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.
Welcome to the BD FACSuite™ Application Academy, a learning portal dedicated to delivering up-to-date insight on the BD FACSuite™ Application. As we continue to make improvements, we want to keep you updated on all that the software has to offer. The BD FACSuite™ Application Academy provides valuable knowledge and is a great source of how-to and training videos all from a single online location. It is also a gateway to special on-demand webinars and special workshop events we offer to further guide you. Please visit often and keep your laboratory up to date on the BD FACSuite™ Application.
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
Setup cleanup: Remove setup data that is no longer needed to improve software performance
SIT flushes: Customize the number of SIT flushes between tubes
개요
BD FACSLyric ™ Flow Cytometry System을 제어하는 소프트웨어는 BD FACSuite ™ Clinical Application 과 BD FACSuite ™ Application으로 구성됩니다. 두 application은 모두 데이터 획득 및 분석을 위해 BD FACSLyric ™ System과 함께 사용할 수 있는 사용하기 쉬운 인터페이스를 제공합니다.
BD FACSuite ™ Clinical Application은 사전 정의된 assay 템플릿을 사용하여 BD IVD 분석을 지원합니다.
BD FACSuite ™ Application은 고유한 assay 전송 기능을 통한 사용자 정의 assays와 협업을 위해 설계되었으며, 간단하고 재현 및 전송 가능한 assay설정을 제공하여 기기 간 및 현장 간 표준화를 쉽게 달성할 수 있습니다.
암호 보호, 감사 추적, 전자 서명 및 IQ / OQ 절차 등 두 application에 포함된 기능은 21 CFR Part 11 규정을 준수하고 전자 기록 무결성을 달성하는 것을 지원합니다.
특징
BD FACSuite ™ Clinical Application 은 간소화된 워크 플로우, BD IVD 분석을 위한 사전 정의된 assay템플릿 및 포괄적인 보고를 제공합니다.
간소화된 워크플로우
BD® CS & T Beads는 세포 분석기 성능을 확인하고 자동으로 조정하여 매일 일관성 있는 기기 설정을 보장하는데 사용됩니다. 또한 BD® CS & T Beads는 성능 QC 등 시스템 초기화 및 설정 중 포괄적인 검사를 수행하고, 시스템 성능을 검증하고, 필요에 따라 자동 laser 조정 프로세스를 trigger 하기 위해 사용됩니다. BD FACSuite™ Clinical Application에서 이러한 기능을 이용할 수 있으며, 수동 개입 없이 전체 프로세스 설정을 수행할 수 있습니다.
사전 정의된 assay 템플릿 및 포괄적인 보고
특정 BD IVD 시약 키트와 함께 사용할 수 있도록 최적화된 사전 정의된 템플릿이 있는 assay 모듈을 BD FACSuite ™ Clinical Application에 설치할 수 있습니다. 이러한 템플릿은 자동화된 gating, 계산 및 보고서 생성 기능을 제공합니다.
특정 BD IVD 시약 키트와 함께 사용할 수 있도록 최적화된 사전 정의된 템플릿이 있는 assay 모듈을 BD FACSuite ™ Clinical Application에 설치할 수 있습니다. 이러한 템플릿은 자동화된 gating, 계산 및 보고서 생성 기능을 제공합니다.
BD FACSLink™ LIS Interface 를 통해 결과를 실험실 정보 시스템(LIS)으로 쉽게 내보낼 수 있습니다.
적용
BD FACSuite ™ Application은 간소화된 워크플로우와 자동화된 표준화를 통해 협업을 가능하게 합니다.
간소화된 워크플로우
BD® CS & T Beads는 세포 분석기 성능을 확인하고 자동으로 조정하여 매일 일관성 있는 기기 설정을 보장하는데 사용됩니다. 또한 BD® CS & T Beads는 성능 QC 등 시스템 초기화 및 설정 중 포괄적인 검사를 수행하고, 시스템 성능을 검증하고, 필요에 따라 자동 laser 조정 프로세스를 trigger 하기 위해 사용됩니다. BD FACSuite™ Clinical Application에서 이러한 기능을 이용할 수 있으며, 수동 개입 없이 전체 프로세스 설정을 수행할 수 있습니다.
개별 tube로 만들어진dried BD® FC 비드를 사용하여 spillover값을 60 일마다 측정합니다. Spillover 값은 소프트웨어내에서 유지되며 PMTV 변경에 따라 자동으로 업데이트됩니다.
표준화 및 협업
Universal 설정은 BD FACSuite ™ Application, BD® CS & T Beads 및 BD® FC Beads를 사용하여 단일 기기에서 기기 MFI target value를 확립하고 유지하는 자동화된 시스템으로, 시간이 지나도 BD FACSLyric ™ 기기 내, 기기 간 결과의 일관성과 재현성을 확보할 수 있습니다.
이러한 설정은 BD FACSuite ™ Application assay 내보내기 및 전송 기능을 통해 기기에서 기기로 쉽게 전송할 수 있으며, 이는 표준화를 자동화하고 여러 실험실(sites) 간 협업을 가능하게 합니다.
BD FACSLyric ™ 기기 간의 결과의 재현성이 높아 표준화 촉진
| 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.
BD FACSLyric™ 유세포 분석기는 1등급 레이저 제품입니다. BD FACSLyric™ Flow Cytometer 는 BD FACSuite™ Clinical Application 와 함께 최대 6색까지 체외 진단용으로 사용됩니다. BD FACSLyric™ Flow Cytometer는 BD FACSuite™ Application와 함께 최대 12색까지 연구용으로만 사용됩니다. 진단용 또는 치료용으로 사용될 수 없습니다.
Cy는 Global Life Sciences Solutions Germany GmbH 또는 Cytiva로 사업을 하는 계열사의 상표입니다.
