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—AOAC Performance Tested MethodSM 122001
| Autor: | Shannon T Green, Nicholas Siciliano, Ronald L. Johnson, Adam C Joelsson, Vikrant Dutta |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
AcademicSubjects/SCI01140
Validation study Analyte Coronavirus disease 2019 (COVID-19) AcademicSubjects/SCI01060 In silico Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viruses AcademicSubjects/SCI00030 Biology medicine.disease_cause AcademicSubjects/SCI01180 01 natural sciences Sensitivity and Specificity Article Analytical Chemistry Matrix (chemical analysis) COVID-19 Testing medicine Environmental Chemistry Humans Coronavirus Pharmacology 010405 organic chemistry SARS-CoV-2 010401 analytical chemistry fungi virus diseases COVID-19 Stainless Steel Virology 0104 chemical sciences Emergency response RNA Viral AcademicSubjects/SCI00980 Agronomy and Crop Science Food Science |
| Zdroj: | Journal of Aoac International |
| ISSN: | 1944-7922 1060-3271 |
| Popis: | Background 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. 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. |
| Databáze: | OpenAIRE |
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