Technical considerations to development of serological tests for SARS-CoV-2

Ernst, E.; Wolfe, Patricia; Stahura, Corrine M.; Edwards, Katie A.

doi:10.1016/j.talanta.2020.121883

Cited by 31 publications

(39 citation statements)

References 99 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Due to the COVID-19 pandemic, there is a pressing need to develop highly specific and sensitive serology tests to assist with the diagnosis of, and to reveal past exposure to, the SARS-CoV-2 virus (17), as well as to support the development of vaccines through distinguishing natural infection-induced immunity from vaccine-induced immunity (9, 18). This was the first multicenter study to demonstrate the performance of the automated Elecsys Anti-SARS-CoV-2 S immunoassay, which detects antibodies against the SARS-CoV-2 S protein RBD.…”

Section: Discussionmentioning

confidence: 99%

“…Emergence of the COVID-19 pandemic has resulted in an urgent and unmet need to develop reliable serological tests to determine past exposure to the virus and the seroprevalence in a given population (17). This information is crucial to support diagnosis, contact tracing, epidemiology studies, and vaccine development to enable characterization of pre-vaccination immune status and vaccine-induced immune response (9, 18-20). There are currently 242 candidate SARS-CoV-2 vaccines in development (21) and, of these, 10 are currently in early, limited, or fully approved use (status February 09, 2021) (22).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S immunoassay

Riester¹,

Findeisen²,

Hegel

et al. 2021

Preprint

View full text Add to dashboard Cite

Background: The Elecsys® Anti-SARS-CoV-2 S immunoassay (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) has been developed for the in vitro quantitative detection of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein. We evaluated the performance of this assay using samples from seven sites in Germany, Austria, and Switzerland. Methods: Anonymized frozen, residual serum, or plasma samples from blood donation centers or routine diagnostic testing were used for this study. For specificity and sensitivity analyses, presumed negative samples collected before October 2019 and SARS-CoV-2 PCR-confirmed single or sequential samples were tested, respectively. The performance of the Elecsys Anti-SARS-CoV-2 S immunoassay was also compared with other commercial immunoassays. Results: The overall specificity (n=7880 pre-pandemic samples) and sensitivity (n=240 PCR-positive samples [≥14 days post-PCR]) for the Elecsys Anti-SARS-CoV-2 S immunoassay were 99.95% (95% confidence interval [CI]: 99.87–99.99) and 97.92% (95% CI: 95.21–99.32), respectively. Compared with seven other immunoassays, the Elecsys Anti-SARS-CoV-2 S assay had comparable or greater specificity and sensitivity. The Elecsys Anti-SARS-CoV-2 S immunoassay had significantly higher specificity compared with the LIAISON® SARS-CoV-2 S1/S2 IgG, ADVIA Centaur® SARS-CoV-2 Total, ARCHITECT SARS-CoV-2 IgG, iFlash-SARS-CoV-2 IgM, and EUROIMMUN Anti-SARS-CoV-2 IgG and IgA assays, and significantly higher sensitivity (≥14 days post-PCR) compared with the ARCHITECT SARS-CoV-2 IgG, iFlash-SARS-CoV-2 IgG and IgM, and EUROIMMUN Anti-SARS-CoV-2 IgG assays. Conclusion: The Elecsys Anti-SARS-CoV-2 S assay demonstrated a robust and favorable performance across samples from multiple European sites, with a very high specificity and sensitivity for the detection of anti-S antibodies.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S immunoassay

Riester¹,

Findeisen²,

Hegel

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…In low-and middle-income countries (LMICs), COVID-19 Ab RDTs have also been deployed for triage, diagnosis and contact tracing [10][11][12]. Specificity testing of COVID-19 Ab RDTs so far has focused on seasonal coronaviruses (NL63, HKU1, 229E, OC43), SARS-CoV, cytomegalovirus, Epstein-Barr virus, human hepatitis B virus, Mycoplasma pneumoniae and parvovirus infection in addition to interfering conditions (rheumatoid factor, autoimmune pathologies and hyperglobulinemia) [8,[13][14][15][16][17][18][19][20][21][22][23][24][25][26]. Tropical diseases such as malaria, dengue, schistosomiasis and human African trypanosomiasis are well-known for their cross-reactivity with HIV-1 antibody LFA RDTs and malaria antigen RDTs [27][28][29][30].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

View full text Add to dashboard Cite

COVID-19 Antibody Detecting Rapid Diagnostic Tests (COVID-19 Ab RDTs) are the preferred tool for SARS-CoV-2 seroprevalence studies, particularly in low- and middle-income countries. The present study challenged COVID-19 Ab RDTs with pre-pandemic samples of patients exposed to tropical pathogens. A retrospective study was performed on archived serum (n = 94) and EDTA whole blood (n = 126) samples obtained during 2010–2018 from 196 travelers with malaria (n = 170), schistosomiasis (n = 25) and dengue (n = 25). COVID-19 Ab RDTs were selected based on regulatory approval status, independent evaluation results and detecting antigens. Among 13 COVID-19 Ab RDT products, overall cross-reactivity was 18.5%; cross-reactivity for malaria, schistosomiasis and dengue was 20.3%, 18.1% and 7.5%, respectively. Cross-reactivity for current and recent malaria, malaria antibodies, Plasmodium species and parasite densities was similar. Cross-reactivity among the different RDT products ranged from 2.7% to 48.9% (median value 14.5%). IgM represented 67.9% of cross-reactive test lines. Cross-reactivity was not associated with detecting antigens, patient categories or disease (sub)groups, except for schistosomiasis (two products with ≥60% cross-reactivity). The high cross-reactivity for malaria, schistosomiasis and—to a lesser extent—dengue calls for risk mitigation when using COVID-19 Ab RDTs in co-endemic regions.

show abstract

“…Of course, the three diagnostic methods give different information: viral gene and antigen detection tests tell if a person is currently infected, whereas serological tests can determine prior infections. Although, in a recent study, the ELISA test could detect antibodies as early as 3 days after the development of the first symptoms [25], serological tests are generally used for rapid screening of post-symptomatic patients who have already developed the immune response [26][27][28][29] for epidemiological surveillance and post-vaccine immunization studies (Figure 1).…”

Section: Introductionmentioning

confidence: 99%

Paper-Based Biosensors: Frontiers in Point-of-Care Detection of COVID-19 Disease

Antiochia

2021

Biosensors

View full text Add to dashboard Cite

This review summarizes the state of the art of paper-based biosensors (PBBs) for coronavirus disease 2019 (COVID-19) detection. Three categories of PBB are currently being been used for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostics, namely for viral gene, viral antigen and antibody detection. The characteristics, the analytical performance, the advantages and drawbacks of each type of biosensor are highlighted and compared with traditional methods. It is hoped that this review will be useful for scientists for the development of novel PBB platforms with enhanced performance for helping to contain the COVID-19 outbreak, by allowing early diagnosis at the point of care (POC).

show abstract

Technical considerations to development of serological tests for SARS-CoV-2

Cited by 31 publications

References 99 publications

Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S immunoassay

Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S immunoassay

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

Paper-Based Biosensors: Frontiers in Point-of-Care Detection of COVID-19 Disease

Contact Info

Product

Resources

About