Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays

Kohmer, Niko; Westhaus, Sandra; Rühl, Cornelia; Ciesek, Sandra; Rabenau, Holger F.

doi:10.1016/j.jcv.2020.104480

Cited by 180 publications

(228 citation statements)

References 9 publications

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“…In addition, there was no association between the type of the antigen and the dynamics of IgG response in the three follow-up patients. Our results show significant individual differences of the IgG response against SARS-CoV-2 as reported by others before [ 1 ], [ 6 ].…”

Section: Discussionsupporting

confidence: 89%

“…Although immunoassays cannot determine the neutralizing ability of SARS-CoV-2-IgG, they facilitate an evaluation of seroprevalence. The results of some tests have been shown to correlate positively with the results of neutralization tests [ 1 ], [ 15 ].…”

Section: Discussionmentioning

confidence: 99%

“…While diagnosis of acute infection with SARS-CoV-2 is done by real-time polymerase chain reaction (RT-PCR) in respiratory samples there is still an increasing demand on serological testing for both epidemiological studies and the assessment of infection status in individuals. Recent studies have confirmed the suitability of various commercial immunoassays including high-throughput random access assays for the determination of SARS-CoV-2-IgG in COVID-19 patients [ 1 ], [ 2 ], [ 3 ], [ 4 ]. Available assays detect antibodies either against the spike (S) protein or against the nucleocapsid (N) protein.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the SARS-CoV-2-IgG response in outpatients by five commercial immunoassays

Wellinghausen

Voss

Ivanova

et al. 2020

GMS Infectious Diseases; 8:Doc22

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of the SARS-CoV-2-IgG response in outpatients by five commercial immunoassays

Wellinghausen

Voss

Ivanova

et al. 2020

GMS Infectious Diseases; 8:Doc22

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“…and Theel et al. [ 18 , 19 ]. Sensitivities differed when only samples collected after 12 days post symptom onset were evaluated.…”

Section: Discussionmentioning

confidence: 99%

Analytical and clinical performances of five immunoassays for the detection of SARS-CoV-2 antibodies in comparison with neutralization activity

et al. 2020

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Background Reliable high-throughput serological assays for SARS-CoV-2 antibodies are urgently needed for the effective containment of the COVID-19 pandemic, as it is of crucial importance to understand the strength and duration of immunity after infection, and to make informed decisions concerning the activation or discontinuation of physical distancing restrictions. Methods In 184 serum samples from 130 COVID-19 patients and 54 SARS-CoV-2 negative subjects, the analytical and clinical performances of four commercially available chemiluminescent assays (Abbott SARS-Cov-2 IgG, Roche Elecsys anti-SARS-CoV-2, Ortho SARS-CoV-2 total and IgG) and one enzyme-linked immunosorbent assay (Diesse ENZY-WELL SARS-CoV-2 IgG) were evaluated and compared with the neutralization activity achieved using the plaque reduction neutralization test (PRNT). Findings Precision results ranged from 0.9% to 11.8% for all assays. Elecsys anti-SARS-CoV-2 demonstrated linearity of results at concentrations within the cut-off value. Overall, sensitivity ranged from 78.5 to 87.7%, and specificity, from 97.6 to 100%. On limiting the analysis to samples collected 12 days after onset of symptoms, the sensitivity of all assays increased, the highest value (95.2%) being obtained with VITRO Anti-SARS-CoV-2 Total and Architect SARS-CoV-2 IgG. The strongest PRNT 50 correlation with antibody levels was obtained with ENZY-Well SARS-CoV-2 IgG (R 2 adj = 0.569). Interpretation The results confirmed that all immunoassays had an excellent specificity, whereas sensitivity varied across immunoassays, depending strongly on the time interval between symptoms onset and sample collection. Further studies should be conducted to achieve a stronger correlation between antibody measurement and PRNT 50 in order to obtain useful information for providing a better management of COVID-19 patients, effective passive antibody therapy, and developing a vaccine against the SARS-CoV-2 virus. Funding None.

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“…The vast majority of the tests are predominantly unsuitable for use at the point of care as many are in open assay format with which significant engagement are needed from skilled operators to prepare the samples for testing, prepare test reagents, operate complex equipment and finally to process the data and interpret the test results. Automated high throughput molecular platforms are available and are capable of processing large numbers of samples with significantly reduced operator input [12][13][14][15] . However, acquiring and operating such equipment comes with high capital costs and a need for appropriate infrastructure, not only for housing the equipment and reagents but also requiring effective specimen collection and transport and the reporting of test data to patients, clinicians, and health care programs after processing.…”

Section: Introductionmentioning

confidence: 99%

Screening Antibodies Raised Against the Spike Glycoprotein of SARS-CoV-2 to Support the Development of Rapid Antigen Assays

Cantera¹,

Cate²,

Golden³

et al. 2020

Preprint

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<p>The spike glycoprotein of SARS-CoV-2 is a highly conserved surface protein and as such may represent a good target for immunoassay detection. We screened a variety of antibodies that were reactive to the S glycoprotein in a highly sensitive liquid immunoassay format and also on paper-based or lateral flow assay (LFA) to assess their analytical performance. Our findings included significant variation in performance when using different sources of S antigen. We identified several antibody pairs that had an LOD of below 10 pg/mL in the liquid immunoassay format with the lowest being 3 pg/mL. The antibodies were highly specific to SARS-Cov-2 based on cross reactivity screening with other human CoVs. The LFA screening found some different optimal antibody pairs from the pool of candidate antibodies used but a several antibodies were observed to have high performance with either immunoassay format.</p><br>

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Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays

Cited by 180 publications

References 9 publications

Evaluation of the SARS-CoV-2-IgG response in outpatients by five commercial immunoassays

Evaluation of the SARS-CoV-2-IgG response in outpatients by five commercial immunoassays

Analytical and clinical performances of five immunoassays for the detection of SARS-CoV-2 antibodies in comparison with neutralization activity

Screening Antibodies Raised Against the Spike Glycoprotein of SARS-CoV-2 to Support the Development of Rapid Antigen Assays

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