Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection

Serrano, Maria Martínez; Rodríguez, David Navalpotro; Tormo, Nuria; Arenas, Roberto Olmos; Córdoba, Marta Moreno; Mochón, Ma Dolores Ocete; Cardona, Concepción Gimeno

doi:10.1016/j.jcv.2020.104529

Cited by 76 publications

(81 citation statements)

References 13 publications

(24 reference statements)

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“…Our data indicate that living with diagnosed or symptomatic people was more relevant in domestic environment than in the workplace, which can be justified by more intimate contact and extensive sharing of areas, in spite the guidelines advising family members to distance themselves. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 21, 2020. ; https://doi.org/10.1101/2020.10.19.20213421 doi: medRxiv preprint Professionals from laboratory areas were 25% while workers who had no direct contact with patients (administrative areas, security and cleaning staff) had a higher infection rate, especially in the areas of logistics (Faíco-Filho, et al, 2020) In our study, we chose to use a rapid test for preliminary results, despite the its reported performance (Sensitivity: 86, 43% [95% CI: 82, 51%~89, 58%] and Specificity: 99, 57% [95% CI: 97, 63%~99,92%]).. We chose to use the serum obtained from the peripheral blood because the test performance was better in terms of sensitivity when used in serum and not in blood capillary, as suggested in others studies (Santos et al, Wu et al, 2020;Serrano et al, 2020). This test may be performed with whole blood, plasma and serum.…”

Section: Correlation Between Seropositivity and Professional Activitymentioning

confidence: 99%

Prevalence of antibodies against sars-cov-2 in professionals of a public health laboratory at são paulo, sp, brazil

Silva

Oliveira

Castejon

et al. 2020

Preprint

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Background: Covid-19 Serology may document exposure and perhaps protection to the virus, and serological test may help understand epidemic dynamics. To evaluate previous exposure to the virus we estimated the prevalence of antibodies against-SARS-CoV-2 among HPs in Adolfo Lutz Institute, State of Sao Paulo, Brazil. Methods: This study was performed among professionals of Adolfo Lutz Institute in Sao Paulo, Brazil and some administrative areas of the Secretary of Health that shares common areas with the institute. We used a lateral flow immunoassay (rapid test) to detect IgG and IgM for SARS-CoV-2; positive samples were further evaluated using Roche Electrochemiluminescence assay and SARS-CoV-2 RNA by real time reverse transcriptase polymerase chain reaction (RT-PCR) was also offered to participants. Results: A total of 406 HPs participated. Thirty five (8.6%) tested positive on rapid test and 32 these rapid test seropositive cases were confirmed by ECLIA.. 43 HPs had SARS-CoV-2 RNA detected at a median of 33 days, and the three cases not reactive at Roche ECLIA had a previous positive RNA. Outsourced professionals (34% seropositive), males (15%) workers referring COVID-19 patients at home (22%) and those living farther form the institute tended to have higher prevalence of seropositivity, but in multivariable logistic analysis only outsourced workers and those with COVID patients at home remained independently associated to seropositivity. We observed no relation of seropositivity to COVID samples handling. Presence of at least one symptom was common but some clinical manifestations as anosmia/dysgeusia. Fatigue, cough and fever were associated to seropositivity. Conclusions: We documented a relatively high (8.6%) of anti-SARS-CoV-2 serological reactivity in this population, with higher rates among outsourced workers and those with referring cohabitation with COVID-19 patients. COVID samples handling was not related to increased seropositivity. Some symptoms how strong association to COVID-19 serology and may be used in scoring tools for screening or diagnosis in resort limited settings.

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Section: Correlation Between Seropositivity and Professional Activitymentioning

confidence: 99%

Prevalence of antibodies against sars-cov-2 in professionals of a public health laboratory at são paulo, sp, brazil

Silva

Oliveira

Castejon

et al. 2020

Preprint

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“…The copyright holder for this preprint this version posted December 4, 2020. ; https://doi.org/10.1101/2020.12.02.20242750 doi: medRxiv preprint including serum IgG ELISAs, albeit at higher cost [18]. These tools, however, could be useful for determining community level immunity, either due to infection itself or after vaccination, especially in areas where access to more sophisticated and expensive quantitative analysis may be limited.…”

Section: Discussionmentioning

confidence: 99%

Clinical Evaluation of a COVID-19 Antibody Lateral Flow Assay using Point of Care Samples

Lee

Straube

Sincic

et al. 2020

Preprint

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IntroductionThe ongoing SARS-CoV-2 pandemic has spurred the development of numerous point of care (PoC) immunoassays. Assessments of performance of available kits are necessary to determine their clinical utility. Previous studies have mostly performed these assessments in a laboratory setting, which raises concerns of translating findings for PoC use. The aim of this study was to assess the performance of a lateral flow immunoassay for the detection of SARS-CoV-2 antibodies using samples collected at PoC.MethodOne lateral flow immunoassay (Humasis® COVID-19 IgG/IgM) was tested. In total, 50 PCR RT-PCR positive and 52 RT-PCR negative samples were collected at PoC. Fifty serum specimens from Dec 2018 to Feb 2019 were used as controls for specificity. Serum samples collected between Dec 2019 to Feb 2020 were used as additional comparators. Clinical data including symptom onset date was collected from patient history and the medical record.ResultsThe overall sensitivity for the kit was 74% (95% CI: 59.7% -85.4%). The sensitivity for IgM and IgG detection >14 days after date of onset was 88% (95% CI: 68.8% -97.5%) and 84% (95% CI: 63.9% – 95.5%), with a negative predictive value (NPV) of 94% for IgM (95% CI: 83.5% - 98.8%) and 93% for IgG (95% CI: 81.8% - 97.9%). The overall specificity was 94% (95% CI: 83.5% - 98.8%). The Immunoglobulin specific specificity was 94% for IgM (95% CI: 83.5% - 98.8%) and 98% for IgG (95% CI: 89.4% - 100.0%), with a positive predictive value (PPV) of 88% for IgM (95% CI: 68.8% - 97.5%) and 95% for IgG (95% CI: 77.2% - 99.9%) respectively for samples collected from patients >14 days after date of onset. Specimen collected during early phase of COVID-19 pandemic (Dec 2019 to Feb 2020) showed 11.8% antibody positivity, and 11.3% of PCR-negative patients demonstrated antibody positivity.DiscussionHumasis® COVID-19 IgG/IgM LFA demonstrates greater than 90% PPV and NPV for samples collected 14 days after the onset of symptoms using samples collected at PoC. While not practical for the diagnosis of acute infection, the use of the lateral flow assays with high specificity may have utility for determining seroprevalence or seroconversion in longitudinal studies.

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“…A Spanish study compared the sensitivity and specificity of a commercial IgG and IgA ELISA (Euroimmun) with three lateral flow immunoassays (Hangzhou Alltest Biotech, Wuhan UNscience Biotechnology, and Guangzhou Wondfo Biotech) from 109 COVID-19 patients. 27 The Euroimmun SARS-CoV-2 test had a sensitivity and specificity of 100% and 80.6%, respectively. The sensitivities of the lateral flow immunoassays ranged from 81.2% to 100%; the specificities ranged from 80.6% to 100%.…”

Section: Spanish Antibody Studiesmentioning

confidence: 97%

“…The sensitivities of the lateral flow immunoassays ranged from 81.2% to 100%; the specificities ranged from 80.6% to 100%. 27 Physicians are encouraged to utilize lateral flow immunoassays with the highest sensitivity possible. A subsequent Spanish study evaluated a lateral flow immunoassay AllTest COVID-19 IgG/IgM using serum samples from 100 SARS-CoV-2-negative patients and 90 patients with SARS-CoV-2 confirmed with nasopharyngeal RT-PCR.…”

Section: Spanish Antibody Studiesmentioning

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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Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection

Cited by 76 publications

References 13 publications

Prevalence of antibodies against sars-cov-2 in professionals of a public health laboratory at são paulo, sp, brazil

Prevalence of antibodies against sars-cov-2 in professionals of a public health laboratory at são paulo, sp, brazil

Clinical Evaluation of a COVID-19 Antibody Lateral Flow Assay using Point of Care Samples

Antibody tests for COVID-19

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