Detection of SARS-CoV-2 in Nasopharyngeal Swabs by Using Multi-Spectral Screening System
The Reliability of the Computer Aided Multi-Spectral Screening System In the Diagnosis of Covid-19
1 other identifier
interventional
4,400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Feb 2021
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2021
CompletedFirst Submitted
Initial submission to the registry
April 25, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2021
CompletedMay 6, 2021
May 1, 2021
3 months
April 25, 2021
May 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
2 MONTHS
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
1 MONTH
Study Arms (1)
Nasopharyngeal swabs
OTHERNasopharyngeal swabs samples of volunteers who is referred with suspicion of Covid19.
Interventions
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.
Eligibility Criteria
You may qualify if:
- All people who applied to hospitals with suspicion of COVID-19
You may not qualify if:
- Person who cannot give nasopharyngeal samples
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital
Sancaktepe, Istanbul, 34785, Turkey (Türkiye)
Related Publications (1)
Tayfur I, Bayramoglu B, Guven R, Avci A. Diagnostic accuracy of artificial intelligence-based multi-spectrum analysis for molecular fingerprint detection of SARS-CoV-2. Medicine (Baltimore). 2025 May 23;104(21):e41928. doi: 10.1097/MD.0000000000041928.
PMID: 40419915DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
İsmail Tayfur, MD
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2021
First Posted
April 27, 2021
Study Start
February 11, 2021
Primary Completion
May 1, 2021
Study Completion
May 15, 2021
Last Updated
May 6, 2021
Record last verified: 2021-05