Development of highly sensitive and rapid antigen detection assay for diagnosis of COVID-19 utilizing optical waveguide immunosensor

Funabashi, Rikako; Miyakawa, Kei; Yamaoka, Yutaro; Yoshimura, Seiko; Yamane, Satoshi; Jeremiah, Sundararaj Stanleyraj; Shimizu, Kohei; Ozawa, Hiroki; Kawakami, Chiharu; Usuku, Shuzo; Tanaka, Nobuko; Yamazaki, Etsuko; Kimura, Hirokazu; Hasegawa, Hideki; Ryo, Akihide

doi:10.1093/jmcb/mjab037

Cited by 8 publications

(13 citation statements)

References 9 publications

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“…Thirty-six studies used the same samples to compare different tests from different companies. Twelve studies used twelve unique techniques that are under development (LC-mass spectrometry [ 36 , 37 ], field-effect transistor (FET) based biosensing devices [ 38 ], organic electrochemical transistors-OECT [ 39 ], voltametric-based immunosensor [ 40 ], optical waveguide-based biosensor technology [ 41 ], deep learning-based surface-enhanced Raman spectroscopy [ 42 ], paper-based impedance sensor [ 43 ], high-field asymmetric waveform ion mobility spectrometry (FAIMS)–parallel reaction monitoring (PRM) [ 44 ], a colorimetric biosensor [ 45 ], an electrochemical glucose sensor [ 46 ], and a urine foaming test [ 47 ]). Finally, two studies were performed with urine samples [ 36 , 47 ].…”

Section: Resultsmentioning

confidence: 99%

“…Furthermore, twelve studies [ 54 , 76 , 85 , 143 , 170 , 199 , 213 , 217 , 233 , 235 , 237 , 241 ] presented data providing LoD values for a POC tests ranging from 5.10 3 (Ct = 27.3 [ 63 ]) to 10 6 RNA copies/swab (Ct = 30) [ 54 , 76 ]. Noteworthily, four studies on the CLEIA method [ 111 , 150 , 156 , 206 ] and four studies [ 41 , 44 , 46 , 47 ]) on in-house tests also investigated virus infectivity in correlation with either Ct values or positivity of these tests, but these were not analyzed since they were not reporting on POC tests. Taken together, the above observations suggest that if SARS-CoV-2-infected cell culture positivity is an indicator of a patient/sample that is likely to be infectious [ 202 , 258 , 259 ], this infectivity better correlates with POC test positivity than rt-PCR positivity.…”

Section: Resultsmentioning

confidence: 99%

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Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis

et al. 2022

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Coronavirus disease 2019 (COVID-19) initiated global health care challenges such as the necessity for new diagnostic tests. Diagnosis by real-time PCR remains the gold-standard method, yet economical and technical issues prohibit its use in points of care (POC) or for repetitive tests in populations. A lot of effort has been exerted in developing, using, and validating antigen-based tests (ATs). Since individual studies focus on few methodological aspects of ATs, a comparison of different tests is needed. Herein, we perform a systematic review and meta-analysis of data from articles in PubMed, medRxiv and bioRxiv. The bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities was used. Most of the AT types for SARS-CoV-2 were lateral flow immunoassays (LFIA), fluorescence immunoassays (FIA), and chemiluminescence enzyme immunoassays (CLEIA). We identified 235 articles containing data from 220,049 individuals. All ATs using nasopharyngeal samples show better performance than those with throat saliva (72% compared to 40%). Moreover, the rapid methods LFIA and FIA show about 10% lower sensitivity compared to the laboratory-based CLEIA method (72% compared to 82%). In addition, rapid ATs show higher sensitivity in symptomatic patients compared to asymptomatic patients, suggesting that viral load is a crucial parameter for ATs performed in POCs. Finally, all methods perform with very high specificity, reaching around 99%. LFIA tests, though with moderate sensitivity, appear as the most attractive method for use in POCs and for performing seroprevalence studies.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis

et al. 2022

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“…The other vulnerability of our approach is that the mAb might have cross-reactivity or degrade in cholera stool matrix which harbors proteases (48, 49). Monoclonal antibodies were raised to recombinant ORF75 and ORF122 proteins, however the mAb to the baseplate protein (ORF75) failed to bind native ICP1 by ELISA, Western blot and phage neutralization assays.…”

Section: Discussionmentioning

confidence: 99%

“…The other vulnerability of our approach is that the mAb might have crossreactivity or degrade in cholera stool matrix which harbors proteases (48,49).…”

Section: Discussionmentioning

confidence: 99%

Development of a monoclonal antibody to a vibriophage as a proxy forVibrio choleraedetection

Sayeed¹,

Paisie

Alam

et al. 2022

Preprint

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Cholera is an acute watery diarrheal disease that causes high rates of morbidity and mortality without treatment. Early detection of the etiologic agent of toxigenic Vibrio cholerae is important to mobilize treatment and mitigate outbreaks. Monoclonal antibody (mAb) based rapid diagnostic tests (RDTs) enable early detection in settings without laboratory capacity. However, the odds of an RDT testing positive are reduced by nearly 90% when the common virulent bacteriophage ICP1 is present. We hypothesize that adding a mAb for the common, and specific, virulent bacteriophage ICP1 as a proxy for V. cholerae to an RDT will increase diagnostic sensitivity when virulent ICP1 phage are present. In this study, we used an in-silico approach to identify immunogenic ICP1 protein targets that were conserved across disparate time periods and locations. Specificity of targets to cholera patients with known ICP1 was determined, and specific targets were used to produce mAbs in a murine model. Candidate mAbs to the head protein demonstrated specificity to ICP1 by ELISA and an ICP1 phage neutralization assay. The limit of detection of the final mAb candidate for ICP1 phage particles spiked into cholera stool matrix was 8 x 105 plaque forming units by Western blot analysis. This mAb will be incorporated into a RDT prototype for evaluation in a future diagnostic study to test the guiding hypothesis behind this study.

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“…Two immunosensors based on specific antibodies against the Cor a 14-hazelnut allergen and electrochemical or SPR-based optical detection were reported and proposed as a platform for hazelnut allergen analysis in food; mammalian IgG and avian IgY anti-analyte antibodies were immobilized on the gold-coated sensors’ surface, with the latter leading to a better outcome regarding mainly assay specificity [ 70 ]. Moreover, an immunosensor for COVID-19 diagnosis was reported based on antibodies against the SARS-CoV-2 nucleocapsid protein; the capture antibodies were conjugated to light scattering particles, while the detection ones were immobilized on an optical waveguide film [ 71 ]. In addition, an immunosensor for collagen I was described which employed a half-reduced monoclonal antibody, i.e., an anti-collagen I antibody the intramolecular S-S bridges of which were enzymatically reduced; subsequent covalent immobilization of the so-treated antibody on a monolayer of self-assembled gold nanoparticles led to a properly oriented and fully-functional antibody layer.…”

Section: Newest Developments In Optical Immunosensors: Bioanalytical ...mentioning

confidence: 99%

Recent Developments in the Field of Optical Immunosensors Focusing on a Label-Free, White Light Reflectance Spectroscopy-Based Immunosensing Platform

Karachaliou

Koukouvinos

Goustouridis

et al. 2022

Sensors

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Optical immunosensors represent a research field of continuously increasing interest due to their unique features, which can mainly be attributed to the high-affinity and specific antibodies they use as biorecognition elements, combined with the advantageous characteristics of the optical transducing systems these sensors employ. The present work describes new developments in the field, focusing on recent bioanalytical applications (2021–2022) of labeled and label-free optical immunosensors. Special attention is paid to a specific immunosensing platform based on White Light Reflectance Spectroscopy, in which our labs have gained specific expertise; this platform is presented in detail so as to include developments, improvements, and bioanalytical applications since the mid-2000s. Perspectives on the field are been briefly discussed as well, highlighting the potential of optical immunosensors to eventually reach the state of a reliable, highly versatile, and widely applicable analytical tool suitable for use at the Point-of-Care.

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Development of highly sensitive and rapid antigen detection assay for diagnosis of COVID-19 utilizing optical waveguide immunosensor

Cited by 8 publications

References 9 publications

Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis

Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis

Development of a monoclonal antibody to a vibriophage as a proxy forVibrio choleraedetection

Recent Developments in the Field of Optical Immunosensors Focusing on a Label-Free, White Light Reflectance Spectroscopy-Based Immunosensing Platform

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