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在印度太平洋地区建立COVID-19抗原测试的质量保证:一项多地点实施研究

Jacqueline Prestedge¹, Marilyn Ninan², Chan Leakhena Phoeung³

¹Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia; Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia.

Diagnostic microbiology and infectious disease

|January 16, 2025

概括

在柬埔寨,老民主共和国和巴布亚新几内亚实施了COVID-19抗原快速诊断测试 (Ag-RDTs) 的质量保证计划 (QAP). 该计划强调了需要操作员培训和改进QAP材料设计,以确保准确的COVID-19诊断测试.

科学领域:

临床诊断临床诊断临床诊断
公共卫生监督是对公共卫生的监督.
传染病管理传染病管理

背景情况:

质量保证计划 (QAP) 对于评估和提高诊断测试的准确性至关重要.
COVID-19抗原快速诊断测试 (Ag-RDTs) 在各种环境中被广泛使用,但它们的性能可能有所不同.
需要专门为Ag-RDTs建立一个QAP,以确保可靠的COVID-19诊断.

研究的目的:

为COVID-19抗原快速诊断测试 (Ag-RDTs) 设计和实施质量保证计划 (QAP).
在柬埔寨,老民主共和国和巴布亚新几内亚的实验室和非实验室环境中评估Ag-RDTs的性能.
确定影响Ag-RDT结果准确性的因素,并提供改进建议.

主要方法:

制造了435个质量控制 (QC) 面板和36个外部质量评估 (EQA) 面板,使用来自Wildtype,Delta和Omicron分离物的非活化SARS-CoV-2材料.
在三个国家的15个地点分发了面板,为标准化测试提供培训和协议.
通过电子报告和纸质表格收集QC和EQA结果.

主要成果:

提交了来自两个国家的369个QC结果和112个EQA结果.
在QC小组中实现了19.3%的正确阳性和99.5%的正确负面报告.
在EQA小组中报告了37.5%的正确阳性和97.5%的正确负面解释,表明了假负结果的可能性.

结论:

实施的QAP强调了操作员培训和QAP材料设计在准确的COVID-19诊断测试中的关键作用.
对阳性COVID-19样本的错误负解读率很高,这表明在测试执行或材料方面需要改进.
这项举措是地区和全球首个此类举措之一,强调了所有测试场所的质量保证的重要性,包括基于社区的地点,以提高COVID-19诊断质量.

关键词:

抗原测试是一种抗原测试.在 COVID-19 疫情中,外部质量评估外部质量评估质量保证质量保证质量保证快速诊断测试是一种快速的诊断测试.

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