COVID-19 Antigen Rapid Test Kit

NCT ID: NCT04889365

Last Updated: 2021-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-11

Study Completion Date

2021-07-10

Brief Summary

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The SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with self-collected nasal swab samples in individuals who are suspected of COVID-19. This test utilizes a lateral flow immunoassay technology for the qualitative detection of spike and nucleocapsid protein antigens of SARS-CoV-2 in individuals with known or suspected COVID-19.

Detailed Description

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Conditions

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SARS-CoV2 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 positive, asymptomatic

COVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19)

SG Diagnostics COVID-19 Antigen Rapid Test Kit

Intervention Type DIAGNOSTIC_TEST

SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)

Polymerase chain reaction (PCR) test

Intervention Type DIAGNOSTIC_TEST

Professional collection of a second swab sample, for confirmation by PCR

COVID-19 positive, symptomatic

COVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19)

SG Diagnostics COVID-19 Antigen Rapid Test Kit

Intervention Type DIAGNOSTIC_TEST

SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)

Polymerase chain reaction (PCR) test

Intervention Type DIAGNOSTIC_TEST

Professional collection of a second swab sample, for confirmation by PCR

COVID-19 negative

COVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19)

SG Diagnostics COVID-19 Antigen Rapid Test Kit

Intervention Type DIAGNOSTIC_TEST

SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)

Polymerase chain reaction (PCR) test

Intervention Type DIAGNOSTIC_TEST

Professional collection of a second swab sample, for confirmation by PCR

Interventions

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SG Diagnostics COVID-19 Antigen Rapid Test Kit

SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)

Intervention Type DIAGNOSTIC_TEST

Polymerase chain reaction (PCR) test

Professional collection of a second swab sample, for confirmation by PCR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult (aged ≥ 18 years) volunteers

Exclusion Criteria

* Children (aged \< 18years)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Polish Society of Disaster Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maria Sklodowska-Curie Medical Academy

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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PTMK_2021_01

Identifier Type: -

Identifier Source: org_study_id

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