Challenges in the Detection of SARS-CoV-2: Evolution of the Lateral Flow Immunoassay as a Valuable Tool for Viral Diagnosis

Castrejón-Jiménez, Nayeli Shantal; Garcı́a-Pérez, Blanca Estela; Rodríguez, Nydia Edith Reyes; Vega-Sánchez, Vicente; Juárez, Víctor Manuel Martínez; Hernández-González, Juan Carlos

doi:10.3390/bios12090728

Cited by 18 publications

(23 citation statements)

References 125 publications

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“…The lateral flow immunochromatographic assay interprets the result with the presence/ absence of test and control lines. However, in some cases, it is difficult to read the lines by the naked eye when the intensity is low [12], and there may be differences among operators. Using a reader is known to improve these limitations [13], but Panbio COVID-19 Ag testing results are interpreted by naked eyes without a reader.…”

Section: Discussionmentioning

confidence: 99%

Verification of the Performance of the Panbio COVID-19 Ag Rapid Test Device for Implementation in the Clinical Laboratory

Chung¹,

Chung²,

Lee³

et al. 2023

Ewha Med J

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Objectives:The Panbio COVID-19 Ag Rapid Test Device (Panbio COVID-19 Ag, Abbott Rapid Diagnostics) is a lateral flow immunochromatographic assay targeting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleoprotein in nasopharyngeal specimens for the diagnosis of coronavirus disease 2019 . This study aimed to verify the performance of the Panbio COVID-19 Ag for implementation in clinical laboratories. Methods: Sixty nasopharyngeal swab specimens (30 positive and 30 negative) dipped in transport medium, and COVID-19 was confirmed using real-time RT-PCR using Allplex SARS-CoV-2 assay (Seegene), were tested using the Panbio COVID-19 Ag. Reproducibility was evaluated using positive and negative control materials. Sensitivity and specificity were calculated based on the results of realtime RT-PCR as the standard test method. Results: Reproducibility was confirmed by the consistent results of repeated tests of the quality control materials. The overall sensitivity and specificity of Panbio COVID-19 Ag were 50.0% and 100.0%, respectively. Panbio COVID-19 Ag demonstrated high sensitivity (88.2%) in analyzing the detection limit cycle threshold (Ct) value of 26.67 provided by the manufacturer as a positive criterion, and the sensitivity was 100.0% for the positive criterion of Ct values <25, although it was less sensitive for Ct ≥ 25. Conclusion:Considering the high sensitivity for positive samples with Ct values <25 and the rapid turnaround of results, Panbio COVID-19 Ag can be used in clinical laboratories to diagnose COVID-19 in limited settings.

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Section: Discussionmentioning

confidence: 99%

Verification of the Performance of the Panbio COVID-19 Ag Rapid Test Device for Implementation in the Clinical Laboratory

Chung¹,

Chung²,

Lee³

et al. 2023

Ewha Med J

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“…However, it has to be remarked that although this and other similar expedients can increase the sensitivity of these assays, additional equipment, preparation steps and a prolonged testing time are required. This makes difficult the use of these assays as POC tests, although the advantage that less amount of reagent is needed compared to standard centralized tests [57] .…”

Section: Overview On Serological Detectionmentioning

confidence: 99%

An update on lateral flow immunoassay for the rapid detection of SARS-CoV-2 antibodies

Spicuzza¹,

Campagna²,

Maria³

et al. 2023

AIMSMICRO

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<abstract> <p>Over the last three years, after the outbreak of the COVID-19 pandemic, an unprecedented number of novel diagnostic tests have been developed. Assays to evaluate the immune response to SARS-CoV-2 have been widely considered as part of the control strategy. The lateral flow immunoassay (LFIA), to detect both IgM and IgG against SARS-CoV-2, has been widely studied as a point-of-care (POC) test. Compared to laboratory tests, LFIAs are faster, cheaper and user-friendly, thus available also in areas with low economic resources. Soon after the onset of the pandemic, numerous kits for rapid antibody detection were put on the market with an emergency use authorization. However, since then, scientists have tried to better define the accuracy of these tests and their usefulness in different contexts. In fact, while during the first phase of the pandemic LFIAs for antibody detection were auxiliary to molecular tests for the diagnosis of COVID-19, successively these tests became a tool of seroprevalence surveillance to address infection control policies. When in 2021 a massive vaccination campaign was implemented worldwide, the interest in LFIA reemerged due to the need to establish the extent and the longevity of immunization in the vaccinated population and to establish priorities to guide health policies in low-income countries with limited access to vaccines. Here, we summarize the accuracy, the advantages and limits of LFIAs as POC tests for antibody detection, highlighting the efforts that have been made to improve this technology over the last few years.</p> </abstract>

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“…A general comparison between LFI, RT-PCR and ELISA is presented in Table 1 . Although the applications of LFI for COVID-19 testing have been covered in recent reviews [ 12 , 13 , 14 , 15 ], there were no attempts to provide a comprehensive overview of LFIs that have received EUA from the US FDA. As of 11 October 2022, a total of 69 LFIs have been granted EUA: 44 are antigen diagnostic tests and the remaining 25 are serological tests that detect antibodies, such as immunoglobulin (Ig) M and/or IgG, against SARS-CoV-2.…”

Section: Introductionmentioning

confidence: 99%

Lateral Flow Immunoassays for SARS-CoV-2

et al. 2022

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The continued circulation of SARS-CoV-2 virus in different parts of the world opens up the possibility for more virulent variants to evolve even as the coronavirus disease 2019 transitions from pandemic to endemic. Highly transmissible and virulent variants may seed new disruptive epidemic waves that can easily put the healthcare system under tremendous pressure. Despite various nucleic acid-based diagnostic tests that are now commercially available, the wide applications of these tests are largely hampered by specialized equipment requirements that may not be readily available, accessible and affordable in less developed countries or in low resource settings. Hence, the availability of lateral flow immunoassays (LFIs), which can serve as a diagnostic tool by detecting SARS-CoV-2 antigen or as a serological tool by measuring host immune response, is highly appealing. LFI is rapid, low cost, equipment-free, scalable for mass production and ideal for point-of-care settings. In this review, we first summarize the principle and assay format of these LFIs with emphasis on those that were granted emergency use authorization by the US Food and Drug Administration followed by discussion on the specimen type, marker selection and assay performance. We conclude with an overview of challenges and future perspective of LFI applications.

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Challenges in the Detection of SARS-CoV-2: Evolution of the Lateral Flow Immunoassay as a Valuable Tool for Viral Diagnosis

Cited by 18 publications

References 125 publications

Verification of the Performance of the Panbio COVID-19 Ag Rapid Test Device for Implementation in the Clinical Laboratory

Verification of the Performance of the Panbio COVID-19 Ag Rapid Test Device for Implementation in the Clinical Laboratory

An update on lateral flow immunoassay for the rapid detection of SARS-CoV-2 antibodies

Lateral Flow Immunoassays for SARS-CoV-2

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