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The world’s only purpose-built QC solution for clinical next-generation sequencing.
Clinical genomics laboratories often struggle with successfully validating and operationalizing clinical NGS assays that are fully compliant with CAP/AMP guidelines. Particularly because they necessitate the monitoring of dozens of quality metrics to ensure optimal assay performance.
Best-in-class QC strategies for clinical genomics laboratories include
- The ability to consistently monitor performance of every step in the workflow and relevant variants in a panel over time
- Incorporating a sustainable source of truth-set reference materials
- Using a purpose-built QC software solution for reviewing the many QC metrics required by industry guidelines such as CAP/AMP
SeraCare offers the world’s only fit-for-purpose clinical NGS QC management solution which includes iQ NGS QC Management software - a cloud-based cockpit featuring a single integrated environment for tracking, trending, troubleshooting, and reporting NGS QC data - and Seraseq reference materials which are designed for the unique demands of NGS.
Reduce Assay Downtime with Proactive Monitoring and Troubleshooting
An industry-wide survey found that 52% of clinical NGS labs experience at least 12 days of downtime for troubleshooting per year.
SeraCare’s exclusive Confidence Score™ cuts troubleshooting time from hours to minutes. This single, quantitative assessment of your assay’s performance aggregates the data from highly multiplexed Seraseq reference materials. The Confidence Score enables you to spot and address overarching trends in assay performance by understanding drift and performance across reagent lots, instruments, and operators.
Track and Trend Performance Across the Entire NGS Workflow
Utilizing SeraCare’s industry leading Seraseq reference materials, the iQ NGS QC Management solution provides an intuitive, highly visual cockpit for tracking and trending all aspects of the NGS workflow in a single, centralized environment. Sample and sequencing run data are also easily integrated with VCF information resulting in a streamlined solution for final QC review.
Final variant calls are impacted in different ways by each of the many dimensions of quality that cumulatively make up NGS run performance. Incorporating reference materials that best represent patient samples being tested with the proper mix of variants and variant types, along with associated quantitative metrics, is the key to truly comprehensive run performance assessments.
Ensure CAP/AMP Compliance with Pre-Developed QC Templates and Reports
SeraCare’s iQ NGS QC Management solution provides pre-developed QC templates that include CAP/AMP recommended metrics to help your laboratory minimize the time needed to develop and incorporate a robust QC program that is ready for inspections by associations like the College of American Pathologists (CAP).
Quickly generate QC reports for inspections with just a few mouse clicks and choose from an array of pre-built reports for demonstrating the equivalency of instruments and operators at set intervals throughout the year to ensure quality and operational efficiency over time.
Optimize Operations and Automate QC Reporting
Accurately tracking and reviewing your assay’s QC data in a timely manner is essential to the quality management system of your clinical laboratory. Optimize and safeguard your operations by moving away from manual tracking of QC metrics in Excel and paper folders.
iQ NGS also has an array of pre-built reports for demonstrating the equivalency of instruments and operators at set intervals throughout the year to ensure quality and operational efficiency over time. Save precious time and money by catching drift before it can affect patient results.
Learn more about the components of our QC Solution
With SeraCare’s complete QC solution of Seraseq biosynthetic NGS reference materials and iQ NGS QC Management software, you’ll spend less time wrangling with QC data and hunting down suitable remnant specimens, and more time running your lab. Trust SeraCare’s 30-plus years of experience supporting clinical laboratories around the world with comprehensive solutions to their greatest QC challenges.
"You can’t underestimate all of the complexities and subtleties involved in [NGS] testing. There are a lot of factors that can impact test performance, so you really need a very robust QC program to make sure you’re meeting that benchmark."
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