Journal Information
Journal ID (publisher-id): BM
Journal ID (nlm-ta): Biochem Med (Zagreb)
Title: Biochemia Medica
Abbreviated Title: Biochem. Med. (Zagreb)
ISSN (print): 1330-0962
ISSN (electronic): 1846-7482
Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
Article Information
Copyright statement: Copyright Croatian Society of Medical Biochemistry and Laboratory Medicine
Copyright: 2018, Copyright Croatian Society of Medical Biochemistry and Laboratory Medicine
License (http://creativecommons.org/licenses/by/4.0/):
This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY) 4.0 License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Date received: 02 March 2018
Date accepted: 20 August 2018
Publication date (print and electronic): 15 October 2018
Volume: 28
Issue: 3
Electronic Location Identifier: 030711
Publisher ID: bm-28-3-030711
DOI: 10.11613/BM.2018.030711
A collaborative study by the Working Group on Hemostasis and Thrombosis of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) on the interference of haemolysis on five routine blood coagulation tests by evaluation of 269 paired haemolysed/non-haemolysed samples
Matteo Vidali[2]
Bruno Brando[1]
Benedetto Morelli[3]
Giovanna Andreani[4]
Marina Arini[5]
Paola Calzoni[6]
Roberta Giacomello[7]
Barbara Montaruli[8]
Emanuela Muccini[9]
Angela Papa[10]
Paola Pradella[11]
Lucia Ruocco[12]
Fosca Siviero[13]
Filomena Gemma Viola[14]
Mario Zanchetta[15]
Lorena Zardo[16]
Giuseppe Lippi[17]
[1] Transfusion Center and Haematology Laboratory, Western Milan Area Hospital Consortium, Legnano General Hospital, Legnano, Italy
[2] Clinical Chemistry Unit, Maggiore della Carità Hospital, Novara, Italy
[3] Synlab Laboratory, Castenedolo, Italy
[4] Clinical Chemistry Laboratory, Apuan Hospital, Massa, Italy
[5] Clinical and Microbiological Analysis Laboratory, Dell’Angelo Hospital, Mestre, Italy
[6] Clinical Pathology, University Hospital of Siena, Siena, Italy
[7] Department of Medical Area, University of Udine, Department of Laboratory Medicine, ASUI UD, University Hospital, Udine, Italy
[8] Laboratory Analysis, A.O. Ordine Mauriziano, Turin, Italy
[9] Clinical Biochemistry Laboratory, Azienda O.U. S. Giovanni Battista, Turin, Italy
[10] Laboratory Medicine, G. Monasterio Foundation, CNR-Regione Toscana, Pisa, Italy
[11] Transfusion Medicine, University Hospital “Ospedali Riuniti” of Trieste, Trieste, Italy
[12] Clinical Analysis Laboratory, University Hospital of Pisa, Pisa, Italy
[13] Laboratory Medicine, Bassano del Grappa Hospital, Bassano del Grappa, Italy
[14] Department of Laboratory Medicine, Tor Vergata University Hospital of Rome, Rome, Italy
[15] Laboratory Analysis, Degli Infermi Hospital, Ponderano, Italy
[16] Laboratory Analysis, San Giacomo Apostolo Hospital, Castelfranco Veneto, Italy
[17] Section of Clinical Biochemistry, University of Verona, Verona, Italy
Author notes:
The first two authors contributed equally to this work.
[*] Corresponding author: chiara.novelli@asst-ovestmi.it
Introduction
Haemolysis is the leading cause of sample rejection in laboratory haemostasis. Most studies focused on artificially haemolysed samples. The aim of this study was a prospective assessment of spontaneous haemolysis on haemostasis tests, by comparing results of haemolysed (H) versus new, non-haemolysed (NH) specimens, collected within 4hrs. As new coagulometers can identify interfering substances, visual assessment of haemolysis was also compared with instrumental haemolysis index and stratified in subclasses.
Materials and methods
Two hundred and sixty nine paired samples were collected and analysed using ACL TOP750-CTS (Instrumentation Laboratory, Bedford, USA), for prothrombin time (PT), activated partial thromboplastin time (aPTT), D-Dimer (DD), fibrinogen (Fib) and antithrombin (AT). Bias between H and NH was calculated and compared with the respective critical difference (CD).
Results
Mean bias was - 0.1 s for PT (P = 0.057), - 1.1 s for aPTT (P < 0.001), 1025 ng/mL for DD (P < 0.001), - 0.04 g/L for Fib (P = 0.258) and 1.4% for AT (P = 0.013). Bias exceeding the CD varied according to the method, with larger differences for aPTT (36.1%) and DD (17.1%) and < 8% for PT, Fib and AT. No correlation emerged between free haemoglobin values and difference in haemostasis tests in H and NH samples for any tests. Moderate/severe haemolysis involved > 95% of samples. The agreement between visual assessment and instrumental evaluation of haemolysis was 0.62.
Conclusion
Spurious haemolysis deeply influences aPTT and DD, and to a lesser extent AT and Fib. Prothrombin time seems only slightly influenced, suggesting that PT can be accepted also in haemolysed samples. Although a good inter-observer correlation of haemolysis evaluation was found, the instrumental assessment of haemolysis seems recommendable.
Keywords: blood coagulation tests; haemolysis; preanalytical phase
