4. Check sensitivity
Sensitivity must be clearly defined. It can be :
the sensitivity of a diagnosis, so-called "true positive" results;
analytical sensitivity, where limit of detection and limit of quantification are the appropriate terms;
the sensitivity of a method, as opposed to its robustness.
4.1 Diagnosis
Diagnostic sensitivity is the probability of a device giving a positive result in the presence of the target marker. Diagnostic specificity is the probability of a device giving a negative result in the absence of the target marker.
The aim of this study is to verify the reliability of a result. For this study, it is...
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Bibliography
Analytical validation guide: SFSTP commission report: 1994 and 2006
Guideline ICHQ2 (R1), Validation of Analytical Procedures: text and methodoly
NF T 90-210, Protocole d'évaluation initiale des performances d'une méthode dans un laboratoire – AFNOR – 2009
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