1 research outputs found
International Interlaboratory Digital PCR Study Demonstrating High Reproducibility for the Measurement of a Rare Sequence Variant
This study tested the claim that
digital PCR (dPCR) can offer highly reproducible quantitative measurements
in disparate laboratories. Twenty-one laboratories measured four blinded
samples containing different quantities of a <i>KRAS</i> fragment encoding G12D, an important genetic marker for guiding
therapy of certain cancers. This marker is challenging to quantify
reproducibly using quantitative PCR (qPCR) or next generation sequencing (NGS) due to the presence
of competing wild type sequences and the need for calibration. Using
dPCR, 18 laboratories were able to quantify the G12D marker within
12% of each other in all samples. Three laboratories appeared to measure
consistently outlying results; however, proper application of a follow-up
analysis recommendation rectified their data. Our findings show that
dPCR has demonstrable reproducibility across a large number of laboratories
without calibration. This could enable the reproducible application
of molecular stratification to guide therapy and, potentially, for
molecular diagnostics