Novel Rapid POC Diagnostics for COVID-19

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19 Respiratory Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age Presenting to testing locations linked to the clinical sites Suspected to have COVID-19 (as per WHO or national guidelines). These include the following groups: Individuals with acute onset of any of the following signs or symptoms: fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anorexia/nausea/vomiting, diarrhoea, altered mental status (for 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 Provided voluntary written consent to participate in this study Provided a specimen suitable for testing Exclusion Criteria: Individuals unable to cooperate with respiratory sample collection Individuals on oxygen therapy Recent history of excessive nose bleeds Individuals unable to give informed consent Hemodynamic instability as determined by the treating physician

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity | Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using RT-PCR as reference standard | at enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at enrolment |