Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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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.
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Get Out of QC Spreadsheet Agony

Catagory: NGS Management Software, QC Reporting

Posted by Dale Yuzuki on Jun 29, 2017 10:00:00 AM
As a manager of a clinical genomics laboratory, how many times have you been faced with the following situations? You need to produce trending performance data over the past three months as a part of an internal audit You need to examine the last runs performed that used a particular piece of equipment that you suspect may be out of specification You need to produce a QC report for an upcoming regulatory inspection You need to find out root cause of an assay failure
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