CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both expressed in (μL)-1.
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both expressed in μL-1.
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both dimensionless.
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both expressed in μL-1.
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both expressed in μL-1.
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both dimensionless quantity.
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both expressed in μL-1.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
µL-1 |
µL-1 |
µL-1 |
||
| NIMT | -10440 | 9609 | ||
| KRISS | -3740 | 11703 | ||
| VNIIM | -1544 | 9991 | ||
| NMIA | -940 | 9194 | ||
| NIM | -840 | 9194 | ||
| INMETRO | 824 | 10155 | ||
| INM(CO) | 2820 | 9720 | ||
| INRIM | 6765 | 11393 | ||
| UME | 8970 | 10411 |
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
% |
% |
% |
||
| NIMT | -17.9 | 16.4 | ||
| KRISS | -6.4 | 20.0 | ||
| VNIIM | -2.6 | 17.1 | ||
| NMIA | -1.6 | 15.7 | ||
| NIM | -1.4 | 15.7 | ||
| INMETRO | 1.4 | 17.4 | ||
| INM(CO) | 4.8 | 16.6 | ||
| INRIM | 11.6 | 19.5 | ||
| UME | 15.3 | 17.8 |
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both expressed in μL-1.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
µL-1 |
µL-1 |
µL-1 |
||
| NIMT | -4380 | 4766 | ||
| KRISS | -1180 | 5425 | ||
| VNIIM | -2153 | 3808 | ||
| NMIA | -980 | 3404 | ||
| NIM | -180 | 3393 | ||
| INMETRO | 1636 | 4793 | ||
| INM(CO) | 272 | 3664 | ||
| INRIM | 3763 | 4883 | ||
| UME | 4274 | 4532 |
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
% |
% |
% |
||
| NIMT | -14.4 | 15.7 | ||
| KRISS | -3.9 | 17.9 | ||
| VNIIM | -7.1 | 12.5 | ||
| NMIA | -3.2 | 11.2 | ||
| NIM | -0.6 | 11.2 | ||
| INMETRO | 5.4 | 15.8 | ||
| INM(CO) | 0.9 | 12.1 | ||
| INRIM | 12.4 | 16.1 | ||
| UME | 14.1 | 14.9 |
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both dimensionless.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
Dimensionless |
Dimensionless |
Dimensionless |
||
| INMETRO | -0.08 | 0.24 | ||
| KRISS | -0.03 | 0.16 | ||
| NIMT | -0.03 | 0.34 | ||
| NML | -0.03 | 0.06 | ||
| NIM | -0.02 | 0.05 | ||
| INRIM | -0.02 | 0.32 | ||
| UME | 0.01 | 0.24 | ||
| NMIA | 0.03 | 0.12 | ||
| INM(CO) | 0.07 | 0.08 | ||
| VNIIM | 0.07 | 0.20 |
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
% |
% |
% |
||
| INMETRO | -4.1 | 12.3 | ||
| KRISS | -1.6 | 8.5 | ||
| NIMT | -1.6 | 17.6 | ||
| NML | -1.6 | 3.0 | ||
| NIM | -1.0 | 2.8 | ||
| INRIM | -1.0 | 16.5 | ||
| UME | 0.5 | 12.4 | ||
| NMIA | 1.6 | 6.3 | ||
| INM(CO) | 3.6 | 3.9 | ||
| VNIIM | 3.6 | 10.3 |
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both expressed in μL-1.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
µL-1 |
µL-1 |
µL-1 |
||
| VNIIM | -238560 | 284713 | ||
| NIMT | -133000 | 280916 | ||
| INRIM | -99279 | 338158 | ||
| NMIA | -62000 | 280325 | ||
| KRISS | -33000 | 346782 | ||
| NIM | 77000 | 279181 | ||
| INMETRO | 183291 | 334698 | ||
| INM(CO) | 206486 | 300854 | ||
| UME | 269085 | 424772 |
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
% |
% |
% |
||
| VNIIM | -17.9 | 21.4 | ||
| NIMT | -10.0 | 21.1 | ||
| INRIM | -7.4 | 25.4 | ||
| NMIA | -4.7 | 21.0 | ||
| KRISS | -2.5 | 26.0 | ||
| NIM | 5.8 | 20.9 | ||
| INMETRO | 13.8 | 25.1 | ||
| INM(CO) | 15.5 | 22.6 | ||
| UME | 20.2 | 31.9 |
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both expressed in μL-1.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
µL-1 |
µL-1 |
µL-1 |
||
| VNIIM | -3399 | 5592 | ||
| NIMT | -2500 | 5423 | ||
| INRIM | -2710 | 7572 | ||
| NMIA | -2100 | 5139 | ||
| KRISS | -1400 | 8235 | ||
| NIM | 1600 | 5323 | ||
| INMETRO | 4247 | 8144 | ||
| INM(CO) | 3400 | 6117 | ||
| UME | 7851 | 8289 |
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
% |
% |
% |
||
| VNIIM | -8.8 | 14.5 | ||
| NIMT | -6.5 | 14.1 | ||
| INRIM | -7.0 | 19.7 | ||
| NMIA | -5.5 | 13.3 | ||
| KRISS | -3.6 | 21.4 | ||
| NIM | 4.2 | 13.8 | ||
| INMETRO | 11.0 | 21.2 | ||
| INM(CO) | 8.8 | 15.9 | ||
| UME | 20.4 | 21.5 |
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented by Di = (xI - xR) and its expanded uncertainty Ui at a 95 % level of confidence, both dimensionless quantity.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
Dimensionless |
Dimensionless |
Dimensionless |
||
| VNIIM | -3.69 | 3.61 | ||
| NIMT | -2.39 | 3.18 | ||
| UME | -0.29 | 5.43 | ||
| NMIA | 0.01 | 2.08 | ||
| NML | 0.11 | 0.37 | ||
| INRIM | 0.42 | 8.05 | ||
| NIM | 0.51 | 2.53 | ||
| INMETRO | 0.58 | 7.17 | ||
| KRISS | 0.81 | 3.39 | ||
| INM(CO) | 1.86 | 2.42 |
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
Degrees of equivalence represented in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
| LABi | Di | Uneg,i | Upos,i | |
|---|---|---|---|---|
% |
% |
% |
||
| VNIIM | -10.6 | 10.3 | ||
| NIMT | -6.9 | 9.1 | ||
| UME | -0.8 | 15.6 | ||
| NMIA | 0.0 | 6.0 | ||
| NML | 0.3 | 1.1 | ||
| INRIM | 1.2 | 23.1 | ||
| NIM | 1.5 | 7.3 | ||
| INMETRO | 1.7 | 20.5 | ||
| KRISS | 2.3 | 9.7 | ||
| INM(CO) | 5.3 | 6.9 |
| Metrology area, Sub-field | Chemistry and Biology, Nucleic Acid Analysis |
| Description | Copy number variant of HER2 in human tissue |
| Time of measurements | 2021 - 2022 |
| Status | Approved for equivalence |
| Final Reports of the comparisons | |
| Measurand | Measurand 1: copy number concentration of HER2 Measurand 2: copy number concentration of RPPH1 Measurand 3: ratio of HER2 to RPPH1 Measurand 4: copy number concentration of CEP17 (optional) Measurand 5: ratio of HER2 to CEP17 (optional) |
| Comparison type | Key Comparison |
| Consultative Committee | CCQM (Consultative Committee for Amount of Substance) |
| Conducted by | CCQM (Consultative Committee for Amount of Substance) |
| Comments | Testing of the core competencies of laboratories that deliver measurement services of copy number variant (CNV) analytes and CNV measurement has not been covered previously. Agreement was received in the October 2019 meeting of the NAWG in Torino to conduct the HER2 CNV measurement as a key comparison. This study is proposed as a follow up study to CCQM-P184 Copy number concentration and fractional abundance of a mutation (SNV or INDEL) mixed with wild-type DNA. In CCQM-P184, all participants measured single nucleotide (BRAF gene) and small deletion (EGFR gene) variants in a background of wild type genomic DNA, so CMC can be claimed for copy number concentration and copy number ratio measurements of small variants (gene regions) by digital PCR. Thus, this proposed study aims to extend participants' capability from SNV and INDEL measurement to structural variant measurement, focusing on gene copy number variation. |
| Pilot institute |
NIM
National Institute of Metrology China |
| Contact person | lianhua dong 86-10-64524959 |
| Pilot laboratory | |
|---|---|
| NIM |
National Institute of Metrology, China, APMP |
| INM (CO) |
Instituto Nacional de Metrología de Colombia, Colombia, SIM |
| INMETRO |
Instituto Nacional de Metrologia, Qualidade e Tecnologia, Brazil, SIM |
| INRIM |
Istituto Nazionale di Ricerca Metrologica, Italy, EURAMET |
| KRISS |
Korea Research Institute of Standards and Science, Korea, Republic of, APMP |
| LGC |
Laboratory of the Government Chemist, United Kingdom, EURAMET |
| NIMT |
National Institute of Metrology (Thailand), Thailand, APMP |
| NMIA |
National Measurement Institute, Australia, Australia, APMP |
| UME |
TÜBITAK Ulusal Metroloji Enstitüsü, Türkiye, EURAMET |
| VNIIM |
D.I. Mendeleyev Institute for Metrology, Rosstandart, Russian Federation, COOMET |
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CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
The key comparison reference value xR and its associated standard uncertainty uR are calculated from the results of all participants, based on a restricted maximum likelihood (REML) estimator as described in pages 16 to 25 of the CCQM-K176 Final report.
xR = 58 440 μL-1 uR = 2 500 μL-1
The degree of equivalence of laboratory i relative to the key comparison reference value xR is given by a pair of terms, both expressed in μL-1:
Di = (xi - xR) and its expanded uncertainty Ui at a 95 % level of confidence where Ui = 2(ui 2 + uq2 - uR 2 )1/2 with uq the additional variance between laboratories.
The degrees of equivalence are also given in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
The key comparison reference value xR and its associated standard uncertainty uR are calculated based on a restricted maximum likelihood (REML) estimator as described in pages 16 to 25 of the CCQM-K176 Final report.
xR = 30 380 μL-1 uR = 1 200 μL-1
The degree of equivalence of laboratory i relative to the key comparison reference value xR is given by a pair of terms, both expressed in μL-1:
Di = (xi - xR) and its expanded uncertainty Ui at a 95 % level of confidence where Ui = 2(ui 2 + uq2 - uR 2 )1/2 with uq the additional variance between laboratories.
The degrees of equivalence are also given in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
The key comparison reference value xR and its associated standard uncertainty uR are calculated based on a restricted maximum likelihood (REML) estimator as described in pages 16 to 25 of the CCQM-K176 Final report.
xR = 1.93 uR = 0.03
The degree of equivalence of laboratory i relative to the key comparison reference value xR is given by a pair of terms, both dimensionless:
Di = (xi - xR) and its expanded uncertainty Ui at a 95 % level of confidence where Ui = 2(ui 2 + uq2 - uR 2 )1/2 with uq the additional variance between laboratories.
The degrees of equivalence are also given in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
The key comparison reference value xR and its associated standard uncertainty uR are calculated based on a restricted maximum likelihood (REML) as described in pages 16 to 25 of the CCQM-K176 Final report.
xR = 1 333 000 μL-1 uR = 62 000 μL-1
The degree of equivalence of laboratory i relative to the key comparison reference value xR is given by a pair of terms, both expressed in μL-1:
Di = (xi - xR) and its expanded uncertainty Ui at a 95 % level of confidence where Ui = 2(ui 2 + uq2 - uR 2 )1/2 with uq the additional variance between laboratories.
The degrees of equivalence are also given in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
The key comparison reference value xR and its associated standard uncertainty uR are calculated based on a restricted maximum likelihood (REML) estimator as described in pages 16 to 25 of the CCQM-K176 Final report.
xR = 38 500 μL-1 uR = 1 200 μL-1
The degree of equivalence of laboratory i relative to the key comparison reference value xR is given by a pair of terms, both expressed in μL-1:
Di = (xi - xR) and its expanded uncertainty Ui at a 95 % level of confidence where Ui = 2(ui 2 + uq2 - uR 2 )1/2 with uq the additional variance between laboratories.
The degrees of equivalence are also given in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
The key comparison reference value xR and its associated standard uncertainty uR are calculated based on a restricted maximum likelihood (REML) estimator as described in pages 16 to 25 of the CCQM-K176 Final report.
xR = 34.9 uR = 0.6
The degree of equivalence of laboratory i relative to the key comparison reference value xR is given by a pair of terms, both dimensionless:
Di = (xi - xR) and its expanded uncertainty Ui at a 95 % level of confidence where Ui = 2(ui 2 + uq2 - uR 2 )1/2 with uq the additional variance between laboratories.
The degrees of equivalence are also given in relative terms by Di = (xI - xR) /xR and its expanded uncertainty Ui /xR at a 95 % level of confidence, both expressed in %.
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
xi measurement value submitted by laboratory i, Labi
ui combined standard uncertainty of xi
| Labi | xi | ui | |
| µL-1 | µL-1 | ||
| NIMT | 48 000 | 2 200 | |
| KRISS | 54 700 | 4 000 | |
| VNIIM | 56 896 | 2 591 | |
| NMIA | 57 500 | 1 700 | |
| NIM | 57 600 | 1 700 | |
| INMETRO | 59 264 | 2 746 | |
| INM(CO) | 61 260 | 2 319 | |
| INRIM | 65 205 | 3 769 | |
| UME | 67 410 | 2 976 |
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
xi measurement value submitted by laboratory i, Labi
ui combined standard uncertainty of xi
| Labi | xi | ui | |
| µL-1 | µL-1 | ||
| NIMT | 26 000 | 1 900 | |
| KRISS | 29 200 | 2 300 | |
| VNIIM | 28 227 | 1 248 | |
| NMIA | 29 400 | 910 | |
| NIM | 30 200 | 900 | |
| INMETRO | 32 016 | 1 917 | |
| INM(CO) | 30 652 | 1 135 | |
| INRIM | 34 143 | 1 973 | |
| UME | 34 654 | 1 751 |
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 1
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
xi measured mass fraction reported by laboratory i, Labi
ui combined standard uncertainty of xi
| Labi | xi | ui | |
| NIMT | 1.90 | 0.17 | |
| NML | 1.9 | 0.0314 | |
| KRISS | 1.9 | 0.083 | |
| VNIIM | 2.0 | 0.1 | |
| NMIA | 1.96 | 0.062 | |
| NIM | 1.91 | 0.03 | |
| INMETRO | 1.85 | 0.1196 | |
| INM(CO) | 2.00 | 0.04 | |
| INRIM | 1.91 | 0.16 | |
| UME | 1.94 | 0.12 |
CCQM-K176
MEASURAND Copy number concentration of HER2 gene sequence in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
xi measurement value submitted by laboratory i, Labi
ui combined standard uncertainty of xi
| Labi | xi | ui | |
| µL-1 | µL-1 | ||
| NIMT | 1 200 000 | 42 000 | |
| KRISS | 1 300 000 | 110 000 | |
| VNIIM | 1 094 440 | 47 968 | |
| NMIA | 1 271 000 | 41 000 | |
| NIM | 1 410 000 | 39 000 | |
| INMETRO | 1 516 291 | 100 206 | |
| INM(CO) | 1 539 486 | 68 292 | |
| INRIM | 1 233 721 | 103 069 | |
| UME | 1 602 085 | 164 752 |
CCQM-K176
MEASURAND Copy number concentration of a single copy reference gene RPPH1 in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
xi measurement value submitted by laboratory i, Labi
ui combined standard uncertainty of xi
| Labi | xi | ui | |
| µL-1 | µL-1 | ||
| NIMT | 36 000 | 1 400 | |
| KRISS | 37 100 | 3 400 | |
| VNIIM | 35 101 | 1 557 | |
| NMIA | 36 400 | 1 100 | |
| NIM | 40 100 | 1 300 | |
| INMETRO | 42 747 | 3 345 | |
| INM(CO) | 41 900 | 1 990 | |
| INRIM | 35 790 | 2 990 | |
| UME | 46 351 | 3 433 |
CCQM-K176
MEASURAND Ratio of HER2 copy number to RPPH1 copy number in isolated human gDNA in buffered aqueous solution
SAMPLE Sample 2
Two study materials (Sample 1 and Sample 2) with different HER2 CNV levels prepared by mixing HER2 ‘normal’ (2 HER2 gene copies per diploid cell) and HER2 ‘positive’ (HER2-amplified) gDNAs
xi measurement value submitted by laboratory i, Labi
ui combined standard uncertainty of xi
| Labi | xi | ui | |
| NIMT | 32.5 | 1.7 | |
| NML | 35 | 0.628 | |
| KRISS | 35.7 | 1.8 | |
| VNIIM | 31.2 | 1.9 | |
| NMIA | 34.9 | 1.2 | |
| NIM | 35.4 | 1.4 | |
| INMETRO | 35.47 | 3.633 | |
| INM(CO) | 36.75 | 1.35 | |
| INRIM | 35.31 | 4.07 | |
| UME | 34.6 | 2.8 |
