PlasmaCon N, L1, and L2
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PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
|Catalog #||Product||Kit Configuration||Regulatory Classification||Product Insert (PDF)|
|30-201||PlasmaCon N||10 x 1 mL||510(k), CE||PCon N_IFU|
|31-201||PlasmaCon L1||10 x 1 mL||510(k), CE||PCon L1_IFU|
|32-201||PlasmaCon L2||10 x 1 mL||510(k), CE||PCon L2_IFU|
Principle of the Test
PlasmaCon control plasmas provide the laboratory a two or three level set of controls for its daily QC of its PT and APTT reagents. PlasmaCon control plasmas are manufactured from pooled plasma to which buffers and stabilizers have been added. PlasmaCon N is manufactured from pooled normal plasma. PlasmaCon L1 and L2 are manufactured from pooled plasma that is selectively depleted of various clotting factors, creating abnormal plasmas of different severities.
Handbooks and Guidelines
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.
- Phospholin ES – Ellagic acid APTT Reagent & 25 mM Calcium Chloride (5 x 5 mL each)
- Phosphoplastin RL – Liquid Thromboplastin, ISI < 1.3, for Prothrombin Time assays (10 x 5 mL)