title: ProC Global: the first functional screening assay for the complete protein C pathway.
abstract: In clinical practice, venous thromboembolic complications are much more frequent than bleeding disorders. In fact, disturbances within the protein C pathway due to coagulation factor V (FV) Leiden mutation and deficiency of protein C or protein S are the most frequent abnormalities in hereditary thrombophilia. Furthermore, acquired dysfunctions of the protein C system may predispose the single individual to an increased thrombotic risk. A routine-suited screening assay that would allow the monitoring of the proper interplay of factors in the protein C pathway could add an important factor to the basic coagulation profile. This consists of the prothrombin time and of the activated partial thromboplastin time, which currently allow only a screening for increased risk for bleeding but not for venous thromboembolism. A new functional screening test for the protein C system such as the presented ProC Global should therefore facilitate detection of FV Leiden as well as deficiency of protein C and protein S. The results of the present evaluation indicate that ProC Global is highly sensitive to activated protein C resistance/FV Leiden (100%) and protein C deficiency (90%) and sensitive to protein S deficiency (63%). Furthermore, the assay gives a quantitative measure of the net potential of the protein C pathway in relation to the intrinsic procoagulant system. The use of this assay for a prospective assessment of thromboembolic risk is the subject of current studies.
authors.affiliation: Behring Diagnostics GmbH, Marburg/Germany. dati@msmbwma.hoechst.com
authors.forename: F
authors.initials: F
authors.lastname: Dati
authors.forename: G
authors.initials: G
authors.lastname: Hafner
authors.forename: H
authors.initials: H
authors.lastname: Erbes
authors.forename: W
authors.initials: W
authors.lastname: Prellwitz
authors.forename: M
authors.initials: M
authors.lastname: Kraus
authors.forename: F
authors.initials: F
authors.lastname: Niemann
authors.forename: M
authors.initials: M
authors.lastname: Noah
authors.forename: C
authors.initials: C
authors.lastname: Wagner
mesh_terms: D001778:Blood Coagulation Disorders / Q000175:diagnosis*; D001782:Blood Donors; D004198:Disease Susceptibility; D005165:Factor V / Q000032:analysis*; D006801:Humans; D008403:Mass Screening / Q000295:instrumentation / Q000379:methods; D009154:Mutation; D010314:Partial Thromboplastin Time; D011486:Protein C / Q000032:analysis*; D020151:Protein C Deficiency; D017293:Protein S / Q000032:analysis*; D011933:Reagent Kits, Diagnostic; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013927:Thrombosis / Q000097:blood / Q000175:diagnosis
chemical_list: D011486:Protein C; D017293:Protein S; D011933:Reagent Kits, Diagnostic; C095381:factor V Leiden; D005165:Factor V