Comparison of quantitative detection of BCR::ABL1 p210 transcript levels: a multicenter study
10.3760/cma.j.cn112151-20240110-00024
- VernacularTitle:BCR：：ABL1 p210转录水平定量检测多中心比对
- Author:
Chuting ZHAO
1
;
Canrong NI
;
Yani LIN
;
Xiaoli MA
;
Qisheng WU
;
Fang WANG
;
Xiaoxue HAN
;
Feng LIU
;
Yang XU
;
Hongxing LIU
;
Jie CHEN
;
Kun RU
;
Minghua ZHU
Author Information
1. 天津见康华美医学诊断中心，天津 300385
- Keywords:
Leukemia, myelogenous, chronic, BCR-ABL positive;
Fusion proteins, bcr-abl;
Real-time polymerase chain reaction
- From:
Chinese Journal of Pathology
2024;53(7):672-677
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To assess the capability of seven reference medical laboratories to detect BCR::ABL1 p210 transcription levels and to compare the results among those laboratories.Methods:The interlaboratory comparison was carried out in two stages. The samples were prepared by the reference laboratory. The quantitative values of BCR::ABL1 p210 of the comparison samples covered 0.001%-0.01%, 0.01%-0.1%, 0.1%-1%, 1%-10% and>10% in each stage. Real-time quantitative PCR (RT-PCR) and dPCR (digital PCR) were used to examine the samples. The conversion factor (CF) was calculated and validated for each laboratory.Results:In the RT-PCR comparison, one laboratory was failed to detect BCR::ABL1 p210 in fourteen samples at the first stage. The results of the other six laboratories were qualified with the bias <±1.2 folds (-0.133-0.338) and 95% limits of agreement within ±5 folds (upper limit 0.147-0.785, lower limit -0.770--0.109), and the corresponding CF values were calculated and validated. In the dPCR comparison, one laboratory did not report results at the second stage. The results of the other six laboratories were qualified with the bias <±1.2 folds (-0.026-0.267) and 95% limits of agreement within±5 folds (upper limit 0.084-0.991, lower limit -0.669--0.135), and the corresponding CF values were calculated and validated. The samples with BCR::ABL1 p210 quantitative values of 0.01%-0.1%, 0.1%-1%, 1%-10% and >10% could be detected by both RT-PCR and qPCR. When the quantitative value of BCR::ABL1 p210 was 0.001%-0.01%, the detection rate of dPCR was higher than that of RT-PCR (85.56% vs. 68.00%).Conclusions:A good consistency is present among various laboratories. The quantitative value of BCR::ABL1 p210 is comparable among laboratories as shown by the CF value conversion. For quantitative detection of BCR::ABL1 p210 deep molecular reaction, dPCR has a higher positive detection rate and more advantages than RT-PCR. To ensure the accuracy and reproducibility of the BCR::ABL1 p210 test, it is imperative for every laboratory to enhance their daily quality control practices.
