scholarly journals Comparative sensitivity evaluation for 122 CE-marked SARS-CoV-2 antigen rapid tests

2021 ◽  
Author(s):  
Heinrich Scheiblauer ◽  
Angela Filomena ◽  
Andreas Nitsche ◽  
Andreas Puyskens ◽  
Victor Corman ◽  
...  
Keyword(s):  
Market Access ◽  
High Sensitivity ◽  
Lower Sensitivity ◽  
Viral Loads ◽  
Sensitivity Evaluation ◽  
Independent Evaluation ◽  
Wide Range ◽  
German Healthcare System ◽  
Rapid Tests ◽  
Minimum Sensitivity

Abstract Objective Independent evaluation of the sensitivity of CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) offered in Germany. Method The sensitivity of 122 Ag RDT was adressed using a common evaluation panel. Minimum sensitivity of 75% for panel members with CT<25 was used for differentiation of devices eligible for reimbursement in in the German healthcare system. Results The sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with CT <25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which were completely failing. Some devices exhibited high sensitivity, e.g. 100% for CT<30. Conclusion This comparative evaluation succeeded to distinguish less sensitive from better performing Ag RDT. Most of the Ag RDT evaluated appear to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.

scholarly journals Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021

2021 ◽  
Vol 26 (44) ◽  
Author(s):  
Heinrich Scheiblauer ◽  
Angela Filomena ◽  
Andreas Nitsche ◽  
Andreas Puyskens ◽  
Victor M Corman ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Market Access ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Lower Sensitivity ◽  
Viral Loads ◽  
Sensitivity Evaluation ◽  
Wide Range ◽  
German Healthcare System ◽  
Minimum Sensitivity

Introduction Numerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims. Aim We performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany. Methods We addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system. Results The sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30. Conclusions This comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.

scholarly journals Screening for SARS-CoV-2 infections with colorimetric RT-LAMP and LAMP sequencing

2020 ◽  
Author(s):  
Viet Loan Dao Thi ◽  
Konrad Herbst ◽  
Kathleen Boerner ◽  
Matthias Meurer ◽  
Lukas PM Kremer ◽  
...  
Keyword(s):  
Public Health Problem ◽  
Lamp Assay ◽  
Rna Isolation ◽  
Cycle Number ◽  
Clinical Patient ◽  
Viral Loads ◽  
Wide Range ◽  
Significant Public Health ◽  
Validation Procedure ◽  
Rapid Tests

AbstractThe COVID-19 pandemic caused by the novel SARS-CoV-2 virus poses a significant public-health problem. In order to control the pandemic, rapid tests for detecting existing infections and assessing virus spread are critical.Approaches to detect viral RNA based on reverse transcription loop-mediated isothermal amplification (RT-LAMP) hold outstanding promise towards greatly simplified and broadly applicable testing methods. RT-LAMP assays appear more robust than qPCR-based methods and only require incubation at a constant temperature, thus eliminating the need for sophisticated instrumentation.Here, we tested a two-color RT-LAMP protocol using clinical SARS-CoV-2 samples and also established a protocol that does not require prior RNA isolation (“swab-to-RT-LAMP”). Our study is based on several hundred clinical patient samples with a wide range of viral loads, thus allowing, for the first time, to accurately determine the sensitivity and specificity of the RT-LAMP assay for the detection of SARS-CoV-2 in patients. We found that RT-LAMP can reliably detect SARS-CoV-2 samples with a qPCR threshold cycle number (CT value) of up to 30 in the standard RT-qPCR assay. We used both, either purified RNA or direct pharyngeal swab specimens and showed that RT-LAMP assays have, despite a decreased sensitivity compared to RT-qPCR, excellent specificity. We also developed a multiplexed LAMP-sequencing protocol as a diagnostic and validation procedure to detect and record the outcome of RT-LAMP assays. LAMP-sequencing is fully scalable and can assess the results of thousands of LAMP reactions in parallel. Finally, we propose applications of RT-LAMP based assays for SARS-CoV-2 detection.

scholarly journals Identifying and Minimising Uncertainty for Experimental Journal Bearing Studies

2005 ◽  
Vol 2005 (3) ◽  
pp. 221-231 ◽  
Author(s):  
G. D. Wale ◽  
D. Mba
Keyword(s):  
Measurement Errors ◽  
Best Practice ◽  
Journal Bearing ◽  
High Sensitivity ◽  
Lower Sensitivity ◽  
Sources Of Error ◽  
Wide Range ◽  
Experimental Errors ◽  
Source Of Information ◽  
Good Agreement

Over the last few decades, different experimental methods, with varying forms of data analysis, have been employed on a wide range of journal bearing types. Under these circumstances, it is not surprising that the results presented, and their accuracy, are subject to varying scatter. Many of the assessments have been rather imprecise, often using unquantified statements such as “generally good agreement with predictions.” Most authors seem to have accepted that the appreciable scatter of results, especially in the dynamic oil film coefficients, was inevitable. Uncertainty is defined as the estimate of the errors. Note that the estimate may often be too optimistic because some sources of error have not been identified. This paper highlights sources of error for experimental journal studies, including some associated with the measurement system and physical misalignment. It is intended that this paper presents a coherent source of information on best practice in the field of experimental bearing research, offering a clearly prescribed methodology to estimate uncertainty and reduce error. The results of calculations of the sensitivity of the dynamic bearing coefficients to experimental errors in some commonly used rig configurations are presented. It is shown that one of the excitation schemes gives significantly lower sensitivity, but even this scheme has quite high sensitivity to measurement errors, especially phase. In conclusion, some of the critical precautions in the search for good quality results for experimental journal bearing studies are described.

scholarly journals Implementing SARS-CoV-2 Rapid Antigen Testing in the Emergency Ward of a Swiss University Hospital: The INCREASE Study

2021 ◽  
Vol 9 (4) ◽  
pp. 798
Author(s):  
Giorgia Caruana ◽  
Antony Croxatto ◽  
Eleftheria Kampouri ◽  
Antonios Kritikos ◽  
Onya Opota ◽  
...  
Keyword(s):  
Immunoglobulin A ◽  
University Hospital ◽  
Lower Sensitivity ◽  
Clinical Settings ◽  
Rt Pcr ◽  
Emergency Ward ◽  
Viral Loads ◽  
Asymptomatic Patients ◽  
Asymptomatic Subjects ◽  
Antigen Testing

Following the Swiss Federal Office of Public Health (FOPH) authorization of the rapid antigen test (RAT), we implemented the use of the RAT in the emergency ward of our university hospital for patients’ cohorting. RAT triaging in association with RT-PCR allowed us to promptly isolate positive patients and save resources. Among 532 patients, overall sensitivities were 48.3% for Exdia and 41.2% for Standard Q®, PanbioTM and BD Veritor™. All RATs exhibited specificity above 99%. Sensitivity increased to 74.6%, 66.2%, 66.2% and 64.8% for Exdia, Standard Q®, PanbioTM and BD Veritor™, respectively, for viral loads above 105 copies/mL, to 100%, 97.8%, 96.6% and 95.6% for viral loads above 106 copies/mL and 100% for viral loads above 107 copies/mL. Sensitivity was significantly higher for patients with symptoms onset within four days (74.3%, 69.2%, 69.2% and 64%, respectively) versus patients with the evolution of symptoms longer than four days (36.8%, 21.1%, 21.1% and 23.7%, respectively). Among COVID-19 asymptomatic patients, sensitivity was 33%. All Immunoglobulin-A-positive patients resulted negative for RAT. The RAT might represent a useful resource in selected clinical settings as a complementary tool in RT-PCR for rapid patient triaging, but the lower sensitivity, especially in late presenters and COVID-19 asymptomatic subjects, must be taken into account.

scholarly journals Gold–Carbon Nanocomposites for Environmental Contaminant Sensing

Micromachines ◽  
2021 ◽  
Vol 12 (6) ◽  
pp. 719
Author(s):  
Shahrooz Rahmati ◽  
William Doherty ◽  
Arman Amani Babadi ◽  
Muhamad Syamim Akmal Che Mansor ◽  
Nurhidayatullaili Muhd Julkapli ◽  
...  
Keyword(s):  
Environmental Pollutants ◽  
High Sensitivity ◽  
Environmental Crisis ◽  
World Population ◽  
Chemical Contaminants ◽  
Carbon Nanocomposites ◽  
Minimal Sample ◽  
Wide Range ◽  
And Control ◽  
Analytical Tools

The environmental crisis, due to the rapid growth of the world population and globalisation, is a serious concern of this century. Nanoscience and nanotechnology play an important role in addressing a wide range of environmental issues with innovative and successful solutions. Identification and control of emerging chemical contaminants have received substantial interest in recent years. As a result, there is a need for reliable and rapid analytical tools capable of performing sample analysis with high sensitivity, broad selectivity, desired stability, and minimal sample handling for the detection, degradation, and removal of hazardous contaminants. In this review, various gold–carbon nanocomposites-based sensors/biosensors that have been developed thus far are explored. The electrochemical platforms, synthesis, diverse applications, and effective monitoring of environmental pollutants are investigated comparatively.

scholarly journals 60–700 K CTAT and PTAT Temperature Sensors with 4H-SiC Schottky Diodes

Sensors ◽  
2021 ◽  
Vol 21 (3) ◽  
pp. 942
Author(s):  
Razvan Pascu ◽  
Gheorghe Pristavu ◽  
Gheorghe Brezeanu ◽  
Florin Draghici ◽  
Philippe Godignon ◽  
...  
Keyword(s):  
Low Cost ◽  
Schottky Diodes ◽  
Schottky Contact ◽  
High Sensitivity ◽  
Xrd Analysis ◽  
Absolute Temperature ◽  
Lower Sensitivity ◽  
Readout Circuit ◽  
Sensing Element ◽  
High Performing

A SiC Schottky dual-diode temperature-sensing element, suitable for both complementary variation of VF with absolute temperature (CTAT) and differential proportional to absolute temperature (PTAT) sensors, is demonstrated over 60–700 K, currently the widest range reported. The structure’s layout places the two identical diodes in close, symmetrical proximity. A stable and high-barrier Schottky contact based on Ni, annealed at 750 °C, is used. XRD analysis evinced the even distribution of Ni2Si over the entire Schottky contact area. Forward measurements in the 60–700 K range indicate nearly identical characteristics for the dual-diodes, with only minor inhomogeneity. Our parallel diode (p-diode) model is used to parameterize experimental curves and evaluate sensing performances over this far-reaching domain. High sensitivity, upwards of 2.32 mV/K, is obtained, with satisfactory linearity (R2 reaching 99.80%) for the CTAT sensor, even down to 60 K. The PTAT differential version boasts increased linearity, up to 99.95%. The lower sensitivity is, in this case, compensated by using a high-performing, low-cost readout circuit, leading to a peak 14.91 mV/K, without influencing linearity.

scholarly journals Pulsed Electromagnetic Cross-Well Exploration for Monitoring Permafrost and Examining the Processes of Its Geocryological Changes

Geosciences ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 60
Author(s):  
Viacheslav Glinskikh ◽  
Oleg Nechaev ◽  
Igor Mikhaylov ◽  
Kirill Danilovskiy ◽  
Vladimir Olenchenko
Keyword(s):  
High Performance ◽  
Geophysical Methods ◽  
Three Dimensional ◽  
High Sensitivity ◽  
Data Interpretation ◽  
Industrial Facilities ◽  
Wide Range ◽  
Vector Finite Element ◽  
A New Technique ◽  
Pulsed Electromagnetic

This paper is dedicated to the topical problem of examining permafrost’s state and the processes of its geocryological changes by means of geophysical methods. To monitor the cryolithozone, we proposed and scientifically substantiated a new technique of pulsed electromagnetic cross-well sounding. Based on the vector finite-element method, we created a mathematical model of the cross-well sounding process with a pulsed source in a three-dimensional spatially heterogeneous medium. A high-performance parallel computing algorithm was developed and verified. Through realistic geoelectric models of permafrost with a talik under a highway, constructed following the results of electrotomography field data interpretation, we numerically simulated the pulsed sounding on the computing resources of the Siberian Supercomputer Center of SB RAS. The simulation results suggest the proposed system of pulsed electromagnetic cross-well monitoring to be characterized by a high sensitivity to the presence and dimensions of the talik. The devised approach can be oriented to addressing a wide range of issues related to monitoring permafrost rocks under civil and industrial facilities, buildings, and constructions.

scholarly journals Overview of Popular Techniques of Raman Spectroscopy and Their Potential in the Study of Plant Tissues

Molecules ◽  
2021 ◽  
Vol 26 (6) ◽  
pp. 1537
Author(s):  
Aneta Saletnik ◽  
Bogdan Saletnik ◽  
Czesław Puchalski
Keyword(s):  
Raman Spectroscopy ◽  
Cell Walls ◽  
Structural Changes ◽  
Spatial Information ◽  
Technological Development ◽  
Analytical Techniques ◽  
High Sensitivity ◽  
Plant Tissues ◽  
Wide Range ◽  
Identification Technique

Raman spectroscopy is one of the main analytical techniques used in optical metrology. It is a vibration, marker-free technique that provides insight into the structure and composition of tissues and cells at the molecular level. Raman spectroscopy is an outstanding material identification technique. It provides spatial information of vibrations from complex biological samples which renders it a very accurate tool for the analysis of highly complex plant tissues. Raman spectra can be used as a fingerprint tool for a very wide range of compounds. Raman spectroscopy enables all the polymers that build the cell walls of plants to be tracked simultaneously; it facilitates the analysis of both the molecular composition and the molecular structure of cell walls. Due to its high sensitivity to even minute structural changes, this method is used for comparative tests. The introduction of new and improved Raman techniques by scientists as well as the constant technological development of the apparatus has resulted in an increased importance of Raman spectroscopy in the discovery and defining of tissues and the processes taking place in them.

scholarly journals Estimating the number of usability problems affecting medical devices: modelling the discovery matrix

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Vincent Vandewalle ◽  
Alexandre Caron ◽  
Coralie Delettrez ◽  
Renaud Périchon ◽  
Sylvia Pelayo ◽  
...  
Keyword(s):  
Medical Devices ◽  
Market Access ◽  
Real Life ◽  
Usability Testing ◽  
Probability Of Detection ◽  
Usability Problems ◽  
Usability Problem ◽  
Wide Range ◽  
The Matrix ◽  
Problem Detection

Abstract Background Usability testing of medical devices are mandatory for market access. The testings’ goal is to identify usability problems that could cause harm to the user or limit the device’s effectiveness. In practice, human factor engineers study participants under actual conditions of use and list the problems encountered. This results in a binary discovery matrix in which each row corresponds to a participant, and each column corresponds to a usability problem. One of the main challenges in usability testing is estimating the total number of problems, in order to assess the completeness of the discovery process. Today’s margin-based methods fit the column sums to a binomial model of problem detection. However, the discovery matrix actually observed is truncated because of undiscovered problems, which corresponds to fitting the marginal sums without the zeros. Margin-based methods fail to overcome the bias related to truncation of the matrix. The objective of the present study was to develop and test a matrix-based method for estimating the total number of usability problems. Methods The matrix-based model was based on the full discovery matrix (including unobserved columns) and not solely on a summary of the data (e.g. the margins). This model also circumvents a drawback of margin-based methods by simultaneously estimating the model’s parameters and the total number of problems. Furthermore, the matrix-based method takes account of a heterogeneous probability of detection, which reflects a real-life setting. As suggested in the usability literature, we assumed that the probability of detection had a logit-normal distribution. Results We assessed the matrix-based method’s performance in a range of settings reflecting real-life usability testing and with heterogeneous probabilities of problem detection. In our simulations, the matrix-based method improved the estimation of the number of problems (in terms of bias, consistency, and coverage probability) in a wide range of settings. We also applied our method to five real datasets from usability testing. Conclusions Estimation models (and particularly matrix-based models) are of value in estimating and monitoring the detection process during usability testing. Matrix-based models have a solid mathematical grounding and, with a view to facilitating the decision-making process for both regulators and device manufacturers, should be incorporated into current standards.

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