September 29, 2020
Why PPV and NPV should be considered when setting sensitivity and specificity requirements

This blog will dive deeper into positive predictive values (PPVs) and negative predictive values (NPVs) and using them as a way to consider setting limits for sensitivity and specificity. The used definitions are shown in the standard 2x2 table (Table 1), commonly used for comparing a new qualitative assay method to a reference method or clinical truth.

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Qserve is the largest consultant company in the EU that is 100% focused on medical devices and In-Vitro Diagnostics. Check out our company video.

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Our knowledge of the European Medical Device Regulation (EU-MDR) ensures that we can train and support you with an efficient regulatory strategy.

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We have supported hundreds of Medical device manufacturers with FDA submission. Qserve’s legal entity can act as US Agent and Official Correspondent.

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  • We know exactly what should be prepared to become and stay in compliance with the regulations
  • Strong international team with technical, regulatory quality and clinical competence
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  • We have a team where we use multiple levels, from junior to principal. Depending on your project we are able to form a cost-effective team
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