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Detection of SARS-CoV-2 in Nasopharyngeal Swabs by Using Multi-Spectral Screening System

2 de mayo de 2021 actualizado por: Fable Biyoteknoloji San ve Tic A.S

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

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

At this point, FableCorp's AP-23 system uses data from a minimally invasive or non-invasive simple measurement based on multi-spectral screening technology to calculate the presence or concentration of the desired product in a biological liquid as the solution to be used.

The most unique approach of the FableCorp system, is to use the A.I. to detect the desired biochemical / cell / virus is to scan appropriate multi-spectral inputs. Data mining tools, where it simultaneously eliminates noise in raw data generated from various multi-spectral spectroscopy inputs, give very clear results. This approach makes multi-spectral technology suitable for use as point-of-care systems for any end user, and also leads to the realization of full automation (Internet of Things) systems.

A.I. the base solution for Pointer signal detection / processing eliminates biochemical additives (kits) and specialized personnel.

AI's evaluation of data takes place within 15-30 seconds. If the effectiveness of this application is proven in the diagnosis of SARS-COV-2, many more people will be able to be screened in a much faster time, much cheaper, and filiation will be applied to the necessary people much faster.

Study Design Stage 1: Nasopharyngeal samples taken from COVID-19 suspected individuals will be given to artificial intelligence to learn positive and negative cases, and the learning results will be calculated as the learning accuracy for negative and positive samples. (n=4000, 2000 positive and 2000 negative)

Stage 1, Output Parameters (Evaluation of Learning Performance of Artificial Intelligence):

PCR results and AP-23 results obtained as a result of comparison; PCR Accordance, PCR Accordance for Negative Samples, PCR Accordance for Positive Samples.

Stage 2: Based on the Artificial Intelligence Learning accuracy rate second stage of the study will be initiated. At this stage, Nasopharyngeal swab samples will be tested by PCR, AP-23, and the results will be tested and be compared and the sensitivity of detection compared with results obtained by (n=400, 200 positive and 200 negative)

Stage 2, Output Parameters (Evaluation of Test Performance of Artificial Intelligence):

Nasopharyngeal swab obtained by comparison with PCR and AP-23 results in samples; Sensitivity, Specificity, Negative Prediction Value, Positive Prediction Value.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

4400

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Istanbul
      • Sancaktepe, Istanbul, Pavo, 34785
        • Reclutamiento
        • Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital
        • Contacto:
          • İsmail Tayfur, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 95 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

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

Exclusion Criteria:

Person who cannot give nasopharyngeal samples

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Nasopharyngeal swabs
Nasopharyngeal swabs samples of volunteers who is referred with suspicion of Covid19.
AP-23 newly developed point of care system as a well-automated combination of multi-spectral technology and a distributed cloud computing A.I. system which has been developed to detect COVID-19.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Assessment of AI's Learning Performance:
Periodo de tiempo: 2 MONTHS
Compared PCR results with AP-23 results; PCR Accordance, PCR Accordance for Negative Samples, PCR Accordance for Positive Samples.
2 MONTHS
Evaluation of Artificial Intelligence's Test Performance)
Periodo de tiempo: 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
1 MONTH

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: İsmail Tayfur, MD, Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de febrero de 2021

Finalización primaria (Anticipado)

1 de mayo de 2021

Finalización del estudio (Anticipado)

15 de mayo de 2021

Fechas de registro del estudio

Enviado por primera vez

25 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

25 de abril de 2021

Publicado por primera vez (Actual)

27 de abril de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de mayo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

2 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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