RNA Virus InfectionsNCT04517682
COVID-19 and SARS-CoV-2 Detection in Saliva
An observational study of RNA Virus Infections, run by Ambry Genetics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- RNA Virus Infections
- What is being tested?
- RT-PCR
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2020to 5 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population will be comprised of individuals age 18 years or older who are willing and able to provide verbal consent to provide a saliva sample AND a NP swab. The number of participants required is estimated to be 300 individuals whose infection status is unknown or 50 infection positive individuals and 50 infection negative individuals. The population will generally be symptomatic for, or at high risk of COVID-19 disease by criteria set forth in local testing sites. In addition, investigators will collect paired NP swabs and saliva from an equivalent size cohort of individuals known or suspected to NOT be infected with SARS-CoV-2.
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to provide consent.
- Pregnant female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS -CoV-2 Detection in Saliva Samples: A Test Validation Protocol
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.
Read the 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
- Conditions
- RNA Virus Infections
- Being tested
- RT-PCR
- Keywords
- Detection
- Medical subject headings
- RNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-PCRDiagnostic test
The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples
| Study group | Role | What they receive |
|---|---|---|
| Positive for SARS-CoV-2 | 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. Receives: Diagnostic Test: RT-PCR | |
| Negative for SARS-CoV-2 | 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. Receives: Diagnostic Test: RT-PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples
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.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start21 May 2020
- Primary completion16 Mar 2021
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RNA Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambry Genetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Saratoga Hospital, St. Joseph Hospital of Orange, Crozer-Keystone Health System
- Responsible party
- Sponsor
- Investigators
- Brigette Tippin Davis, PhD, Principal investigator, Ambry Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517682
- Sponsor's protocol ID
- COV_20_001
- Status last verified
- Mar 2022
- First submitted
- 19 May 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS -CoV-2 Detection in Saliva Samples: A Test Validation Protocol
- ClinicalTrials.gov ID
- NCT04517682
- Acronym / sponsor ID
- COV_20_001
- Conditions
- RNA Virus Infections
- Keywords
- Detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ambry GeneticsIndustry (pharma, biotech, devices)
- Collaborators
- The Saratoga Hospital, St. Joseph Hospital of Orange, Crozer-Keystone Health System
- Study start
- 21 May 2020 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive for SARS-CoV-2 | – | Diagnostic Test: RT-PCRIndividuals 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 | – | Diagnostic Test: RT-PCRIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be comprised of individuals age 18 years or older who are willing and able to provide verbal consent to provide a saliva sample AND a NP swab. The number of participants required is estimated to be 300 individuals whose infection status is unknown or 50 infection positive individuals and 50 infection negative individuals. The population will generally be symptomatic for, or at high risk of COVID-19 disease by criteria set forth in local testing sites. In addition, investigators will collect paired NP swabs and saliva from an equivalent size cohort of individuals known or suspected to NOT be infected with SARS-CoV-2.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling or unable to provide consent.
- Pregnant female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-PCRThe RT-PCR assay will be performed on paired nasopharyngeal and saliva samples | Diagnostic test | Negative for SARS-CoV-2, Positive for SARS-CoV-2 |
Primary outcome
Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigette Tippin Davis, PhD principal investigator
Ambry Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RNA Virus Infections, run by Ambry Genetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.