Clinical trial NCT05605769: Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained
Official title: Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Covid 19 self- testing, lay users
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 3266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 4 weeks
measure: To determine the ability of the intended users to correctly interpret testing results by evaluating the correctness of user's interpretation of contrived results
timeFrame: 4 weeks
measure: Phase 11 Outcomes
timeFrame: 6weeks
Secondary outcomes:
measure: To evaluate the usability in specific subgroups defined based on demographic characteristics such as age and education level
timeFrame: 6 weeks
measure: 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
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Ezintsha Research Centre
state: Guateng
city: Kampala
country: Uganda
facility: Uganda National Health Laboratories Services
Study officials:
affiliation: Lugar Centre
name: Maia Alkhazashvili, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uganda National Laboratory Services
name: Isaac Ssewanyana, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Ezintsha Research Centre
name: Mohhamed Majam, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: UPCH
name: Cesar Ugarte, Phd
role: PRINCIPAL_INVESTIGATOR
References: