scholarly journals Evaluation of the accuracy and ease-of-use of Abbott PanBio - A WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2

2020 ◽  
Author(s):  
L.J. Krüger ◽  
M. Gaeddert ◽  
F. Tobian ◽  
F. Lainati ◽  
C. Gottschalk ◽  
...  
Keyword(s):  
Diagnostic Test ◽  
Point Of Care ◽  
Independent Study ◽  
Ease Of Use ◽  
Routine Testing ◽  
System Usability Scale ◽  
Accuracy Study ◽  
Internal Funds ◽  
Charité Berlin ◽  
Large Manufacturer

AbstractBackgroundDiagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic is needed to support testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT).MethodsThis prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with RT-PCR, a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub analyses accordingly to cycle-threshold values, days of symptoms, disease severity and study site. Additionally, an ease-of-use assessment and System Usability Scale (SUS) were performed.Findings1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9·6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86·8% (95% CI: 79·0% - 92·0%) and a specificity of 99·9% (95% CI: 99·4%-100%). The sub analyses indicated that sensitivity was 95·8% in CT-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of- care settings.InterpretationThe Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources.FundingThe Foundation of Innovative New Diagnostics supplied the test kits for the study. The internal funds from the Heidelberg University as well as the Charité Berlin supported this study.

scholarly journals The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2—Evaluation of the accuracy and ease-of-use

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0247918
Author(s):  
Lisa J. Krüger ◽  
Mary Gaeddert ◽  
Frank Tobian ◽  
Federica Lainati ◽  
Claudius Gottschalk ◽  
...  
Keyword(s):  
Diagnostic Test ◽  
Symptom Onset ◽  
Point Of Care ◽  
Independent Study ◽  
Ease Of Use ◽  
Routine Testing ◽  
System Usability Scale ◽  
Accuracy Study ◽  
Polymerase Chain ◽  
Large Manufacturer

Objectives Diagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic device is needed for effective testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT). Methods This prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with reverse-transcriptase polymerase chain reaction (RT-PCR), a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub-analyses accordingly to cycle-threshold values, days after symptom onset, disease severity and study site. Additionally, an ease-of-use assessment (EoU) and System Usability Scale (SUS) were performed. Results 1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9.6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86.8% (95% CI: 79.0% - 92.0%) and a specificity of 99.9% (95% CI: 99.4%-100%). The sub-analyses indicated that sensitivity was 95.8% in Ct-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of-care settings. Conclusion The Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources.

scholarly journals Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2

2020 ◽  
Author(s):  
L.J. Krüger ◽  
M. Gaeddert ◽  
L. Köppel ◽  
L. E. Brümmer ◽  
C. Gottschalk ◽  
...  
Keyword(s):  
Limit Of Detection ◽  
Point Of Care ◽  
Ease Of Use ◽  
Rt Pcr ◽  
Large Variability ◽  
Point Of Care Diagnostics ◽  
System Usability Scale ◽  
Accuracy Study ◽  
The Uk ◽  
Analytical Limit

AbstractBackgroundReliable point-of-care (POC) diagnostics not requiring laboratory infrastructure could be a game changer in the COVID-19 pandemic, particularly in the Global South. We assessed performance, limit of detection and ease-of-use of three antigen-detecting, rapid POC tests (Ag-RDT) for SARS-CoV-2.MethodsThis prospective, multi-centre diagnostic accuracy study recruited participants suspected to have SARS-CoV-2 in Germany and the UK. Paired nasopharyngeal swabs (NP) or NP and/or oropharyngeal swabs (OP) were collected from participants (one for clinical RT-PCR and one for Ag-RDT). Performance of each of three Ag-RDTs was compared to RT-PCR overall, and according to predefined subcategories e.g. cycle threshold (CT)-value, days from symptoms onset, etc. In addition, limited verification of the analytical limit-of-detection (LOD) was determined. To understand the usability a System Usability Scale (SUS) questionnaire and ease-of-use (EoU) assessment were performed.ResultsBetween April 17th and August 25th, 2020, 2417 participants were enrolled, with 70 (3.0%) testing positive by RT-PCR. The best-performing test (SD Biosensor, Inc. STANDARD Q) was 76×6% (95% Confidence Interval (CI) 62×8-86×4) sensitive and 99×3% (CI 98×6-99×6) specific. A sub-analysis showed all samples with RT-PCR CT-values <25 were detectable by STANDARD Q. The test was considered easy-to-use (SUS 86/100) and suitable for POC. Bioeasy and Coris showed specificity of 93×1% (CI 91×0%-94×8%) and 95×8% (CI 93×4%-97×4%), respectively, not meeting the predefined target of ≥98%.ConclusionThere is large variability in performance of Ag-RDT with SD Biosensor showing promise. Given the usability at POC, this test is likely to have impact despite imperfect sensitivity; however further research and modelling are needed.

scholarly journals Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected anterior nasal swab versus professional-collected nasopharyngeal swab

2020 ◽  
Author(s):  
Andreas K. Lindner ◽  
Olga Nikolai ◽  
Franka Kausch ◽  
Mia Wintel ◽  
Franziska Hommes ◽  
...  
Keyword(s):  
Point Of Care ◽  
Rapid Test ◽  
High Viral Load ◽  
Ease Of Use ◽  
Healthcare Personnel ◽  
Nasopharyngeal Swab ◽  
Swab Sample ◽  
Rt Pcr ◽  
Percent Agreement ◽  
Accuracy Study

AbstractBackgroundTwo antigen-detecting rapid diagnostic tests (Ag-RDTs) are now approved through the WHO Emergency Use Listing procedure and can be performed at the point-of-care. However, both tests use nasopharyngeal (NP) swab samples. NP swab samples must be collected by trained healthcare personnel with protective equipment and are frequently perceived as uncomfortable by patients.MethodsThis was a manufacturer-independent, prospective diagnostic accuracy study with comparison of a supervised, self-collected anterior nose (AN) swab sample with a professional-collected NP swab sample, using a WHO-listed SARS-CoV-2 Ag-RDT, STANDARD Q COVID-19 Ag Test (SD Biosensor), which is also being distributed by Roche. The reference standard was RT-PCR from an oro-/nasopharyngeal swab sample. Percent positive and negative agreement as well as sensitivity and specificity were calculated.ResultsAmong the 289 participants, 39 (13.5%) tested positive for SARS-CoV-2 by RT-PCR. The positive percent agreement of the two different sampling techniques for the Ag-RDT was 90.6% (CI 75.8-96.8). The negative percent agreement was 99.2% (CI 97.2-99.8). The Ag-RDT with AN sampling showed a sensitivity of 74.4% (29/39 PCR positives detected; CI 58.9-85.4) and specificity of 99.2% (CI 97.1-99.8) compared to RT-PCR. The sensitivity with NP sampling was 79.5% (31/39 PCR positives detected; CI 64.5-89.2) and specificity was 99.6% (CI 97.8-100). In patients with high viral load (>7.0 log 10 RNA SARS-CoV2/swab), the sensitivity of the Ag-RDT with AN sampling was 96% and 100% with NP sampling.ConclusionSupervised self-sampling from the anterior nose is a reliable alternative to professional nasopharyngeal sampling using a WHO-listed SARS-CoV-2 Ag-RDT. Considering the ease-of-use of Ag-RDTs, self-sampling and potentially patient self-testing at home may be a future use case.

scholarly journals Aeroallergen sensitisation for detecting asthma in primary care: a diagnostic test accuracy study

2021 ◽  
Author(s):  
Janwillem W.H. Kocks ◽  
Heinze J.H. Andringa ◽  
Ellen van Heijst ◽  
Renaud Louis ◽  
Inigo Ojanguren Arranz ◽  
...  
Keyword(s):  
Primary Care ◽  
Diagnostic Test ◽  
Diagnostic Test Accuracy ◽  
Test Accuracy ◽  
Accuracy Study

scholarly journals The Collaborative Metadata Repository (CoMetaR) Web App: Quantitative and Qualitative Usability Evaluation (Preprint)

2021 ◽  
Author(s):  
Mark R Stöhr ◽  
Andreas Günther ◽  
Raphael W Majeed
Keyword(s):  
Qualitative Analysis ◽  
Medical Informatics ◽  
Ease Of Use ◽  
Metadata Management ◽  
System Usability Scale ◽  
Standards And Guidelines ◽  
Use Efficiency ◽  
Metadata Repository ◽  
Web App ◽  
Further Development

BACKGROUND In the field of medicine and medical informatics, the importance of comprehensive metadata has long been recognized, and the composition of metadata has become its own field of profession and research. To ensure sustainable and meaningful metadata are maintained, standards and guidelines such as the FAIR (Findability, Accessibility, Interoperability, Reusability) principles have been published. The compilation and maintenance of metadata is performed by field experts supported by metadata management apps. The usability of these apps, for example, in terms of ease of use, efficiency, and error tolerance, crucially determines their benefit to those interested in the data. OBJECTIVE This study aims to provide a metadata management app with high usability that assists scientists in compiling and using rich metadata. We aim to evaluate our recently developed interactive web app for our collaborative metadata repository (CoMetaR). This study reflects how real users perceive the app by assessing usability scores and explicit usability issues. METHODS We evaluated the CoMetaR web app by measuring the usability of 3 modules: <i>core module</i>, <i>provenance module</i>, and <i>data integration module</i>. We defined 10 tasks in which users must acquire information specific to their user role. The participants were asked to complete the tasks in a live web meeting. We used the System Usability Scale questionnaire to measure the usability of the app. For qualitative analysis, we applied a modified think aloud method with the following thematic analysis and categorization into the ISO 9241-110 usability categories. RESULTS A total of 12 individuals participated in the study. We found that over 97% (85/88) of all the tasks were completed successfully. We measured usability scores of 81, 81, and 72 for the 3 evaluated modules. The qualitative analysis resulted in 24 issues with the app. CONCLUSIONS A usability score of 81 implies very good usability for the 2 modules, whereas a usability score of 72 still indicates acceptable usability for the third module. We identified 24 issues that serve as starting points for further development. Our method proved to be effective and efficient in terms of effort and outcome. It can be adapted to evaluate apps within the medical informatics field and potentially beyond.

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