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Details : C21RMP8 - NIM Reference measurement procedure for ''HER2 ''copy number variation
| Type (acronym) | rmp |
|---|---|
| Type | reference measurement procedure |
| Unique Nomination Number | C21RMP8 |
| Analyte Name | Copy number variation (HER2) |
| Method capable of Traceability of Analyte to SI or Defined Procedure | SI-traceable |
| Applicable Matrices | Calibration solution |
| Name | NIM Reference measurement procedure for HER2 copy number variation |
| Organization that developed Validated Method | National institute of metrology, China |
| Measurement Techniques Used | digital PCR |
| Comments 1 | The reference measurement procedure gives HER2 copy number variation . |
| Comments 2 | We have organized an international comparison of HER2 measurement and satisfied result was obtained by using our proposed RMP |
| Quantity | DNA Copy number ratio |
| From (0) | 1 |
| To (0) | 40 |
| Unit (0) | (dimensionless) |
| From (1) | 2.4 |
| To (1) | 4.7 |
| Unit (1) | % |
| Level of Confidence (%) | 95% |
| Comments on Concentration Range | The reference measurement procedure gives HER2 copy number ratio which dimensionless. |
| Peer Reviewed Publication | Establishment and evaluation of digital PCR methods for HER2 copy number variation in breast cancer, Wang X. et al, Analytical and Bioanalytical Chemistry 2023 451(1) 725-733 |
| Comments to be published via JCTLM DB | The HER2 assay 1 (exon 4 specific assay) and RPPH1 assay are used for the RMP. It is recommended to digest the genomic DNA by restriction enzyme e.g.EcoR1. A reference material (RM) without any HER2 copy number variation (CNV) (GBW09900) is recommended as the negative control and the RM with known HER2 CNV (GBW09117) is recommended as the positive control. The precision of repeatability, intermediate precision and reproducibility are < 5 %, < 6 % and < 5 % in the HER2 CNV range from 1.0 to 40. Partition volume of 0.837 nL and relative standard 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 gene ID and the genomic coordinates of the dPCR assay are the following : 1) Gene: HER2/ERBB2; Gene ID: 2064; Genomic coordinates: GRCh38,17:39695065…39695122 2) Gene: Reference gene (RPPH1); Gene ID: 85495; Genomic coordinates: GRCh38,14:20343320…20343403 |
| Analyte Category Name | Nucleic acids |
| CCQM Key Comparison Report | CCQM-K186 comparison on copy number variant of HER2 in human tissue |
| CCQM Key Comparison Report Hyperlink | https://doi.org/10.1088/0026-1394/61/1A/08017 |
| Measurement principle/technique | Digital PCR |