Evaluation and Comparison of Serological Methods for COVID-19 Diagnosis

Abstract

The worldwide pandemic of COVID-19 has become a global public health crisis. Various clinical diagnosis methods have been developed to distinguish COVID-19–infected patients from healthy people. The nucleic acid test is the golden standard for virus detection as it is suitable for early diagnosis. However, due to the low amount of viral nucleic acid in the respiratory tract, the sensitivity of nucleic acid detection is unsatisfactory. As a result, serological screening began to be widely used with the merits of simple procedures, lower cost, and shorter detection time. Serological tests currently include the enzyme-linked immunosorbent assay (ELISA), lateral flow immunoassay (LFIA), and chemiluminescence immunoassay (CLIA). This review describes various serological methods, discusses the performance and diagnostic effects of different methods, and points out the problems and the direction of optimization, to improve the efficiency of clinical diagnosis. These increasingly sophisticated and diverse serological diagnostic technologies will help human beings to control the spread of COVID-19.

Development of Serological Assays and Seroprevalence Studies of the New Coronavirus 2019 (COVID-19): Reports from Saudi Arabia

“…Many labs in Saudi Arabia possess FDA-approved serological assays that enable sensitive and specific detection of SARS-CoV-2 antibodies. However, accumulating evidence has raised concerns with regards to the performance of some of these assays [ 11 , 12 , 13 , 14 , 15 ]. Sensitivity and specificity of these commercial assays, in some cases, were below 70% [ 13 ].…”

“…However, accumulating evidence has raised concerns with regards to the performance of some of these assays [ 11 , 12 , 13 , 14 , 15 ]. Sensitivity and specificity of these commercial assays, in some cases, were below 70% [ 13 ]. Hence, some research groups decided to develop their own in-house or semi-in-house assays in order to minimize the potential of misdiagnosis and “false” reporting [ 16 , 17 , 18 , 19 ].…”

Microarray-Based Detection of Antibodies against SARS-CoV-2 Proteins, Common Respiratory Viruses and Type I Interferons

“…In addition to a number of approved uniplex commercial SARS-CoV-2 immunoassays [15], a wide range of serological immunoassays have been developed for simultaneous detection of antibodies against the SARS-CoV-2 and other respiratory viruses [16][17][18][19]. The performance of these assays varies depending on format of test, choice of the antigens, and sample cohorts [20,21]. Protein and peptide microarrays are versatile tools for multiple detection of virus-specific antibodies in patient sera and for efficient identification of specific immunodominant epitopes of viral proteins [22][23][24][25][26].…”

Longitudinal monitoring of SARS-CoV-2 neutralizing antibody titers and its impact on employee personal wellness decisions

“…Unfortunately, most clinically approved antibody tests lack the ability to measure vnAbs, the antibody class that has been shown to correlate with protection. Instead, they detectoften qualitativelyantibodies capable of binding to the SARS-CoV-2 spike glycoprotein or nucleocapsid [19][20][21] . Because many binding antibodies are incapable of preventing virus infection, the information provided by such tests can be informative, but does not correlate as strongly to levels of protection as vnAb titers.…”