Assuring Highest Quality NGS Analyses
Strand Center for Genomics and Personalized Medicine and Strand’s laboratory in HCG’s Center of Excellence in Bangalore have received laboratory accreditation from the College of American Pathologists (CAP), an internationally recognized organization for quality assurance in diagnostics. This means that our labs are subject to the following rigorous processes on an ongoing basis:
- 203 checkpoint criteria have been implemented across the entire process – from acquisition of sample to delivery of results.
- A process audit is conducted every 6 months to ensure consistent and accurate test performance.
- Accuracy of our custom-built bioinformatics workflow is ascertained vide 25 quality check parameters, applied at each step of the analysis for all samples.
- Iterative variations within all processes at Strand Center have been minimized to less than 10%.
- Strand’s 152-gene StrandAdvantage test has been benchmarked against global competitors and found to be at par by an independent agency.1
Research Independent of Clinical Business
- Process validations for single as well as multiple parameter variations are conducted independent of clinical analyses. Stringent records of validations ensure that test results are accurate.
- Proficiency testing and benchmarking of wet lab process and bioinformatics workflow are conducted to ensure parity with global standards.
- Consistency in usage of test probes, samples run in multiples and controls included with each set of analyses.
- Implementation of CAP guidelines shows reduction of methodological errors by 35% in clinical research settings.2
- Patient care protocols resulted in enhanced performance (10-55%) post implementation of CAP guidelines.3
- Mori, Y., Levenson, V. & Otto, J. Tumor Genomic Profiling Reports from Different Vendors: A Comparison with Respect to Clinical Action Ability of the Provided Data. Adv Mol Diag 1, 110–121 (2016).
- Ibrahim, F. et al. Good clinical laboratory practices improved proficiency testing performance at clinical trials centers in Ghana and Burkina Faso. PLoS One 7, e39098 (2012).
- Sartin, J. S. et al. Implementing CAP Guidelines: Impediments and Opportunities. Wis. Med. J. 106, (2007).