Variability between laboratories performing coagulation tests with identical platforms: a nationwide evaluation study

Thrombosis Journal

Walter A Wuillemin⁹  Dimitrios A Tsakiris¹  Hans Stricker⁶  Guido Reber⁷  Adriana Mendez⁴  Wolfgang Korte²  Lars M Asmis⁵  Anne Angelillo-Scherrer³  Lorenzo Alberio^1,11  Lucas M Bachmann⁸  Michael Nagler^1,10 

[1] Diagnostic Hematology, University Hospital of Basel, Basel CH-4031, Switzerland;Institute for Clinical Chemistry and Hematology, Cantonal Hospital St Gallen, St Gallen CH-9007, Switzerland;Service and Central Laboratory of Hematology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne CH-1011, Switzerland;Center for Laboratory Medicine, Cantonal Hospital Aarau, Aarau CH-5001, Switzerland;Unilabs Zurich, Zurich CH-8034, Switzerland;Division of Surgery, Regional Hospital La Carita, Locarno CH-6600, Switzerland;Laboratory for Special Hemostasis, University Hospital of Geneva, Geneva CH-1211, Switzerland;Medignition Inc, Zug CH-6300, Switzerland;University of Berne, Berne CH-3000, Switzerland;Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, Lucerne 16 CH-6000, Switzerland;Department of Hematology and Central Hematology Laboratory, Inselspital University Hospital and University of Berne, Berne CH-3010, Switzerland

关键词: Test validity;    Reproducibility of testing;    Intraclass correlation coefficient;    Inter-rater variability;   

Others  :  838638
DOI  :  10.1186/1477-9560-11-6

 received in 2012-11-30, accepted in 2013-02-13,  发布年份 2013

【 摘 要 】

Background

While the assessment of analytical precision within medical laboratories has received much attention in scientific enquiry, the degree of as well as the sources causing variation between them remains incompletely understood. In this study, we quantified the variance components when performing coagulation tests with identical analytical platforms in different laboratories and computed intraclass correlations coefficients (ICC) for each coagulation test.

Methods

Data from eight laboratories measuring fibrinogen twice in twenty healthy subjects with one out of 3 different platforms and single measurements of prothrombin time (PT), and coagulation factors II, V, VII, VIII, IX, X, XI and XIII were analysed. By platform, the variance components of (i) the subjects, (ii) the laboratory and the technician and (iii) the total variance were obtained for fibrinogen as well as (i) and (iii) for the remaining factors using ANOVA.

Results

The variability for fibrinogen measurements within a laboratory ranged from 0.02 to 0.04, the variability between laboratories ranged from 0.006 to 0.097. The ICC for fibrinogen ranged from 0.37 to 0.66 and from 0.19 to 0.80 for PT between the platforms. For the remaining factors the ICC’s ranged from 0.04 (FII) to 0.93 (FVIII).

Conclusions

Variance components that could be attributed to technicians or laboratory procedures were substantial, led to disappointingly low intraclass correlation coefficients for several factors and were pronounced for some of the platforms. Our findings call for sustained efforts to raise the level of standardization of structures and procedures involved in the quantification of coagulation factors.

【 授权许可】

   
2013 Nagler et al; licensee BioMed Central Ltd.

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