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CV009: Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained

Sponsor
Foundation for Innovative New Diagnostics, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05605769
Collaborator
(none)
800
Enrollment
2
Locations
9.6
Anticipated Duration (Months)
400
Patients Per Site
41.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to independently evaluate the usability and performance of rapid assays detecting SARS-CoV-2 antigen(s) and intended for self-testing. For this, the results of the test performed and interpreted by an untrained lay user will be compared to the results obtained by a trained healthcare professional using the same test kit, and, separately, to the current gold standard for testing, RT-PCR detecting SARS-CoV-2 RNA

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The COVID-19 pandemic has rapidly spread across the globe. As 03 March 2022, there are approximately 438 517 285 confirmed cases worldwide. Recent surge of new infections globally due to omicron variant led to significant increase of testing demand. Although rapid diagnostic tests (RDT) detecting SARS-CoV-2 antigens are now authorized in most countries and contribute substantially to expanding of testing capacity, shortage of healthcare resources is an important barrier to further scale up. Self-testing has been widely used in many high-income countries as an additional tool to provide convenient and timely access to testing. A number of self-tests detecting SARS-CoV-2 have been authorized by stringent regulatory authorities (SRA) such as US Food and Drug Administration (FDA), CE-IVD, Health Canada, Therapeutics Goods Administration (TGA) under an Emergency Use Authorization (EUA). In low- and middle-income countries (LMIC) self-testing for SARS-CoV-2 has not yet been widely adopted. Data on self-test use in LMIC are still very limited and the performance of SARS-CoV-2 self-test assays was not evaluated in LMIC settings. Additionally, the price for self-test kits is often prohibitive to its wide use in low resource settings. In 2021, FIND, the Diagnostic Alliance, through an open request for proposal (RFP) has identified several manufacturers of affordable and easy-to-use self-testing assays for SARS-CoV-2 antigen detection in nasal swabs and saliva specimens. FIND and [NAME OF THE PARTNER] aim to evaluate these novel affordable self-testing solutions in LMIC settings in a 2-phase study

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained Users
    Actual Study Start Date :
    Jul 13, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Apr 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. To determine the SARS-CoV-2 self-tests label comprehension by the intended users by assessing the extent to which the users understand the information in the self-test labelling [4 weeks]

      Proportion of study participants that correctly comprehend key messages from packaging and labelling measured by the proportion of participants providing correct responses to a self-administered semi-structured question

    2. To determine the ability of the intended users to correctly interpret testing results by evaluating the correctness of user's interpretation of contrived results [4 weeks]

      Percentage of the agreement between the pre-defined results of contrived self-testing devices and their interpretation by study participants

    3. Phase 11 Outcomes [6weeks]

      a. Proportion of participants that performed the self-testing procedure correctly and usability index of each testing step (Proportion of participants that performed each step correctly); documented errors and difficulties faced at each self-testing step

    Secondary Outcome Measures

    1. To evaluate the usability in specific subgroups defined based on demographic characteristics such as age and education level [6 weeks]

      Proportion of participants that correctly comprehend key messages from packaging and labelling, performed the self-testing procedure and interpreted the results correctly in specific subgroups defined based on age and educational level. Documented errors and difficulties at each self-testing step in these subgroups

    2. To evaluate diagnostic accuracy of SARS-CoV-2 self-tests in specific subgroups defined based on the presence of symptoms, RT-PCR Ct values, vaccination status [6 weeks]

      Point estimates of sensitivity and specificity of index test with 95% confidence intervals in specific subgroups defined based on presence of symptoms, RT-PCR Ct values, vaccination status

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Phase 1 Inclusion Criteria:

    • 18 years of age

    • Able to speak and read local language depending on site of recruitment

    • Provided voluntary written consent to participate in this stud

    Phase 11 inclusion Criteria:

    • 18 years of age

    • Able to speak and read local language depending on site of recruitment

    • Suspected to have COVID-19 (as per WHO or national guidelines).

    • SYMPTOMATIC group)

    • Contacts of confirmed cases of COVID-19

    • Individuals residing or working in an area with high risk of transmission of virus

    • Individuals residing or travelling to an area with community transmission

    • Individuals working in any health care setting, including within health facilities or within the community

    • Written consent

    • Provided the required number of specimens suitable for testing. Exclusion criteria

    • Participated in Phase I or Phase II of the study

    • Prior medical or clinical laboratory training

    • Prior experience with self-testing for SARS-CoV-2

    • Hemodynamic instability as determined by the treating physician

    • unable to cooperate with respiratory sample collection or on oxygen therapy

    • Recent history of excessive nose bleeds

    • Any condition which, in the opinion of the investigator feels unable to participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ezintsha Research Centre Johannesburg Guateng South Africa
    2 Uganda National Health Laboratories Services Kampala Uganda

    Sponsors and Collaborators

    • Foundation for Innovative New Diagnostics, Switzerland

    Investigators

    • Principal Investigator: Maia Alkhazashvili, MD, Lugar Centre
    • Principal Investigator: Isaac Ssewanyana, Phd, Uganda National Laboratory Services
    • Principal Investigator: Mohhamed Majam, Msc, Ezintsha Research Centre
    • Principal Investigator: Cesar Ugarte, Phd, UPCH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Foundation for Innovative New Diagnostics, Switzerland
    ClinicalTrials.gov Identifier:
    NCT05605769
    Other Study ID Numbers:
    • CV009
    First Posted:
    Nov 4, 2022
    Last Update Posted:
    Nov 4, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Foundation for Innovative New Diagnostics, Switzerland
    Covid 19 self- testing, lay users
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Nov 4, 2022