scholarly journals Assessment of Commercial SARS-CoV-2 Antibody Assays, Jamaica

Author(s):  
Tiffany R Butterfield ◽  
Alrica Bruce-Mowatt ◽  
Yakima Z R Phillips ◽  
Nicole Brown ◽  
Keisha Francis ◽  
...  

The performance of the Roche Elecsys® Anti-SARS-CoV-2, Abbott Architect SARS-CoV-2 IgG, Euroimmun SARS-CoV-2 IgA, Euroimmun SARS-CoV-2 IgG ELISA, and Trillium IgG/IgM rapid assays was evaluated in Jamaica, the largest country of the English-speaking Caribbean. Diagnostic sensitivities of the assays were assessed by testing serum samples from SARS-CoV-2 PCR-confirmed persons. Serum samples collected ≥14 days after onset of symptoms, or ≥14 days after an initial SARS-CoV-2 RT-PCR positive test for asymptomatics, showed diagnostic sensitivities ranging from 67.9-75.0% when including all possible disease severities and increased to 90.0-95.0% when examining those with moderate to critical disease. Grouping moderate to critical disease showed a significant association with a SARS-CoV-2 antibody positive result for all assays. Diagnostic specificity, assessed by testing serum samples collected during 2018-2019 from healthy persons and from persons with antibodies to a wide range of viral infections, ranged from 96.7-100.0%. For all assays examined, SARS-CoV-2 real-time PCR cycle threshold (Ct) values of the initial nasopharyngeal swab sample testing positive were significantly different for samples testing antibody positive versus negative. These data from a predominantly African descent Caribbean population shows comparable diagnostic sensitivities and specificities for all testing platforms assessed and limited utility of these tests for persons with asymptomatic and mild infections.

2020 ◽  
Vol 26 (27) ◽  
pp. 3234-3250
Author(s):  
Sushil K. Kashaw ◽  
Prashant Sahu ◽  
Vaibhav Rajoriya ◽  
Pradeep Jana ◽  
Varsha Kashaw ◽  
...  

Potential short interfering RNAs (siRNA) modulating gene expression have emerged as a novel therapeutic arsenal against a wide range of maladies and disorders containing cancer, viral infections, bacterial ailments and metabolic snags at the molecular level. Nanogel, in the current medicinal era, displayed a comprehensive range of significant drug delivery prospects. Biodegradation, swelling and de-swelling tendency, pHsensitive drug release and thermo-sensitivity are some of the renowned associated benefits of nanogel drug delivery system. Global researches have also showed that nanogel system significantly targets and delivers the biomolecules including DNAs, siRNA, protein, peptides and other biologically active molecules. Biomolecules delivery via nanogel system explored a wide range of pharmaceutical, biomedical engineering and agro-medicinal application. The siRNAs and DNAs delivery plays a vivacious role by addressing the hitches allied with chronic and contemporary therapeutic like generic possession and low constancy. They also incite release kinetics approach from slow-release while mingling to rapid release at the targets will be beneficial as interference RNAs delivery carriers. Therefore, in this research, we focused on the latest improvements in the delivery of siRNA loaded nanogels by enhancing the absorption, stability, sensitivity and combating the hindrances in cellular trafficking and release process.


Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 550
Author(s):  
Peter A. C. Maple

In the UK, population virus or antibody testing using virus swabs, serum samples, blood spots or oral fluids has been performed to a limited extent for several diseases including measles, mumps, rubella and hepatitis and HIV. The collection of population-based infection and immunity data is key to the monitoring of disease prevalence and assessing the effectiveness of interventions such as behavioural modifications and vaccination. In particular, the biological properties of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and its interaction with the human host have presented several challenges towards the development of population-based immunity testing. Measuring SARS-CoV-2 immunity requires the development of antibody assays of acceptable sensitivity and specificity which are capable of accurately detecting seroprevalence and differentiating protection from non-protective responses. Now that anti-COVID-19 vaccines are becoming available there is a pressing need to measure vaccine efficacy and the development of herd immunity. The unprecedented impact of the SARS-CoV-2 pandemic in the UK in terms of morbidity, mortality, and economic and social disruption has mobilized a national scientific effort to learn more about this virus. In this article, the challenges of testing for SARS-CoV-2 infection, particularly in relation to population-based immunity testing, will be considered and examples given of relevant national level studies.


2020 ◽  
Vol 45 (5) ◽  
pp. 491-498
Author(s):  
Fatih Yesildal ◽  
Ferruh Kemal Isman

AbstractObjectiveCOVID-19 pandemia still continues to threaten the whole world. High dose ascorbic acid (AA) infusion is a choice of treatment and its efficiency is still being investigated. AA interferes with many clinical chemistry tests. However, data about the interference of high concentrations of AA is not sufficient. In this study, we aimed to investigate the interference of AA at high concentrations on commonly used chemistry assays.Materials and MethodsSerum samples at AA concentrations of 200, 150, 100, 75, 50, 25, 10, 5, 2 and 0 mg/dL were prepared by using the stock solution of 15000 mg/dL AA. Each sample was analyzed by using the most common 30 chemistry tests (Abbott Architect C8000, Illinois, USA) and a POCT glucometer (STANDARD GlucoNavii, Gyeonggi-do, Republic of Korea).ResultsCreatinine, sodium and glucose (POCT) tests were found to be positively interfered by increasing AA concentrations; while direct bilirubin, lipase, UIBC, triglyceride, total cholesterol, HDL/LDL cholesterol tests were negatively interfered. Absolute interference (%) increased as the AA concentration increased.ConclusionThis is the largest and first study to investigate the interference of high dose AA, which is used in severe COVID-19 patients nowadays. Manufacturers and clinicians should be aware of the possibility of aberrant results due to high dose AA infusion. Clinicians should not forget to consult a laboratory specialist, since he is the only person to monitor the reactions in all assays, and know the technical subjects like interferences, assay method specifications. This issue is very important for correct decision-making and interpretation of the data-mining studies accurately and efficiently.


Author(s):  
Walaa A. Kamel ◽  
Ismail Ibrahim Ismail ◽  
Mohamed Ibrahim ◽  
Jasem Y. Al-Hashel

Abstract Background Parkinson’s disease (PD) is a neurodegenerative condition that has been reported following viral infections in rare occasions. Several neurological complications have emerged in association with coronavirus disease 2019 (COVID-19), since its declaration as a pandemic. Herein, we present a novel case of unexplained worsening of PD as the sole initial presentation of COVID-19, in the absence of fever or respiratory symptoms. Case presentation A 56-year-old male with advanced PD presented with severe rigidity, dystonic posturing of both feet, and confusion of 4 days duration. His condition progressed to an akinetic-rigid state and confusion during the following week, and a routine nasopharyngeal swab tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on the 9th day of onset. He developed fever and dyspnea later and was intubated on the 10th day. Conclusion To our knowledge, worsening of PD symptoms as the sole initial manifestation of SARS-CoV-2 infection, in the absence of other cardinal features of COVID-19, has not been reported in the literature. We suggest testing for COVID-19 infection in patients with PD, especially advanced cases, who present with unexplained worsening of symptoms, even in the absence of COVID-19 cardinal features.


Author(s):  
Timo Huber ◽  
Philipp Steininger ◽  
Pascal Irrgang ◽  
Klaus Korn ◽  
Matthias Tenbusch ◽  
...  

AbstractSARS-CoV-2 antibody assays are used for epidemiological studies and for the assessment of vaccine responses in highly vulnerable patients. So far, data on cross-reactivity of SARS-CoV-2 antibody assays is limited. Here, we compared four enzyme-linked immunosorbent assays (ELISAs; Vircell SARS-CoV-2 IgM/IgA and IgG, Euroimmun SARS-CoV-2 IgA and IgG) for detection of anti-SARS-CoV-2 antibodies in 207 patients with COVID-19, 178 patients with serological evidence of different bacterial infections, 107 patients with confirmed viral respiratory disease, and 80 controls from the pre-COVID-19 era. In COVID-19 patients, the assays showed highest sensitivity in week 3 (Vircell-IgM/A and Euroimmun-IgA: 78.9% each) and after week 7 (Vircell-IgG: 97.9%; Euroimmun-IgG: 92.1%). The antibody indices were higher in patients with fatal disease. In general, IgM/IgA assays had only limited or no benefit over IgG assays. In patients with non-SARS-CoV-2 respiratory infections, IgG assays were more specific than IgM/IgA assays, and bacterial infections were associated with more false-positive results than viral infections. The specificities in bacterial and viral infections were 68.0 and 81.3% (Vircell-IgM/IgA), 84.8 and 96.3% (Euroimmun-IgA), 97.8 and 86.0% (Vircell-IgG), and 97.8 and 99.1% (Euroimmun-IgG), respectively. Sera from patients positive for antibodies against Mycoplasma pneumoniae, Chlamydia psittaci, and Legionella pneumophila yielded particularly high rates of unspecific false-positive results in the IgM/IgA assays, which was revealed by applying a highly specific flow-cytometric assay using HEK 293 T cells expressing the SARS-CoV-2 spike protein. Positive results obtained with anti-SARS-CoV-2 IgM/IgA ELISAs require careful interpretation, especially if there is evidence for prior bacterial respiratory infections.


Author(s):  
Mary Kathryn Bohn ◽  
Siobhan Wilson ◽  
Alexandra Hall ◽  
Khosrow Adeli

Abstract Objectives The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays. Methods Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established. Results Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life. Conclusions Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.


2015 ◽  
Author(s):  
Αιμιλία Ψαρούλη

Recent developments in the fields of bioanalytical chemistry and microelectronics have resulted in a growing trend of transferring the classical analytical methods from the laboratory bench to the field through the development of portable devices or microsystems based on biosensors. Biosensors are self-contained integrated devices capable to provide analytical information using biological recognition molecules in direct spatial contact with a transducer. Biosensors using antibodies or antigens as biological recognition elements are termed as immunosensors and they are based on the same principle as the classical solid-phase immunoassays.The aim of this thesis was to develop and evaluate an optical immunosensor based on Mach-Zehnder Interferometry and integrated on silicon substrate for the immunochemical determination of clinical analytes. The optical sensor developed is fabricated entirely by mainstream silicon technology by the Optical Biosensors group of the Institute of Nanoscience and Nanotechnology of NCSR “Demokritos” and combines arrays of ten sensors in a single silicon chip. Each sensor consists of an integrated on silicon light source that emits a broad spectrum in visible-near ultraviolet range and it is coupled to an integrated silicon nitride waveguide which has been patterned into Mach-Zehnder interferometer. The signal is recorded either through a photodetector monolithically integrated onto the same silicon chip (fully integrated configuration) or through an external spectrometer (semi-integrated configuration). In the fully integrated configuration, the signal recorded is the total photocurrent across the whole spectral range, while in semi-integrated configuration the whole transmission spectrum is continuously recorded and is mathematically transformed (Fourier Transform) to phase shift. As in the classical Mach-Zehnder interferometers, the waveguide in the proposed sensor is split into two arms, the sensing one which is appropriately modified with recognition biomolecule and the reference arm that is covered by a protective layer. The specific binding of the analyte with the immobilized onto the surface recognition biomolecule causes an effective refractive index change at the surface of the sensing arm thus affecting the phase of the waveguided light with respect to the reference arm. Thus, when the two arms converge again, an interference spectrum is generated that is altered during bioreaction providing the ability of monitoring in real-time and without using labels. The main difference of the sensor developed with respect to classical Mach-Zehnder interferometers is that the light source is monolithically integrated on the same silicon substrate with the waveguides and the waveguided light is not monochromatic, but broad spectrum.At first in this study, the method for chemical activation of biofunctionalization of chips was optimized. It was found that the highest signals were obtained when chips where activated by (3-aminopropyl)triethoxysilane and deposition of biomolecules solutions using a microarray spotter. Then, a comparison of the two sensor configurations, i.e. the fully and the semi-integrated configuration was performed using a model binding assay namely the streptavidin-biotin reaction. Semi-integrated configuration provided higher detection sensitivities mainly due to lower between-sensor signal variation in the same chip and between different chips. Thus, this configuration was selected for further evaluation with respect to the determination of analytes of clinical interest and especially of immunochemical determination of C-reactive protein in human serum samples. CRP is a marker of inflammation widely used in everyday clinical practice for diagnosis and therapy monitoring of inflammatory situations. Nevertheless, CRP has been also proposed as a prognostic marker of myocardial infraction and three risk levels have been established; low risk for serum CRP concentrations < 1 μg/mL; medium risk for concentrations in the range 1-3 μg/mL; and high risk for concentrations >3 μg/mL. In the frame of the present thesis, enzyme immunoassays for the determination of CRP in microtitration plates both competitive and non-competitive were developed in order to select the most appropriate reagents and define the immunoassay conditions. Then both assay format were transferred and evaluated on the sensor. It was found that the non-competitive format offered higher responses and ability for regeneration of immobilized onto the sensor antibody against CRP and was therefore selected for the final sensor evaluation. The assay developed following the competitive format was sensitive and accurate as was demonstrated through recovery and dilution linearity experiments, and provided for analysis of samples with a wide range of CRP concentrations since it was immune to the presence of serum. In addition, the CRP values determined with the immunosensor developed in serum samples from unknown donors were in good agreement with those determined for the same samples by commercially available kits and instruments showing the reliability of the determinations performed with the immunosensor developed and its potential for analysis of clinical samples.


2012 ◽  
Vol 59 (2) ◽  
pp. 214-244 ◽  
Author(s):  
JAMES ROBSON

The reception of Aristophanes has gained extraordinary momentum as a topic of academic interest in the last few years. Contributions range from Gonda Van Steen's ground-breaking Venom in Verse. Aristophanes in Modern Greece to Hall and Wrigley's Aristophanes in Performance 421 BC–AD 2007, which contains contributions from a wide range of scholars and writers, a number of whom have had experience of staging Aristophanes' plays as live theatre. In Found in Translation, J. Michael Walton has also made strides towards marrying the theory of translation to the practice of translating Aristophanes (something I have myself also sought to do in print). And with the history of Aristophanic translation, adaptation, and staging being rapidly pieced together (in the English-speaking world at least, where Hall, Steggle, Halliwell, Sowerby, Walsh, and Walton, for example, have all made their own contributions), much of the groundwork has been laid for a study such as is attempted in this article. Here I aim to take a broad look across a range of translations in order to see how one particular text type within Aristophanic drama has been approached by translators, namely Aristophanes' lyric passages. The aim of this study will be to give both an insight into the numerous considerations that translators take into account when translating Aristophanic lyric and an impression of the range of end products that have emerged over the last two hundred years.


2020 ◽  
Vol 21 (8) ◽  
pp. 2748 ◽  
Author(s):  
Ruth Barral-Arca ◽  
Alberto Gómez-Carballa ◽  
Miriam Cebey-López ◽  
María José Currás-Tuala ◽  
Sara Pischedda ◽  
...  

There is a growing interest in unraveling gene expression mechanisms leading to viral host invasion and infection progression. Current findings reveal that long non-coding RNAs (lncRNAs) are implicated in the regulation of the immune system by influencing gene expression through a wide range of mechanisms. By mining whole-transcriptome shotgun sequencing (RNA-seq) data using machine learning approaches, we detected two lncRNAs (ENSG00000254680 and ENSG00000273149) that are downregulated in a wide range of viral infections and different cell types, including blood monocluclear cells, umbilical vein endothelial cells, and dermal fibroblasts. The efficiency of these two lncRNAs was positively validated in different viral phenotypic scenarios. These two lncRNAs showed a strong downregulation in virus-infected patients when compared to healthy control transcriptomes, indicating that these biomarkers are promising targets for infection diagnosis. To the best of our knowledge, this is the very first study using host lncRNAs biomarkers for the diagnosis of human viral infections.


2019 ◽  
Vol 3 (6) ◽  
pp. 936-942 ◽  
Author(s):  
Jayson V Pagaduan ◽  
Estella Tam ◽  
Sridevi Devaraj

Abstract Background Procalcitonin (PCT) is an emerging biomarker for detecting sepsis. Recently, the US Food and Drug Administration cleared the expanded use of this biomarker for guiding clinicians regarding antibiotic treatment. To our knowledge, there are no published method validations for the Abbott Architect PCT assay. This article will discuss the process of method validation of the B·R·A·H·M·S PCT assay on the Abbott Architect platform. Methods We studied the precision, accuracy, and linearity of the Architect method following the guidance of the Clinical and Laboratory Standards Institute EP5-A2 document. Furthermore, we also tested the impact of major sources of interference from hemolysate, lipoproteins, and bilirubin. To validate the Architect method, we compared patients' serum PCT measurements with our previously established Mini VIDAS (bioMerieux) PCT assay. Results Statistical analysis showed that the 2 assays have good correlation (r &gt; 0.99), slope of 1.023, and intercept of −0.760. The calculated bias is −7.435%. The Architect method showed good precision with %CV &lt; 3.5% for both interassay and intraassay compared with %CV &lt; 6.5% for Mini VIDAS, which was previously determined at our institution. No bias &gt;10% was observed with the Architect method when pooled serum samples were spiked with interferants. The turnaround time for both platforms was the same (20 min); however, in contrast with Mini VIDAS, the Architect system has automated pipetting of samples and can perform multiple assays simultaneously. Conclusion These results showed that the Architect B·R·A·H·M·S PCT assay has analytical characteristics conducive for diagnostic use in clinical laboratories. Our method validation report will be beneficial for other institutions to adapt this assay on existing Abbott Architect i1000 immunoassay analyzers.


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