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Measurement uncerta...
Measurement uncertainty as a tool for evaluating the ‘grey zone’ to reduce the false negatives in immunochemical screening of blood donors for infectious diseases
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- Pereira, Paulo (författare)
- Portuguese Institute of Blood and Transplantation, Portugal,Portuguese Institute Blood and Transplantat, Portugal
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- Magnusson, Bertil (författare)
- RISE,Kemi,SP Technical Research Institute Sweden, Sweden
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- Theodorsson, Elvar (författare)
- Linköpings universitet,Avdelningen för mikrobiologi och molekylär medicin,Medicinska fakulteten,Region Östergötland, Klinisk kemi
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- Westgard, James O. (författare)
- University of Wisconsin, WI USA
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- Encarnação, Pedro (författare)
- Catholic University of Portugal, Portugal
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(creator_code:org_t)
- 2015-11-24
- 2016
- Engelska.
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Ingår i: Accreditation and Quality Assurance. - : Springer-Verlag New York. - 0949-1775 .- 1432-0517. ; 21:1, s. 25-32
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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® 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.
Ämnesord
- TEKNIK OCH TEKNOLOGIER -- Medicinteknik -- Medicinsk laboratorie- och mätteknik (hsv//swe)
- ENGINEERING AND TECHNOLOGY -- Medical Engineering -- Medical Laboratory and Measurements Technologies (hsv//eng)
- NATURVETENSKAP -- Matematik -- Sannolikhetsteori och statistik (hsv//swe)
- NATURAL SCIENCES -- Mathematics -- Probability Theory and Statistics (hsv//eng)
- NATURVETENSKAP -- Kemi -- Analytisk kemi (hsv//swe)
- NATURAL SCIENCES -- Chemical Sciences -- Analytical Chemistry (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Nyckelord
- blood bank
- clinical decision level
- cut-off value
- GUM
- immunoassay
- measurement uncertainty
- screening test
- ‘grey zone’
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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