstrated comparable results between lithium heparin and the novel tube. d-dimer showed comparable results between citrated blood and the novel formulation after dilution correction. We describe a novel antithrombotic formulation tube with the potential to be introduced into clinical laboratories for simultaneous analysis of thirty-two blood analytes.

Sections du résumé

BACKGROUND BACKGROUND
The objective of our study was to evaluate a single blood collection tube with a novel antithrombotic formulation to measure both hematological, biochemical, and d-dimer analytes.
METHODS METHODS
Paired samples of gold standard blood tubes (EDTA, lithium heparin, sodium citrate) and a new antithrombotic formulation blood tube were collected from 187 patients. The new antithrombotic tube is a lithium heparin tube preloaded with a liquid form of prostacyclin analog. The novel tube was tested on seventeen hematological parameters and smears against EDTA, on fourteen biochemical parameters against lithium heparin and on d-dimer against sodium citrate.
RESULTS RESULTS
All correlation coefficients were close to 0.99. The Bland-Altman analyses presented a satisfactory correspondence for all analytes. All the hematological examinations demonstrated comparable results between EDTA and the novel formulation, except for platelet counts analyzed by impedance method, but not by fluorescence. We detected lower mean platelet volume with/without outliers (5.06%)/(5.13%) in the novel formulation and increased mean corpuscular hemoglobin concentration (2.55%). All the biochemistry analytes demonstrated comparable results between lithium heparin and the novel tube. d-dimer showed comparable results between citrated blood and the novel formulation after dilution correction.
CONCLUSIONS CONCLUSIONS
We describe a novel antithrombotic formulation tube with the potential to be introduced into clinical laboratories for simultaneous analysis of thirty-two blood analytes.

Identifiants

pubmed: 36279940
pii: S0009-8981(22)01333-X
doi: 10.1016/j.cca.2022.10.006
pii:
doi:

Substances chimiques

Heparin 9005-49-6
Iloprost JED5K35YGL
Fibrinolytic Agents 0
Lithium 9FN79X2M3F
Edetic Acid 9G34HU7RV0
Sodium Citrate 1Q73Q2JULR

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

87-95

Informations de copyright

Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Aneta Radziwon-Balicka (A)

Department of Clinical Biochemistry, North Zealand Hospital, University of Copenhagen, Denmark. Electronic address: aneta.radziwon@gmail.com.

Elias F Wiwe (EF)

Department of Clinical Biochemistry, North Zealand Hospital, University of Copenhagen, Denmark.

Tomas Ø Jensen (TØ)

Department of Infectious Diseases and Respiratory Medicine, North Zealand Hospital, University of Copenhagen, Denmark.

Signe G Nielsen (SG)

Department of Oncology and Palliative Medicine, North Zealand Hospital, University of Copenhagen, Denmark.

Miljena Copois (M)

Department of Infectious Diseases and Respiratory Medicine, North Zealand Hospital, University of Copenhagen, Denmark.

Niclas Sunde (N)

Department of Endocrinology and Nephrology, North Zealand Hospital, University of Copenhagen, Denmark.

Nina C Peytz (NC)

Gynecology Obstetric Department, North Zealand Hospital, University of Copenhagen, Denmark.

Dhergam A A Al-Mousawi (DAA)

Orthopedic Surgery Department, North Zealand Hospital, University of Copenhagen, Denmark.

Mie C Hansen (MC)

Orthopedic Surgery Department, North Zealand Hospital, University of Copenhagen, Denmark.

Jesper F Petersen (JF)

Gynecology Obstetric Department, North Zealand Hospital, University of Copenhagen, Denmark.

Anne S Nørskov (AS)

Department of Endocrinology and Nephrology, North Zealand Hospital, University of Copenhagen, Denmark.

Maria E Lendorf (ME)

Department of Oncology and Palliative Medicine, North Zealand Hospital, University of Copenhagen, Denmark.

Young B L Hansen (YBL)

Department of Clinical Biochemistry, North Zealand Hospital, University of Copenhagen, Denmark.

Thomas S Hansen (TS)

Radiometer Medical ApS, Brønshøj, Denmark.

Melanie A Burkhardt (MA)

Radiometer Medical ApS, Brønshøj, Denmark.

Kristian M Hansen (KM)

Radiometer Medical ApS, Brønshøj, Denmark.

Claus A J Jensen (CAJ)

Department of Clinical Biochemistry, North Zealand Hospital, University of Copenhagen, Denmark.

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Classifications MeSH