The importance of preanalytics for the coagulation laboratory

G. Endler; G. Slavka; T. Perkmann; A. Haushofer

doi:10.1055/s-0037-1617045

Hämostaseologie, Table of Contents

Hamostaseologie 2010; 30(02): 63-70
DOI: 10.1055/s-0037-1617045

Review

Schattauer GmbH

The importance of preanalytics for the coagulation laboratory

Die Bedeutung der Präanalytik für das Gerinnungslabor

G. Endler

¹Klinisches Institut für medizinische und chemische Labordiagnostik, Medizinische Universität Wien, Österreich

²Zentrallabor, Wilhelminenspital der Stadt Wien, Österreich

,

G. Slavka

²Zentrallabor, Wilhelminenspital der Stadt Wien, Österreich

,

T. Perkmann

¹Klinisches Institut für medizinische und chemische Labordiagnostik, Medizinische Universität Wien, Österreich

,

A. Haushofer

³Institut für Laboratoriumsmedizin, Landesklinikum St. Pölten, Österreich

› Author Affiliations

Abstract

Summary

Im Vergleich zu anderen Labortests weisen Gerinnungstests eine relativ große Fehleranfälligkeit und eine größere analytische Variabilität auf, was nicht zuletzt mit der relativ komplexen Präanalytik zusammenhängt. Daher mehrere Richtlinien erschienen, die helfen sollen, die Präanalytik in der Hämostaseologie zu standardisieren. Obwohl die publizierten Richtlinien zweifellos wertvolle Anhaltspunkte für die tägliche Laborpraxis darstellen, handelt es sich in einigen Bereichen um Maximalkriterien, die sich technisch und logistisch im diagnostischen Alltag nicht immer vollständig umsetzen lassen.

In diesem Übersichtsartikel sollen häufige Problemfelder in der Präanalytik der Routine-Gerinnungstests diskutiert werden. Da die Stabilität von Gerinnungstests wie z. B. der Prothrombinzeit und der partiellen Thromboplastinzeit stark von lokalen Faktoren abhängen (z. B. Röhrchentyp, Hersteller, Reagenzien und Analysesysteme) wird empfohlen, dass jedes Labor auf Basis der Richtlinien detaillierte Verfahrensanweisungen für die Ein-sender entwickelt, um die präanalytische Variabilität zu vermindern.

Zusammenfassung

Due to their complex preanalytics coagulation tests show a higher rate of rejected samples due to insufficient quality and a higher intraand inter-individual test variability. In the last years several guidelines addressed this issue in an effort to standardize preanalytic procedures. However, in daily laboratory work, these guidelines frequently cannot be fully executed, due to technical limitations or sample transport logistics. In this manuscript several important issues in sample collection, handling and transportation will be discussed. Since the stability and variability of routine coagulation tests such as prothrombin time and partial prothrombin time are significantly influenced by a number of variables such as tube type, manufacturer, reagents used and analyzer systems, it is recommended that each laboratory develops its own manuals for sample collection, based on published data and internal evaluations.

Keywords

Preanalytical errors - coagulation tests - stability

Schlüsselwörter

Präanalytischer Fehler - Gerinnungstests - Stabilität

Full Text

References

Literatur
1 DIN 58905–1 Gewinnung von venösem Citratplasma für hämostaseologische Analysen. 2000
2 Transport of Infectious Substances.. World Health Organisation. 2004 http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_ LYO_2004_ 9Final.pdf.
3 CLSI.. Collection, Transport and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and molecular Hemostasis Assays; Approved Guideline. 5^th ed. H21-A5. 2008
4 Adcock D, Kressin D, Marlar RA. The effect of time and temperature variables on routine coagulation tests. Blood Coagul Fibrinolysis 1998; 9: 463-470.
5 Adcock DM, Kressin DC, Marlar RA. Effect of 3.2% vs 3.8% sodium citrate concentration on routine coagulation testing. Am J Clin Pathol 1997; 107: 105-110.
6 Adcock DM, Kressin DC, Marlar RA. Minimum specimen volume requirements for routine coagulation testing: dependence on citrate concentration. Am J Clin Pathol 1998; 109: 595-599.
7 Appert-Flory A, Fischer F, Jambou D, Toulon P. Evaluation and performance characteristics of the automated coagulation analyzer ACL TOP. Thromb Res 2007; 120: 733-743.
8 Arambarri M, Oriol A, Sancho JM. et al. Interference in blood coagulation tests on lipemic plasma. Correction using n-hexane clearing. Sangre (Barc). 1998; 43: 13-19.
9 Bamberg R, Cottle JN, Williams JC. Effect of drawing a discard tube on PT and APTT results in healthy adults. Clin Lab Sci 2003; 16: 16-19.
10 Barthels M. Gerinnungsdiagnostik. Hämostaseologie 2004; 24: 123-134.
11 Boudaoud L, Divaret G, Marie P, Bezeaud A. Rapid centrifugation for routine coagulation testing. Ann Biol Clin (Paris) 2006; 64: 315-317.
12 Chuang J, Sadler MA, Witt DM. Impact of evacuated collection tube fill volume and mixing on routine coagulation testing using 2.5-ml (pediatric) tubes. Chest 2004; 126: 1262-1266.
13 Dugan L, Leech L, Speroni KG, Corriher J. Factors affecting hemolysis rates in blood samples drawn from newly placed IV sites in the emergency department. J Emerg Nurs 2005; 31: 338-345.
14 Duncan EM, Casey CR, Duncan BM, Lloyd JV. Effect of concentration of trisodium citrate anticoagulant on calculation of the International Normalised Ratio and the International Sensitivity Index of thromboplastin. Thromb Haemost 1994; 72: 84-88.
15 Elbeik T, Nassos P, Kipnis P. et al. Evaluation of the VACUTAINER PPT Plasma Preparation Tube for use with the Bayer VERSANT assay for quantification of human immunodeficiency virus type 1 RNA. J Clin Microbiol 2005; 43: 3769-3771.
16 Favaloro EJ. Stability of coagulation assays performed in plasma from citrated whole blood transported at ambient temperature: only a part of the story. Thromb Haemost 2008; 99: 1122-1123.
17 Favaloro EJ, Lippi G, Adcock DM. Preanalytical and postanalytical variables: the leading causes of diagnostic error in hemostasis?. Semin Thromb Hemost 2008; 34: 612-634.
18 Favaloro EJ, Soltani S, McDonald J. Potential laboratory misdiagnosis of hemophilia and von Wille-brand disorder owing to cold activation of blood samples for testing. Am J Clin Pathol 2004; 122: 686-692.
19 Fiebig EW, Etzell JE, Ng VL. Clinically relevant differences in prothrombin time and INR values related to blood sample collection in plastic vs glass tubes. Am J Clin Pathol 2005; 124: 902-909.
20 Gosselin RC, Janatpour K, Larkin EC. et al. Comparison of samples obtained from 3.2% sodium citrate glass and two 3.2% sodium citrate plastic blood collection tubes used in coagulation testing. Am J Clin Pathol 2004; 122: 843-848.
21 Grant MS. The effect of blood drawing techniques and equipment on the hemolysis of ED laboratory blood samples. J Emerg Nurs 2003; 29: 116-121.
22 Guder W. Use of anticoagulants in diagnostic laboratory investigations. World Health Organisation 2002
23 Kaatz SS, White RH, Hill J. et al. Accuracy of laboratory and portable monitor international normalized ratio determinations. Comparison with a criterion standard. Arch Intern Med 1995; 155: 1861-1867.
24 Kamal AH, Tefferi A, 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: 864-873.
25 Kemme MJ, Faaij RA, Schoemaker RC. et al. Disagreement between bedside and laboratory activated partial thromboplastin time and international normalized ratio for various novel anticoagulants. Blood Coagul Fibrinolysis 2001; 12: 583-591.
26 Kratz A, Stanganelli N, Van Cott EM. A comparison of glass and plastic blood collection tubes for routine and specialized coagulation assays: a comprehensive study. Arch Pathol Lab Med 2006; 130: 39-44.
27 Laga AC, Cheves TA, Sweeney JD. The effect of specimen hemolysis on coagulation test results. Am J Clin Pathol 2006; 126: 748-755.
28 Laxson CJ, Titler MG. Drawing coagulation studies from arterial lines: an integrative literature review. Am J Crit Care 1994; 3: 16-22.
29 Lippi G, Montagnana M, Salvagno GL, Guidi GC. Interference of blood cell lysis on routine coagulation testing. Arch Pathol Lab Med 2006; 130: 181-184.
30 Lippi G, Salvagno GL, Montagnana M. et al. Influence of the centrifuge time of primary plasma tubes on routine coagulation testing. Blood Coagul Fibrinolysis 2007; 18: 525-528.
31 Marlar RA, Potts RM, Marlar AA. Effect on routine and special coagulation testing values of citrate anticoagulant adjustment in patients with high hematocrit values. Am J Clin Pathol 2006; 126: 400-405.
32 McGlasson DL, More L, Best HA. et al. Drawing specimens for coagulation testing: is a second tube necessary?. Clin Lab Sci 1999; 12: 137-139.
33 Nelson S, Pritt A, Marlar RA. Rapid preparation of plasma for ‘Stat’ coagulation testing. Arch Pathol Lab Med 1994; 118: 175-176.
34 Nowatzke WL, Landt M, Smith C. et al. Whole blood international normalization ratio measurements in children using near-patient monitors. J Pediatr Hematol Oncol 2003; 25: 33-37.
35 Pape KW WH. Impact of centrifuation conditions on platelets and coagulation testing. J Thromb Haemost 2007; 5 (Suppl. 02) P-W-094.
36 Pappas AA, Palmer SK, Meece D, Fink LM. Rapid preparation of plasma for coagulation testing. Arch Pathol Lab Med 1991; 115: 816-817.
37 Polack B, Schved JF, Boneu B. Preanalytical recommendations of the Groupe d‘Etude sur l‘Hemostase et la Thrombose (GEHT) for venous blood testing in hemostasis laboratories. Haemostasis 2001; 31: 61-68.
38 Powers JM. Obtaining blood samples for coagulation studies from a normal saline lock. Am J Crit Care. 1999; 8: 250-253.
39 Quehenberger P, Kapiotis S, Handler S. et al. Evaluation of the automated coagulation analyzer SYSMEX CA 6000. Thromb Res 1999; 96: 65-71.
40 Rao LV, Okorodudu AO, Petersen JR, Elghetany MT. Stability of prothrombin time and activated partial thromboplastin time tests under different storage conditions. Clin Chim Acta 2000; 300: 13-21.
41 Rapaport SI, Vermylen J, Hoylaerts M. et al. The multiple faces of the partial thromboplastin time APTT. J Thromb Haemost 2004; 2: 2250-2259.
42 Reneke J, Etzell J, Leslie S. et al. Prolonged prothrombin time and activated partial thromboplastin time due to underfilled specimen tubes with 109 mmol/L (3.2%) citrate anticoagulant. Am J Clin Pathol 1998; 109: 754-757.
43 Renner SW, Howanitz PJ, Bachner P. Wristband identification error reporting in 712 hospitals. A College of American Pathologists’ Q-Probes study of quality issues in transfusion practice. Arch Path-ol Lab Med 1993; 117: 573-577.
44 Salvagno GL, Lippi G, Bassi A. et al. Prevalence and type of pre-analytical problems for inpatients samples in coagulation laboratory. J Eval Clin Pract 2008; 14: 351-353.
45 Schuster B. Monitoring of anticoagulants of secondary haemostasis. Hämostaseologie 2009; 29: 268-73.
46 Sharp MK, Mohammad SF. Hemolysis in needleless connectors for phlebotomy. ASAIO J 2003; 49: 128-130.
47 Siegel JE, Swami VK, Glenn P, Peterson P. Effect (or lack of it) of severe anemia on PT and APTT results. Am J Clin Pathol 1998; 110: 106-110.
48 Spannagl MDA, Peetz D. Neue orale Antikoagulantien als Stör- und Einflussgrößen in der Gerinnungsdiagnostik. INSTAND Deutschland;. 2009 www.instandev.de/fileadmin/instand/downloads/Neue_Antikoagulantien_Version_Labor_13_08.pdf.
49 Spannagl M. MG. Hämostaseologische Globalteste. Hämostaseologie 2006; 26: 27-37.
50 Töpfer GZB, Hornig F, Sauer K, Friedel G. Verwen-dung von Zitrat/Theophyllin/Adensosin/Dipyramidol (CTAD)-Blut in Hämostaseologie und Hämatologie. J Lab Med 2002; 26: 296-306.
51 Toulon P, Aillaud MF, Arnoux D. et al. Multicenter evaluation of a bilayer polymer blood collection tube for coagulation testing: effect on routine hemostasis test results and on plasma levels of coagulation activation markers. Blood Coagul Fibrino -lysis 2006; 17: 625-631.
52 Van den Besselaar AM, Meeuwisse-Braun J, Jansen-Gruter R, Bertina RM. Monitoring heparin therapy by the activated partial thromboplastin time--the effect of pre-analytical conditions. Thromb Haemost 1987; 57: 226-231.
53 Van Geest-Daalderop JH, Mulder AB, Boonman-de Winter LJ. et al. Preanalytical variables and off-site blood collection: influences on the results of the prothrombin time/international normalized ratio test and implications for monitoring of oral anticoagulant therapy. Clin Chem 2005; 51: 561-568.
54 Wang S, Ho V. Corrections of clinical chemistry test results in a laboratory information system. Arch Pathol Lab Med 2004; 128: 890-892.
55 Zurcher M, Sulzer I, Barizzi G. et al. Stability of coagulation assays performed in plasma from citrated whole blood transported at ambient temperature. Thromb Haemost 2008; 99: 416-426.