Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Keep Calm and Standardize On

A Panel of Experts Discusses Best Practices for Clinical NGS Quality Management in the Rapidly Evolving Field of Clinical Genomics

Posted by Peter Duncan on Oct 5, 2018 10:00:00 AM

There is that old adage that says the only thing that is constant is change. This is one of those universal truths we have all come to accept. Heck, even Dunkin' Donuts, widely credited as being the inventor of the word “Donut,” is dropping the word from their brand name. Blasphemy! But that is for another blog...

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Topics: NGS Management Software, QC Management Software, QC Challenges

A First of its Kind Survey to Assess the QC Habits of Labs Running Clinical NGS Assays

Posted by Trevor Brown on Jul 12, 2018 9:30:00 AM
 
While good progress has been made of late with more clarity around FDA requirements, as well as organizations such as CAP and AMP providing more 'meat' in their guidance to clinical laboratories, there still remains a ways to go before this modality of testing is more standardized and uniform across the various laboratories offering the testing--be it via commercially available IVD kits or multiple different LDTs providing similar performance characteristics.
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Topics: Clinical NGS Assays, NGS reference materials, QC Challenges, QC Reporting, assay performance

Next-Generation QC Precision Metrics for Next-Generation Sequencing

Introducing the SeraCare Confidence Score, a comprehensive precision metric designed for NGS assays

Posted by Lorn Davis on Apr 16, 2018 4:00:00 PM

Introduction

There is an even greater onus to track quality control metrics for NGS assays because of the number of steps and elements that must successfully work together to produce consistent results. The Standards and Guidelines for Validating NGS Bioinformatics, published in January by AMP and CAP, highlight the importance of tracking QC metrics over time because “trends in these metrics can indicate an emerging issue with an NGS process that has not yet manifested itself in failed tests.”

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Topics: qc management, QC Management Software, QC Challenges, NGS Management Software, Quality Management Systems, bioinformatics, confidence score, SeraCare Confidence Score, Clinical NGS Assays, NGS assays

What Is The Difference Between Quality Control Software Like iQ NGS And LIMS?

Posted by Lorn Davis on Apr 6, 2018 8:00:00 AM

SeraCare Life Sciences, in partnership with GenomeWeb, recently offered this exciting on-demand webinar: 

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Topics: qc management, Clinical NGS Assays, QC Management Software, performance-based metrics, assay performance, QC Challenges

Does your NGS lab struggle with quality control? [Free Guide]

Posted by Meagan Gregoire on Aug 11, 2017 12:02:00 PM

As clinical genomics diagnostics continues to evolve, the primary challenge for laboratories has shifted from data acquisition, to ensuring their NGS tests are safe and effective. Whether they are developing an assay for circulating tumor DNA, validating a test to predict an antiviral therapy response, or are in production to provide parents with life changing health information, the underlining goal remains the same: your results must be accurate, precise, and consistent. High-quality, highly-multiplexed reference materials and the effective use of quality control metrics for monitoring the health of your assays are two solutions to help achieve those goals.

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Topics: QC Challenges, NGS-Based Tests, highly-multiplexed reference material, clinical genomics

Clinical Laboratories: You Are Not Alone. (Part II)

"The most effective ways to use QC data to monitor the health of your NGS assay."

Posted by Matt Ryder on Dec 7, 2016 4:00:00 PM

Previously, we wrote about some of the Quality Control challenges that clinical laboratories performing Next Generation Sequencing (NGS) face towards ensuring their assays are safe and effective for guiding medical management decisions.  Reliable access to high quality reference materials is necessary to help overcome these challenges; however, it is not sufficient.  Insights that reference materials provide into the health of an NGS assay are only as good as laboratories’ ability to use their QC data effectively.

With limited time and resources to collect, organize, access, and analyze QC metrics, laboratories may frequently rely on reference materials as binary indicators of Pass/Fail:  As long as the expected endpoint results are obtained, an assay is considered to be performing well.  The drawback of this approach is that it is reactive, rather than proactive:  A sufficient number of failures must occur within a given timeframe before a troubleshooting investigation is performed.  By the time a problem is recognized, resources have been wasted and turnaround times (TAT) delayed; in some cases, fidelity of patient results may even have been put at risk.  Additional time and costs are then incurred as the investigation proceeds.

Specimen analysis by NGS yields a wealth of information in addition to endpoint variant calls that is indicative of assay performance.  Data such as nucleic acid quantity and quality at different steps throughout the workflow (PDF) and sequencing library characteristics are generated every time a reference material is tested.  However, these data must be carefully tracked and trended to allow use as highly informative QC parameters.  For clinical laboratories whose primary focus is on patient testing and reporting, granular QC metrics may not be captured and reviewed as part of routine test monitoring.

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Topics: NGS, NGS assays, next gen sequencing, Reference Material, False Negative, False Positive, Sequencing quality control, ctDNA, qcdata management, QC Challenges

 
 

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