SARS-CoV Infection Clinical Trial
Official title:
Evaluation of Self-Collected Saliva Samples Without Viral Transport Media for SARS-CoV-2 Testing Via RT-PCR
Verified date | August 2021 |
Source | David Grant U.S. Air Force Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 18, 2021 |
Est. primary completion date | August 18, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | David Grant U.S. Airforce Medical Center | Travis Air Force Base | California |
Lead Sponsor | Collaborator |
---|---|
David Grant U.S. Air Force Medical Center |
United States,
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. — View Citation
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. — View Citation
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). pii: e01109-20. doi: 10.1128/JCM.01109-20. Print 2020 Jul 23. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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