Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR

February 11, 2021 updated by: Reinoud Cartuyvels, Jessa Hospital

Comparison of the Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR

The performance of 3 different sampling methods (2 nasopharyngeal swabs, 1 oropharyngeal swab) for the detection of SARS-CoV-2 with real-time reverse transcriptase polymerase chain reaction will be compared.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Thirty volunteers will be recruited from health care workers suspicious for Covid-19, who consult the ocupational physician for Covid-19 testing.

For each volunteer, 3 swabs will be taken:

  • Flocked eSwab (Copan, Italy) of the oropharynx
  • Flocked nasopharyngeal eSwab (Copan, Italy) of the nasopharynx
  • Dry flocked nasopharyngeal Swab, placed in lysis buffer Each swab will be tested for the presence of SARS-CoV-2 with an in-house reverse-transcriptase real-time PCR (Egene).

Performance of each method will be calculated.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Jessa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • health care workers with symptoms suspicious for Covid-19

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Health Care Workers with Covid-19 symptoms
3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer
Other: samling of oropharynx and nasopharynx
Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity
Time Frame: 1 month
sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessa Hospital

Investigators

  • Principal Investigator: Reinoud Cartuyvels, Jessa Hospital, Hasselt, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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