Studies should be performed in a representative sample of the intended use population (i.e., representation of both diseased and non-diseased cases, and controlling for subject demographics and morbidity factors that may affect the level of device performance). When a disease is rare or samples are needed specifically to challenge cut-off points, sponsors may use enriched samples, panels of credentialed samples (e.g., Center for Disease Control and Prevention (CDC) panels), and/or spiked or contrived samples. The acceptance of simulated specimens depends on how well they represent specimens from the intended-use population and whether their performance accurately reflects what the IVD device user can expect.
