Clinical Trials Logo

Clinical Trial Summary

This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.


Clinical Trial Description

Investigators will carry out validation of a laboratory assay to detect SARS-CoV-2 nucleic acids in human saliva samples. Data for the validation will include the test results from standard nasopharyngeal (NP) swabs (controls) AND matched saliva samples (experimental group) of individuals who are either known to be infected or at high risk of being infected. Investigators hypothesize that the performance of an assay designed specifically for saliva will not perform differently, as defined by a predetermined margin, from the standard assay performed on NP and other respiratory samples ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04517682
Study type Observational
Source Ambry Genetics
Contact
Status Completed
Phase
Start date May 21, 2020
Completion date August 5, 2021

See also
  Status Clinical Trial Phase
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT04644484 - A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety Phase 3
Completed NCT00984945 - Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults Phase 1
Active, not recruiting NCT05284097 - Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study Phase 2
Completed NCT03739112 - Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly Phase 3
Completed NCT01991587 - Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults Phase 1/Phase 2
Completed NCT03294473 - Centralized Reminder Recall - Flu RCT2 N/A
Completed NCT01244867 - Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine Phase 2
Not yet recruiting NCT05394623 - Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)
Recruiting NCT03776760 - Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
Active, not recruiting NCT04365101 - Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19 Phase 1/Phase 2
Completed NCT05307991 - Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
Completed NCT03110770 - VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents Phase 2
Completed NCT04772469 - Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men N/A
Terminated NCT02120274 - Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C Phase 4
Completed NCT02768805 - Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults Phase 2
Completed NCT03642977 - DNA and RNA Viruses of the Blood Virome of Allogeneic Hematopoietic Stem Cell Transplant Recipients
Recruiting NCT04627623 - Prevalence and Risk Factors of COVID-19 in the Upper Silesian Agglomeration
Completed NCT01991561 - Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine. Phase 2
Completed NCT01587131 - DNA-based Influenza Vaccine in the Elderly Phase 1