Performance of a qualitative rapid chromatographic immunoassay to diagnose COVID-19 in patients in a middle-income country

Costa, Sílvia Figueiredo; Buss, Lewis; Espinoza, Evelyn Patrícia Sánchez; Vieira, J.M.; Silva, Lea Campos de Oliveira da; Souza, Regina Maia de; Neto, Lauro Vieira Perdigão; Porto, Ana Paula Matos; Lázari, Carolina S.; Santos, Vera Aparecida dos; Duarte, Alberto da Silva; Nastri, Ana Catharina; Leite, Gabriel Fialkovitz da Costa; Manuli, Erika R.; Oliveira, Maura Salaroli de; Zampelli, Daniella Bosco; Pastore, Laerte; Segurado, Aluísio Cotrim; Levin, Anna S.; Sabino, Éster Cerdeira

doi:10.1016/j.jcv.2020.104592

Cited by 12 publications

(15 citation statements)

References 14 publications

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“…The color change was compared to the assay standard. 23 For viral culture, Vero cells (ATCC CCL-81) were used as previously described. [24][25][26] Vero CCL81 cells were cultured in Dulbecco minimal essential medium supplemented with heat-inactivated fetal bovine serum (10%) and antibiotics/antimycotics (Cultilab).…”

Section: Methodsmentioning

confidence: 99%

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Vertical transmission of SARS‐CoV2 during pregnancy: A high‐risk cohort

Maeda

Brizot

Gibelli³

et al. 2021

Prenatal Diagnosis

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Objective: Identify the potential for and risk factors of SARS-CoV-2 vertical transmission.Methods: Symptomatic pregnant women with COVID-19 diagnosis in whom PCR for SARS-CoV-2 was performed at delivery using maternal serum and at least one of the biological samples: cord blood (CB), amniotic fluid (AF), colostrum and/or oropharyngeal swab (OPS) of the neonate. The association of parameters with maternal, AF and/or CB positivity and the influence of SARS-CoV-2 positivity in AF and/or CB on neonatal outcomes were investigated.Results: Overall 73.4% (80/109) were admitted in hospital due to COVID-19, 22.9% needed intensive care and there were four maternal deaths. Positive RT-PCR for SARS-CoV-2 was observed in 14.7% of maternal blood, 13.9% of AF, 6.7% of CB, 2.1% of colostrum and 3.7% of OPS samples. The interval between

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Section: Methodsmentioning

confidence: 99%

“…The result was read in 15 min by three people that had received appropriate training. The color change was compared to the assay standard 23 …”

Section: Methodsmentioning

confidence: 99%

Vertical transmission of SARS‐CoV2 during pregnancy: A high‐risk cohort

Maeda

Brizot

Gibelli³

et al. 2021

Prenatal Diagnosis

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show abstract

“…The use of POC-based tests for rapid antibody detection can be helpful in identifying patients at different stages of infection, due to the early production of IgM followed by IgG response, although, in patients with COVID-19, the response of IgM and IgG could be simultaneous [ 7 , 8 ]. Our results demonstrated that overall sensitivity achieved by Bioclin LFIA (85.71%) with whole blood samples is compared to those obtained with serum or plasma for Wondfo (from 71.7 to 85.8%) [ 12 – 14 ] and Livzon (86.7%) [ 15 ], in contrast to Livzon and Wondfo LFIAs which showed sensitivities below 50%.…”

Section: Discussionmentioning

confidence: 62%

“…A better sensitivity for capillary whole blood with Wondfo LFIA test was reported by Silveira et al [ 13 ] at 77.1% in 83 volunteers with positive RT-PCR results at least 10 days before the LFIA test. In a larger study with hospitalized patients, Costa et al [ 12 ] evaluated the Wondfo LFIA, in serum samples or plasma, and obtained a sensitivity of 85.8%. In another evaluation of the Wondfo LFIA, Wu et al [ 17 ] have shown a sensibility of 75.8% in serum samples.…”

Section: Discussionmentioning

confidence: 99%

Comparative analysis of three point-of-care lateral flow immunoassays for detection of anti-SARS-CoV-2 antibodies: data from 100 healthcare workers in Brazil

et al. 2021

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Since the coronavirus disease 2019 (COVID-19) pandemic, Brazil has the third-highest number of confirmed cases and the second-highest number of recovered patients. SARS-CoV-2 detection by real-time RT-PCR is the gold standard but requires a certified laboratory infrastructure with high-cost equipment and trained personnel. However, for large-scale testing, diagnostics should be fast, cost-effective, widely available, and deployed for the community, such as serological tests based on lateral flow immunoassay (LFIA) for IgM/IgG detection. We evaluated three different commercial point-of-care (POC) LFIAs for anti-SARS-CoV-2 IgM and IgG detection in capillary whole blood of 100 healthcare workers (HCW) from São Paulo university hospital previously tested by RT-PCR: (1) COVID-19 IgG/IgM BIO (Bioclin, Brazil), (2) Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Livzon, China), and (3) SARS-CoV-2 Antibody Test (Wondfo, China). A total of 84 positives and 16 negatives HCW were tested. The data was also analyzed by the number of days post symptoms (DPS) in three groups: <30 ( n =26), 30–59 ( n =42), and >59 ( n =16). The observed sensibility was 85.71%, 47.62%, and 44.05% for Bioclin, Wondfo, and Livzon, respectively, with a specificity of 100% for all LFIA. Bioclin was more sensitive ( p <0.01), regardless of the DPS. Thus, the Bioclin may be used as a POC test to monitor SARS-CoV-2 seroconversion in HCW.

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“…The use of POC based tests for rapid antibody detection can be helpful in identifying patients at different stages of infection, due to the early production of IgM followed by IgG response, although, in patients with COVID-19, the response of IgM and IgG could be simultaneous. Our results demonstrated that overall sensitivity achieved by Bioclin LFIA (85.71%) with whole blood samples is compared to those obtained with serum or plasma, in contrast to Livzon and Wondfo LFIAs which showed sensitivities below 50% [7-10].…”

Section: Discussionmentioning

confidence: 68%

Comparative analysis of three point-of-care lateral flow immunoassays for detection of anti-SARS-CoV-2 antibodies: data from 100 healthcare workers in Brazil

Conte

Carvalho

Luna

et al. 2020

Preprint

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Since the Coronavirus Disease 2019 (COVID-19) pandemic, Brazil has the third-highest number of confirmed cases and the second-highest number of recovered patients. SARS-CoV-2 detection by real-time RT-PCR is the gold standard in certified infrastructured laboratories. However, for large-scale testing, diagnostics should be fast, cost-effective, widely available, and deployed for the community, such as serological tests based on lateral flow immunoassay (LFIA) for IgM/IgG detection. We evaluated three different commercial point-of-care (POC) LFIAs for anti-SARS-CoV-2 IgM and IgG detection in capillary whole blood of 100 healthcare workers (HCW) previously tested by RT-PCR: 1) COVID-19 IgG/IgM BIO (Bioclin, Brazil), 2) Diagnostic kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Livzon, China); and 3) SARS-CoV-2 Antibody Test (Wondfo, China). A total of 84 positives and 16 negatives HCW were tested. The data was also analyzed by the number of days post symptoms (DPS) in three groups: <30 (n=26), 30-59 (n=42), and >59 (n=16). Overall detection was 85.71%, 47.62%, and 44.05% for Bioclin, Livzon, and Wondfo, respectively, with a specificity of 100%, and 98.75% for Livzon on storage serum samples. Bioclin was more sensitive (p<0.01), regardless of the DPS. Thus, the Bioclin can be used as a POC test to monitor SARS-CoV-2 seroconversion in HCW.

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Performance of a qualitative rapid chromatographic immunoassay to diagnose COVID-19 in patients in a middle-income country

Abstract: Highlights COVID-19 diagnosis; high sensitivity and specificity qualitative rapid chromatographic immunoassays; can be used for the diagnosis of RT-PCR-negative patients.

Cited by 12 publications

References 14 publications

Vertical transmission of SARS‐CoV2 during pregnancy: A high‐risk cohort

Vertical transmission of SARS‐CoV2 during pregnancy: A high‐risk cohort

Comparative analysis of three point-of-care lateral flow immunoassays for detection of anti-SARS-CoV-2 antibodies: data from 100 healthcare workers in Brazil

Comparative analysis of three point-of-care lateral flow immunoassays for detection of anti-SARS-CoV-2 antibodies: data from 100 healthcare workers in Brazil

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