PlasmaCon LA

Assay Type

Control Plasmas and Calibrators

Description

PlasmaCon LA is lyophilized human plasma that includes Lupus Anticoagulants

Intended Use

PlasmaCon LA is intended for use as a LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays, performed in professional clinical laboratories, for the presence of lupus anticoagulants in citrated plasma.

Uses

PlasmaCon LA is used as an LA positive control plasma for in vitro diagnostic lupus anticoagulant tests in the clinical coagulation laboratory.

Ordering Information

Catalog #	Product	Kit Configuration	Regulatory Classification	Product Insert (PDF)
150-201	PlasmaCon LA	10 x 1 mL	510(k), CE	LL-4530_C PConLA

Principle of the Test

All laboratory assays require internal quality control (QC) as a component of the laboratory’s Quality Assurance program. Control ranges are determined with each lot change of reagent, with each lot change of control, and with major service of the instrument. Thereafter controls are run according to the requirements of the Clinical Laboratory Improvement Amendments. Currently the minimum requirement is two levels of control run every 24 hours; laboratories should consult the current CLIA or ISO regulations and the reagent manufacturers’ recommendations when they design their internal QC programs.

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.