How is the precision of the artus® kits determined?

The precision of the artus® kits is determined by measuring the

  • intra-assay variability: deviation of Ct values of a standard of defined concentration (in eight-fold replicates) within one run
  • inter-assay variability: deviation of Ct values of a standard of defined concentration on three instruments, performed by three different lab workers
  • inter-lot variability: deviation of Ct values of a standard of defined concentration in three PCR runs using three different batches of as many kit components as possible; obligatorily, three different primers and probes batches have to be used for the determination of the inter-lot variability

These three variabilities are stated as coefficients of variation (in percent) and allow the determination of the total variance which is indicative for the reliability of the detection system.

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