[Comparison of quantitative detection of BCR::ABL1 p210 transcript levels: a multicenter study].
Zhonghua Bing Li Xue Za Zhi
; 53(7): 672-677, 2024 Jul 08.
Article
in Zh
| MEDLINE
| ID: mdl-38955697
ABSTRACT
Objective:
To assess the capability of seven reference medical laboratories to detect BCRABL1 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 BCRABL1 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 BCRABL1 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 BCRABL1 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 BCRABL1 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 BCRABL1 p210 is comparable among laboratories as shown by the CF value conversion. For quantitative detection of BCRABL1 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 BCRABL1 p210 test, it is imperative for every laboratory to enhance their daily quality control practices.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Fusion Proteins, bcr-abl
/
Real-Time Polymerase Chain Reaction
Limits:
Humans
Language:
Zh
Journal:
Zhonghua Bing Li Xue Za Zhi
Year:
2024
Document type:
Article
Affiliation country:
China