Abstract

There have been tremendous advances in in vitro diagnostics (IVD) for coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although the confirmatory clinical diagnosis is made by real-time reverse transcriptase polymerase chain reaction (RT-PCR), lateral flow immunoassay (LFIA) based viral antigen (Ag) detection is used for mass population screening at point-of-care (POC) settings. The rapid RT-PCR tests (such as from Cepheid and Bosch) have an assay duration of less than 40 min, while most rapid Ag tests (such as Abbott’s BinaxNOW™ COVID-19 Ag card) have an assay duration of about 15 min. Of interest is the POC molecular test (ID NOW™) from Abbott that takes less than13 min. Similarly, many immunoassays (IAs), i.e., automated chemiluminescent IA (CLIA), manual ELISA, and LFIA, have been developed to detect immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) produced in subjects after SARS-CoV-2 infection. Many IVD tests have been approved by the United States Food and Drug Administration (FDA) under emergency use authorization (EUA), and almost all IVD tests are Conformité Européenne (CE) certified.

Highlights

  • SARS-CoV-2 is a positive-sense single-stranded ribonucleic acid (RNA) virus with characteristic spikes on its surface that provide its crown-like appearance

  • Various in vitro diagnostics (IVD) assays have been developed for the detection of SARS-CoV-2 viral RNA, antibodies, and antigens, which encompass assays performed in certified COVID-19 diagnostic laboratories and rapid tests employed at POC settings

  • The positive predictive agreement (PPA) to PCR for the detection of anti-SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies in serum and plasma were 100% in samples collected from COVID-19 patients ≥15 days post onset of symptoms

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Summary

Introduction

SARS-CoV-2 is a positive-sense single-stranded ribonucleic acid (RNA) virus with characteristic spikes on its surface that provide its crown-like appearance. It comprises different structural proteins, namely nucleocapsid protein (NP), spike protein (SP), membrane protein (MP), and envelope protein (EP), which play an important role in the manifestation of SARS-CoV-2 infection (Figure 1). With 12.6 and 12.2 million cases, Brazil and India have the subsequent highest incidence of COVID-19 Some nations, such as Singapore, New Zealand, and China, have effectively controlled the COVID-19 incidence by acting proactively and taking the desired measures at the right time. Several deficiencies have been reported where they were unable to detect COVID-19 during the early stages of infection and provided false negatives results to subjects [10, 11]. There is a need for continuous improvement in IVD assays to ensure reliable detection of SARS-CoV-2 infection without being impacted by the SP mutations

Structure of SARS-CoV-2
In vitro diagnostics for COVID-19
Molecular diagnostics
Antigen detection
Antibodies detection
Automated CLIA
Rapid LFIA
Challenges and future directions
Findings
Conclusions
Full Text
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