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Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum

NCT05024461 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1159

Last updated 2021-08-27

No results posted yet for this study

Summary

Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. The clinical circumstances of the diagnosis, the age of the patient, the associated terrain (diabetes, immunodepression, pregnancy) will be noted. The nasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining samples will be frozen and stored at the CRB before being sent to the University Hospital of Caen for analysis and concordance verification.

The expected benefits are:

Possibility of repeating tests in the same person more easily due to the absence of pain and thus reduce the barriers to diagnosis and screening.

Possibility of self-sampling, which could simply be sent to the laboratory, which would relieve the diagnostic sites that mobilize staff and require a fairly heavy organization. Avoid long waiting lines that can be an obstacle and lead to a renunciation of the diagnosis.

Conditions

  • Covid19

Interventions

DIAGNOSTIC_TEST

Salivary test for COVID19

Results of nasopharyngeal and salivary samples taken at the Cayenne hospital and the Caen university center, * Pre-analytical particularities and analytical particularities * Cycle threeshold * Demographic variables * Clinical variables * Clinical criteria * Questionnaire on the perception of the 2 sampling methods

Sponsors & Collaborators

  • Centre Hospitalier de Cayenne

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2020-11-12
Completion
2021-11-12

Countries

  • French Guiana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024461 on ClinicalTrials.gov