Quality control
Control samples should always be used to assure the day-to-day validity of results. The controls should be run in the same way as the samples. Controls at two different levels are included in the kit. These controls should be run in each assay; if the assay includes more than one plate, controls should be run on each plate. Each laboratory should establish its own mean and acceptable range. The established mean should be within ± 2 SD of the values stated on the quality control certificate. It is recommended that the laboratories establish their own controls at different levels in addition to the controls included in the kit. Sample results should only be reported if control results for the assay meet the laboratory's established criteria for acceptability (17)
We also recommend participation in external quality assessment schemes.