Expected value range

Starrsed Control is assayed for Starrsed ESR analyzers. The software always calculates a temperature corrected result because only temperature corrected results can be compared with the Assay mean value. The assayed mean values, expected ranges and reference values are derived from validation measurements on multiple instruments at different sites. All these values are mentioned on the product insert (the assayed mean value encoded in the tubes barcode) and are lot-specific. Individual laboratory means should fall within the corresponding acceptable range; however, laboratory means may vary from the listed values during the life of this product. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation calibrating method and reagents. It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as guides.

Whenever the Controls fail to perform consistently within the acceptable ranges, patient results should be considered invalid. Contact your Starrsed instrument provider for assistance. The values from the reference methods are only an indication for that method and not for comparison with the Assay mean value.
If results vary outside the specified assay ranges, discard the tube and utilize a new tube. If difficulties persist, contact your supplier for further assistance and/or instructions.