title: Protein C assay performance: an analysis of North American specialized coagulation laboratory association proficiency testing results.
abstract: To determine the performance and frequency of protein C reagents currently used by clinical laboratories, we analyzed North American Specialized Coagulation Laboratory Association (NASCOLA) protein C proficiency testing data from 6 surveys conducted in 2009 and 2010 (2009-1 to 2009-3 and 2010-1 to 2010-3). Interlaboratory coefficients of variation (CV) for commonly used reagents on a survey with normal protein C ranged from 8% to 12% for antigenic assays, from 4% to 7% for chromogenic activity assays, and from 7% to 22% for clot-based activity assays. CVs for commonly used reagents on specimens with abnormal protein C ranged from 15% to 24% for antigenic, 4% to 11% for chromogenic, and 10% to 17% for clot-based assays (averaged across 3 surveys). Some reagents were used by relatively few laboratories and therefore additional study may be needed for those reagents. For all commonly used reagents, biases were usually small and often not statistically significant. All assessed reagents were clinically accurate, and were considered acceptable options for a specialized coagulation laboratory.
authors.affiliation: Department of Pathology, Massachusetts GeneralHospital, Harvard Medical School, Boston, MA 02114, USA.
authors.forename: Jason M
authors.initials: JM
authors.lastname: Baron
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Johnson
authors.forename: Marlies R
authors.initials: MR
authors.lastname: Ledford-Kraemer
authors.forename: Catherine P
authors.initials: CP
authors.lastname: Hayward
authors.forename: Piet
authors.initials: P
authors.lastname: Meijer
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Van Cott
mesh_terms: D000925:Anticoagulants / Q000032:analysis* / Q000097:blood; D001777:Blood Coagulation; D019411:Clinical Laboratory Techniques / Q000379:methods / Q000592:standards*; D003625:Data Collection; D006801:Humans; D007202:Indicators and Reagents / Q000145:classification / Q000592:standards; D059021:Laboratory Proficiency Testing / Q000379:methods / Q000592:standards*; D009656:North America; D011486:Protein C / Q000032:analysis*; D020151:Protein C Deficiency / Q000150:complications / Q000175:diagnosis*; D011933:Reagent Kits, Diagnostic
chemical_list: D000925:Anticoagulants; D007202:Indicators and Reagents; D011486:Protein C; D011933:Reagent Kits, Diagnostic