Solution reagent 108-20

laboratorydiagnosticquality control

Laboratories can utilize the Fujirebio Diagnostics Tumor Marker Control as an independent internal quality control to monitor the performance of their tumor marker testing. The only available multi-constituent control containing the novel biomarker HE4 Contains clinically relevant proportions of FREE PSA and PSA-ACT Lyophilized, 100% human serum matrix Reconstituted stability up to 60 days at <-20°C Stable for up to 9 freeze/thaw cycles Assayed values available for manual and automated methodologies Details Intended Use For In Vitro Diagnostic Use Only. Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA. Typical Values The values shown in the typical values below are provided solely as an example of typical values. For actual values, please refer to the lot specific assigned values sheet supplied with the product. Values were obtained from testing performed on the Abbott ARCHITECT and AxSYM Immunoassay systems except for HE4 (Fujirebio Diagnostics EIA).