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Overview
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Overview

The software that controls the BD FACSLyric™ Flow Cytometry System comprises two applications, BD FACSuite™ Clinical Application and BD FACSuite™ Application. Both applications provide an easy-to-use interface for data acquisition and analysis with the BD FACSLyric™ System.

 

The BD FACSuite™ Clinical Application supports BD IVD assays with predefined assay templates. 

 

The BD FACSuite™ Application is designed for user-defined assays and collaboration through the unique assay transfer feature, providing simple, reproducible and transferrable assay setup facilitating instrument-to-instrument and site-to-site standardization.

 

Functions included in both applications, including password protection, audit trail, electronic signatures and IQ/OQ procedures, assist in supporting 21 CFR Part 11 compliance and electronic record integrity.

 
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FEATURES

The BD FACSuite™ Clinical Application provides a streamlined workflow, predefined assay templates for BD IVD assays, and comprehensive reporting

A streamlined workflow

BD® CS&T Beads are used to check cytometer performance and automatically make adjustments, ensuring consistent instrument setup from day to day. They are also used to perform comprehensive checks during system initialization and setup, including performance QC; verify system performance; and trigger the automated laser alignment process if required. This functionality is enabled by the BD FACSuite™ Clinical Application and ensures the entire setup process can be performed without manual intervention.

 

Predefined assay templates and comprehensive reporting

Assay modules with predefined templates optimized for use with specific BD IVD reagent kits can be installed on the BD FACSuite™ Clinical Application. These templates feature automated gating, calculations and report generation.

 
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APPLICATION

The BD FACSuite™ Application provides a streamlined workflow and automated standardization enabling collaboration

A streamlined workflow

BD® CS&T Beads are used to perform comprehensive checks during system initialization and setup, including performance QC; verify system performance; ensure that detector settings are optimal; and trigger the automated laser alignment process if required. This functionality enabled by the BD FACSuite™ Application ensures the entire setup process can be performed without manual intervention.

 

Spillover value measurement is performed every 60 days using predispensed dried BD® FC Beads. Spillover values are maintained within the software and updated automatically with PMTV changes.

 

Standardization and collaboration

Universal setup is an automated system that establishes and maintains instrument MFI target values on a single instrument using the BD FACSuite™ Application, BD® CS&T Beads and BD® FC Beads, allowing for reproducible and consistent results within and between BD FACSLyric™ instruments over time.

 

These settings can be easily transferred from instrument-to-instrument via the BD FACSuite™ Application assay export and transfer feature automating standardization and enabling collaboration across sites.

 

Highly reproducible results between BD FACSLyric™ instruments drive standardization

 

BD FACSLyric™ System Variance (CVs)
15 BD FACSLyric™ Systems: Lyse/Wash settings and BD® FC Beads
Blue Laser %CV Red laser %CV Violet laser %CV
FITC 4.2 APC 5.3 BD Horizon™ V450 11.1
PE 4.4 APC-Cy7 4.1 BD Horizon™ V500 11
PE-Cy7 4.8 APC-H7 3.9 BD Horizon™ BV605 13.6
PerCP 10.2 APC-R700 4.2 BD Horizon™ BV711 7.5
PerCP-Cy5.5 7.9     BD Horizon™ BV786 15.3

Between-instrument reproducibility of target MFI values on the BD FACSLyric™ Systems

 

Lyse/wash assay settings were imported across 15 instruments to show effects of standardization on beads. The CVs of the fluorescence intensity across all channels varies by less than 15.3%. Daily QC with one lot of BD® CS&T Beads was run on fifteen BD FACSLyric™ Cytometers. For each instrument, the PMTV gains were automatically adjusted to meet the target values. BD® FC Beads acquired on each BD FACSLyric™ Instrument. The MFI of positive populations was measured for all parameters across all instruments. The %CV is shown.

 

The data for this internal study were acquired using BD® FC Beads across 15 instruments. Greater between-instrument variability could be observed when running biological samples, when using non BD reagents or when comparing fewer instruments.

Bead Lot Files and Related Products
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The information provided herein is not meant to be used, nor should it be used, to diagnose or treat any medical condition. All content, including text, graphics, images and information etc., contained in or available through this literature is for general information purposes only. For diagnosis or treatment of any medical condition, please consult your physician/doctor. Becton Dickinson India Private Limited and or its affiliates, its employees are not liable for any damages/claims to any person in any manner whatsoever. BD-25482