Novel Rapid POC Diagnostics for COVID-19

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: COVID-19 Respiratory Infection

Study type: Observational

Funder types: Other

Identifiers

NCT05438589

CV008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,283 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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