The fundamentals of the polymerase chain reaction (PCR) and how to calculate the specific concentration or molarity of the reaction elements required to perform a PCR reaction.

Speaker: Art Braden, Ph.D., Roche Diagnostics

Areas of discussion include Chromosome Structure, Workflow of molecular testing, Biological Sample, Building a Real-Time PCR Reaction, Absolute Quantification Analysis, Automated Quantification Analysis, Data Analysis, Statistical Analysis.

Speaker: Nicole Robinson, Ph.D., Roche Diagnostics

An overview of the theoretical application of Accuracy and Precision in the validation of a Laboratory Assay and a practical example.

Overview of Limit of Detection (LoD) and Limit of Quantification (LoQ) as important analytical measurements in the performance of molecular assay

Overview of how disease prevalence effects the concept of positive predictive value of a diagnostic test and also how changes in performance characteristics can affect the positive predictive value.

Sensitivity and Specificity are analytical methods that help determine the performance of a laboratory test.

Method comparisons are a way to determine if a new method can replace an old method by confirming that the two tests sufficiently agree. This agreement is assessed based on visual and statistical parameters, which are discussed in the presentation.