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Thromb Haemost 2016; 116(01): 50-57
DOI: 10.1160/TH15-12-0918
Coagulation and Fibrinolysis
Schattauer GmbH

Protein S testing in patients with protein S deficiency, factor V Leiden, and rivaroxaban by North American Specialized Coagulation Laboratories

Kristi J. Smock
1   Department of Pathology, University of Utah, ARUP Laboratories, Salt Lake City, Utah, USA
,
Elizabeth A. Plumhoff
2   Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA
,
Piet Meijer
3   ECAT Foundation, Voorschoten, Netherlands
,
Peihong Hsu
4   Department of Pathology and Laboratory Medicine, Northwell Health System and Hofstra NorthwellSchool of Medicine, Lake Success, New York, USA
,
Nicole D. Zantek
5   Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA
,
Nahla M. Heikal
1   Department of Pathology, University of Utah, ARUP Laboratories, Salt Lake City, Utah, USA
,
Elizabeth M. Van Cott
6   Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts, USA
› Author AffiliationsFinancial support: NDZ has received research funding from Sekisui Diagnostics, Inc. The other authors declare no conflicts of interest related to the content of the manuscript.
Further Information

Publication History

Received: 02 December 2015

Accepted after major revision: 26 March 2016

Publication Date:
27 November 2017 (online)

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Summary

In 2010–2012, the North American Specialized Coagulation Laboratory Association (NASCOLA) distributed 12 proficiency testing challenges to evaluate laboratory testing for protein S (PS). Results were analysed to assess the performance of PS activity, PS free antigen, and PS total antigen testing. Statistical analysis was performed on the numeric results and qualitative classification submitted for each method. There were 2,106 total results: 716 results from PS activity assays, 833 results from PS free antigen assays, and 557 results from PS total antigen assays. The three assay types performed well in the classification of five normal samples and nine abnormal samples, although certain PS activity methods were more likely to classify normal samples as abnormal and one PS total antigen assay was more likely to classify abnormal samples as normal. PS activity methods were affected by interfering substances such as heterozygous or homozygous factor V Leiden mutation (underestimation) and the anticoagulant drug rivaroxaban (overestimation). In conclusion, NASCOLA laboratories using a variety of PS assays performed well in the classification of clearly normal and abnormal samples. Laboratories performing PS activity assays should be aware of potential interferences in samples positive for FV Leiden or containing certain anticoagulant medications.

Keywords

Protein S - proficiency testing - NASCOLA - factor V Leiden - direct oral anticoagulants
 

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