Dynamic profile for the detection of anti-SARS-CoV-2 antibodies using four immunochromatographic assays

Demey, Baptiste; Daher, N.; François, Clément; Lanoix, Jean Philippe; Duverlie, Gilles; Castelain, Sandrine; Brochot, Étienne

doi:10.1016/j.jinf.2020.04.033

Cited by 58 publications

(62 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…However, due to RT-PCR infr astructure limitations and lack of supplies, which limit the number of people with access of a diagnostic tests, a rapid serologic assay was develop to expand laboratories testing capacity and reach all the population [10]. In this line, several rapid tests based on immunochromatographic method for SARS-CoV-2 IgM/IgG antibody have been developed [8,11]. Nevertheless, to achieve the goal of help in public health, this test needs to be a well-validated diagnostic tool that are sensitive, rapid and speci ic for the detection of SARS-CoV-2.…”

Section: Discussionmentioning

confidence: 99%

“…Demey, et al [11] using 4 different immunochromatographic rapid tests describe that this kind of diagnostic tool have good performance for the detection of antibodies after SARS-CoV-2 infection. However, Vásárhelyi, et al [12] found low ef icacy in a rapid immunochromatographic tests detecting IgM and IgG antibodies against SARS-CoV-2 virus, suggesting that this test should not be used in the differential diagnosis of coronavirus infection.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Can the Wondfo® SARS-CoV-2 IgM/IgG antibodies be used as a rapid diagnostic test?

Pinto¹,

Brito²,

Valadão³

et al. 2020

Arch Biotechnol Biomed

View full text Add to dashboard Cite

Background: An outbreak of novel coronavirus (SARS-CoV-2) disease (COVID-19) has rapidly spread worldwide. The aim of this study was to evaluate and validate the performance of the Wondfo® lateral-flow immunochromatographic assay that detect SARS-CoV-2- IgG, IgM antibodies (Wondfo® IC), using the results obtained by the fluorescence immunoassay test as reference diagnostic. Material and methods: 97 serum specimens collected and analyzed by four independent laboratories of Sergipe/Brazil was used for validated the Wondfo® SARS-CoV-2 IgM/IgG antibodies test. The COVID-19 positive serum specimens were determined by fluorescence immunoassay technique, used as reference standard. Results: An overall of 97 serum specimens show 39 (39/97) SARS-CoV-2 IgG positive specimens, 33 (33/97) SARS-CoV-2 IgM positive specimen and 25 non-reagent specimens (25/97). However, the Wondfo® IC assay detected only 9 (9/97) IgM/IgG positive specimen and 25 (25/97) no-reagent specimen. A weak correlation was found between the outcomes of the Wondfo® IC assay and fluorescence test. The accuracy between the two tests was 32.08%. The sensitivity, specificity, positive predictive value, and negative predictive value of Wondfo® IC assay were of 11.12%, 100%, 100% and 25.27%, respectively. Moreover, no false positive sample was determinate, whereas 88.89% of false negative results were found. Conclusion: The Wondfo® IC test failed in providing a quick, valid, and reliable results and appears not to be a good alternative for clinical use in detecting pandemic coronavirus. However, if the limitations of the rapid test are known, some correction factors can be used in order to adjust the epidemiological data.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Can the Wondfo® SARS-CoV-2 IgM/IgG antibodies be used as a rapid diagnostic test?

Pinto¹,

Brito²,

Valadão³

et al. 2020

Arch Biotechnol Biomed

View full text Add to dashboard Cite

show abstract

“…Diagnostic accuracy studies and clinical performance specifications should be driven by the actual purpose of test use. Of note, clinical sensitivity determined in validation studies can be considerably lower than manufacturer's claim, although clinical specificity tend to be more consistent [21,[25][26][27][28][29][30][31]. Key components when selecting samples for evaluating clinical performance include: patient setting (e.g., inpatient vs. outpatient), severity of cases (e.g., asymptomatic, moderately symptomatic, and severe), and timing of assessment (e.g., 1-2 months or, 3+ months after exposure to the virus).…”

Section: Recommendation [B2]mentioning

confidence: 91%

“…One major concern regarding the implementation of serological testing into clinical practice is the potential for cross-reactivity, especially given that over 90% of adults are estimated to have antibodies against other commonly circulating coronaviruses [11]. Many manufacturers and most available literature report minimal assay crossreactivity, although some false positives against endemic coronaviruses and other species have been reported [21,[25][26][27][28][29][30][31].…”

Section: Recommendation [B2]mentioning

confidence: 99%

IFCC Interim Guidelines on Serological Testing of Antibodies against SARS-CoV-2

Bohn

Loh

Wang

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

View full text Add to dashboard Cite

Serological testing for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is emerging as an important component of the clinical management of patients with coronavirus disease 2019 (COVID-19) as well as the epidemiological assessment of SARS-CoV-2 exposure worldwide. In addition to molecular testing for the detection of SARS-CoV-2 infection, clinical laboratories have also needed to increase testing capacity to include serological evaluation of patients with suspected or known COVID-19. While regulatory approved serological immunoassays are now widely available from diagnostic manufacturers globally, there is significant debate regarding the clinical utility of these tests, as well as their clinical and analytical performance requirements prior to application. This document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Taskforce on COVID-19 provides interim guidance on: (A) clinical indications and target populations, (B) assay selection, (C) assay evaluation, and (D) test interpretation and limitations for serological testing of antibodies against SARS-CoV-2 infection. These evidence-based recommendations will provide practical guidance to clinical laboratories in the selection, verification, and implementation of serological assays and are of the utmost importance as we expand our pandemic response from initial case tracing and containment to mitigation strategies to minimize resurgence and further morbidity and mortality.

show abstract

“…Detectable amounts of antibodies appear in the patient’s blood after a few days of the initial onset of symptoms. Although on average IgM appears in detectable quantity after about 5 days, based on variations reported, that can be as late at 11–12 days after infection onset [ 151 , 152 , 153 ]. Even in a 4–5-day window period, one can be asymptomatic but highly contagious and can infect other people in the close surroundings.…”

Section: Challenges and Pitfallsmentioning

confidence: 99%

Rapid Antibody-Based COVID-19 Mass Surveillance: Relevance, Challenges, and Prospects in a Pandemic and Post-Pandemic World

Augustine

Das

Hasan

et al. 2020

JCM

View full text Add to dashboard Cite

The aggressive outbreak of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) as COVID-19 (coronavirus disease-2019) pandemic demands rapid and simplified testing tools for its effective management. Increased mass testing and surveillance are crucial for controlling the disease spread, obtaining better pandemic statistics, and developing realistic epidemiological models. Despite the advantages of nucleic acid- and antigen-based tests such as accuracy, specificity, and non-invasive approaches of sample collection, they can only detect active infections. Antibodies (immunoglobulins) are produced by the host immune system within a few days after infection and persist in the blood for at least several weeks after infection resolution. Antibody-based tests have provided a substitute and effective method of ultra-rapid detection for multiple contagious disease outbreaks in the past, including viral diseases such as SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). Thus, although not highly suitable for early diagnosis, antibody-based methods can be utilized to detect past infections hidden in the population, including asymptomatic ones. In an active community spread scenario of a disease that can provide a bigger window for mass detections and a practical approach for continuous surveillance. These factors encouraged researchers to investigate means of improving antibody-based rapid tests and employ them as reliable, reproducible, sensitive, specific, and economic tools for COVID-19 mass testing and surveillance. The development and integration of such immunoglobulin-based tests can transform the pandemic diagnosis by moving the same out of the clinics and laboratories into community testing sites and homes. This review discusses the principle, technology, and strategies being used in antibody-based testing at present. It also underlines the immense prospect of immunoglobulin-based testing and the efficacy of repeated planned deployment in pandemic management and post-pandemic sustainable screenings globally.

show abstract

Dynamic profile for the detection of anti-SARS-CoV-2 antibodies using four immunochromatographic assays

Cited by 58 publications

References 6 publications

Can the Wondfo® SARS-CoV-2 IgM/IgG antibodies be used as a rapid diagnostic test?

Can the Wondfo® SARS-CoV-2 IgM/IgG antibodies be used as a rapid diagnostic test?

IFCC Interim Guidelines on Serological Testing of Antibodies against SARS-CoV-2

Rapid Antibody-Based COVID-19 Mass Surveillance: Relevance, Challenges, and Prospects in a Pandemic and Post-Pandemic World

Contact Info

Product

Resources

About