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|Catalog #||Product||Kit Configuration||Regulatory Classification||Product Insert (PDF)|
|150-201||PlasmaCon LA||10 x 1 mL||510(k), CE||PConLA_IFU|
Principle of the Test
PlasmaCon LA control plasma is manufactured from a blend of normal and LA positive plasmas to which buffers and stabilizers have been added, and is used as an LA positive control for lupus anticoagulant tests such as LupoTek KCT, LupoTek Detectin VL, and LupoTek Correctin VL.
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.
- Clinical Laboratory Standards Institute, “One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline – Second Edition”, CLSI document H47-A2, 2008.