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DOI: 10.1055/s-0038-1657721
Standardisation of Protein S in Plasma: Calibration of the 1st International Standard
Publication History
Received 09 1997
Accepted after revision 04 June 1997
Publication Date:
12 July 2018 (online)
![](https://www.thieme-connect.de/media/10.1055-s-00035024/199701/lookinside/thumbnails/10-1055-s-0038-1657721-1.jpg)
Summary
An international collaborative study, involving 16 laboratories, was carried out to calibrate the 1st International Standard Protein S, plasma, for total and free Protein S antigen and for Protein S function. Potency estimates were calculated relative to locally collected fresh normal plasma pools. Estimates of total Protein S antigen showed good agreement between laboratories with inter-laboratory geometric coefficient of variation (gcv%) of 8.8% and a mean value of 0.89 IU/ampoule. Estimates of free Protein S antigen calculated relative to total Protein S antigen in the fresh normal pools were more variable (gcv 26.8%) than estimates calculated relative to free Protein S antigen (gcv 15.3%); the latter comparison was used for calibration with a mean value of 0.89 IU/ampoule. Functional Protein S was estimated using commercial kits which gave an overall mean value of 0.92 IU/ampoule (gcv 14.0%). The 1st International Standard Protein S, plasma, (coded 93/590) was established in October 1995 with a single potency of 0.90 IU/ampoule for all three parameters.
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References
- 1 Walker FJ. Regulation of activated protein C by a new protein. J Biol Chem 1980; 255: 5521-5524
- 2 Walker FJ. Regulation of activated protein C by protein S. The role of phospholipid in factor Va inactivation. J Biol Chem 1981; 256: 11128-11131
- 3 Comp PC, Esmon CT. Recurrent thromboembolism in patients with a partial deficiency of protein S. N Engl J Med 1984; 311: 1525-1528
- 4 Comp PC, Nixon RR, Cooper MR, Esmon CT. Familial Protein S deficiency is associated with recurrent thrombosis. J Clin Invest 1984; 74: 2082-2088
- 5 Schwarz HP, Fischer M, Hopmeier P, Batard MA, Griffin JH. Plasma Protein S deficiency in familial thrombotic disease. Blood 1984; 64: 1297-1300
- 6 Broekmans AW, Bertina RM, Reinalda-Poot J, Engesser L, Muller HP, Leeuw JA, Michiels JJ, Brommer EJP, Briët E. Hereditary Protein S deficiency and venous thromboembolism. A study in three Dutch families. Thromb Haemost 1985; 54: 273-277
- 7 Dahlbäck B, Stenflo J. High molecular weight complex in human plasma between vitamin K dependent Protein S and complement component C4b-binding protein. Proc Natl Acad Sci USA 1981; 78: 2512-2516
- 8 Dahlbäck B. Purification of human C4b-binding protein and formation of its complex with vitamin K-dependent protein S. Biochem J 1983; 209: 847-856
- 9 Dahlbäck B. Interaction between vitamin K-dependent protein S and the complement protein C4b-binding protein. Semin Thromb Hemostas 1984; 10: 139-148
- 10 Hubbard AR, Wong MY. A collaborative study on the measurement of Protein S antigen in plasma. Thromb Haemost 1992; 68: 115-118
- 11 Campbell PJ. International biological standards and reference preparations. 1. Preparation and presentation of materials to serve as standards and reference preparations. J Biol Stand 1974; 2: 249-267
- 12 Woodhams BJ. The simultaneous measurement of total and free protein S by ELISA. Thromb Res 1988; 50: 213-220
- 13 Comp PC, Doray D, Patton D, Esmon CT. An abnormal plasma distribution of protein S occurs in functional protein S deficiency. Blood 1986; 67: 504-508
- 14 Malm J, Laurell M, Dahlbäck B. Changes in the plasma levels of vitamin K-dependent proteins C and S and of C4b-binding protein during pregnancy and oral contraception. Br J Haematol 1988; 68: 437-443
- 15 Amiral J, Adam M, Plassart V, Minard F, Vissac AM. Immunoassays for the measurement of protein S. In: Fibrinolysis: current prospects. Gaffney PJ, Castellino FJ, Flow EF, Takada A. (eds) Libbey and Co.; London: 1988. pp 125-128
- 16 Tripodi A, Bertina RM, Conard J, Pabinger I, Sala N, Mannucci PM. Multicenter evaluation of three commercial methods for measuring protein S antigen. Thromb Haemost 1992; 68: 149-154
- 17 Deutz-Terlouw PP, Ballering L, van Wijngaarden A, Bertina RM. Two ELISA’s for measurement of protein S, and their use in the laboratory diagnosis of protein S deficiency. Clin Chim Acta 1989; 186: 321-334
- 18 Wolf M, Boyer-Neumann C, Leroy-Matheron C, Martinoli JL, Contant G, Amiral J, Meyer D, Larrieu MJ. Functional assay of protein S in 70 patients with congenital and acquired disorders. Blood Coag Fibrinol 1991; 2: 705-712
- 19 Amiral J, Grosley M, Boyer-Neumann C, Marfaing-Koka A, Peynaud-Debayle E, Wolf M, Meyer D. New direct assay of free protein S antigen using two distinct monoclonal antibodies specific for the free form. Blood Coag Fibrinol 1994; 5: 179-186
- 20 Wolf M, Boyer-Neumann C, Peynaud-Debayle E, Marfaing-Koka A, Amiral J, Meyer D. Clinical applications of a direct assay of free protein S antigen using monoclonal antibodies. A study of 59 cases. Blood Coag Fibrinol 1994; 5: 187-192
- 21 Wolf M, Boyer-Neumann C, Martinoli JL, Leroy-Matheron C, Amiral J, Meyer D, Larrieu MJ. A new functional assay for human protein S activity using activated factor V as substrate. Thromb Haemost 1989; 62: 1144-1145
- 22 Preda L, Tripodi A, Valsecchi C, Lombardi A, Finotto E, Mannucci PM. A prothrombin time-based functional assay of Protein S. Thromb Res 1990; 60: 19-32
- 23 van de WaartP, Jentsch P, Waterval M, Woodhams BJ. Automation of functional assays for human Protein S using a specific chromogenic substrate assay. Thromb Haemost 1993; 69: 1120
- 24 Finney DJ. Statistical Method in Biological Assay. 3. rd edition Griffin and Co Ltd; London: 1978
- 25 Kirkwood TBL. Geometric means and measures of dispersion. Biometrics 1979; 35: 908-909
- 26 Kirkwood TBL, Tydeman MS. Design and analysis of accelerated degradation tests for the stability of biological standards II. A flexible computer program for data analysis. J Biol Standardisation 1984; 12: 207-214
- 27 Bertina RM, van Wijngaarden A, Reinalda-Poot J, Poort SR, Bom VJJ. Determination of plasma protein S – the protein cofactor of activated protein C. Thromb Haemost 1985; 53: 268-272
- 28 Bertina RM, Koeleman BPC, Koster T, Rosendaal FR, Dirven RJ, de Ronde H, van der VeldenPA, Reitsma PH. Mutation in blood coagulation factor V associated with resistance to activated protein C. Nature 1994; 369: 64-67
- 29 Zöller B, Dahlbäck B. Linkage between inherited resistance to activated protein C and factor V gene mutation in venous thrombosis. Lancet 1994; 343: 1536-1538
- 30 Faioni EM, Franchi F, Asti D, Sacchi E, Bemardi F, Mannucci PM. Resistance to activated protein C in nine thrombophilic families: interference in a protein S functional assay. Thromb Haemost 1993; 70: 1067-1071
- 31 Cooper PC, Hampton KK, Makris M, Abuzenadah A, Paul B, Preston FE. Further evidence that activated protein C resistance can be misdiagnosed as inherited functional protein S deficiency. Br J Haematol 1994; 88: 201-203
- 32 Simioni P, Gavasso S, Luni S, Invidiato S, Girolami A. A protein S functional assay yields unsatisfactory results in patients with activated protein C resistance. Blood Coag Fibrinol 1995; 6: 286-287