{"title":"东京都政府2023年门诊SARS-CoV-2核酸扩增检测外部质量评价","authors":"Rie Moriuchi, Ryouta Inaba, Miyuki Nagano, Mayuko Oda, Takayuki Shinkai, Toshihisa Noguchi, Yoshiyuki Sugishita, Itaru Nishizuka, Yoshikazu Ishii","doi":"10.7883/yoken.JJID.2024.205","DOIUrl":null,"url":null,"abstract":"<p><p>In 2023, an external quality assessment (EQA) of nucleic acid amplification tests for SARS-CoV-2 was conducted among clinics that implemented testing instruments through the Tokyo Subsidy Program for Facilities and Equipment for Testing in COVID-19. The survey samples consisted of sample 1 (20,000 copies/mL), sample 2 (10,000 copies/mL), and a negative sample. Results were obtained through cycle threshold (Ct) values and positive-negative result determinations. On-site technical support was provided to clinics that responded incorrectly. A total of 544 clinics (589 instruments) participated, and Abbott's ID NOW <sup>TM</sup> (82.2%) was the most widely used instrument. The qualitative test results showed high accuracy rates of 95.2% for Sample 1, 93.2% for Sample 2, and 96.3% for negative samples. Differences in Ct values were observed between reagents and instruments. Technical support was provided to 63 clinics. The discrepancies in the qualitative tests were mainly due to deviations from the protocol instructions, mixing of all three survey samples into one vial, and errors caused by foaming. This survey was unique in that the participants were mostly end users who were not laboratory testing specialists and mainly used point-of-care testing instruments. It is important to continue EQA to improve and maintain testing accuracy.</p>","PeriodicalId":14608,"journal":{"name":"Japanese journal of infectious diseases","volume":" ","pages":"125-134"},"PeriodicalIF":1.1000,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Tokyo Metropolitan Government External Quality Assessment of SARS-CoV-2 Nucleic Acid Amplification Tests for Clinics in 2023.\",\"authors\":\"Rie Moriuchi, Ryouta Inaba, Miyuki Nagano, Mayuko Oda, Takayuki Shinkai, Toshihisa Noguchi, Yoshiyuki Sugishita, Itaru Nishizuka, Yoshikazu Ishii\",\"doi\":\"10.7883/yoken.JJID.2024.205\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>In 2023, an external quality assessment (EQA) of nucleic acid amplification tests for SARS-CoV-2 was conducted among clinics that implemented testing instruments through the Tokyo Subsidy Program for Facilities and Equipment for Testing in COVID-19. The survey samples consisted of sample 1 (20,000 copies/mL), sample 2 (10,000 copies/mL), and a negative sample. Results were obtained through cycle threshold (Ct) values and positive-negative result determinations. On-site technical support was provided to clinics that responded incorrectly. A total of 544 clinics (589 instruments) participated, and Abbott's ID NOW <sup>TM</sup> (82.2%) was the most widely used instrument. The qualitative test results showed high accuracy rates of 95.2% for Sample 1, 93.2% for Sample 2, and 96.3% for negative samples. Differences in Ct values were observed between reagents and instruments. Technical support was provided to 63 clinics. The discrepancies in the qualitative tests were mainly due to deviations from the protocol instructions, mixing of all three survey samples into one vial, and errors caused by foaming. This survey was unique in that the participants were mostly end users who were not laboratory testing specialists and mainly used point-of-care testing instruments. It is important to continue EQA to improve and maintain testing accuracy.</p>\",\"PeriodicalId\":14608,\"journal\":{\"name\":\"Japanese journal of infectious diseases\",\"volume\":\" \",\"pages\":\"125-134\"},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2025-08-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Japanese journal of infectious diseases\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.7883/yoken.JJID.2024.205\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/31 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Japanese journal of infectious diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.7883/yoken.JJID.2024.205","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/31 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0
摘要
对通过东京2023年新冠病毒检测设施设备补贴计划引进检测仪器的诊所进行了新冠病毒核酸扩增检测的外部质量评估。调查样本由样本1(20000份/mL)、样本2(10000份/mL)和阴性样本组成。通过循环阈值(Ct)和阳性阴性结果测定获得结果。对反应不正确的诊所提供现场技术支持。共有544家诊所(589台器械)参与了本次调查,雅培的ID NOW TM(82.2%)在本次调查中使用最为广泛。定性检验结果表明,样品1的正确率为95.2%,样品2的正确率为93.2%,阴性样品的正确率为96.3%。不同试剂和仪器Ct值存在差异。向63个诊所提供了技术支助。结果表明,定性测试的差异主要是由于偏离了方案说明,将三种调查样品混合在一个小瓶中以及起泡引起的误差。这项调查的独特之处在于,参与者大多是终端用户,他们不是实验室检测专家,主要使用即时检测仪器。继续EQA以提高和保持测试准确性是很重要的。
The Tokyo Metropolitan Government External Quality Assessment of SARS-CoV-2 Nucleic Acid Amplification Tests for Clinics in 2023.
In 2023, an external quality assessment (EQA) of nucleic acid amplification tests for SARS-CoV-2 was conducted among clinics that implemented testing instruments through the Tokyo Subsidy Program for Facilities and Equipment for Testing in COVID-19. The survey samples consisted of sample 1 (20,000 copies/mL), sample 2 (10,000 copies/mL), and a negative sample. Results were obtained through cycle threshold (Ct) values and positive-negative result determinations. On-site technical support was provided to clinics that responded incorrectly. A total of 544 clinics (589 instruments) participated, and Abbott's ID NOW TM (82.2%) was the most widely used instrument. The qualitative test results showed high accuracy rates of 95.2% for Sample 1, 93.2% for Sample 2, and 96.3% for negative samples. Differences in Ct values were observed between reagents and instruments. Technical support was provided to 63 clinics. The discrepancies in the qualitative tests were mainly due to deviations from the protocol instructions, mixing of all three survey samples into one vial, and errors caused by foaming. This survey was unique in that the participants were mostly end users who were not laboratory testing specialists and mainly used point-of-care testing instruments. It is important to continue EQA to improve and maintain testing accuracy.
期刊介绍:
Japanese Journal of Infectious Diseases (JJID), an official bimonthly publication of National Institute of Infectious Diseases, Japan, publishes papers dealing with basic research on infectious diseases relevant to humans in the fields of bacteriology, virology, mycology, parasitology, medical entomology, vaccinology, and toxinology. Pathology, immunology, biochemistry, and blood safety related to microbial pathogens are among the fields covered. Sections include: original papers, short communications, epidemiological reports, methods, laboratory and epidemiology communications, letters to the editor, and reviews.