High-Sensitivity Lateral Flow Assays for SARS-CoV-2 and Other Infections, 2nd Edition

A special issue of Biomedicines (ISSN 2227-9059). This special issue belongs to the section "Molecular and Translational Medicine".

Deadline for manuscript submissions: 30 June 2025 | Viewed by 9678

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Institute for NanoSuit Research, Preeminent Medical Photonics Education & Research Center, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan
Interests: pathology; virus; neuroscience; electron microscopy; nanoSuit
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Special Issue Information

Dear Colleagues,

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other infections are serious threats to public health and the global economy. The World Health Organization (WHO) designated the coronavirus disease 2019 (COVID-19) outbreak as a pandemic in March 2020. According to the WHO, the global cumulative number of novel coronavirus infections exceeds 300 million to date. The rapid identification and isolation of patients diagnosed with SARS-CoV-2 are important for preventing transmission.

Point-of-care testing (POCT) is applicable to a variety of areas of medicine and can make a significant difference in patient care. Lateral flow assays (LFAs) are critical in POCT. An LFA is a simple-to-use piece of diagnostic equipment that is used to confirm the presence or absence of a target analyte, such as SARS-CoV-2 or other infective agents, biomarkers in humans or animals, or pollutants in drinking water, food, or animal feed; however, its clinical utility has been questioned due to its limited sensitivity. Numerous strategies are used to improve sensitivity and quantitative detection, e.g., employing several visualization methods, using different labeling reporters, and integrating LFAs into other detection methods, resulting in their benefiting from both LFAs and the advantages of integrated detection devices for SARS-CoV-2 or other infections. This Special Issue invites submissions of novel and innovative original studies as well as comprehensive reviews on this topic.

Dr. Hideya Kawasaki
Guest Editor

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Keywords

  • lateral flow assay
  • point-of-care testing
  • SARS-CoV-2
  • high sensitivity
  • detection device
  • labeling reporters
  • antigens
  • pathogens

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Related Special Issue

Published Papers (3 papers)

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Research

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13 pages, 869 KiB  
Article
Detection of SARS-CoV-2 Using the Abbott™ PANBIO™ COVID-19 SELF-TEST Rapid Test in Patients Seen at INER
by Kenny Alonso Cantón Cruz, Martha Angella Durán Barrón, Israel Agustín Morales Lozada, Mario Alberto Mujica Sánchez, Grecia Gabriela Deloya Brito, María del Carmen García Colín, Hansel Hugo Chávez Morales, José Nicolás Aguirre Pineda, Cinthya Karen Cid del Prado Rojas, Stephanie Jara Valdés and Eduardo Becerril Vargas
Biomedicines 2025, 13(5), 1012; https://doi.org/10.3390/biomedicines13051012 - 22 Apr 2025
Abstract
The COVID-19 pandemic has highlighted the need for rapid and accurate tests to detect SARS-CoV-2. Objectives: This study evaluates the effectiveness of the Panbio™ COVID-19 Antigen Self-Test rapid test compared to reverse transcriptase polymerase chain reaction (RT-PCR). Methods: A prospective diagnostic testing [...] Read more.
The COVID-19 pandemic has highlighted the need for rapid and accurate tests to detect SARS-CoV-2. Objectives: This study evaluates the effectiveness of the Panbio™ COVID-19 Antigen Self-Test rapid test compared to reverse transcriptase polymerase chain reaction (RT-PCR). Methods: A prospective diagnostic testing study was performed. Patients with respiratory symptoms who provided informed consent were included. Results: We included 205 patients with COVID-19 symptoms who underwent both tests. The mean age was 35.55 ± 12.62 years, and 64% of the participants were female. Sensitivity and specificity were 71.2% (95% CI: 62.5–79.9%) and 100% (95% CI: 96.4–100%), respectively. Conclusions: If a test is positive within the first 72 h after the onset of symptoms, we can be sure that it is a case of COVID-19; however, when the antigen test is negative, confirmation with RT-PCR is necessary. Its ease of use and results with moderate precision make it a valuable tool for early detection. Full article
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13 pages, 4358 KiB  
Article
Evaluation of Multiplex Rapid Antigen Tests for the Simultaneous Detection of SARS-CoV-2 and Influenza A/B Viruses
by Ho-Jae Lim, Ji-Yoon Lee, Young-Hyun Baek, Min-Young Park, Dong-Jae Youm, Inhee Kim, Min-Jin Kim, Jongmun Choi, Yong-Hak Sohn, Jung-Eun Park and Yong-Jin Yang
Biomedicines 2023, 11(12), 3267; https://doi.org/10.3390/biomedicines11123267 - 9 Dec 2023
Cited by 7 | Viewed by 4939
Abstract
Single-target rapid antigen tests (RATs) are commonly used to detect highly transmissible respiratory viruses (RVs), such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza viruses. The simultaneous detection of RVs presenting overlapping symptoms is vital in making appropriate decisions about treatment, [...] Read more.
Single-target rapid antigen tests (RATs) are commonly used to detect highly transmissible respiratory viruses (RVs), such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza viruses. The simultaneous detection of RVs presenting overlapping symptoms is vital in making appropriate decisions about treatment, isolation, and resource utilization; however, few studies have evaluated multiplex RATs for SARS-CoV-2 and other RVs. We assessed the diagnostic performance of multiplex RATs targeting both the SARS-CoV-2 and influenza A/B viruses with the GenBody Influenza/COVID-19 Ag Triple, InstaView COVID-19/Flu Ag Combo (InstaView), STANDARDTM Q COVID-19 Ag Test, and STANDARDTM Q Influenza A/B Test kits using 974 nasopharyngeal swab samples. The cycle threshold values obtained from the real-time reverse transcription polymerase chain reaction results showed higher sensitivity (72.7–100%) when the values were below, rather than above, the cut-off values. The InstaView kit exhibited significantly higher positivity rates (80.21% for SARS-CoV-2, 61.75% for influenza A, and 46.15% for influenza B) and cut-off values (25.57 for SARS-CoV-2, 21.19 for influenza A, and 22.35 for influenza B) than the other two kits, and was able to detect SARS-CoV-2 Omicron subvariants. Therefore, the InstaView kit is the best choice for routine screening for both SARS-CoV-2 and influenza A/B in local communities. Full article
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Review

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19 pages, 3038 KiB  
Review
Transitions in Immunoassay Leading to Next-Generation Lateral Flow Assays and Future Prospects
by Koyu Fujiuchi, Noriko Aoki, Tetsurou Ohtake, Toshihide Iwashita and Hideya Kawasaki
Biomedicines 2024, 12(10), 2268; https://doi.org/10.3390/biomedicines12102268 - 6 Oct 2024
Cited by 2 | Viewed by 3904
Abstract
In the field of clinical testing, the traditional focus has been on the development of large-scale analysis equipment designed to process high volumes of samples with fully automatic and high-sensitivity measurements. However, there has been a growing demand in recent years for the [...] Read more.
In the field of clinical testing, the traditional focus has been on the development of large-scale analysis equipment designed to process high volumes of samples with fully automatic and high-sensitivity measurements. However, there has been a growing demand in recent years for the development of analytical reagents tailored to point-of-care testing (POCT), which does not necessitate a specific location or specialized operator. This trend is epitomized using the lateral flow assay (LFA), which became a cornerstone during the 2019 pandemic due to its simplicity, speed of delivering results—within about 10 min from minimal sample concentrations—and user-friendly design. LFAs, with their paper-based construction, combine cost-effectiveness with ease of disposal, addressing both budgetary and environmental concerns comprehensively. Despite their compact size, LFAs encapsulate a wealth of technological ingenuity, embodying years of research and development. Current research is dedicated to further evolving LFA technology, paving the way for the next generation of diagnostic devices. These advancements aim to redefine accessibility, empower individuals, and enhance responsiveness to public health challenges. The future of LFAs, now unfolding, promises even greater integration into routine health management and emergency responses, underscoring their critical role in the evolution of decentralized and patient-centric healthcare solutions. In this review, the historical development of LFA and several of the latest LFA technologies using catalytic amplification, surface-enhanced Raman scattering, heat detection, electron chemical detections, magnetoresistance, and detection of reflected electrons detection are introduced to inspire readers for future research and development. Full article
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