2012, Number 5
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Rev Invest Clin 2012; 64 (5)
Reference values for the blood coagulation tests in Mexico: usefulness of the pooled plasma from blood donors
Calzada-Contreras A, Moreno-Hernández M, Castillo-Torres NP, Souto-Rosillo G, Hernández-Juárez J, Ricardo-Moreno MT, Sánchez-Fernández MGJ, García-González A, Majluf-Cruz A
Language: Spanish
References: 38
Page: 437-443
PDF size: 175.26 Kb.
ABSTRACT
Introduction. The blood coagulation system maintains the
blood in a liquid state and bleeding and thrombosis are
the manifestations of its malfunction. Blood coagulation laboratory
evaluates the physiology of this system.
Objective. To
establish both, the reference values for several tests performed
at the blood coagulation laboratory as well as the utility
of the pooled plasma to perform these assays.
Material and
methods. In this descriptive, cross-sectional, randomized
study, we collected plasma from Mexican Mestizos. Each
pooled plasma was prepared with the plasma from at least 20
blood donors. We performed screening and special tests and
the Levey-Jennings graphs were built and interpreted after
each pass. Results of the tests were analyzed and their distribution
was established using the Kolmogorov-Smirnov
test. To establish the reference values we used 95% confidence
intervals.
Results. We collected 72 pooled plasmas. The
distribution for PT, APTT, and TT tests was abnormal.
Although the PT test showed a bimodal distribution it was
normal for factor VII. The reference values for the hemostatic,
anticoagulant, and fibrinolytic factors were different
from those suggested by the manufacturers.
Conclusion. We
established the reference values for the blood coagulation
tests in the adult Mexican population. We have shown that
the pooled plasma must be used for the screening tests. We
suggest that each clinical laboratory should establish its own
reference values (at least for the screening tests). To reach
this objective, we encourage the use of the pooled plasma.
REFERENCES
Davie EW, Fujikawa K, Kisiel W. The coagulation cascade: initiation, maintenance, and regulation. Biochemistry 1991; 30: 10363-70.
Lippi G, Favaloro EJ, Franchini M, Guidi GC. Milestones and perspectives in coagulation and hemostasis. Semin Thromb Hemost 2009; 35: 9-22.
Bauer KA, Rosenberg RD. The pathophysiology of the prethrombotic state in humans. Insights gained from studies using markers of hemostatic system activation. Blood 1987; 70: 343-55.
Mann KG. Biochemistry and physiology of blood coagulation. Thromb Haemost 1999; 82: 165-74.
Koreth R, Weinert C, Weisdorf DJ, Key NS. Measurement of bleeding severity: a critical review. Transfusión 2004; 44: 605-17.
Crowther MA, Kelton JG. Congenital thrombophilic states associated with venous thrombosis: a qualitative overview and proposed classification system. Ann Intern Med 2003; 138: 128-34.
Kitchens CS. Approach to the bleeding patient. Hematol Oncol Clin North Am 1992; 6: 983-9.
Bachman F. Diagnostic approach to mild bleeding disorders. Semin Hematol 1980:17: 292-305.
Plebani M, Sanzari MC, Zardo L. Quality control in coagulation testing. Semin Thromb Hemost 2008; 34: 642-6.
Bonar R, Favaloro EJ, Adcock DM. Quality in coagulation and haemostasis testing. Biochem Med 2010; 20: 184-99.
Martínez MC. El problema trombótico. Incidencia. Enfermedad tromboembólica venosa, Guía Práctica. México, D. F.: Editorial Alfil; 2007; 24-8.
Mina A, Favaloro EJ, Mohammed S, Koutts J. A laboratory evaluation into the short activated partial thromboplastin time. Blood Coagul Fibrinolysis 2010; 21: 152-7.
Clinical and Laboratory Standards Institute (CLSI). One-stage prothrombin time (PT) test and activated partial thromboplastin time (APTT) test: Approved guideline. 2nd. ed. 2008. Clinical and Laboratory Standards Institute Document H47-A2.
Bajaj SP, Joist JH. New insights into how blood clots: implications for the use of APTT and PT as coagulation screening tests and in monitoring of anticoagulant therapy. Semin Thromb Hemost 1999; 25: 407-18.
Kamal AH, Tefferi, Pruthi RK. How to interpret and pursue an abnormal prothrombin time, activated partial thromboplastin time, and bleeding time in adults. Mayo Clin Proc 2007; 82: 864-73.
Healy NJ, Ingram GI. The “normal range” in test of haemostasis. Thromb Haemost 1978; 39: 504-9.
Poller L, Thomson JM. The interpretation of prothrombin results. A national survey. Brit J Haemat 1969; 16: 31-7.
Lippi G, Favarolo EJ. Activated partial thromboplastin time: new tricks for an old dogma. Semin Thromb Hemost 2008; 34: 604-11.
Bolton MP, Perry D. The rare coagulation disorders-review with guidelines for management from UK Haemophilia Centre Doctors Organization. Haemophilia 2004; 10: 593-628.
Lowe G. Factor IX and thrombosis. Br J Haematol 2001; 115: 507-13.
Nicolaes GAF, Dahlbäck B. Factor V and thrombotic disease: description of a Janus-Faced protein. Arterioscler Thromb Vasc Biol 202; 22: 530-8.
Mettine HA, Camire RM. Blood coagulation factors V and VIII: molecular mechanisms of procofactor activation. JCD 2010; 2: 19-20.
Sansores-García L, Majluf-Cruz A, Vargas-Vorackova F, Labardini- Méndez J. Valores de referencia de la actividad de proteína C en sujetos adultos sanos en México. Rev Invest Clin 1994; 46: 231-5.
Aich M, Gandrille S, Emmerich J. A review of mutations causing deficiencies of antithrombin, protein C and protein S. Thromb Haemost 1995; 74: 81-9.
Zavala HC, Hernández ZE, Martínez MC, Arenas SM, González OAE, Reyes ME. Asociación de la RPCA con mutaciones Leiden y Cambridge del factor V de la coagulación en pacientes mexicanos con trombofilia primaria. Cir Cir 2010; 78: 131-6.
Rijken DC, Lijnen HR. New insights into the molecular mechanisms of the fibrinolytic system. J Thromb Haemost 2009; 7: 4-13.
Miyakis S, Lockshin MD, Atsumi T. International consensus statement on an update of the classification criteria for definite anti-phospholipid syndrome (APS). J Thromb Haemost 2006; 4: 295-306.
Mackie JL, Donohoe S, Machin SJ. Lupus anticoagulant measurement. En: Khamashta MA (ed.). Hughes Syndrome. Antiphospholipid syndrome. London: Springer; 2000; 214-24.
Westgard JO. The need for a system of quality standards for modern quality management. Scand J Clin Lab Invest 1999; 59: 483-6.
Favaloro EJ, Lippi G. Laboratory reporting of haemostasis assays: The final post-analytical opportunity to reduce errors of clinical diagnosis in hemostasis? Clin Chem Lab Med 2010; 48: 309-21.
Heuck C, Nageh EL. Quality specifications of clinical laboratory procedures: Developing country needs. Scand J Clin Lab Invest 1999; 59: 559-62.
Clinical and Laboratory Standards Institute (CLSI). How to define and determine reference intervals in the clinical laboratory: Approved guideline. 2nd. Ed. 2000; Clinical and Laboratory Standards Institute Document C28-A2.
Majluf-Cruz A, Moreno-Hernández M, Martínez-Esquivel N, Ruiz de Chávez-Ochoa AA, Coria-Ramírez E, Monroy-García R, et al. Actividad del FVIII en pacientes mexicanos jóvenes con infarto agudo de miocardio. Gac Med Mex 2008; 144: 199-206.
Guardado-Mendoza R, Jiménez-Ceja L, Pacheco-Carrasco MF, Aguayo-Godínez A, Molina-Padilla J, Villa-Godinez G, et al. Fibrinogen is associated with silent myocardial ischaemia in type 2 diabetes mellitus. Acta Cardiologica 2009; 64: 523-30.
van den Besselaar AM, Barrowcliffe TW, Houbouyan-Réveillard LL, Jespersen J, Johnston M, Poller L, et al. Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination. J Thromb Haemost 2004; 2: 1946-53.
D’Angelo A, Galli L, Lang H. Comparison of mean normal prothrombin time with PT of fresh normal pooled plasma or of a lyophilized control plasma (R82A) as denominator to express PT results. Clinical Chemistry 1997; 43; 2169-74.
NCCLS. Collection, transport and processing of blood specimens for coagulation testing and general performance of coagulation assays: approved guidelines. 2nd. Ed. 1991: H21-A2.
Polack B, Schved JF, Boneu B. Preanalytical recommendations of the ‘Groupe d’Etude sur l’Hémostase et la Thrombose’ (GEHT) for venous blood testing in hemostasis laboratories. Haemostasis 2001; 31: 61-8.