COVID-19 and SARS-CoV-2 Detection in Saliva

Completed

• Conditions: RNA Virus Infections
• Interventions: Diagnostic Test: RT-PCR

• Registration Number: NCT04517682
• Lead Sponsor: Ambry Genetics

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2020-05-19
• Study Start: 2020-05-21
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-18
• Primary Completion: 2021-03-16
• Study Completion: 2021-08-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Reads and understands English or Spanish
• Willing and able to provide consent
• Diagnosed with COVID-19 or at high risk of disease based on objective criteria

Exclusion Criteria

• Unwilling or unable to provide consent.
• Pregnant female

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Positive for SARS-CoV-2	RT-PCR	Individuals who are symptomatic for COVID 19 disease, at high risk of infection or part of a screening program will provide samples for analysis which may reveal a positive result.
Negative for SARS-CoV-2	RT-PCR	Individuals who are symptomatic for COVID 19 disease, at high risk of infection or part of a screening program will provide samples for analysis which may reveal a negative result.

Primary Outcome Measures

Name	Time	Method
Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples	up to 7 days	TaqPath RT-PCR assay performed on saliva compared to TaqPath RT-PCR performed on nasopharyngeal samples for assay accuracy, concordance, reproducibility/precision, analytical sensitivity and analytical specificity.

Trial Locations

Locations (1)

Ambry Genetics; 🇺🇸 Aliso Viejo, California, United States