Novel Rapid POC Diagnostics for COVID-19

Completed

• Conditions: COVID-19 Respiratory Infection

• Registration Number: NCT05438589
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief 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.

Study Timeline

• Study Start: 2022-04-25
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-06-30
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1283

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity	at enrolment	Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using RT-PCR as reference standard

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity in specific subgroups	at enrolment	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

Trial Locations

Locations (2)

National Center for Disease Control; 🇬🇪 Tbilisi, Georgia

Ezintsha; 🇿🇦 Johannesburg, South Africa