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

NCT04604145 | Completed

• 1 other identifier: FWH20200198H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Percent positive agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples

  Percent positive agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).

  within 1 week of SARS-CoV-2 testing

• Percent negative agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples

  Percent negative agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).

  within 1 week of SARS-CoV-2 testing

• Percent overall agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples

  Percent overall agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).

  within 1 week of SARS-CoV-2 testing

Study Arms (2)

Positive NP results

OTHER

SARS-CoV-2 testing on self-collected saliva specimens, associated with a positive NP result, using the Eppendorf Thermal Cycler Polymerase chain reaction (PCR) system

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

Negative NP results

OTHER

SARS-CoV-2 testing on self-collected saliva specimens, associated with a negative NP result, using the Eppendorf Thermal Cycler Polymerase chain reaction (PCR) system

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

Interventions

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

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).

Negative NP results; Positive NP results

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who have COVID-19 NP testing at DGMC and are willing to provide a saliva sample within 72 hours
• Adult patients (i.e., inpatient, outpatient) who have positive COVID-19 NP test results at DGMC and are willing to provide a saliva sample within 72 hours of the positive COVID-19 NP test

You may not qualify if:

• Patients unwilling to wait or have eaten, drank or smoked within the past 10 minutes
• Patients unwilling or unable to provide 2 mls of saliva
• For positive control participants only, patients whose most recent positive COVID-19 NP test was collected more than 72 hours ago

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead

Study Sites (1)

David Grant U.S. Airforce Medical Center

Travis Air Force Base, California, 94533, United States

Location

Related Publications (4)

• Fakheran O, Dehghannejad M, Khademi A. Saliva as a diagnostic specimen for detection of SARS-CoV-2 in suspected patients: a scoping review. Infect Dis Poverty. 2020 Jul 22;9(1):100. doi: 10.1186/s40249-020-00728-w.

  PMID: 32698862 BACKGROUND

• Azzi L, Carcano G, Gianfagna F, Grossi P, Gasperina DD, Genoni A, Fasano M, Sessa F, Tettamanti L, Carinci F, Maurino V, Rossi A, Tagliabue A, Baj A. Saliva is a reliable tool to detect SARS-CoV-2. J Infect. 2020 Jul;81(1):e45-e50. doi: 10.1016/j.jinf.2020.04.005. Epub 2020 Apr 14.

  PMID: 32298676 BACKGROUND

• McCormick-Baw C, Morgan K, Gaffney D, Cazares Y, Jaworski K, Byrd A, Molberg K, Cavuoti D. Saliva as an Alternate Specimen Source for Detection of SARS-CoV-2 in Symptomatic Patients Using Cepheid Xpert Xpress SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8):e01109-20. doi: 10.1128/JCM.01109-20. Print 2020 Jul 23. No abstract available.

  PMID: 32414838 BACKGROUND

• Takeuchi Y, Furuchi M, Kamimoto A, Honda K, Matsumura H, Kobayashi R. Saliva-based PCR tests for SARS-CoV-2 detection. J Oral Sci. 2020;62(3):350-351. doi: 10.2334/josnusd.20-0267.

  PMID: 32581183 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Nolan R Hudson, MS

  David Grant Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate/Medical Technologist, Principal Investigator

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 27, 2020
• Study Start: February 3, 2021
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

US (1)