Emicizumab Controls – Not for Sale in the U.S.
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Control Plasmas and Calibrators
Plasma Controls, Level 1 (25ug/mL) Level 2 (75ug/mL)
Emicizumab Controls Level 1 and Level 2 are assayed controls intended for quality control of a modified one-stage FVIII activity assay for determination of active emicizumab concentration from a clot time measurement performed on an automated coagulation analyze
Emicizumab Controls may be used together with the Emicizumab Calibrator and a modified one-stage FVIII assay as QC material for use in a laboratory’s quality control program.
|Catalog #||Product||Kit Configuration||Regulatory Classification||Product Insert (PDF)|
|152-401-CE||Emicizumab Controls||5 x 1 mL each||CE||LL-4533_CE_B-Emi-Controls-Level-1-and-Level-2.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. Control of the accuracy of the emicizumab result is enabled by using Emicizumab Controls with assayed emicizumab values.
25 ug/mL and 75 ug/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.