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Emicizumab Calibrator – Not For Sale in the U.S.

Description

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Assay Type

Control Plasmas and Calibrators

Description

Plasma Calibrator (100ug/mL Emicizumab)

Intended Use

Emicizumab Calibrator is a calibrator plasma intended for use in the calibration of a modified one-stage FVIII activity assay for determination of active emicizumab concentration from a clot time measurement performed on an automated coagulation analyzer.

Uses

Emicizumab Calibrator may be used together with a modified one-stage FVIII assay to generate a calibration curve for emicizumab determination using citrated plasma from patients with hemophilia A being treated with the drug.

Ordering Information
Catalog # Product Kit Configuration Regulatory Classification Product Insert (PDF)
151-201-CE Emicizumab Calibrator 5 x 1 mL CE LL-4532_CE_B-Emi-Calibrator.pdf

 

Principle of the Test

The principle of the modified one-stage FVIII assay for emicizumab measurement relies upon measuring the degree of correction of the APTT when patient plasma is added to FVIII deficient plasma. The degree of correction is related to the amount of emicizumab in the patient’s sample. Quantification of the degree of correction is enabled by using a calibration curve constructed using the Emicizumab Calibrator.

Reporting Units

100ug/mL

Handbooks and Guidelines
  • Westgard J, Basic QC Practices: Third Edition, Westgard QC Inc., 2010.
  • Kitchen S, Olson J, and Preston F, Chapter 5 “Internal Quality Control”, in Quality in Laboratory Hemostasis and Thrombosis, Kitchen, Olson, and Preston ed., Wiley-Blackwell, 2009.
  • CLIA 88 current regulations: http://wwwn.cdc.gov/clia/regs/toc.aspx.
  • Westgard J., et. al., CLIA Final Rules for Quality Systems, Westgard QC Inc., 2004.
  • ISO 15189 “Medical laboratories — Particular requirements for quality and competence”, International Organization for Standardization, http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics….
  • Clinical Laboratory Standards Institute, “Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition”, CLSI document GP26-A4, 2011.
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