Table 1.

Example of how serial results of RQ-PCR assays can be presented with local and international scale values shown. Codes can be used to clarify interpretation.
 Sensitivity and measurement reliability data are always included to assist interpretation. In this case cumulative results of an imatinib-treated de-novo patient in chronic phase are shown. The Y253H P-loop mutation was detected at the rise in BCR-ABL at 12 and 15 months of imatinib. The sensitivity indicator provides an indication of the sensitivity of each assay as determined by the number of amplifiable copies of the control gene. For instance, if BCR-ABL is undetectable but the BCR copy number is less than 100,000, then it is not possible to determine whether the real level of BCR-ABL is below 0.01%. Measurement reliability is an indication of the ability of an assay to obtain the same result for the same sample each time it is tested.

Collection DateSource of MaterialBCR-ABLCopy NumberBCRControl Gene Copy NumberRatio (%)International Scale Conversion (%)CodeComment
Codes: 
A: BCR-ABL at a level > 1% on international scale suggests patient has not achieved CCR 
B: BCR-ABL at a level < 1% on international scale suggests patient has achieved CCR 
C: Major molecular response achieved 
D: Significant rise in BCR-ABL level from nadir and mutation analysis is pending 
Sensitivity indicator: 
BCR level 100,000–400,000 sensitivity at least 0.01% on international scale. 
BCR level > 400,000 sensitivity at least 0.003% on international scale. 
Measurement reliability: 
BCR-ABL values < 0.1% CV = 27.7% 
BCR-ABL values 0.11–1% CV = 19.8% 
BCR-ABL values > 1% CV = 15.3% 
02/17/2003 Blood 66,235 80,950 82 105  Pre-imatinib 
05/29/2003 Blood 6,665 173,920 3.8 4.8 A 3 months on imatinib 
08/21/2003 Blood 105 106,915 0.10 0.13 B 6 months on imatinib 
11/13/2003 Blood 95 120,035 0.08 0.10 C 9 months on imatinib 
02/05/2004 Blood 200 90,625 0.22 0.28 D 12 months on imatinib 
05/05/2004 Blood 565 204,000 0.28 0.35 D 15 months on imatinib 
Collection DateSource of MaterialBCR-ABLCopy NumberBCRControl Gene Copy NumberRatio (%)International Scale Conversion (%)CodeComment
Codes: 
A: BCR-ABL at a level > 1% on international scale suggests patient has not achieved CCR 
B: BCR-ABL at a level < 1% on international scale suggests patient has achieved CCR 
C: Major molecular response achieved 
D: Significant rise in BCR-ABL level from nadir and mutation analysis is pending 
Sensitivity indicator: 
BCR level 100,000–400,000 sensitivity at least 0.01% on international scale. 
BCR level > 400,000 sensitivity at least 0.003% on international scale. 
Measurement reliability: 
BCR-ABL values < 0.1% CV = 27.7% 
BCR-ABL values 0.11–1% CV = 19.8% 
BCR-ABL values > 1% CV = 15.3% 
02/17/2003 Blood 66,235 80,950 82 105  Pre-imatinib 
05/29/2003 Blood 6,665 173,920 3.8 4.8 A 3 months on imatinib 
08/21/2003 Blood 105 106,915 0.10 0.13 B 6 months on imatinib 
11/13/2003 Blood 95 120,035 0.08 0.10 C 9 months on imatinib 
02/05/2004 Blood 200 90,625 0.22 0.28 D 12 months on imatinib 
05/05/2004 Blood 565 204,000 0.28 0.35 D 15 months on imatinib 
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