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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04361448
Enrollment
30
Registered
2020-04-24
Start date
2020-04-20
Completion date
2020-06-30
Last updated
2021-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19, Diagnosis, Polymerase Chain Reaction, SARS-CoV-2

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.

Interventions

OTHERsamling of oropharynx and nasopharynx

Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs

Sponsors

Jessa Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Each participant get study number. Samples will be identified by the study number.

Intervention model description

Beside the regular sampling method of 1 nasopharyngeal swab, 2 extra swabs will be taken in each volunteer. Performance of the 3 methods for laboratory diagnosis by PCR of Covid-19 will be compared.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* health care workers with symptoms suspicious for Covid-19

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
sensitivity1 monthsensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026