In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends

Diagnostics (Basel). 2020 Apr 5;10(4). pii: E202. doi: 10.3390/diagnostics10040202.
Pictor Private Limited, 24 Balfour Road Parnell, 1052 Auckland, New Zealand.

Abstract

There have been tremendous advances in in vitro diagnostic (IVD) assays for coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main IVD assays used for COVID-19 employ real-time reverse transcriptase polymerase chain reaction (RT-PCR) that takes a few hours. But the assay duration has been shortened to 45 min by Cepheid. Of interest is the point-of-care (POC) molecular assay by Abbott that decreased the assay duration to just 5 min. Most molecular tests have been approved by the United States Food and Drug Administration (FDA) under emergency use authorization (EUA) and are Conformité Européenne (CE) marked. A wide range of serology immunoassays (IAs) have also been developed that complement the molecular assays for the diagnosis of COVID-19.

The most prominent IAs are automated chemiluminescent IA (CLIA), manual ELISA, and rapid lateral flow IA (LFIA), which detect the immunoglobulin M (IgM) and immunoglobulin G (IgG) produced in persons in response to SARS-CoV-2 infection. The ongoing research efforts and advances in complementary technologies will pave the way to new POC IVD assays in the coming months. However, the performance of IVD assays needs to be critically evaluated before they are employed for the clinical diagnosis of COVID-19.

Several CE marked manual ELISA kits have also been developed by various IVD manufacturers, such as Euroimmun, IBL International, DRG Diagnostics GmbH, and Epitope Diagnostics. Most of them target the IgG and IgM produced in subjects in response to SARS-CoV-2 infection.

However, the performance of IVD assays needs to be critically evaluated before they are employed for the clinical diagnosis of COVID-19.