Phylagen, Inc., 164 Welsh Street, San Francisco, CA 94107, USA.
J AOAC Int. 2021 Aug 20;104(4):948-958. doi: 10.1093/jaoacint/qsab051.
The COVID-19 Indoor Test™ by Phylagen uses a real-time PCR Assay to detect nucleic acid from SARS-CoV-2, the causative agent of COVID-19, which is extracted from swabs sampled from environmental surfaces. This information can be used to detect the presence of the virus in indoor environments.
To validate the COVID-19 Indoor TestTM by Phylagen as part of the AOAC Research Institute's Emergency Response Validation Performance Tested Method(s)SM program.
The COVID-19 Indoor Test by Phylagen assay was evaluated for specificity using in silico analysis of 15 764 SARS-CoV-2 sequences and 65 exclusivity organisms. The candidate method was also evaluated in an unpaired matrix study design for one environmental surface (stainless steel) and compared to the U.S. Centers for Disease Control and Prevention 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (Revision 4, Effective 6/12/2020).
Results of the in silico analysis demonstrated the specificity of the method in being able to detect SARS-CoV-2 target sequences and discriminate them from near-neighbors. In the matrix study, the candidate method demonstrated statistically significant better recovery of the target analyte than the reference method (2 × 103 GU/2 × 2" test surface).
The COVID-19 Indoor Test by Phylagen is a rapid and accurate method that can be utilized to monitor the presence of SARS-CoV-2, the causative agent of COVID-19, on stainless-steel surfaces in built environments.
The COVID-19 Indoor Test by Phylagen assay performed significantly better than the reference method when used to detect SARS-CoV-2 from environmental surfaces.
Phylagen 的 COVID-19 室内检测使用实时 PCR 检测来检测 SARS-CoV-2 的核酸，这是从环境表面采集的拭子中提取的，SARS-CoV-2 是 COVID-19 的病原体。该信息可用于检测室内环境中病毒的存在。
通过 AOAC 研究所的紧急响应验证性能测试方法来验证 Phylagen 的 COVID-19 室内检测。
通过对 15764 个 SARS-CoV-2 序列和 65 个排他性生物体的计算机分析，评估了 Phylagen 的 COVID-19 室内检测方法的特异性。候选方法还在非配对基质研究设计中对一种环境表面（不锈钢）进行了评估，并与美国疾病控制与预防中心 2019 年新型冠状病毒（2019-nCoV）实时 RT-PCR 诊断试剂盒（修订版 4，有效日期 2020 年 6 月 12 日）进行了比较。
计算机分析结果表明，该方法能够特异性地检测 SARS-CoV-2 靶序列，并将其与近邻区分开来。在基质研究中，候选方法在目标分析物的回收方面明显优于参考方法（2×103GU/2×2"测试表面）。
Phylagen 的 COVID-19 室内检测是一种快速准确的方法，可用于监测 SARS-CoV-2 在建筑环境中不锈钢表面的存在，SARS-CoV-2 是 COVID-19 的病原体。
当用于从环境表面检测 SARS-CoV-2 时，Phylagen 的 COVID-19 室内检测试剂盒的性能明显优于参考方法。
