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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.

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.

Predefined reports for BD IVD assays include laboratory, physician and supplemental reports and make reporting results fast and easy. Results can be easily exported to a laboratory information system (LIS) through the BD FACSLink™ LIS Interface.

View the application note for a simplified workflow using automated instrument setup and compensation on the BD FACSLyric™ Flow Cytometer.

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.

Overview

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

A streamlined workflow

Predefined assay templates and comprehensive reporting

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

A streamlined workflow

Standardization and collaboration

Highly reproducible results between BD FACSLyric™ instruments drive standardization

Concatenation: Create a new FCS file by merging multiple files together

Reporting: Create a custom analysis report

Drill down: Create a gated plot directly from the parent gate

Apply gate positions: Define gate locations in one entry and apply those locations to other entries

Laser setup: Align your own lasers using BD^®CS&T Beads

Ordering populations: Choose the order of viewed populations in a plot

Overview

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

A streamlined workflow

Predefined assay templates and comprehensive reporting

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

A streamlined workflow

Standardization and collaboration

Highly reproducible results between BD FACSLyric™ instruments drive standardization

Concatenation: Create a new FCS file by merging multiple files together

Reporting: Create a custom analysis report

Drill down: Create a gated plot directly from the parent gate

Apply gate positions: Define gate locations in one entry and apply those locations to other entries

Laser setup: Align your own lasers using BD® CS&T Beads

Ordering populations: Choose the order of viewed populations in a plot

Laser setup: Align your own lasers using BD^®CS&T Beads