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Self-Collected Saliva Samples Without Viral Transport Media for COVID-19 Testing Via RT-PCR

NCT04604145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-08-30

No results posted yet for this study

Summary

This is a study that will attempt to validate the process for detecting SARS-CoV-2 (COVID19) on a non-FDA-approved technology using self-collected saliva as the specimen. Investigators will compare self-collected saliva samples and healthcare-worker collected nasopharyngeal samples (Nasal swabs) to see if the self-collected saliva samples are similar in terms of diagnostic accuracy. Investigators will be performing this testing at the site where patients regularly go for COVID19 testing. There will be minimal risk of harm as consenting patients will only have to provide a small amount of saliva into a tube.

Conditions

  • SARS-CoV Infection
  • Polymerase Chain Reaction
  • Laboratory Testing

Interventions

DIAGNOSTIC_TEST

SARS-CoV-2 testing on the Eppendorf Thermal Cycler PCR system using self-collected saliva as the specimen

Obtain self-collected saliva sample, perform SARS-CoV-2 testing using the Eppendorf Thermal Cycler Polymerase chain reaction (PCR) system on 30 samples associated with a positive and 30 samples associated with a negative NP sample, then compare saliva results to healthcare worker collected NP sample results evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® (gold standard).

Sponsors & Collaborators

  • David Grant U.S. Air Force Medical Center

    lead FED

Principal Investigators

  • Nolan R Hudson, MS · David Grant Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2021-08-18
Completion
2021-08-18

Countries

  • United States

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 NCT04604145 on ClinicalTrials.gov