Validation Study for VERIPRO® SARS-CoV-2 Env Assay for the Detection of SARS-CoV-2 from Stainless-Steel Environmental Surface Swabs: Emergency Response Validation AOAC Performance Tested MethodSM 122001

Background: The VERIPRO (R) 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. Objective: 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. Method: 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: 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. Conclusions: 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. Highlights: 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.