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定量检测BCR-ABL(P210)转录本水平室内质控体系的完善及多中心推广应用

OBJECTIVE: The study aims to establish a perfect BCR-ABL(P210)internal quality control system and ensure the long-term stability and comparability of the detection results between laboratories and to popularize and apply it in the three hospitals. METHODS: The Qilu Hospital of Shandong University (H...

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Formato: Online Artículo Texto
Lenguaje:English
Publicado: Editorial office of Chinese Journal of Hematology 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9395572/
https://www.ncbi.nlm.nih.gov/pubmed/36709133
http://dx.doi.org/10.3760/cma.j.issn.0253-2727.2022.07.006
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collection PubMed
description OBJECTIVE: The study aims to establish a perfect BCR-ABL(P210)internal quality control system and ensure the long-term stability and comparability of the detection results between laboratories and to popularize and apply it in the three hospitals. METHODS: The Qilu Hospital of Shandong University (H1) prepared a set of the BCR-ABL (P210) quality control substances to establish and improve internal quality control system. We went to other three participating hospitals (H2, H3, and H4) to inspect quality control before the measurement. In addition, we mailed 25 sets of quality control substances to each of the hospital for detection. The slope and intercept of the standard curve of each hospital and the detection results were analyzed and statistically judged using the Levey-Jennings quality control chart combined with the Westgard multirule theory. Then, we made a quality control evaluation. RESULTS: ①An internal quality control system for the BCR-ABL (P210) transcript levels monitoring was successfully established for the quality inspection before the measurement, statistical judgment during the measurement, and evaluation after the measurement. ② Both the slope and intercept of the standard curve of the four hospitals was under control. ③The multicenter quality control substance judgment results were as follows: for H1 hospital, two times of “1(2s)” warning were found in the middle-level quality control substance, which was judged as being under control; for H2 hospital, one time of “1(2s)” warning was found for each quality control substance, which was judged as being “2(2s)” out of control; for H3 hospital, its high-level quality control substance violated the “1(3s)” rule, and low-level quality control substance appeared “1(2s)” warning, which was judged as “1(3s)” out of control; and all quality control substances were under control in H4 hospital. ④The quality control evaluation and correction were as follows: two hospitals were under control, and the other two hospitals had an “out of control.” We found out the reason for the out of control and corrected them. ⑤The comparisons of the original values of the multicenter quality control substance were as follows: there were statistical differences in the results of high-level quality control substance among the four hospitals, and no significant difference was found in the results of the medium-level and low-level quality control substance. ⑥The comparisons of the IS values of the multicenter quality control substance were as follows: the IS values of the three quality control substance in H2 and H3 hospitals were significantly higher than those of H1 hospital, and H2 hospital was significantly higher than H3 hospital. CONCLUSION: A perfect and stable internal quality control system for the BCR-ABL (P210) transcripts has been established, which can effectively ensure the accuracy and stability of the clinical detection results. This internal quality control system has been successfully popularized and applied in other hospitals.
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spelling pubmed-93955722022-08-24 定量检测BCR-ABL(P210)转录本水平室内质控体系的完善及多中心推广应用 Zhonghua Xue Ye Xue Za Zhi 论著 OBJECTIVE: The study aims to establish a perfect BCR-ABL(P210)internal quality control system and ensure the long-term stability and comparability of the detection results between laboratories and to popularize and apply it in the three hospitals. METHODS: The Qilu Hospital of Shandong University (H1) prepared a set of the BCR-ABL (P210) quality control substances to establish and improve internal quality control system. We went to other three participating hospitals (H2, H3, and H4) to inspect quality control before the measurement. In addition, we mailed 25 sets of quality control substances to each of the hospital for detection. The slope and intercept of the standard curve of each hospital and the detection results were analyzed and statistically judged using the Levey-Jennings quality control chart combined with the Westgard multirule theory. Then, we made a quality control evaluation. RESULTS: ①An internal quality control system for the BCR-ABL (P210) transcript levels monitoring was successfully established for the quality inspection before the measurement, statistical judgment during the measurement, and evaluation after the measurement. ② Both the slope and intercept of the standard curve of the four hospitals was under control. ③The multicenter quality control substance judgment results were as follows: for H1 hospital, two times of “1(2s)” warning were found in the middle-level quality control substance, which was judged as being under control; for H2 hospital, one time of “1(2s)” warning was found for each quality control substance, which was judged as being “2(2s)” out of control; for H3 hospital, its high-level quality control substance violated the “1(3s)” rule, and low-level quality control substance appeared “1(2s)” warning, which was judged as “1(3s)” out of control; and all quality control substances were under control in H4 hospital. ④The quality control evaluation and correction were as follows: two hospitals were under control, and the other two hospitals had an “out of control.” We found out the reason for the out of control and corrected them. ⑤The comparisons of the original values of the multicenter quality control substance were as follows: there were statistical differences in the results of high-level quality control substance among the four hospitals, and no significant difference was found in the results of the medium-level and low-level quality control substance. ⑥The comparisons of the IS values of the multicenter quality control substance were as follows: the IS values of the three quality control substance in H2 and H3 hospitals were significantly higher than those of H1 hospital, and H2 hospital was significantly higher than H3 hospital. CONCLUSION: A perfect and stable internal quality control system for the BCR-ABL (P210) transcripts has been established, which can effectively ensure the accuracy and stability of the clinical detection results. This internal quality control system has been successfully popularized and applied in other hospitals. Editorial office of Chinese Journal of Hematology 2022-07 /pmc/articles/PMC9395572/ /pubmed/36709133 http://dx.doi.org/10.3760/cma.j.issn.0253-2727.2022.07.006 Text en 2022年版权归中华医学会所有 https://creativecommons.org/licenses/by/3.0/This work is licensed under a Creative Commons Attribution 3.0 License.
spellingShingle 论著
定量检测BCR-ABL(P210)转录本水平室内质控体系的完善及多中心推广应用
title 定量检测BCR-ABL(P210)转录本水平室内质控体系的完善及多中心推广应用
title_full 定量检测BCR-ABL(P210)转录本水平室内质控体系的完善及多中心推广应用
title_fullStr 定量检测BCR-ABL(P210)转录本水平室内质控体系的完善及多中心推广应用
title_full_unstemmed 定量检测BCR-ABL(P210)转录本水平室内质控体系的完善及多中心推广应用
title_short 定量检测BCR-ABL(P210)转录本水平室内质控体系的完善及多中心推广应用
title_sort 定量检测bcr-abl(p210)转录本水平室内质控体系的完善及多中心推广应用
topic 论著
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9395572/
https://www.ncbi.nlm.nih.gov/pubmed/36709133
http://dx.doi.org/10.3760/cma.j.issn.0253-2727.2022.07.006
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