key: cord-0897314-bathj96k
authors: Totten, Arthur H.; Youn, Jung-Ho; Roder, Allison; Ghedin, Elodie; Palmore, Tara N.; Frank, Karen M.; Das, Sanchita; Zelazny, Adrian M.
title: Detection of SARS-CoV2 variants by Mesa Accula
date: 2021-06-19
journal: J Clin Virol
DOI: 10.1016/j.jcv.2021.104901
sha: 20928d514fbd96ad08483c1c9109acf13de0fad5
doc_id: 897314
cord_uid: bathj96k

nan

Rapid and accurate point-of-care (POC) testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) diagnosis is a cornerstone of patient care (1, 2) . In order to decentralize testing and enhance rapid diagnosis and implementation of infection control measures, the Mesa Accula SARS-CoV2 test (Mesa POC, Mesa Biotech) was adopted at the National Institute of Health Clinical Center (NIH CC) in addition to other laboratory-based PCR assays with longer turn-around times. Emergence of viral variants over time are not unexpected for SARS-CoV-2 and as a proactive response, the Food and Drug Administration (FDA) routinely monitors potential influence of viral variants on diagnostic assays (3) . In January 2021 one such variant (28881 GGG > AAC) was reported to potentially reduce the diagnostic efficacy of Mesa POC (3, 4) . However, this was based on in silico analysis.

In this study we attempted to determine the performance of the Mesa POC for the viral variants that can affect test sensitivity according to the FDA (4). Previous validation of the instrument was performed using 14 positive and 10 negative SARS-CoV-2 specimens, supporting sensitivity and specificity of the assay. The genetic variant that may impact assay performance (28881 GGG > AAC) was the target of this study, but we also included emerging viral variants R. 1 In summary, we investigated the accuracy and specificity of the Mesa POC test for variants of SARS-CoV-2 in a limited specimen set. The FDA release suggested 28881 GGG > AAC mutation may impact assay performance (4). Our findings do not support in silico predictions that SARS-CoV-2 detection is impaired for clinically relevant variants that were targeted within this study (4, 5) . Our study had a limited number of variants tested, and contrived specimens may not adequately represent viral heterogeneity within different populations. Further analysis and examination of emerging variants will continue at the NIH CC to ensure detectability of SARS-CoV-2 as the virus continues to evolve. This underscores the need for in vitro studies to validate predictions generated by in silico analysis. 

Clinical, molecular, and epidemiological characterization of the SARS-CoV-2 virus and the Coronavirus Disease 2019 (COVID-19), a comprehensive literature review

Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens

SARS-CoV-2 Variants of Concern in the United States-Challenges and Opportunities

Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 -Letter to Clinical Laboratory Staff and Health Care Providers

Center for Disease Control and Prevention C. 2021. Emerging SARS-CoV2 Variants

Arthur H. Totten 1 , Jung-Ho Youn 1 , Allison Roder 2 , Elodie Ghedin 2 , Tara N. Palmore 3 , Karen M. 

We declare that we have no conflicts of interest.