scholarly journals A hemagglutination-based, semi-quantitative test for point-of-care determination of SARS-CoV-2 antibody levels

2021 ◽  
Author(s):  
Robert L. Kruse ◽  
Yuting Huang ◽  
Alyssa Lee ◽  
Xianming Zhu ◽  
Ruchee Shrestha ◽  
...  
Keyword(s):  
Point Of Care ◽  
Neutralizing Antibody ◽  
Antibody Test ◽  
Quantitative Information ◽  
Elisa Test ◽  
Lateral Flow ◽  
Plasma Samples ◽  
Hemagglutination Test ◽  
Lateral Flow Assays

Serologic, point-of-care tests to detect antibodies against SARS-CoV-2 are an important tool in the COVID-19 pandemic. The majority of current point-of-care antibody tests developed for SARS-CoV-2 rely on lateral flow assays, but these do not offer quantitative information. To address this, we developed a novel antibody test leveraging hemagglutination, employing a dry card format currently used for typing ABO blood groups. 200 COVID-19 patient and 200 control plasma samples were reconstituted with O-negative RBCs to form whole blood and added to dried viral-antibody fusion protein, followed by a stirring step and a tilting step, 3-minute incubation, and a second tilting step. The sensitivity for the hemagglutination test, Euroimmun IgG ELISA test and RBD-based CoronaChek lateral flow assay was 87.0%, 86.5%, and 84.5%, respectively, using samples obtained from recovered COVID-19 individuals. Testing pre-pandemic samples, the hemagglutination test had a specificity of 95.5%, compared to 97.3% and 98.9% for the ELISA and CoronaChek, respectively. A distribution of agglutination strengths was observed in COVID-19 convalescent plasma samples, with the highest agglutination score (4) exhibiting significantly higher neutralizing antibody titers than weak positives (2) (p<0.0001). Strong agglutinations were observed within 1 minute of testing, and this shorter assay time also increased specificity to 98.5%. In conclusion, we developed a novel rapid, point-of-care RBC agglutination test for the detection of SARS-CoV-2 antibodies that can yield semi-quantitative information on neutralizing antibody titer in patients. The five-minute test may find use in determination of serostatus prior to vaccination, post-vaccination surveillance and travel screening.

A Time-Resolved-Fluorescence Lateral Flow Assay for Rapid Detection of Cholyglycine Acid for the Diagnosis of Liver Diseases

2021 ◽  
Vol 11 (10) ◽  
pp. 2023-2029
Author(s):  
Wang Zhang ◽  
Yujun Zhou ◽  
Xiuli Xu ◽  
Yaping Tian ◽  
Chunyan Zhang
Keyword(s):  
Rapid Detection ◽  
Liver Diseases ◽  
Point Of Care ◽  
Quantitative Information ◽  
Lateral Flow ◽  
Lateral Flow Assay ◽  
Time Resolved Fluorescence ◽  
Time Resolved ◽  
Homogeneous Enzyme Immunoassay

Liver disease is a great danger to human health. The determination of blood level of Cholyglycine acid (CG) is a vital biomarker for the assessment of liver function in clinic, which is contribute to the diagnosis of liver diseases. Thus, establishing accuracy, rapid and convenient method for the detection of glycolic acid is of great significance. In this study, a time-resolved-fluorescence (TRF) lateral flow assay for rapid detection of CG was development. The analytical detection limit (mean of zero-2 SD) was 0.06 μg/mL The method showed good linearity in the range of 0.2–40 g/mL and was not affected by biomolecules with similar structure to CG. The analytical mean recovery of control was between 90–110% and the imprecision of intra- and inter-assay of CVs was less than 10%. No significant matrix effect was observed in saline, serum, plasma or whole blood. A good correlation was found with the homogeneous enzyme immunoassay (HEIA) assay (slopes 1.0463, y-intercepts 0.2721 μg/mL, R = 0.989, n = 50, P < 0.001). The CG TRF analysis could provide reproducible and quantitative information about the state of liver in a few minutes, which is suitable for the detection of liver diseases in point-of-care-testing (POCT) conditions.

scholarly journals Comparative assessment of multiple COVID-19 serological technologies supports continued evaluation of point-of-care lateral flow assays in hospital and community healthcare settings

2020 ◽  
Author(s):  
Suzanne Pickering ◽  
Gilberto Betancor ◽  
Rui Pedro Galão ◽  
Blair Merrick ◽  
Adrian W. Signell ◽  
...  
Keyword(s):  
Point Of Care ◽  
Antibody Test ◽  
Lateral Flow ◽  
Diagnostic Tools ◽  
Antibody Testing ◽  
Community Healthcare ◽  
Diagnostic Assays ◽  
Healthcare Settings ◽  
Lateral Flow Assays ◽  
Diagnostic Capabilities

AbstractThere is a clear requirement for an accurate SARS-CoV-2 antibody test, both as a complement to existing diagnostic capabilities and for determining community seroprevalence. We therefore evaluated the performance of a variety of antibody testing technologies and their potential as diagnostic tools. A highly specific in-house ELISA was developed for the detection of anti-spike (S), -receptor binding domain (RBD) and -nucleocapsid (N) antibodies and used for the cross-comparison of ten commercial serological assays – a chemiluminescence-based platform, two ELISAs and seven colloidal gold lateral flow immunoassays (LFIAs) – on an identical panel of 110 SARS-CoV-2-positive samples and 50 pre-pandemic negatives. There was a wide variation in the performance of the different platforms, with specificity ranging from 82% to 100%, and overall sensitivity from 60.9% to 87.3%. However, the head-to-head comparison of multiple sero-diagnostic assays on identical sample sets revealed that performance is highly dependent on the time of sampling, with sensitivities of over 95% seen in several tests when assessing samples from more than 20 days post onset of symptoms. Furthermore, these analyses identified clear outlying samples that were negative in all tests, but were later shown to be from individuals with mildest disease presentation. Rigorous comparison of antibody testing platforms will inform the deployment of point-of-care technologies in healthcare settings and their use in the monitoring of SARS-CoV-2 infections.

scholarly journals Towards Lateral Flow Quantitative Assays: Detection Approaches

Biosensors ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. 89 ◽  
Author(s):  
Urusov ◽  
Zherdev ◽  
Dzantiev
Keyword(s):  
Point Of Care ◽  
Visual Assessment ◽  
Quantitative Information ◽  
Lateral Flow ◽  
Advanced Manufacturing ◽  
Global Trend ◽  
Lateral Flow Assays ◽  
Qualitative Conclusion ◽  
Lateral Flow Tests ◽  
Further Development

Point-of-care (POC) or bedside analysis is a global trend in modern diagnostics. Progress in POC testing has largely been provided by advanced manufacturing technology for lateral flow (immunochromatographic) test strips. They are widely used to rapidly and easily control a variety of biomarkers of infectious diseases and metabolic and functional disorders, as well as in consumer protection and environmental monitoring. However, traditional lateral flow tests rely on visual assessment and qualitative conclusion, which limit the objectivity and information output of the assays. Therefore, there is a need for approaches that retain the advantages of lateral flow assays and provide reliable quantitative information about the content of a target compound in a sample mixture. This review describes the main options for detecting, processing, and interpreting immunochromatographic analysis results. The possibilities of modern portable detectors that register colored, fluorescent, magnetic, and conductive labels are discussed. Prospects for further development in this direction are also examined.

Gold-Aptamer-Nanoconstructs Engineered to Detect Conserved Enteroviral Nucleic Acid Sequences

2019 ◽  
Author(s):  
Veeren Chauhan ◽  
Mohamed M Elsutohy ◽  
C Patrick McClure ◽  
Will Irving ◽  
Neil Roddis ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
In Silico ◽  
Point Of Care ◽  
Lateral Flow ◽  
Nucleic Acid Sequence ◽  
In Silico Screening ◽  
Lateral Flow Assays ◽  
Life Threatening ◽  
Software And Hardware ◽  
Nucleic Acid Sequences

<p>Enteroviruses are a ubiquitous mammalian pathogen that can produce mild to life-threatening disease. Bearing this in mind, we have developed a rapid, accurate and economical point-of-care biosensor that can detect a nucleic acid sequences conserved amongst 96% of all known enteroviruses. The biosensor harnesses the physicochemical properties of gold nanoparticles and aptamers to provide colourimetric, spectroscopic and lateral flow-based identification of an exclusive enteroviral RNA sequence (23 bases), which was identified through in silico screening. Aptamers were designed to demonstrate specific complementarity towards the target enteroviral RNA to produce aggregated gold-aptamer nanoconstructs. Conserved target enteroviral nucleic acid sequence (≥ 1x10<sup>-7</sup> M, ≥1.4×10<sup>-14</sup> g/mL), initiates gold-aptamer-nanoconstructs disaggregation and a signal transduction mechanism, producing a colourimetric and spectroscopic blueshift (544 nm (purple) > 524 nm (red)). Furthermore, lateral-flow-assays that utilise gold-aptamer-nanoconstructs were unaffected by contaminating human genomic DNA, demonstrated rapid detection of conserved target enteroviral nucleic acid sequence (< 60 s) and could be interpreted with a bespoke software and hardware electronic interface. We anticipate our methodology will translate in-silico screening of nucleic acid databases to a tangible enteroviral desktop detector, which could be readily translated to related organisms. This will pave-the-way forward in the clinical evaluation of disease and complement existing strategies at overcoming antimicrobial resistance.</p>

scholarly journals Integrating high-performing electrochemical transducers in lateral flow assay

2021 ◽  
Author(s):  
Antonia Perju ◽  
Nongnoot Wongkaew
Keyword(s):  
High Performance ◽  
Point Of Care ◽  
Low Cost ◽  
High Sensitivity ◽  
Lateral Flow ◽  
Analytical Performance ◽  
Label Free ◽  
High Performing ◽  
Lateral Flow Assays ◽  
Electrochemical Transducers

AbstractLateral flow assays (LFAs) are the best-performing and best-known point-of-care tests worldwide. Over the last decade, they have experienced an increasing interest by researchers towards improving their analytical performance while maintaining their robust assay platform. Commercially, visual and optical detection strategies dominate, but it is especially the research on integrating electrochemical (EC) approaches that may have a chance to significantly improve an LFA’s performance that is needed in order to detect analytes reliably at lower concentrations than currently possible. In fact, EC-LFAs offer advantages in terms of quantitative determination, low-cost, high sensitivity, and even simple, label-free strategies. Here, the various configurations of EC-LFAs published are summarized and critically evaluated. In short, most of them rely on applying conventional transducers, e.g., screen-printed electrode, to ensure reliability of the assay, and additional advances are afforded by the beneficial features of nanomaterials. It is predicted that these will be further implemented in EC-LFAs as high-performance transducers. Considering the low cost of point-of-care devices, it becomes even more important to also identify strategies that efficiently integrate nanomaterials into EC-LFAs in a high-throughput manner while maintaining their favorable analytical performance.

Development of a Smartphone Based Reader for the Quantitative Analysis of Lateral Flow Assays

2018 ◽  
Vol 941 ◽  
pp. 2522-2527
Author(s):  
Sylvio Schneider ◽  
Martina Selig ◽  
Verena Keil ◽  
Matthias Lehmann ◽  
Andreas H. Foitzik ◽  
...  
Keyword(s):  
Quantitative Analysis ◽  
Medical Devices ◽  
Limit Of Detection ◽  
Point Of Care ◽  
Thrombotic Event ◽  
Lateral Flow ◽  
Proof Of Concept ◽  
Lateral Flow Assays ◽  
Further Development ◽  
D Dimer

Smartphones are developing into all-purposes devices. In the present work, the employment/application of smartphones as medical devices in home care and point-of-care (POC) diagnostics are investigated in the analysis of Lateral Flow Assays (LFA). A smartphone-based LFA reader was developed for the quantitative analysis of D-Dimer – a biomarker indicating e.g. thrombotic event or danger of embolism.The proof-of-concept has been shown with multiple smartphones in establishing: (I) Optimal dimensions of the LFA cell of 72.11mm distance of smartphone to D-Dimer test leading to a coefficients of variances (CV) between 0.8% and 4.2%. (II) Inter-device investigations: CVs around 13.5%; a limit of detection (LOD) of 100ng/ml (DDU) D-Dimer. (III) Inter-smartphone investigations: CV about 16%, a limit of detection (LOD) at 66.4ng/ml (DDU). (IV) Calibrations: CV and LOD of three smartphones are comparable to the commercial available LFA reader. Further development to put the multiple smartphone-based LFA reader on the market.

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