liu.seSearch for publications in DiVA
Change search
ReferencesLink to record
Permanent link

Direct link
Measurement uncertainty as a tool for evaluating the grey zone to reduce the false negatives in immunochemical screening of blood donors for infectious diseases
Portuguese Institute Blood and Transplantat, Portugal.
SP Technical Research Institute Sweden, Sweden.
Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Chemistry.
University of Wisconsin, WI USA.
Show others and affiliations
2016 (English)In: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 21, no 1, 25-32 p.Article in journal (Refereed) PublishedText
Abstract [en]

The risk of misclassifying infected individuals as healthy constitutes a crucial challenge when screening blood donors by means of immunoassays. This risk is especially challenging when the numerical results are close to the clinical decision level, i.e. in the grey zone. The concept of using measurement uncertainty for evaluating the grey zone has previously not been systematically applied in this context. This article explains methods, models and empirical (top-down) approaches for the calculation of measurement uncertainty using results from a blood bank according to the internationally accepted GUM principles, focusing on uncertainty sources in the analytical phase. Of the different approaches available, the intralaboratory empirical approaches are emphasised since modelling (bottom-up) approaches are impracticable due to the lack of reliable model equations for immunoassays. Different methods are applied to estimate the measurement uncertainty for the Abbott Prism(A (R)) HCV immunoassay. The expanded uncertainty obtained at the clinical decision level from the intralaboratory empirical approach was 36 %. The estimated uncertainty was used to set acceptance and rejection zones following the procedure set in the Eurachem guideline, emphasising the need to minimise the occurrence of false negatives.

Place, publisher, year, edition, pages
SPRINGER , 2016. Vol. 21, no 1, 25-32 p.
Keyword [en]
Blood bank; Grey zone; GUM; Immunoassay; Measurement uncertainty; Screening test; Clinical decision level; Cut-off value
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:liu:diva-125690DOI: 10.1007/s00769-015-1180-xISI: 000369319400004OAI: oai:DiVA.org:liu-125690DiVA: diva2:908200
Available from: 2016-03-01 Created: 2016-02-29 Last updated: 2016-03-01

Open Access in DiVA

No full text

Other links

Publisher's full text

Search in DiVA

By author/editor
Theodorsson, Elvar
By organisation
Division of Microbiology and Molecular MedicineFaculty of Medicine and Health SciencesDepartment of Clinical Chemistry
In the same journal
Accreditation and Quality Assurance
Clinical Medicine

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 885 hits
ReferencesLink to record
Permanent link

Direct link