Tumor Marker 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
  • Contains medically relevant levels for HE4, AFP, CA 125, CA 15-3, CA 19-9, CEA, Ferritin, PSA, and Free PSA
  • 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

 

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Tumor Marker Control

Product number 108-20 / 108-20W

6 x 3 mL
Please contact your local Fujirebio representative for the availability of this product in your country.

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    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.

     

    Description

    Tumor Marker Controls - table 1

    Packaging: 6 x 3 mL (3 vials of each of 2 levels – Lyophilized)
     

    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).

    Tumor Marker Controls - table 2

    **Higher values as seen with Abbott ARCHITECT assay.

    Architect and AxSYM are registered trademarks of Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA

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    To read the end user conditions of sale for this product please visit our Resource center.

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