An evaluation of screening tests for defects in the protein C pathway: commercial kits lack sensitivity and specificity

Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis
C GardinerS J Machin

Abstract

A comparative evaluation of four commercial coagulation test kits for screening the protein C pathway kits was performed at two centres. The tests were Acticlot V-OUT (V-OUT), the PCA test (PCA), the GradiThrom PCP test (PCP) and ProC Global (ProC). Reference ranges were established in 40 normal subjects and, with the exception of V-OUT and ProC, significant differences were observed between males and females. Consequently, sex-specific normal cut-off values (fifth percentile) were used that led to greatly improved sensitivity when compared with the manufacturers' recommended cut-off values. Plasma from patients with factor V Leiden (n = 23), congenital protein S deficiency (n = 19), congenital protein C deficiency (n = 11), lupus anticoagulant (n = 17) and thrombophilia with no demonstrable protein C pathway defect (n = 20) were tested. All kits showed 100% sensitivity to factor V Leiden, but sensitivity was variable for protein C deficiency (27-73%), and poor for protein S deficiency (29-35%). The lupus anticoagulant affected all kits to some degree, with 29-35% giving values below the fifth percentile of normal, whereas all kits gave 1/20 unexpected abnormal results in the thrombophilia group, with the same sample accounting...Continue Reading

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Citations

Jun 12, 2010·International Journal of Health Care Quality Assurance·Amanda Edgeworth, Edward C Coles
Nov 9, 2010·Clinical Chemistry and Laboratory Medicine : CCLM·Sandra Margetic
Apr 17, 2007·Seminars in Hematology·Ian MackieSteve Kitchen
Dec 17, 2003·British Journal of Haematology·David M KeelingUNKNOWN Haemostasis and Thrombosis Task Force of the British Committee for Standards in Haematology
Feb 11, 2012·International Journal of Laboratory Hematology·P C CooperR M Maclean
Aug 15, 2006·Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis·Chris GardinerIan J Mackie
Nov 7, 2006·IUBMB Life·Zhimin Lu, Shuichan Xu

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