Testing for SARS-CoV-2 (COVID-19): a systematic review and clinical guide to molecular and serological in-vitro diagnostic assays

Antonio La Marca, Martina Capuzzo, Tiziana Paglia, Laura Roli, Tommaso Trenti, Scott M Nelson, Antonio La Marca, Martina Capuzzo, Tiziana Paglia, Laura Roli, Tommaso Trenti, Scott M Nelson

Abstract

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its associated coronavirus disease 2019 (COVID-19) pandemic has demanded rapid upscaling of in-vitro diagnostic assays to enable mass screening and testing of high-risk groups, and simultaneous ascertainment of robust data on past SARS-CoV-2 exposure at an individual and a population level. To meet the exponential demand in testing, there has been an accelerated development of both molecular and serological assays across a plethora of platforms. The present review discusses the current literature on these modalities, including nucleic acid amplification tests, direct viral antigen tests and the rapidly expanding laboratory-based and point of care serological tests. This suite of complementary tests will inform crucial decisions by healthcare providers and policy makers, and understanding their strengths and limitations will be critical to their judicious application for the development of algorithmic approaches to treatment and public health strategies.

Keywords: Antibody testing; COVID-19; Diagnostic test; SARS-CoV-2; Serology.

Crown Copyright © 2020. Published by Elsevier Ltd. All rights reserved.

Figures

Figure 1
Figure 1
The time relationship between viral load, symptoms and positivity on diagnostic tests. The onset of symptoms (day 0) is usually 5 days after infection (day –5). At this early stage corresponding to the window or asymptomatic period, the viral load could be below the RT-PCR threshold and the test may give false-negative results. The same is true at the end of the disease, when the patient is recovering. Seroconversion may usually be detectable between 5–7 days and 14 days after the onset of symptoms; therefore, in the first phase of the disease, the serological tests are more likely to give false-negative results. The dotted black line in the graph illustrates the sensitivity of the chemiluminescent assay as derived from the data sheet of a commercial test (Abbott Diagnostics, USA). Ig, immunoglobulin; RT-PCR, reverse transcription-PCR; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

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Source: PubMed

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