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Cooperation experience in a multicentre study to define the upper limits in a normal population for the diagnostic assessment of the functional lupus anticoagulant assays

  • Paola Pradella EMAIL logo , Gabriella Azzarini , Liliana Santarossa , Livio Caberlotto , Cristina Bardin , Alessandra Poz , Federica D’Aurizio and Roberta Giacomello
Published/Copyright: September 22, 2012

Abstract

Background: Phospholipid-dependent coagulation tests for lupus anticoagulant (LA) are considered an important step for the diagnosis of anti-phospholipid syndrome; however, LA laboratory detection is difficult because of many variables. Five hospital laboratories, located in a North-Italy area and using the same method for LA testing, cooperated to standardise sample treatment and analytical procedure in order to define the upper values for LA negativity.

Methods: In total, 200 normal subjects (40 for each centre) were studied for six LA functional assays, using the same procedure, reagent lot and analyser type. The first tests done were LA screen and LA confirm assays, based on diluted Russell’s Viper Venom Time, with low and high phospholipid content, respectively. The second tests performed were silica clotting time screen and confirm assays, based on activated partial thromboplastin time, with low and high phospholipid content, respectively. Finally, two mixing assays were executed for both screening assays, diluting patient sample with a pool prepared with plasma collected from the study population.

Results: Data analysis demonstrated a difference between centres for all assays when results were expressed in seconds; the difference disappeared when results are normalised with the local mean normal value of each centre and are expressed as a normalised ratio. The study population was normally distributed; so the value corresponding to 99th percentile was used as limit value for LA negativity. Values expressed as normalised ratio, for LA and silica clotting time screenings were 1.22 and 1.23, respectively.

Conclusions: The study allowed us to define a uniform approach to LA testing and evaluation for laboratories employing the same methods.


Corresponding author: Paola Pradella, Haemostasis Laboratory, Department of Transfusion Medicine, AOUTs “Ospedali riuniti”, University Hospital of Cattinara, Strada di Fiume 447, 34149 Trieste, Italy, Phone: +39 040 3994337, Fax: +39 040 3994893

A wholehearted acknowledgement to Dr. Massimo Gion, director of the Department of Clinical Pathology, AULLS 12, General Hospital “Dell’Angelo”, Venezia-Mestre, Italy, for his helpful feedback and suggestions. The authors would like to thank the Instrumentation Laboratory for providing reagent kits to perform the assays.

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

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Received: 2012-06-14
Accepted: 2012-08-20
Published Online: 2012-09-22
Published in Print: 2013-02-01

©2013 by Walter de Gruyter Berlin Boston

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