Details

Autor(en) / Beteiligte

• Whale, Alexandra S
• Devonshire, Alison S
• Karlin-Neumann, George
• Regan, Jack
• Javier, Leanne
• Cowen, Simon
• Fernandez-Gonzalez, Ana
• Jones, Gerwyn M
• Redshaw, Nicholas
• Beck, Julia
• Berger, Andreas W
• Combaret, Valérie
• Dahl Kjersgaard, Nina
• Davis, Lisa
• Fina, Frederic
• Forshew, Tim
• Fredslund Andersen, Rikke
• Galbiati, Silvia
• González Hernández, Álvaro
• Haynes, Charles A
• Janku, Filip
• Lacave, Roger
• Lee, Justin
• Mistry, Vilas
• Pender, Alexandra
• Pradines, Anne
• Proudhon, Charlotte
• Saal, Lao H
• Stieglitz, Elliot
• Ulrich, Bryan
• Foy, Carole A
• Parkes, Helen
• Tzonev, Svilen
• Huggett, Jim F

Titel

International Interlaboratory Digital PCR Study Demonstrating High Reproducibility for the Measurement of a Rare Sequence Variant

Ist Teil von

• Analytical chemistry (Washington), 2017-02, Vol.89 (3), p.1724-1733

Ort / Verlag

United States: American Chemical Society

Erscheinungsjahr

2017

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 KRAS 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.