福克斯蔡斯癌症中心用于 SARS-CoV-2 检测的替代标本采集试剂盒的临床验证。
Clinical Validation of an Alternative Specimen Collection Kit for SARS-CoV-2 Testing at Fox Chase Cancer Center.
机构信息
Department of Pathology Fox Chase Cancer Center - Temple Health PhiladelphiaPennsylvania19111 USA.
Cell Culture Facility Fox Chase Cancer Center - Temple Health PhiladelphiaPennsylvania19111 USA.
出版信息
J Biomol Tech. 2022 Dec 5;33(3). doi: 10.7171/3fc1f5fe.2008dbc6. eCollection 2022 Oct 15.
BACKGROUND
Supply chain disruptions during the COVID-19 pandemic have affected the availability of components for specimen collection kits to detect SARS-CoV-2. Plastic injection molding offers a rapid and cheap method for mass production of swabs for upper respiratory tract sampling. Local production of virus transport medium increases flexibility to assemble sample collection kits if the medium provides appropriate stability for SARS-CoV-2 detection.
METHODS
A locally produced virus transport medium and a novel injection molded plastic swab were validated for SARS-CoV-2 detection by reverse-transcription quantitative polymerase chain reaction. Both components were compared to standard counterparts using viral reference material and representative patient samples.
RESULTS
Clinical testing showed no significant differences between molded and flocked swabs. Commercial and in-house virus transport media provided stable test results for over 40 days of specimen storage and showed no differences in test results using patient samples.
CONCLUSIONS
This collection kit provides new supply chain options for SARS-CoV-2 testing.
背景
COVID-19 大流行期间的供应链中断影响了用于采集 SARS-CoV-2 样本的采集试剂盒组件的供应。塑料注塑为呼吸道采样拭子的大规模生产提供了快速且廉价的方法。如果病毒运输介质具有适当的 SARS-CoV-2 检测稳定性，则本地生产病毒运输介质可增加组装样本采集试剂盒的灵活性。
方法
通过逆转录定量聚合酶链反应对本地生产的病毒运输介质和新型注塑塑料拭子进行了 SARS-CoV-2 检测的验证。使用病毒参考物质和代表性患者样本将这两种成分与标准对照进行了比较。
结果
临床测试显示，注塑和植绒拭子之间没有显著差异。商业和内部病毒运输介质为标本储存 40 多天以上提供了稳定的测试结果，并且使用患者样本时测试结果没有差异。
结论
该采集套件为 SARS-CoV-2 检测提供了新的供应链选择。
Zotero 插件