Novel Rapid POC Diagnostics for COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Respiratory Infection

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 Type: Observational
• Enrollment (Actual): 1283

Contacts and Locations

• Study Contact: Name: Rossella Baldan, PhD; Phone Number: +41227100590; Email: rossella.baldan@finddx.org
• Study Contact Backup: Name: Elena Ivanova Reipold, MD, PhD; Phone Number: +41227100590; Email: elena.ivanova@finddx.org

Study Locations

• Georgia
  • Tbilisi, Georgia
    • National Center for Disease Control
• South Africa
  • Johannesburg, South Africa
    • Ezintsha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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:

1. SYMPTOMATIC: Individuals (≥ 18 years old) suspected to have COVID-19 (as per national or WHO guidelines) and presenting at the testing site(s) with symptoms of COVID-19.
2. ASYMPTOMATIC: Individuals (≥ 18 years old) at risk of COVID-19 (as per national or WHO guidelines) and presenting at the testing site(s) with no symptoms of COVID-19

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Investigators: Principal Investigator: Elena Ivanova Reipold, MD, PhD, Find

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Tract Infections
• Other Study ID Numbers: CV008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No