Diagnostic performance of two serological assays for the detection of SARS-CoV-2 specific antibodies: surveillance after vaccination

Fresco-Taboada, Alba; García-Durán, Marga; Aira, Cristina; López, Lissette; Sastre, Patricia; Hoek, Lia van der; Gils, Marit J. van; Brouwer, Philip J.M.; Sanders, Rogier W.; Holzer, Barbara; Zimpernikc, Irene; López-Collazo, Eduardo; Muñoz, Patricia; Rueda, Paloma; Vela, Carmen

doi:10.1016/j.diagmicrobio.2022.115650

Cited by 4 publications

(2 citation statements)

References 28 publications

(33 reference statements)

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“…The significant impact of the SARS-CoV-2 emergence in public health and the massive vaccination programs carried out to limit the COVID-19 pandemic justifies extensive epidemiological studies using serological tests (11,12) to survey virus spread and assess how vaccine-induced immunity progresses in various populations and settings (13). However, due to the large volume of tests generated it is important to assess the clinical performance of the diverse immunoassays available, particularly using clinical samples from the population where the tests are implemented (14)(15)(16)(17).…”

Section: Discussionmentioning

confidence: 99%

Clinical performance of a chemiluminescence SARS-CoV-2 antibody assay in a cohort of healthcare workers, blood donors and COVID-19 patients

Rangel

Lopez

Chavarria

et al. 2023

Preprint

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Introduction: Serological detection of antibodies against SARS-CoV-2 has become an essential tool to test vaccine efficacy and epidemiological surveillance of COVID-19. There have been limited published studies documenting the performance of SARS-CoV-2 antibody assays within hispanic populations. Materials and methods: We evaluated the diagnostic performance of a chemiluminescence enzyme immunoassay (CLIA) on a set of 1,035 samples including pre-pandemic samples, healthcare workers (HCW), blood donors (BD) and COVID-19 positive confirmed by RT-PCR collected from April to December 2020. Results: Through a ROC curve the CLIA test had a high diagnostic performance, with an AUC of 0.9854 (CI95% 95.68-100), P<0.0001. The analysis yielded a cut-off point 0.1950, sensitivity of 98.4% (CI95% 95 91.54-99.9), and specificity of 93.8% (CI95% 79.8 - 98.9). The diagnostic performance was also evaluated comparing the results with those obtained using other diagnostic techniques. Substantial agreement with the lateral flow chromatography and RT-PCR tests was found, and a high level of agreement with ELISA, with %PPA of 91.3 (CI95% 84.0-95.5), %NPA of 97.7 (CI95% 96.3-98.6), %OPA of 97.7 (CI95% 96.3-98.6) and Cohens kappa value of 90.4 (CI95% 85.8-94.9). A logistic regression was used to determine which of the independent variables predicted reactivity to CLIA test. A higher age was associated with an odds ratio (OR) of 1.043 (CI95% 1.022-1.065), while the presence of at least one chronic disease was associated with an OR of 5.649 (CI95% 3.089-10.329) greater likelihood of reactivity. Conclusions: CLIA test exhibited excellent performance making it a suitable test for seroprevalence surveillance at the community level.

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Section: Discussionmentioning

confidence: 99%

Clinical performance of a chemiluminescence SARS-CoV-2 antibody assay in a cohort of healthcare workers, blood donors and COVID-19 patients

Rangel

Lopez

Chavarria

et al. 2023

Preprint

View full text Add to dashboard Cite

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“…Nevertheless, the scientific community also focused on the early diagnosis of the virus, to develop remedies that can support the active vaccination campaign. Indeed, the diagnostic assays can be a powerful tool to facilitate the surveillance after the vaccination as vaccinated people can also be infected by the virus (Fresco-Taboada et al, 2022). In this scenario, nanotechnologies could be an optimal alternative for early SARS-CoV-2 diagnostic, especially using metallic NPs.…”

Section: Focus On the Sars-cov-2mentioning

confidence: 99%

Identification of SARS-CoV-2 by gold nanoparticles

Rizzello¹,

Matteis²

2022

Biocell

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The SARS-CoV-2 outbreaks highlighted the need for effective, reliable, fast, easy-to-do and cheap diagnostics procedures. We pragmatically experienced that an early positive-case detection, inevitably coupled with a mass vaccination campaign, is a milestone to control the COVID-19 pandemic. Gold nanoparticles (AuNPs) can indeed play a crucial role in this context, as their physicochemical, optics and electronics properties are being extensively used in photothermal therapy (PTT), radiation therapy (RT), drug delivery and diagnostic. AuNPs can be synthesized by several approaches to obtain different sizes and shapes that can be easily functionalized with many kinds of molecules such as antibodies, proteins, probes, and lipids. In addition, AuNPs showed high biocompatibility making them useful tool in medicine field. We thus reviewed here the most relevant evidence on AuNPs as effective way to detect the presence of SARS-CoV-2 antigens. We trust future diagnostic efforts must take this 'old-fashioned' nanotechnology tool into consideration for the development and commercialization of reliable and feasible detection kits.

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