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JOURNAL TITLE: Indian Journal of Medical Biochemistry
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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