Novel Rapid POC Diagnostics for COVID-19

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.

Completed

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Key information

Conditions

COVID-19 Respiratory Infection

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Disease Control, Tbilisi, Georgia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Sensitivity and specificity

Time frame: at enrolment

Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using RT-PCR as reference standard

Secondary outcomes

Sensitivity and specificity in specific subgroups

Time frame: 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

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jun 30, 2022
Registry last updated: Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed