NCT05024461

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

Comparison of the Results, Feasibility and Acceptability of Molecular Detection of SARS-CoV2 Between Nasopharyngeal Swab Specimens Recovered in Virological Transport Medium and Those Obtained by Salivary Sputum

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,159 (actual)
• Sponsor: Centre Hospitalier de Cayenne · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-08-10
• Primary completion: 2020-11-12
• Completion: 2021-11-12
• First posted: 2021-08-27
• Last updated: 2021-08-27

Locations

1 site across 1 country: French Guiana