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

COVID-19 Clinical Trial

— CV009  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05605769
• Other study ID #: CV009
• Status: Completed
• Start date: July 13, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3266
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
South Africa	Ezintsha Research Centre	Johannesburg	Guateng
Uganda	Uganda National Health Laboratories Services	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland

Countries where clinical trial is conducted

South Africa,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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