Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Intended Purpose and Scientific Validity

• Art. 2.38. ‘scientific validity of an analyte’ means the association of an analyte with a clinical condition or a physiological state. • The intended purpose defines the analyte and the clinical condition of physiological state. • The intended purpose is the main input for the Scientific Validity exercise • The intended purpose thus determines the expected output of Scientific Validity exercise

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Intended Purpose and Scientific Validity

• The clinical condition: how detailed? • Fairly clear but do not try to be comprehensive. • An example for aldosterone:

• Too vague, not really associated with a condition: “Aldosterone measurements are useful to identify excessive or deficient levels of aldosterone.” • Too detailed: “Aldosterone measurements are useful to aid in the diagnosis of adrenal hyperplasia, adrenal adenoma, adrenal carcinoma, massive ascites, ventricular failure, cor pulmonale, proximal renal tubular acidosis, fibromuscular dysplasia, excessive licorice intake, etc., etc.” • Better: “Aldosterone measurements are useful to aid in the diagnosis of conditions associated with primary or secondary hyperaldosteronism (e.g., congenital adrenal hyperplasia) or with primary or secondary hypoaldosteronism (e.g., primary adrenal insufficiency).”

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