Diagnosis value of SARS‐CoV‐2 antigen/antibody combined testing using rapid diagnostic tests at hospital admission

Abstract

The implementation of rapid diagnostic tests (RDTs) may enhance the efficiency of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing, as RDTs are widely accessible and easy to use. The aim of this study was to evaluate the performance of a diagnosis strategy based on a combination of antigen and immunoglobulin M (IgM) or immunoglobulin G (IgG) serological RDTs. Plasma and nasopharyngeal samples were collected between 14 March and 11 April 2020 at hospital admission from 45 patients with reverse transcription polymerase chain reaction (RT-PCR) confirmed COVID-19 and 20 negative controls. SARS-CoV-2 antigen (Ag) was assessed in nasopharyngeal swabs using the Coris Respi-Strip. For IgM/IgG detection, SureScreen Diagnostics and Szybio Biotech RDTs were used in addition to laboratory assays (Abbott Alinity i SARS-CoV-2 IgG and Theradiag COVID-19 IgM enzyme-linked immunosorbent assay). Using the Ag RDT, 13 out of 45 (29.0%) specimens tested positive, the sensitivity was 87.0% for cycle threshold (C t ) values ≤25% and 0% for C t values greater than 25. IgG detection was associated with high C t values and the amount of time after the onset of symptoms. The profile of isolated IgM on RDTs was more frequently observed during the first and second week after the onset of symptoms. The combination of Ag and IgM/IgG RDTs enabled the detection of up to 84.0% of COVID-19 confirmed cases at hospital admission. Antigen and antibody-based RDTs showed suboptimal performances when used alone. However when used in combination, they are able to identify most COVID-19 patients admitted in an emergency department.

COVID-19 Antibody Detecting Rapid Diagnostic Tests Show High Cross-Reactivity When Challenged with Pre-Pandemic Malaria, Schistosomiasis and Dengue Samples

“…The selection of RDT products covered the different antigens used and had various regulatory approvals. Some of them were produced by reputable manufacturers and had been successfully validated in peer-reviewed studies [ 6 , 21 , 25 , 34 , 63 , 64 , 65 , 66 ] and approved by regulatory authorities (FDA EUA) and independent actors such as FIND [ 2 ]. In addition, the laboratory workflow was highly standardized and monitored.…”

Real-world clinical performance of commercial SARS-CoV-2 rapid antigen tests in suspected COVID-19: A systematic meta-analysis of available data as per November 20, 2020

“…15 studies compared the clinical performance of one RAT against RT-PCR: six studies compared the Roche/SDB; 12-17 six compared the Abbott; [18][19][20][21][22][23] and three compared the Coris RAT. [24][25][26] All studies provided descriptions of the study populations, regarding mean age and gender distribution (data not shown), as well as symptoms, prevalence rates, and Ct of the RT-PCR-positive samples. Prevalence rate -here meaning the number of RT-PCR-positive samples within the overall study population -varied between 1.9-100%.…”

Detection of SARS-CoV-2 and its S and N proteins using surface enhanced Raman spectroscopy

“…Developments include immunological methods, such as Enzyme Linked Immunosorbent Assays (ELI-SAs), chemiluminescence immunoassays (CLIAs), lateral ow immunoassays (LFIAs), and multiple others. [3][4][5][6][7] Recently, the development of clustered regularly interspaced short palindromic repeats (CRISPR)-based diagnostics has been used to detect the SARS-CoV-2 virus. 8,9 This method is very promising but is still in an early stage.…”