Multicenter Technical Validation of 30 Rapid Antigen Tests for the Detection of SARS-CoV-2 (VALIDATE)

During COVID19 pandemic, SARS-CoV-2 rapid antigen tests (RATs) were marketed with minimal or no performance data. We aimed at closing this gap by determining technical sensitivities and specificities of 30 RATs prior to market release. We developed a standardized technical validation protocol and assessed 30 RATs across four diagnostic laboratories. RATs were tested in parallel using the Standard Q® (SD Biosensor/Roche) assay as internal reference. We used left-over universal transport/optimum media from nasopharyngeal swabs of 200 SARS-CoV-2 PCR-negative and 100 PCR-positive tested patients. Transport media was mixed with assay buffer and applied to RATs according to manufacturer instructions. Sensitivities were determined according to viral loads. Specificity of at least 99% and sensitivity of 95%, 90%, and 80% had to be reached for 107, 106, 105 virus copies/mL, respectively. Sensitivities ranged from 43.5% to 98.6%, 62.3% to 100%, and 66.7% to 100% at 105, 106, 107 copies/mL, respectively. Automated assay readers such as ExDia or LumiraDx showed higher performances. Specificities ranged from 88.8% to 100%. Only 15 of 30 (50%) RATs passed our technical validation. Due to the high failure rate of 50%, mainly caused by lack of sensitivity, we recommend a thorough validation of RATs prior to market release.

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Faculty Opinions recommendation of Midterm prospective evaluation of TVT-Secur reveals high failure rate.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.3739960.3466059 ◽

2010 ◽

Author(s):

Apostolos Apostolidis ◽

Athanassios Oeconomou

Keyword(s):

Failure Rate ◽

Prospective Evaluation ◽

High Failure Rate

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High failure rate of cementless threaded acetabular cups:A radiographic and histologic study in the goat

Acta Orthopaedica Scandinavica ◽

10.3109/17453679608994657 ◽

1996 ◽

Vol 67 (2) ◽

pp. 133-137 ◽

Cited By ~ 5

Author(s):

Jon D Bruijn ◽

Jan L Seelen ◽

Roel W Veldhuizen ◽

Rob M Feenstra ◽

Frans P Bernoski ◽

...

Keyword(s):

Failure Rate ◽

High Failure Rate ◽

Histologic Study

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INNOVATIVE BEHAVIOUR OF INDIAN MICRO SMALL AND MEDIUM ENTERPRISES: AN EMPIRICAL STUDY

International Journal of Innovation Management ◽

10.1142/s136391961750061x ◽

2017 ◽

Vol 21 (07) ◽

pp. 1750061 ◽

Cited By ~ 1

Author(s):

NOMITA SHARMA

Keyword(s):

Environmental Factors ◽

Empirical Study ◽

Failure Rate ◽

Small And Medium Enterprises ◽

High Failure Rate ◽

Innovation Activities ◽

Skilled Manpower ◽

Innovative Behaviour ◽

Medium Enterprises

The aim of this paper is to explore innovative behaviour of Indian Micro Small and Medium Enterprises. It is interesting to study innovative behaviour of microsmau and medium enterprises (MSMEs) since they try to innovate while surrounded by many barriers. They also face high failure rate in doing so. This failure is due to presence of barriers that MSMEs fail to manage. But it has been observed that many MSMEs are now awakening to their potential and becoming innovative. They tend to respond to environmental factors in an innovative way, either by cutting cost or changing ways of management. This innovative way defines their innovative behaviour. The innovative behaviour of MSMEs is studied through three variables, i.e., size, age and barriers faced by them. The result shows that size does influence innovation activities undertaken by MSMEs and statistically, there is no correlation between age and innovative behaviour. Their innovative behaviour is affected by barriers like shortage of technical skilled manpower, technology and shortage of funds or complex funding procedure. The paper is concluded by summarising the key findings, discussing implications, limitations and further scope of study.

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The influence of dissection on clinical anatomical knowledge for surgical needs

Surgical and Radiologic Anatomy ◽

10.1007/s00276-021-02802-w ◽

2021 ◽

Author(s):

Georg Feigl ◽

Andreas Sammer

Keyword(s):

Success Rate ◽

Failure Rate ◽

Human Body ◽

Visceral Surgery ◽

High Failure Rate ◽

Anatomical Knowledge ◽

High Good ◽

Primary Focus ◽

Head Neck ◽

Dissection Course

Abstract Purpose Due to the ongoing discussion of the usefulness of dissection on human bodies in medical curricula, we investigated the influence of anatomical knowledge collected in the dissection course and requested for modules of visceral surgery. Methods Students attending the dissection course of topographic anatomy had to answer a questionnaire of 22 questions with focus on anatomical knowledge required for visceral surgical modules. Failure was defined as 13 or fewer correct answers, success categorized as high, good or moderate. The same questionnaire was handed out to 245 students prior to the module on visceral surgery. Students provided information on which regions they had dissected during the course or prior to the module. The results were compared to the result of a written Multiple Choice Question (MCQ) exam of the module visceral surgery (n = 160 students) with an unannounced primary focus on anatomy. Results Students who dissected the truncal regions of the human body succeeded in answering the questionnaire with high success. Students dissecting regions of the Head/Neck or Limbs had a high failure rate, and none of them reached the “high” success level. In the MCQ exam, students dissecting truncal regions had a high success rate, while those who had not dissected or who dissected the Head/Neck or Limbs had a high failure rate. Conclusion Dissections support and improve the required knowledge for surgical modules. For the visceral surgical module, students dissecting the region prior to the module greatly benefited. Therefore, entire human body dissection assumes to be preferable.

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Abnormally high failure rate for femoral angioplasty in patients with pseudoxanthoma elasticum

Journal of Vascular Surgery Cases ◽

10.1016/j.jvsc.2015.10.001 ◽

2015 ◽

Vol 1 (4) ◽

pp. 276-278 ◽

Cited By ~ 1

Author(s):

Myriam Ammi ◽

Guido Kranenburg ◽

Loukman Omarjee ◽

Ludovic Martin ◽

Wilko Spiering ◽

...

Keyword(s):

Failure Rate ◽

Pseudoxanthoma Elasticum ◽

High Failure Rate

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Investigating the Success of OSS Software Projects

Advances in Systems Analysis, Software Engineering, and High Performance Computing - Human Factors in Software Development and Design ◽

10.4018/978-1-4666-6485-2.ch005 ◽

2015 ◽

pp. 92-102

Author(s):

Amir Hossein Ghapanchi

Keyword(s):

Open Source ◽

Failure Rate ◽

Network Structure ◽

Success Factors ◽

Research Community ◽

Literature Survey ◽

High Failure Rate ◽

Software Projects ◽

Critical Success ◽

Insight Into

Whereas there are several instances of Open Source Software (OSS) projects that have achieved huge success in the market, a high failure rate has been reported for OSS projects. This study conducts a literature survey to gain insight into existing studies on the success of OSS projects. More specifically, this study seeks to extract the critical success factors for OSS projects. Based on the literature survey in this study, the authors found determinants of success in OSS projects and classified them into three broad categories of project traits, product traits, and network structure. These findings have important implications for both the OSS research community and OSS practitioners.

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A Needle in a Haystack

Handbook of Research on Technology Project Management, Planning, and Operations - Advances in IT Personnel and Project Management ◽

10.4018/978-1-60566-400-2.ch020 ◽

2011 ◽

pp. 310-320

Author(s):

Chad J. Cray

Keyword(s):

Decision Making ◽

Information Technology ◽

Empirical Research ◽

Failure Rate ◽

Project Managers ◽

Decision Making Process ◽

High Failure Rate ◽

It Projects ◽

Extant Literature ◽

Development Methodology

Considering the high failure rate of information technology (IT) projects over the last 40 years, project managers should use all the tools at their disposal in order to make their project a success; however, more than half of all project managers fail to use a powerful tool that is readily available – a development methodology. A development methodology provides structure to a project, which facilitates communication, establishes expectations, enhances quality and promotes consistency. One potential reason project managers do not employ a development methodology is that selecting the correct methodology from among the hundreds available can be an overwhelming task. For this reason, understanding the decision-making process, and identifying those factors that influence it, is a worthwhile endeavor. While empirical research in this area is lacking, a review of the extant literature reveals several factors that are important when choosing a development methodology. In this chapter, many of these factors are identified, a model for categorizing them is proposed, and a model for selecting a methodology is presented.

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Lean, Light, Adaptive, Agile and Appropriate Software Development

Practicing Software Engineering in the 21st Century ◽

10.4018/978-1-93177-750-6.ch004 ◽

2003 ◽

pp. 42-52

Author(s):

John Mendonca ◽

Jeff Brewer

Keyword(s):

Software Engineering ◽

Software Development ◽

Failure Rate ◽

Environmental Context ◽

High Failure Rate ◽

Adaptive Approach ◽

Definition Of ◽

Oriented Approach

Historically, the approach to software engineering has been based on a search for an optimal (ideal) methodology — that is, the identification and application of a set of processes, methods and tools that can consistently and predictably lead to software development success. This chapter presents the basis for pursuing a more flexible and adaptive approach to methodology. Less methodical methodologies, under a variety of names, take a contingency-oriented approach. Because of the limitations in the nature of methodology, the high failure rate in software development, the need to develop methodology within an environmental context and the pressures of fast-paced “e-development,” the authors argue that further exploration and definition of an adaptive, contingency-based approach to methodology is justified.

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