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Details : C15RMP10 - LGC reference method for KRAS G12D/WT in solution by digital PCR
| Type (acronym) | rmp |
|---|---|
| Type | reference measurement procedure |
| Unique Nomination Number | C15RMP10 |
| Analyte Name | KRAS DNA wild type sequence and gene mutation |
| IUPAC IFCC Number | KRAS DNA |
| Method capable of Traceability of Analyte to SI or Defined Procedure | SI |
| Applicable Matrices | water, buffer, carrier DNA |
| Name | LGC reference method for KRAS G12D/WT in solution by digital PCR |
| Organization that developed Validated Method | LGC |
| Measurement Techniques Used | Digital PCR |
| Quantity | Amount-of-substance concentration (copy number concentration) |
| From (0) | 130 |
| To (0) | 70000 |
| Unit (0) | (copies/20 ml reaction) |
| From (1) | 10 |
| To (1) | 20 |
| Unit (1) | % |
| Level of Confidence (%) | 95% |
| Comments on Concentration Range | lambda ~ 0.004 to lambda ~ 3.0 |
| Peer Reviewed Publication | Assessment of digital PCR as a primary reference measurement procedure to support advances in precision medicine, Whale A. et al., Clinical Chemistry 2018 64(9) 1296-1307 |
| Comments to be published via JCTLM DB | Scope of reference method: synthetic KRAS DNA template (e.g. plasmid, amplicon, oligonucleotide controls) in aqueous solution or non-mammalian carrier nucleic acid. This reference method has not been validated for use with human genomic DNA samples. |
| Hyperlink to Final Report of extent of Equivalence Studies among | C18 RMP6 NIM Extent-of-equivalence Report for KRAS G12D RMP.pdf |
| Analyte Category Name | Nucleic acids |
| CCQM Key Comparison Report | See reference cited for comparability assessment study |
| Non-CCQM Key Comparison Report | LGC Extent-of-equivalence Report for KRAS G12D RMPs |
| Non-CCQM Key Comparison Report Hyperlink | https://www.jctlmdb.org/backend/api/jctlmFile/downloadFile/849/9 |
| Measurement principle/technique | Digital PCR |