bioMérieux, 595 Anglum Road, Hazelwood, MO 63042, USA.
Invisible Sentinel, 3711 Market Street, Philadelphia, PA 19104, USA.
J AOAC Int. 2021 Aug 20;104(4):914-923. doi: 10.1093/jaoacint/qsab048.
The VERIPRO® SARS-CoV-2 Env assay uses reverse transcriptase (RT) PCR to detect SARS-CoV-2, the causative agent of COVID-19, from stainless-steel environmental sample swabs.
To validate the VERIPRO SARS-CoV-2 Env assay as part of the AOAC Research Institute's Emergency Response Validation Performance Tested Method(s)SM program.
The VERIPRO SARS-CoV-2 Env assay was evaluated for specificity using in silico analysis of 15 764 SARS-CoV-2 sequences and 65 exclusivity organisms (both near neighbors and background organisms). The candidate method was evaluated in an unpaired 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, Instructions for Use (Revision 4, Effective 6/12/2020).
Results of the in silico analysis demonstrate the specificity of the method in being able to detect 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.
The VERIPRO SARS-CoV-2 Env assay is a rapid and accurate method that can be utilized by food producers to detect the causative agent of COVID-19 on food contact surfaces.
The VERIPRO SARS-CoV-2 Env assay can be performed without the need for an optional RNA purification step to detect SARS-CoV-2 from environmental surfaces.
VERIPRO® SARS-CoV-2 Env 检测使用逆转录（RT）PCR 从不锈钢环境样本拭子中检测导致 COVID-19 的 SARS-CoV-2。
作为 AOAC 研究院紧急响应验证性能测试方法（SM）计划的一部分，验证 VERIPRO SARS-CoV-2 Env 检测。
通过对 15764 个 SARS-CoV-2 序列和 65 种专属性生物体（包括近缘和背景生物体）的计算机分析，评估 VERIPRO SARS-CoV-2 Env 检测的特异性。候选方法采用非配对研究设计，对一种环境表面（不锈钢）进行评估，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，使用说明（修订版 4，有效日期 2020 年 6 月 12 日）进行比较。
计算机分析结果表明，该方法能够检测目标序列并将其与近缘序列区分开来，具有特异性。在基质研究中，候选方法对目标分析物的回收率明显优于参考方法。
VERIPRO SARS-CoV-2 Env 检测是一种快速准确的方法，可用于食品生产商在食品接触表面检测 COVID-19 的病原体。
VERIPRO SARS-CoV-2 Env 检测无需可选的 RNA 纯化步骤，即可从环境表面检测 SARS-CoV-2。
