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Target product profiles in laboratory medicine: a framework for defining test requirements and supporting

Alison F Smith1,2,3, Paola Cocco1,2,3, Kile Green4

  • 1Leeds Institute of Health Sciences (LIHS), University of Leeds, Leeds, UK.

Clinical Chemistry and Laboratory Medicine
|October 1, 2026
PubMed

Keywords:
analytical performance specificationsclinical performance specificationsdiagnostic test developmentlaboratory medicineoutcome-based performance specificationstarget product profiles

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