Avoiding False Rejection in Comparison Studies

JOURNAL TITLE: Indian Journal of Medical Biochemistry

Author
1. Puneet Kumar Nigam
2. Vishal Wadhwa
ISSN
0972-1207
DOI
10.5005/jp-journals-10054-0205
Volume
26
Issue
1
Publishing Year
2022
Pages
4
Author Affiliations
    1. Department of Quality Assurance, Metropolis Healthcare Limited, New Delhi, India
    1. Department of Quality Assurance, Metropolis Healthcare Limited, New Delhi, India
  • Article keywords
    Bias%, Comparison, Correlation

    Abstract

    Aim: Comparison studies are an integral part of method verification in a laboratory. Three cases shared clarify how acceptance criteria should be used carefully before rejecting a new method/analyzer. Background: Verification of a new method/analyzer is undertaken by all laboratories, but care needs to be exercised in the evaluation of results due to the complexity involved and the lack of proper guidance in the literature. Case description: Three examples comparing the results of two equipment have been shared to bring out the unique case scenarios that emerge in the interpretation of important parameters involved, namely, average bias% (B%), correlation (R), and strength of correlation (R2). Conclusion: Results of the comparison study should be evaluated with caution as all parameters may not perform as per acceptance criteria despite having no adverse impact on patient results. Clinical significance: Poorly evaluated verification studies can lead to false rejection of new methods leading to an increase in the cost of patient care.

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