跳至主要内容
临床试验/NCT04860895
NCT04860895Unknown不适用

The Reliability of the Computer Aided Multi-Spectral Screening System In the Diagnosis of Covid-19

Fable Biyoteknoloji San ve Tic A.S1 个研究点 分布在 1 个国家目标入组 4,400 人开始时间: 2021年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
4,400
试验地点
1
主要终点
Assessment of AI's Learning Performance:

研究概览

简要总结

The aim of this research is to use the Multi-Spectral method to measure the biomolecular fingerprint of the virus directly instead of the virus's RNA (RT-PCR) or the body's immune response (antibody) measurement methods to diagnose the SARS-COV-2 virus, thereby determining whether COVID-19 can be diagnosed faster, cheaper and without requiring a medical laboratory environment.

详细描述

The primary purpose of this study is to test whether artificial intelligence (AI) will identify existing SARS-COV-2 in nasopharyngeal swab samples using multi-spectral screening technology..

Multi spectral screening testing device called AP-23 offers a non-invasive system for the diagnosis of SARS-COV-2 as a solution. This approach makes multi-spectral diagnostic methods suitable for use by any end user and allows the establishment of Internet of Things systems.

COVID-19 contagion, which began in the northern hemisphere, continues to affect human health and the world economy in tremendously. Early diagnosis of the disease and, accordingly, the breaking of the transmission chain through filiation studies is very important for public health until an effective and safe vaccine is found. PCR tests, which we currently use as the gold standard to prove the existence of the virus, have not been sufficient to prevent the pandemic for the following reasons;

  1. PCR tests should be performed in a hospital or clinical setting
  2. There is a need for a custom kit
  3. There is a need for trained individuals to perform the test
  4. Standardization is not ensured for the receipt of test sample
  5. With at least 30 minutes for receipt of the test results, it takes up to 3-day
  6. testing is expensive and is usually applied to people who have symptoms and thus asymptomatic carriers are missed.

The primary purpose of this study is to test whether SARS-COV-2 can be detected in nasopharyngeal swab samples using multi-spectral screening technology. Multi-spectral techniques are based on phenomena related to absorption, excitation and propagation of biomolecules. In short, by irradiating the sample with electromagnetic energy, some molecules absorb and re-emit less energetic radiation. This phenomenon is called radiation, and the radiated spectrum is a function of certain molecules that combine microorganisms / viruses.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
12 Years 至 95 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All people who applied to hospitals with suspicion of COVID-19

排除标准

  • •Person who cannot give nasopharyngeal samples

研究组 & 干预措施

Nasopharyngeal swabs

Other

Nasopharyngeal swabs samples of volunteers who is referred with suspicion of Covid19.

干预措施: AP-23 (Diagnostic Test)

结局指标

主要结局

Assessment of AI's Learning Performance:

时间窗: 2 MONTHS

Compared PCR results with AP-23 results; PCR Accordance, PCR Accordance for Negative Samples, PCR Accordance for Positive Samples.

Evaluation of Artificial Intelligence's Test Performance)

时间窗: 1 MONTH

As a result of comparison with the PCR and AP-23 results in nasopharyngeal swab samples; Sensitiviy, Specificity, Negative Prediction Value, Positive Prediction Value

次要结局

未报告次要终点

研究者

发起方
Fable Biyoteknoloji San ve Tic A.S
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验