A new and rapid approach for detecting COVID‐19 based on S1 protein fragments

Abstract

The pandemic of novel coronavirus disease 2019 (COVID‐19) seriously threatened the public health all over the world. A colloidal gold immunochromatography assay for IgM/IgG antibodies against the receptor‐binding domain of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) S1 protein was established to assess its rapid diagnostic value. We first designed and manufactured all contents of the test cassette of SARS‐CoV‐2 rapid test kit: the colloidal gold‐labeled mouse‐antihuman lgM/lgG antibody, the recombinant SARS‐CoV‐2 antigen, the nitrocellulose membrane control line, and specimen diluents. Furthermore, reverse transcription‐polymerase chain reaction (RT‐PCR) assay, colloidal gold immunochromatography assay, serological validation of cross reaction with other common viruses, and clinical validation were performed. The kit was finally evaluated by 75 serum/plasma samples of SARS‐CoV‐2 infection cases and 139 healthy samples as control, with the result of that the sensitivity, specificity, and accuracy for IgM were 90.67%, 97.84%, and 95.33%, whereas for IgG were 69.33%, 99.28%, and 88.79%, respectively; the combination of IgM and IgG could improve the value: 92.00%, 97.12%, and 95.33%, respectively. Therefore, the rapid detection kit has high sensitivity and specificity, especially for IgM&IgG, showing a critical value in clinical application and epidemic control of COVID‐19.

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.…”

“…However, the limitations of this strategy rapidly emerged as well. While specificity was usually at least >95% in the geographic regions where the tests were developed, a broad variety of sensitivities, usually between 70% and 90% depending on the subpopulation assessed [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ] and sometimes even lower [ 47 ], were recorded with an optimum sensitivity two weeks after infection [ 29 ] and decreasing positivity rates afterwards [ 30 ]. Further, age-dependency of serological sensitivity has been demonstrated [ 33 ] next to higher specificity but lower sensitivity of neutralizing antibodies compared to non-neutralizing ones [ 34 ].…”

Development of a SERS-based lateral flow immunoassay for rapid and ultra-sensitive detection of anti-SARS-CoV-2 IgM/IgG in clinical samples

“…(iv) It can accurately distinguish COVID-19 from other respiratory viral infections, such as influenza, and gives results quickly. Several LFIA methods for COVID-19 diagnosis based on anti-SARS-CoV-2 IgM/IgG combined test have been reported [ [15] , [16] , [17] ]. However, these other methods were based on colorimetric analysis, which results in low sensitivity and poor quantitative ability.…”

A living systematic review of the psychological problems in people suffering from COVID-19

“…Many studies have confirmed that the global pandemic has caused a wide range of psychosocial problems( Brooks et al, 2020 ; Galea et al, 2020 ; Kisely et al, 2020 ; Naqos and Khouchani, 2020 ). As for people infected by SARS-CoV-2, who have attracted the most concern, great attention must be paid to their psychological problems, regardless of asymptomatic patients, patients with mild symptoms, or clinically cured patients( Bo et al, 2020 ; Mazza et al, 2020 ; Wu et al, 2020 ).…”