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

2 mei 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

4400

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Istanbul
      • Sancaktepe, Istanbul, Kalkoen, 34785
        • Werving
        • Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital
        • Contact:
          • İsmail Tayfur, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 95 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

Person who cannot give nasopharyngeal samples

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assessment of AI's Learning Performance:
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: İsmail Tayfur, MD, Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 februari 2021

Primaire voltooiing (Verwacht)

1 mei 2021

Studie voltooiing (Verwacht)

15 mei 2021

Studieregistratiedata

Eerst ingediend

25 april 2021

Eerst ingediend dat voldeed aan de QC-criteria

25 april 2021

Eerst geplaatst (Werkelijk)

27 april 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 mei 2021

Laatste update ingediend die voldeed aan QC-criteria

2 mei 2021

Laatst geverifieerd

1 mei 2021

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Covid19

Klinische onderzoeken op AP-23

3
Abonneren