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Biomark Insights. 2014 Apr 09;9:9-13. doi: 10.4137/BMI.S14481. eCollection 2014.

The Range of Uncertainty: a Tool for Efficiently Addressing Result Variability Around Clinical Decision Points for Hepatitis C Response-guided Therapy.

Biomarker insights

Paul Jülicher, Jens Dhein

Affiliations

  1. Abbott GmbH and Co KG, Wiesbaden, Germany.

PMID: 24812481 PMCID: PMC3999813 DOI: 10.4137/BMI.S14481

Abstract

Despite efforts to standardize molecular diagnostic tests, performance differences are not rare. Laboratories are challenged in situations where treatment rules have been established using a reference assay that is different from the assays being used in daily practice. Assessing the viral load status of patients with chronic hepatitis C under modern triple therapy is a recognized example. We demonstrate the use of the range of uncertainty as an easy and efficient tool that can provide information on the certainty of a test result's interpretation in the context of making hepatitis C virus treatment decisions.

Keywords: hepatitis C; in vitro diagnostic tests; precision; response guided therapy; standardization; viral load

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