Laboratory Medicine and Quality Assurance最新文献

{"title":"Development of an Operational Plan for the Liquid Biopsy External Quality Assessment Program in Korea","authors":"Sunyoung Ahn, Hyun-Ki Kim, Ji Hyun Kim, Woochang Lee, S. Chun, W. Lee, A. Min","doi":"10.15263/jlmqa.2020.42.2.91","DOIUrl":"https://doi.org/10.15263/jlmqa.2020.42.2.91","url":null,"abstract":"This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/ by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Background: Liquid biopsy is a useful assay for the diagnosis, treatment, and prognosis prediction of solid tumors and its clinical application is expanding. Therefore, the need for developing an External Quality Assessment (EQA) protocol for liquid biopsy is increasing. In this study, we developed and implemented the liquid biopsy EQA program for the epidermal growth factor receptor mutation. Methods: We validated the feasibility of the protocol using citrate instead of ethylenediaminetetraacetic acid (EDTA). Additionally, we analyzed the homogeneity and stability of the aliquoted quality control (QC) materials. Mutation-positive QC material with four mutations (exon 19 deletion, L858R, T790M, and exon 20 insertion) was used to make two types of QC materials (low and high) and the wild type material was used for the negative controls. If the EQA results showed consensus in more than 80% of the participating laboratories, the results were reported as acceptable or unacceptable. If not, we reported the results as not graded. Results: Citrate showed equivalent performance to EDTA. Highly mutated QC material and mutation-negative QC material passed the homogeneity and stability test, but low-level mutant specimens showed inconsistent results. In total, 11 laboratories participated, and all of them reported consistent results except for low-grade mutant samples. Thus, the evaluation results were acceptable except for low mutation QC material. Conclusions: The applicability of liquid biopsy is expanding. To obtain accurate test results, EQA is indispensable. Here, QC materials for liquid biopsy EQA were produced, distributed, and had its results analyzed. This study could be the foundation for further development of liquid biopsy EQA. (Lab Med Qual Assur 2020;42:91-96)","PeriodicalId":397606,"journal":{"name":"Laboratory Medicine and Quality Assurance","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115963536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Survey on Transfusion Laboratory Work in Medical Institutions Participating in the External Quality Control Program for Blood Bank","authors":"Jong‐Han Lee, Sungwook Song, S. Ryu, Hyun Ok Kim","doi":"10.15263/jlmqa.2020.42.1.40","DOIUrl":"https://doi.org/10.15263/jlmqa.2020.42.1.40","url":null,"abstract":"Background: Laboratory tests in blood banks vary with respect to methods, equipment, and quality control according to the hospital’s environment. Methods: We surveyed institutions that regularly participated in the Korean association of external quality assessment using a web-based questionnaire comprising 79 questions regarding transfusion laboratory work. Results: A total of 84 institutions were surveyed including 17 senior general hospitals, 43 general hospitals, 19 hospitals, four clinics, and one commercial laboratory. ABO cell typing was performed by slide (63, 75.0%), tube (42, 50.0%), automated column (19, 22.6%), and automated microplate (7, 8.3%) methods. ABO serum typing was performed by tube (75, 89.3%), automated column (19, 22.6%), automated microplate (7, 8.3%), and slide (7, 8.3%) methods. Irregular antibody screening test and identification test was performed by 58 (69.0%) and 36 (42.9%) institutions, respectively. Irregular antibody screening test and identification test was performed by the column agglutination method in 34 (40.5%) and 26 (31.0%) institutions, respectively. Room temperature saline, albumin, and anti-globulin reagent crossmatching test (three-step method) was the most popular method (48, 57.1%). The use of anti-globulin reagent in the crossmatching test did not significantly vary according to the size of the hospital. A daily quality control program for ABO, Rh typing, and the crossmatching test was conducted in 58 (69.0%) institutions. Conclusions: There were differences in transfusion-related laboratory tests among the institutions. Although this survey included a limited number of institutions, it can be helpful to evaluate the routine laboratory tests and transfusion-related blood bank work in each institution. (Lab Med Qual","PeriodicalId":397606,"journal":{"name":"Laboratory Medicine and Quality Assurance","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126101062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}