Antibody detection assays for COVID‐19 diagnosis: an early overview

Ejazi, Sarfaraz Ahmad; Ghosh, Sneha; Ali, Nahid

doi:10.1111/imcb.12397

Cited by 85 publications

(87 citation statements)

References 76 publications

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“…False positive antibody seropositivity results are often caused by factors such as differences in kit sensitivity and specificity, as well as patient immune status. 26,27 Furthermore, two patients had positive viral nucleic acid test results, but exhibited IgM and IgG antibody seronegativity. These patients were presumed to be in an early stage of disease, such that specific antibodies…”

Section: Discussionmentioning

confidence: 99%

Seroprevalence of SARS‐CoV‐2 infections among children visiting a hospital

Wang

Cao

et al. 2020

Pediatric Investigation

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Importance In this study, we retrospectively investigated the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) antibodies within serum samples from children in Beijing, China. These findings provide preliminary guidance regarding population susceptibility to SARS‐CoV‐2, which will aid in establishing policy toward coronavirus disease 2019 (COVID‐19) prevention and control. Objective To understand the seropositivity of anti‐SARS‐CoV‐2 IgM/IgG antibodies among children in Beijing, China, evaluate the susceptibility of children in Beijing to SARS‐CoV‐2, and provide prima facie evidence to guide SARS‐CoV‐2 prevention and control. Methods IgM/IgG antibody kits (colloidal gold) were used to conduct preliminary screening of SARS‐CoV‐2 IgM/IgG antibodies in serum samples of children who presented to Beijing Children’s Hospital, Capital Medical University, having fever or requiring hospitalization, from March 2020 to August 2020. Statistical analysis of anti‐SARS‐CoV‐2 antibody seropositivity was performed according to the children’s general demographic characteristics, timing of admission to hospital, presence of pneumonia, and viral nucleic acid test results. Results The study included 19 797 children with both IgM and IgG antibody results. Twenty‐four children had anti‐SARS‐CoV‐2 IgM‐positive results (positive rate of 1.2‰), twelve children had anti‐SARS‐CoV‐2 IgG‐positive results (positive rate of 0.6‰). Viral nucleic acid test results were negative for the above‐mentioned children with positive antibody findings; during the study, two children exhibited positive viral nucleic acid test results, but their anti‐SARS‐CoV‐2 IgM/IgG antibody results were negative. Anti‐SARS‐CoV‐2 IgM antibody seropositivity was higher in the <1‐year‐old group than in the ≥6‐year‐old group. The rates of anti‐SARS‐CoV‐2 IgM seropositivity was highest in August from March to August; IgG results did not significantly differ over time. The rates of anti‐SARS‐CoV‐2 IgM or IgG seropositivity among children with and without suspected pneumonia did not significantly differ between groups. Interpretation During the study period, the rates of anti‐SARS‐CoV‐2 IgM/IgG antibody seropositivity were low among children who presented to Beijing Children’s Hospital, Capital Medical University. The findings suggest that children in Beijing are generally susceptible to SARS‐CoV‐2 infection; COVID‐19 prevention and control measures should be strengthened to prevent disease in children.

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Section: Discussionmentioning

confidence: 99%

Seroprevalence of SARS‐CoV‐2 infections among children visiting a hospital

Wang

Cao

et al. 2020

Pediatric Investigation

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“…This compares variably with previous studies, in which wide ranges of sensitivity (30.0-100.0%) and speci city (69.0-100.0%) have been reported. Variation is affected by many things, such as the population sampled and the period of symptom onset [13,20,21]. The IgG RDT exhibited very strong concordance with immunoassays, with Cohen's kappa coe cients of 0.9 (P < 0.001) for CMIA IgG and 0.8 (P < 0.001) for ELISA IgG.…”

Section: Discussionmentioning

confidence: 99%

Detection of SARS-CoV-2-specific Antibodies via Rapid Diagnostic Immunoassays in COVID-19 Patients with Positive SARS-CoV-2 RNA Real-time Reverse Transcriptase PCR Results

Chansaenroj

Yorsaeng

Posuwan

et al. 2020

Preprint

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Background: Efficient monitoring and control of coronavirus disease 2019 (COVID-19) requires access to diagnostic tests, and serological diagnostic testing is desirable. In the current study antibodies were investigated in patients recently diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.Methods: Cross-sectional data derived from 245 patients in whom SARS-CoV-2 infection had been confirmed via real-time reverse transcriptase-polymerase chain reaction were obtained. Samples were acquired at the onset of COVID-19 symptoms or the first detection of SARS-CoV-2 in asymptomatic patients, and at another timepoint within 8 weeks thereafter. All specimens were tested simultaneously using an IgM/IgG rapid diagnostic test (RDT), nucleocapsid-based and spike protein-based IgG immunoassays, and a spike protein‑based IgA immunoassay. Blood donor samples obtained in 2018 were used as negative controls, and to assess cross-reactivity with seasonal coronaviruses. Results: The IgM/IgG RDT exhibited 97.5% sensitivity and 97.2% specificity compared with a nucleocapsid-IgG-based chemiluminescent microparticle immunoassay, and 98.4% sensitivity and 93.6% specificity compared with a spike protein-based ELISA. IgG RDT detection was 100% concordant with IgG and IgA immunoassays (P < 0.001). IgM, IgG, and IgA were low during the first week after COVID-19 symptom onset or the detection of SARS-CoV-2 RNA. IgM began decreasing after 4 weeks, whereas IgG and IgA remained at appreciable levels over the 8-week study period. No cross-reactivity with seasonal coronaviruses was detected.Conclusions: IgM/IgG RDTs alone or combined with molecular diagnostic tests may be useful for identifying recent SARS-CoV-2 infection.

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“…The results reported above, as well as the studies presented in Table 4 , demonstrate that the performance of the LFIA test depended mainly on the type of kit used and the day of disease onset. LFIA has, nevertheless, played an important role in the fight against coronavirus, as different countries have carried out mass testing for surveillance within their communities, helping to determine antibody prevalence of SARS-CoV-2 [ 33 ]. Through this determination, vulnerable groups can be identified, as was shown in the study by Hallal et al [ 35 ], which highlighted the SARS-CoV-2 antibody prevalence in indigenous populations of Brazil using RDT.…”

Section: Serological Testsmentioning

confidence: 99%

“…Due to this, to minimize false negative results, it is recommended that researchers choose tests with high specificity (99.5% or higher) [ 209 ]. This measure is important because deregulation or misuse of these rapid tests can create an extra panic in society [ 33 ].…”

Section: Serological Testsmentioning

confidence: 99%

“…RT-qPCR helped some countries in Asia, such as Korea and Singapore, to initially control the outbreak caused by SARS-CoV-2 [ 31 , 32 ]. However, the limitation of high prices and lengthy procedures impede the use of these assays as mass testing for middle-income countries [ 33 ]. Many studies are currently being conducted to determine the prevalence of antibodies against SARS-CoV-2 in certain populations, which has increased the demand and use of serologic tests [ 34 , 35 , 36 ].…”

Section: Introductionmentioning

confidence: 99%

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

Machado

Hodel

Barbosa-Júnior

et al. 2020

Viruses

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Diagnostic tests have been considered as the main alternative for the control of coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as a correct diagnosis allows for decision making when facing the disease, particularly as there is a lack of effective therapeutic protocols and vaccines. Thus, in this review, we summarized the main diagnostic approaches currently available for the diagnosis of SARS-CoV-2 infection in humans based on studies available in article databases. The tests can be organized into two main categories: nucleic acid-based tests, recommended for the initial detection of the virus, and serological tests, recommended for assessing the disease progression. The studies have shown that the performance of diagnostic methods depends on different factors, such as the type of samples and the characteristics of each assay. It was identified that the positivity of the tests is mainly related to the onset of symptoms. We also observed that point-of-care diagnoses are considered as one of the main trends in this area, due to the low-cost and simplicity of the assay; however, the analytical performance must be critically analyzed. Thus, the COVID-19 pandemic has highlighted the critical role of diagnostic technologies in the control of infectious diseases.

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Antibody detection assays for COVID‐19 diagnosis: an early overview

Cited by 85 publications

References 76 publications

Seroprevalence of SARS‐CoV‐2 infections among children visiting a hospital

Seroprevalence of SARS‐CoV‐2 infections among children visiting a hospital

Detection of SARS-CoV-2-specific Antibodies via Rapid Diagnostic Immunoassays in COVID-19 Patients with Positive SARS-CoV-2 RNA Real-time Reverse Transcriptase PCR Results

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

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