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Review
. 2021 Sep 24;11(10):1760.
doi: 10.3390/diagnostics11101760.

Development and Efficacy of Lateral Flow Point-of-Care Testing Devices for Rapid and Mass COVID-19 Diagnosis by the Detections of SARS-CoV-2 Antigen and Anti-SARS-CoV-2 Antibodies

Wen-Yeh Hsieh  1 , Cheng-Han Lin  2 , Tzu-Ching Lin  3 , Chao-Hsu Lin  2   4 , Hui-Fang Chang  2   5 , Chin-Hung Tsai  2   6 , Hsi-Tien Wu  7 , Chih-Sheng Lin  2   8   9
Affiliations
Review

Development and Efficacy of Lateral Flow Point-of-Care Testing Devices for Rapid and Mass COVID-19 Diagnosis by the Detections of SARS-CoV-2 Antigen and Anti-SARS-CoV-2 Antibodies

Wen-Yeh Hsieh et al. Diagnostics (Basel). .

Abstract

The COVID-19 pandemic is an ongoing global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2020-2021. COVID-19 is becoming one of the most fatal pandemics in history and brings a huge challenge to the global healthcare system. Opportune detection, confinement, and early treatment of infected cases present the first step in combating COVID-19. Diagnosis via viral nucleic acid amplification tests (NAATs) is frequently employed and considered the standard procedure. However, with an increasing urge for point-of-care tests, rapid and cheaper immunoassays are widely utilized, such as lateral flow immunoassay (LFIA), which can be used for rapid, early, and large-scale detection of SARS-CoV-2 infection. In this narrative review, the principle and technique of LFIA applied in COVID-19 antigen and antibody detection are introduced. The diagnostic sensitivity and specificity of the commercial LFIA tests are outlined and compared. Generally, LFIA antigen tests for SARS-CoV-2 are less sensitive than viral NAATs, the "gold standard" for clinical COVID-19 diagnosis. However, antigen tests can be used for rapid and mass testing in high-risk congregate housing to quickly identify people with COVID-19, implementing infection prevention and control measures, thus preventing transmission. LFIA anti-SARS-CoV-2 antibody tests, IgM and/or IgG, known as serology tests, are used for identification if a person has previously been exposed to the virus or vaccine immunization. Notably, advanced techniques, such as LFT-based CRISPR-Cas9 and surface-enhanced Raman spectroscopy (SERS), have added new dimensions to the COVID-19 diagnosis and are also discussed in this review.

Keywords: COVID-19; SARS-CoV-2; antibodies; antigen; lateral flow immunoassay; lateral flow test.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1
Figure 1
The timeline of the COVID-19 pandemic and key events.
Figure 2
Figure 2
Schematic conception and dipstick assay of the LFIA test strips. LFIA is a paper-based detection technique that allows the sample containing the analyte to flow through the membrane. AuNPs are used as color markers in LFIA, and the presence of an analyte is indicated by the appearance of colored lines on the membrane, which can be analyzed by naked eyes. LFIA, lateral flow immunoassay; Abs, antibodies; AuNPs, gold nanoparticles.
Figure 3
Figure 3
Relationship between the amount/type of antibody generated against SARS-CoV-2 (anti-SARS-CoV-2 IgM and IgG) and the clinical as well as virus (SARS-CoV-2) detectable stage of COVID-19 disease.
Figure 4
Figure 4
Representation of commercial LFIA devices or strips for the detection of SARS-CoV-2 infection. RAD, Rapid antigen diagnostic immunoassay; Ag-RAD, Antigene rapid antigen diagnostic immunoassay. (A) Sensitivity of rapid antigen detection (RAD) (B) Specificity of rapid antigen detection (RAD). Abbott: Abbott Diagnostic GmbH, Panbio™ COVID-19 Ag rapid test device; Roche: Roche-SD Biosensor SARS-CoV-2 Rapid Antigen Test; Healgen: Coronavirus Ag Rapid Test Cassette; RapiGEN: BIOCREDIT COVID-19 Ag Test; Coris BioConcept: COVID-19 Ag Respi-Strip; R-Biopharm AG: RIDA® QUICK SARS-CoV-2 Antigen Test; nal von minden: NADAL® COVID-19 Ag Test; Siemens: Siemens Healthineers, CLINITEST Rapid COVID-19 Antigen Test; Lepu: Lepu Medical, 2019-nCoV Antigen Rapid test kit; SureScreen: COVID-19 Rapid Antigen Test Cassette.
See this image and copyright information in PMC

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