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

NCT05605769 | Completed

• 1 other identifier: CV009
• Study Type: observational
• Target: 3,266
• Locations: 2 countries
• Sites: 2

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

Conditions

COVID-19

Keywords

Covid 19 self- testing, lay users

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• To evaluate the usability in specific subgroups defined based on demographic characteristics such as age and education level

  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

  6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• years of age
• Able to speak and read local language depending on site of recruitment
• Provided voluntary written consent to participate in this stud
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (2)

Ezintsha Research Centre

Johannesburg, Guateng, South Africa

Location

Uganda National Health Laboratories Services

Kampala, Uganda

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 4, 2022
• Study Start: July 13, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

UG (1); ZA (1)