Global Study on the Clinical Detection Performance and Usefulness of Novel Coronavirus Rapid Diagnostic Kit

PHRR220923-005012

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Global Study on the Clinical Detection Performance and Usefulness of Novel Coronavirus Rapid Diagnostic Kit

This study aims to examine the usability of a novel Rapid Antigen Test kit in diagnosing SARS-CoV-2. The accuracy of the test kit result will be evaluated and compared with plate-based polymerase chain reaction result in swab specimens collected. This study will also examine whether the test kit can be used to prove that the participant is SARS-COV-2 negative early from the onset of symptoms.

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Diagnostics
Start Date Duration in Months Target Completion Date Actual Completion Date
2022-08-15 3 2022-11-15 0000-00-00

Ongoing

Institution Classification Region LTO #
National Center for Global Health and Medicine Government Japan
Institution Classification Region LTO #
University of the Philippines - Philippine General Hospital, Department of Laboratories Government NCR 13-0101-22-H3-1
Institution Region
National Center for Global Health and Medicine Japan
Name E-Mail Institution and Institution Address
Erick Yturralde ehyturralde@up.edu.ph Philippine General Hospital, Taft Avenue, Ermita, City of Manila
Name E-Mail Institution and Institution Address
Erick Yturralde ehyturralde@up.edu.ph Philippine General Hospital, Taft Avenue, Ermita, City of Manila
Name Expertise Affiliation
Erick Martin H. Yturralde, RMT, MD Anatomic and Clinical Pathology University of the Philippines - Philippine General Hospital, Department of Laboratories
Joanne Carmela M. Sandejas Adult Infectious Disease University of the Philippines - Philippine General Hospital, Department of Medicine, Division of Infectious Diseases
Waldemar T. Siy Anatomic and Clinical Pathology University of the Philippines - Philippine General Hospital, Department of Laboratories
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
University of the Philippines - Philippine General Hospital, Department of Laboratories Philippine General Hospital, Taft Avenue, Ermita, City of Manila University of the Philippines Manila - Research Ethics Board Erick Martin H. Yturralde, RMT, MD Anatomic and Clinical Pathology
University of the Philippines - Philippine General Hospital, Department of Medicine, Division of Infectious Diseases Philippine General Hospital, Taft Avenue, Ermita, City of Manila University of the Philippines Manila - Research Ethics Board Joanne Carmela M. Sandejas Adult Infectious Disease
University of the Philippines - Philippine General Hospital, Department of Laboratories Philippine General Hospital, Taft Avenue, Ermita, City of Manila University of the Philippines Manila - Research Ethics Board Waldemar T. Siy Anatomic and Clinical Pathology
Project Location Institutional Ethics Review Board
University of the Philippines - Philippine General Hospital, Department of Laboratories University of the Philippines Manila - Research Ethics Board
University of the Philippines - Philippine General Hospital, Department of Medicine, Division of Infectious Diseases University of the Philippines Manila - Research Ethics Board
University of the Philippines - Philippine General Hospital, Department of Laboratories University of the Philippines Manila - Research Ethics Board

Clinical Trial

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To verify that the ESPLINE SARS-CoV-2 (Fuji Rebio, Co. Ltd, Japan) has comparable clinical detection performance to that of RT-PCR, an existing nucleic acid detection test. The following concerns with consideration of the usefulness of the kit as a routine test due to its versatility will be addressed by testing nasopharyngeal swab specimens from participants suspected of the novel coronavirus, SARS-CoV-2 infection.

The agreement rate between the test results of RT-PCR test and the Rapid Antigen Test.

The agreement rate between the Rapid Antigen Test and RT-PCR test in specimens collected at different times after onset and the agreement rate of test results in two different types of specimens.

Completed

  • Philippines

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No result found.

450

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Inclusion criteria:
(1) Participants who willingly participate and sign a voluntary written consent after being informed with full comprehension of the objectives, methods, significance, and entire contents relevant to the study. Minors from whom an assent can be obtained from their representative (father, mother or legally authorized representative e.g. legal guardian, statutory agent)
(2) Participants aged 18 years or older at the time of obtaining informed consent or 12 years or older at the time of obtaining assent.
(3) Participants suspected of being infected with the new coronavirus

Exclusion criteria:
(1) Potential subjects who voluntarily divulge information on the use of illicit drugs within the last 12 months.
(2) Participants who have symptoms 6 days and more from the onset
(3) Other participants who are determined ineligible for the study by the investigator

Observational

ESPLINE Antigen Test

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None

Method of Allocation

Non-Randomized

Masking or Blinding

N/A

Masking Details

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Control

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Assignment

Not Applicable

Phase

Not Applicable

Purpose of the Study

To verify that the ESPLINE SARS-CoV-2 (hereinafter referred to as the Rapid Antigen Test, Fuji Rebio, Co. Ltd, Japan) has comparable clinical detection performance to that of RT-PCR, an existing nucleic acid detection test. The following concerns with consideration of the usefulness of the kit as a routine test due to its versatility will be addressed by testing nasopharyngeal swab specimens from participants suspected of the novel coronavirus, SARS-CoV-2 infection.

Detailed purpose of the study

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Plan to Share IPD

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IPD Description

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Date of posting of result summaries

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Date of the first journal publication of results

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URL hyperlinks related to results and publications

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URL link to protocol files(s) with version and data

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Baseline Characteristics

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Participant Flow

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Adverse Events

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Outcome Measures

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Brief Summary

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Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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