Reproducibility: This section should include reproducibility estimates and information about the studies used to estimate, as appropriate, variability between days, runs, sites, lots, operators and instruments. Such variability is also known as "Intermediate Precision". Reproducibility data is obtained for instrumentation in conjunction with an appropriate assay. Note 1: Such studies should include the use of samples that represent the full range of expected analyte (measurand) that can be measured by the test as claimed by the manufacturer. Note 2: If a recognized standard is used, a declaration/ certificate of conformity to the recognized standard along with a summary of the data and conclusions.