An observational study in COVID-19 Respiratory Infection, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 1,283 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals (≥ 18 years old) suspected to have COVID-19 (as per national or WHO guidelines) presenting at the testing site(s) will be invited to participate. Each participant will have two respiratory swabs collected: one for RT-PCR testing and diagnosis, paired with a second swab to be used on the index Ag RDT. In order to meet the study objectives, two different population groups will be considered:
Suspected to have COVID-19 (as per WHO or national guidelines). These include the following groups:
Exclusion Criteria:
Sensitivity and specificity
Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using RT-PCR as reference standard
Time frame: at enrolment
Sensitivity and specificity in specific subgroups
Point estimates of sensitivity and specificity of index test with 95% confidence intervals in specific subgroups defined based on presence of the symptoms, disease stage (days since symptom onset, e.g. acute, early, late), severity of symptoms, RT-PCR Ct values, vaccination status
Time frame: at enrolment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland