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

Not Applicable

Terminated

• Conditions: SARS-CoV-2; Diagnosis; Covid-19; Polymerase Chain Reaction
• Interventions: Other: samling of oropharynx and nasopharynx

• Registration Number: NCT04361448
• Lead Sponsor: Jessa Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-04-20
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• health care workers with symptoms suspicious for Covid-19

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health Care Workers with Covid-19 symptoms	samling of oropharynx and nasopharynx	3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer

Primary Outcome Measures

Name	Time	Method
sensitivity	1 month	sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Belgium