COVID-19 Serological Tests: How Well Do They Actually Perform?

Abstract

In only a few months after initial discovery in Wuhan, China, SARS-CoV-2 and the associated COVID-19 disease has become a global pandemic causing significant mortality and morbidity. In the absence of vaccines and effective therapeutics, reliable serological testing can be a key element of public health policy to control further spread of the disease and gradually ease quarantine measures. However, prior to launch of large-scale seroprevalence studies to assess herd immunity, it is critical to understand the limits and potential of current SARS-CoV-2 serological tests on the market. In this study, we provide an overview of serological testing and conduct a systematic review of independent evaluations of SARS-CoV-2 serological tests performance. Our findings show significant variability in the accuracy of marketed tests and highlight several lab-based and point-of-care rapid diagnostic tests with high performance level in detecting SRAS-CoV-2 specific antibodies. The findings of this review highlight the need for ongoing independent evaluations of commercialized COVID-19 diagnostic tests.

Comparison of Five Serological Assays for the Detection of SARS-CoV-2 Antibodies

“…The study was conducted to provide information on performance characteristics of commercially available serological assays. Thus, it contributes to previously described assessments [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 ] and provides an additional piece of the puzzle in terms of interpreting the results of serological approaches for the retrospective diagnosis of infections with SARS-CoV-2.…”

“…To close this diagnostic gap, there was an early focus on the implementation of antibody-based surveillance. By doing so, a more realistic view on the real dimensions of the spread of SARS-CoV-2 in the population was aspired to and numerous benchtop-based and point-of-care-testing (POCT)-based serological assays were introduced [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 ]. However, the limitations of this strategy rapidly emerged as well.…”

COVID-19 susceptibility in pregnancy: Immune/inflammatory considerations, the role of placental ACE-2 and research considerations

“…The laboratory diagnosis of SARS COV-2 is based either on detection of the virus via RT-PCR or on evidence of an immune response to the virus derived via serological methods identifying IgG or IgM (IgA; mucosal immunity) in patients’ serum; neither of which are without flaws [ 23 , 24 ]. While RT-PCR detects virus-specific RNA molecules, it is not useful in distinguishing between highly-infectious viruses and those neutralized by the host, may detect lingering residual RNA from a no longer infectious virus, and cannot asses immunity status [ 24 ].…”

The Main Molecular and Serological Methods for Diagnosing COVID-19: An Overview Based on the Literature

“…ELISA is a plate-based assessment method for detecting and quantifying biomolecules, including proteins, such as hormones and antibodies or peptides [ 66 ]. ELISA assays can be found in different formats, including direct, competitive, and, the most commonly used, sandwich or double-antigen-bridging assay (DABA) [ 145 ]. Figure 3 presents an overview of the steps involved in the ELISA test and the main formats.…”