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May 2020 CLC UGM - 7.Maine Health and Environmental Testing Laboratory CLIA Validation for CLC Microbial Genomics - Nicholas Matluk

88 views
May 27, 2020
About the speaker:
Nick Matluk graduated from the University of Maine with degrees in microbiology and biochemistry. His entire career has been spent in Maine working in biotechnology and public health. When he is not working, he enjoys reading science fiction, 3D printing terrain for tabletop games, and spending time with his wife and three children.

From the speaker: There is a major push by academic, clinical, commercial, and governmental agencies to implement and regulate whole genome sequencing in the clinical laboratory setting to detect and characterize bacterial and viral infections. Several years ago, the Maine Health and Environmental Testing Laboratory (HETL) validated to Clinical Laboratory Improvement Amendments (CLIA) standards; the use of Illumina wet bench chemistry combined with Qiagen’s CLC-BIO bioinformatics platform to analyze the antibiotic resistance profiles, MLST, virulence genes, and serogrouping of bacterial isolates deemed to be of public health importance, such as Salmonella enteritidis, E. coli, Mycobacterium tuberculosis, Vibrio cholera, and vaccine preventable diseases such as Neisseria meningitidis and Haemophilus influenzae. This validation included concordance testing between previously characterized samples, technician to technician reproducibility, and sample to sample reproducibility. A robust CLIA quality assurance program was established consisting of: proficiency testing, competency assessments, an individualized Quality Control Plan (IQCP), and a Failure Mode Effects Analysis (FMEA) risk assessment.

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