NCT05438589

Novel Rapid POC Diagnostics for COVID-19

Evaluation of the Performance of Novel Rapid Diagnostics for SARS-CoV-2 at Point-of-care

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,283 (actual)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicentre study in which the diagnostic accuracy of multiple Covid-19 Antigen rapid diagnostic tests will be assessed for COVID-19 case detection using prospectively collected nasal swabs and saliva samples from participants suspected to have Covid-19 infection (with or without symptoms). The study will last approximately 9 months.

Detailed description

Adult individuals with presumptive Covid-19, either symptomatic or asymptomatic, will be screened for inclusion at 4 different study sites located in Georgia and South Africa. Enrolled participants will be asked to provide 2 samples: one nasopharyngeal swab that will be utilized for Covid-19 diagnosis by standard PCR and one sample (either nasal swab or saliva) to be used for the new antigen rapid diagnostic test under evaluation. At least 2 different antigen tests will be evaluated to determine sensitivity and specificity: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Jiangsu Bioperfectus Technologies) and GeneFinder COVID-19 Ag Rapid test (Osang Healthcare). The data gathered from this study, could be used as part of the dossier to be submitted to WHO (world health organization) for review.

Conditions

• COVID-19 Respiratory Infection

Timeline

• Start date: 2022-04-25
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2022-06-30
• Last updated: 2023-12-01

Locations

2 sites across 2 countries: Georgia, South Africa