Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Choose your Article Focus | NGS | Molecular & Serology

The Trouble with Troubleshooting Clinical NGS

Catagory: QC Challenges, QC Management Software, iQ NGS

Posted by Peter Duncan on Nov 15, 2018 11:00:00 AM
Have you ever seen those late night infomercials? One of the things I love whenever I have watched these is the over-the-top acting to depict whatever frustration the target audience must be feeling if they can’t coil up their garden hose or manage their closet space. As frustrated as these actors are, I can’t help but imagine what an actor’s depiction of the level of frustration that a clinical genomics lab director might be feeling when things don’t go according to plan while carrying out an NGS assay. Figure 1 Frustrated Actor in PocketHose Infomercial
Read More

Keep Calm and Standardize On

Catagory: NGS, QC Challenges, QC Management Software, qc management

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...
Read More

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

Catagory: NGS, QC Challenges, QC Reporting

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.
Read More

Next-Generation QC Precision Metrics for Next-Generation Sequencing

Catagory: NGS, QC Challenges, NGS Management Software, QC Management Software, bioinformatics, Quality Management Systems, qc management

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.”
Read More

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

Catagory: NGS, QC Challenges, QC Management Software, qc management

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: 
Read More

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

Catagory: NGS, QC Challenges

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.
Read More

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

Catagory: NGS, ctDNA, QC Challenges, reference materials

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.
Read More