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

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19

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 Type: Observational
• Enrollment (Actual): 3266

Contacts and Locations

Study Locations

• South Africa
  • Guateng
    • Johannesburg, Guateng, South Africa
      • Ezintsha Research Centre
• Uganda
  • Kampala, Uganda
    • Uganda National Health Laboratories Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants from general population who are able to read the local language and have no prior experience with covid self-specimen collection and testing. For Phase II, (less than 18 years) old suspected to be infected with SARS-CoV-2 (as per national or WHO guidelines) presenting at the testing site(s) will be invited to participate.

Participants will come from the following countries: Georgia, South Africa, Uganda and Peru

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	4 weeks
To determine the ability of the intended users to correctly interpret testing results by evaluating the correctness of user's interpretation of contrived results	Percentage of the agreement between the pre-defined results of contrived self-testing devices and their interpretation by study participants	4 weeks
Phase 11 Outcomes	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	6weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the usability in specific subgroups defined based on demographic characteristics such as age and education level	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	6 weeks
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	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	6 weeks

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Covid 19 self- testing, lay users
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CV009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No