COVID-19 Serological Tests: How Well Do They Actually Perform?

Ghaffari, Abdi; Meurant, Robyn; Ardakani, Ali

doi:10.3390/diagnostics10070453

Cited by 126 publications

(109 citation statements)

References 33 publications

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“…In summary, there are several limitations of presently available diagnostic POCT options [ 36-38 ] as well as gaps of knowledge regarding the appropriate interpretation of their results. For serological test assays, in particular, considerable variability of their results has been reported [ 39 ]. Patient age has been shown to play a role for measured antibody titers [ 40 ].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

Dörschug

Schwanbeck

Hahn³

et al. 2020

EuJMI

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IntroductionTo efficiently monitor the COVID-19 pandemic for surveillance purposes, reliable serological rapid diagnostic tests (RDTs) are desirable for settings where well-established high-throughput bench-top solutions are not available. Here, we have evaluated such an RDT.MethodsWe have assessed the Xiamen AmonMed Biotechnology COVID-19 IgM/IgG test kit (Colloidal gold) and the EUROIMMUN benchtop assay with serum samples from patients with polymerase chain reaction (PCR)-confirmed COVID-19 disease. Samples from patients with Epstein-Barr-virus (EBV) infection and blood donors were used for specificity testing.ResultsFor the colloid gold rapid test and the EUROIMMUN assay, the study indicated overall sensitivity of 15.2% and 67.4%, respectively, while specificity of 99.0% and 97.9% with the blood donor sera, as well as 100% and 96.8% with the EBV-patients, were observed, respectively. An association of the time period between positive PCR results and serum acquisition with serological test positivity could be observed for the immunologlobulin G subclass of the EUROIMMUN assay only.ConclusionsIn spite of acceptable specificity of the assessed RDT, the detected poor sensitivity leaves room for improvement. The test results remain difficult to interpret and therefore the RDT can currently not be recommended for routine diagnostic or surveillance use.

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Section: Introductionmentioning

confidence: 99%

Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

Dörschug

Schwanbeck

Hahn³

et al. 2020

EuJMI

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show abstract

“…8 The IgM antibodies are produced soon after infection, while the IgG antibodies are produced later to maintain the body's immune system to the same infection. 8,9 The third type of immunoglobulin, known as IgA, is found on mucous membranes and aids the innate immune response. [9][10][11] Current clinical reports show that antibodies against SARS-CoV-2 viral particles develop between 6 and 10 days after infection, with peak IgM antibody levels at 12 days, and persist for 35 days.…”

Section: Humoral Immune Response To Sars-cov-2mentioning

confidence: 99%

“…In contrast, the IgG antibodies peak around 17 days and persist for up to 49 days. [9][10][11] Serological or antibody tests detect immunoglobulins produced in the presence of antigens from SARS-CoV-2.…”

Section: Humoral Immune Response To Sars-cov-2mentioning

confidence: 99%

Antibody tests for COVID-19

Kopel

Goyal

Perisetti

2020

Baylor University Medical Center Proceedings

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The SARS-CoV-2 virus caused a globally growing pandemic called coronavirus disease 2019 (COVID-19) that has disrupted social, political, and medical environments around the world. Nations are assessing ways to reopen businesses while trying to balance health care risks and economic fallouts. Strategies involving antibody testing have been proposed before phased reopening of the economy. Therefore, assessing the sensitivity and specificity of antibody tests for symptomatic and asymptomatic COVID-19 patients remains paramount to prevent COVID-19 outbreaks. The antibody tests for SARS-CoV-2 detect the presence of IgA, IgM, or IgG antibodies produced by B cells. There are four major types of antibody tests: rapid diagnostic tests, enzymelinked immunosorbent assays, neutralization assays, and chemiluminescent immunoassays. Currently, there is no standard antibody test for detecting SARS-CoV-2 antibodies during or after exposure or infection. The antibody tests for SARS-CoV-2 have a low specificity within the first week of exposure and increase in the second and third weeks. The current data on antibody tests have several limitations in quality and the presence of bias. Specifically, many antibody tests have a high false-negative rate and a high risk of bias for participant selection, application of index tests, reference standard used, and flow and timing for antibody tests that may incorrectly report the accuracy of COVID-19 antibody tests. In this review, we summarize the current methods, sensitivity/specificity, and gaps in knowledge concerning COVID-19 antibody testing.

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“…However, up to the present time it is uncertain whether the recovery from COVID-19 provides immunity [7]. A rapid seroconversion was demonstrated, but the persistence of IgG is only known in the short-term period, since studies on immune response to COVID-19 are to date mostly limited to 5-6 weeks after the symptoms' onset [8], and little is known about the longer-term response [9,10].…”

Section: Introductionmentioning

confidence: 98%

<strong>Two SARS-CoV-2 IgG Immunoassays Comparison and Time-Course Profile of Antibodies Response</strong>

Dittadi

Afshar

Carraro

2020

Preprint

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The role of the immune response to SARS-CoV-2 infection is not yet well known, in particular about the persistence of circulating antibodies. The aim of the study is to compare the results of two automated systems for the determination of IgG antibodies against SARS CoV-2 and to assess the time course of the IgG response after the onset of symptoms for a period longer than that evaluated to date. IgG were measured in 98 specimens of 55 subjects with COVID-19 (time from the onset of symptoms from 3 to 109 days) using the automated tests "Abbott SARS-COV-2 IgG" and the "MAGLUMI 2019-nCoV IgG". The two methods had a concordance of 91.8%, but the quantitative correlation showed very dispersed results. All the specimens resulted positive after 17 days from the onset of the synptoms. However, the median concentrations of IgG, after a rapid increase up to about 20 days, quickly decrease to about 15% of the maximum for Maglumi. The same samples measured by Architect showed a quite constant trend up to 80 day, and then an only moderate decline. The titer of IgG against SARS-CoV-2 in patients exposed to COVID-19 may significantly and rapidly decrease, with a different time-course depending on the method used for the determination.

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COVID-19 Serological Tests: How Well Do They Actually Perform?

Cited by 126 publications

References 33 publications

Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

Antibody tests for COVID-19

<strong>Two SARS-CoV-2 IgG Immunoassays Comparison and Time-Course Profile of Antibodies Response</strong>

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