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

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: COVID-19

Study type: Observational

Funder types: Other

Identifiers

NCT05605769

CV009

Details and patient eligibility

About

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

Full 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

Enrollment: 3,266 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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