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

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ClinicalTrials.gov Identifier: NCT04604145
Recruitment Status : Completed
First Posted : October 27, 2020
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Nolan Hudson, David Grant U.S. Air Force Medical Center

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.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Polymerase Chain Reaction Laboratory Testing Diagnostic Test: SARS-CoV-2 testing on the Eppendorf Thermal Cycler PCR system using self-collected saliva as the specimen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Self-Collected Saliva Samples Without Viral Transport Media for SARS-CoV-2 Testing Via RT-PCR
Actual Study Start Date : February 3, 2021
Actual Primary Completion Date : August 18, 2021
Actual Study Completion Date : August 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Positive NP results
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
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
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
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).




Primary Outcome Measures :
  1. Percent positive agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples [ Time Frame: within 1 week of SARS-CoV-2 testing ]
    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).

  2. Percent negative agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples [ Time Frame: within 1 week of SARS-CoV-2 testing ]
    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).

  3. Percent overall agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples [ Time Frame: within 1 week of SARS-CoV-2 testing ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604145


Locations
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United States, California
David Grant U.S. Airforce Medical Center
Travis Air Force Base, California, United States, 94533
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
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Principal Investigator: Nolan R Hudson, MS David Grant Medical Center
  Study Documents (Full-Text)

Documents provided by Nolan Hudson, David Grant U.S. Air Force Medical Center:
Informed Consent Form  [PDF] April 6, 2021

Publications:
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Responsible Party: Nolan Hudson, Research Associate/Medical Technologist, Principal Investigator, David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT04604145    
Other Study ID Numbers: FWH20200198H
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases