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.
Study Type
OBSERVATIONAL
Enrollment
1,283
National Center for Disease Control
Tbilisi, Georgia
Ezintsha
Johannesburg, South Africa
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
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