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Details : C18RMP6 - NIM Reference measurement procedure for'' KRAS'' G12D fractional abundance
| Type (acronym) | rmp |
|---|---|
| Type | reference measurement procedure |
| Unique Nomination Number | C18RMP6 |
| Analyte Name | Single nucleotide variant (KRAS G12D) |
| Method capable of Traceability of Analyte to SI or Defined Procedure | SI traceable |
| Applicable Matrices | Calibration solution |
| Name | NIM Reference measurement procedure for KRAS G12D fractional abundance |
| Organization that developed Validated Method | National institute of metrology, China |
| Measurement Techniques Used | digital PCR |
| Comments 1 | The reference measurement procedure gives KRAS G12D muntant fractional abundance. |
| Comments 2 | We have organized an international comparison of KRAS measurement and satisfied result was obtained by using our proposed RMP |
| Quantity | Amount-of-substance ratio (DNA copy number ratio) |
| From (0) | 0.1 |
| To (0) | 100 |
| Unit (0) | % |
| From (1) | 25 |
| To (1) | 2 |
| Unit (1) | % |
| Level of Confidence (%) | 95% |
| Comments on Concentration Range | The reference measurement procedure gives KRAS G12D mutant fractional abundance. The unit is % of KRAS G12D mutant fractional abundance in total KRAS gene. |
| Peer Reviewed Publication | Evaluation of droplet digital PCR and next generation sequencing for characterizing DNA reference material for KRAS mutation detection, Dong L. et al, Scientific reports 2018 8 9650 |
| Comments to be published via JCTLM DB | The reported values for comparability of the listed LGC and NIM RMPs are provided in Table 5 of the extent-of-equivalence reports. A reference material without any KRAS mutation (GBW09900) is recommended as the negative control and the RM with a known KRAS G12D mutation type (GBW09842) is recommended as the positive control. The precision of repeatability, intermediate precision and reproducibility are 1.9 %, 1.4 % and 0.93 % for higher fractional abundance (20% - 100%), and are 25 %, 22 % and 25 % for low fractional abundance of 0.1 %. Partition volume of 0.837 nL and uncertainty of 0.8 % were recommended. The measurement uncertainty equation is uc = [(uA/M)2 + (u(Vp) /Vp)2]1/2 where uA is the Type A uncertainty (relative uncertainty) due to precision (repeatability) and M is the replication level and VP is the partition volume. The variant ID and the genomic coordinates of the dPCR assay are listed HERE. |
| 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 | Dong L. et al, Analytical and Bioanalytical Chemistry 2022 414 5899-5906 |
| CCQM Key Comparison Report Hyperlink | https://doi.org/10.1007/s00216-022-04155-8 |
| 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 |