search
Back to results

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

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
AP-23
Sponsored by
Fable Biyoteknoloji San ve Tic A.S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring Artificial Intelligence, AI, SARS-COV2, Point of Care,

Eligibility Criteria

12 Years - 95 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Person who cannot give nasopharyngeal samples

Sites / Locations

  • Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Nasopharyngeal swabs

Arm Description

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

Outcomes

Primary Outcome Measures

Assessment of AI's Learning Performance:
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)
As a result of comparison with the PCR and AP-23 results in nasopharyngeal swab samples; Sensitiviy, Specificity, Negative Prediction Value, Positive Prediction Value

Secondary Outcome Measures

Full Information

First Posted
April 25, 2021
Last Updated
May 2, 2021
Sponsor
Fable Biyoteknoloji San ve Tic A.S
search

1. Study Identification

Unique Protocol Identification Number
NCT04860895
Brief Title
Detection of SARS-CoV-2 in Nasopharyngeal Swabs by Using Multi-Spectral Screening System
Official Title
The Reliability of the Computer Aided Multi-Spectral Screening System In the Diagnosis of Covid-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fable Biyoteknoloji San ve Tic A.S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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; PCR tests should be performed in a hospital or clinical setting There is a need for a custom kit There is a need for trained individuals to perform the test Standardization is not ensured for the receipt of test sample With at least 30 minutes for receipt of the test results, it takes up to 3-day 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Artificial Intelligence, AI, SARS-COV2, Point of Care,

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasopharyngeal swabs
Arm Type
Other
Arm Description
Nasopharyngeal swabs samples of volunteers who is referred with suspicion of Covid19.
Intervention Type
Diagnostic Test
Intervention Name(s)
AP-23
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of AI's Learning Performance:
Description
Compared PCR results with AP-23 results; PCR Accordance, PCR Accordance for Negative Samples, PCR Accordance for Positive Samples.
Time Frame
2 MONTHS
Title
Evaluation of Artificial Intelligence's Test Performance)
Description
As a result of comparison with the PCR and AP-23 results in nasopharyngeal swab samples; Sensitiviy, Specificity, Negative Prediction Value, Positive Prediction Value
Time Frame
1 MONTH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All people who applied to hospitals with suspicion of COVID-19 Exclusion Criteria: Person who cannot give nasopharyngeal samples
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz Unver, MSc.
Phone
+905380246808
Email
deniz.unver@fablecorp.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emre Günerken
Phone
905360300713
Email
emre.gunerken@fablecorp.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail Tayfur, MD
Organizational Affiliation
Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital
City
Sancaktepe
State/Province
Istanbul
ZIP/Postal Code
34785
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
İsmail Tayfur, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs