Calibration of BCR–ABL1 mRNA quantification methods using genetic reference materials is a valid strategy to report results on the international scale

Molecular monitoring of chronic myeloid leukemia: principles and interlaboratory standardization

“…At the time of writing, a number of different kits, systems, and secondary reagents are available that enable testing laboratories to derive patient results on the IS [28,29]. Comparative data is, however, very limited at present, and it is not possible to say which of these approaches is best, but in principle, the use of calibrated reagents is likely to replace the use of CFs in the coming years [30].…”

“…Initially, the only mechanism for laboratories to adopt the IS was to establish a laboratory-specific conversion factor (CF) using a process initiated by the Adelaide laboratory (33). For a testing laboratory to establish a CF, a series of samples (typically [20][21][22][23][24][25][26][27][28][29][30] are exchanged with a reference laboratory that span at least three logs of detectable disease but do not exceed an IS value of roughly 10 %. Samples are analyzed by both centers over a period of 2-3 months typically in order to take into account common intralaboratory variables, e.g., different operators and different batches of reagents.…”

A review of the challenge in measuring and standardizing BCR-ABL1

“…Thus, laboratories can make their reported results on the IS through samples exchange to derive CFs and commercial reference calibrator panels. An experiment designed to compare the two alignment strategies proved that the application of genetic reference materials to calibrate BCR-ABL1 quantification is compatible with the process of samples exchange [43]. Although no considerable data to show which is better, in principle, the use of calibrated reagents is generally accepted by vast majority of laboratories.…”

Changes of Ischemia- Modified Albumin During the Postoperative Period in Patients With Colorectal Surgery

“…1 Key to facilitating this standardization was the establishment of a World Health Organization-approved, primary reference BCR-ABL1 panel, 2 which, in turn, has allowed the development of commercially available, secondary, reference reagents effective in both conversion and correction of BCR-ABL1 values to the international scale, as recently reported in Archives of Pathology & Laboratory Medicine and elsewhere. 3,4 Efforts to standardize BCR-ABL1 measurement are applicable to the 2 common BCR-ABL1 transcript types, namely e13a2 and e14a2, which are the CML-driving species in more than 95% of patients. The remainder of the patients express a variety of variant BCR-ABL1 fusion transcript types, usually formed by alternative splicing of both BCR and ABL1 exons.…”

“…Serum albumin levels were measured by the nephelometric method, and serum IMA levels were assayed with a cobalt 2þ -binding reduction (the interassay and intraassay coefficients of variation for the IMA, 8% and 5%, respectively). 4 The repeatedmeasures analysis of variation with Tukey multicomparison test was used to examine the changes in respective parameters. A P value less than .05 was considered significant.…”