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Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05256589
Recruitment Status : Not yet recruiting
First Posted : February 25, 2022
Last Update Posted : March 11, 2022
Sponsor:
Collaborator:
Nova Scotia Health Authority
Information provided by (Responsible Party):
Sona Nanotech Inc

Brief Summary:
The Sona Saliva C-19 Rapid Self-Test is a lateral flow assay intended for detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to an RT-PCR reference method.

Condition or disease Intervention/treatment Phase
Sars-CoV-2 Infection Diagnostic Test: Sona Saliva C-19 Rapid Self-test Not Applicable

Detailed Description:

This is a prospective, non-randomized clinical evaluation study being carried out in the intended use population in which fresh saliva samples are collected, tested, and interpreted by lay-users and the results are compared to samples evaluated with an authorized high sensitivity molecular RT-PCR test.

The device to be studied is the Sona Saliva C-19 Rapid Self Test.

Participants will be recruited into the study who present at a NS Health Central Zone COVID-19 PCR testing site for COIVID-19 testing. This study does not involve any additional study visits, and all participants will receive the current standard of care.

Patients will provide their RT-PCR sample as per the established testing processes at the health centre and will receive their results through the standard communication pathway. Self-testing using the Sona assay will be conducted at the COVID -19 testing center by individuals in real time.

The participants will be instructed as to not act on the result of their Sona saliva assay, but rather await the gold standard result of RT-PCR.

A usability questionnaire will also be completed by individuals.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

The purpose of this study is to validate the performance of the Sona Saliva C-19 rapid Self-Test for detection of SARS_CoV_2 infection when using saliva specimens. A prospective study to evaluate a rapid point of care antigen test for the detection of viral proteins and compared against an approved RT-PCR test.

Saliva samples will be collected along with the current standard of care collection.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SARS_CoV_2 Antigen Rapid Test

The same group of patients participate in two arms of the study:

One arm is for obtaining performance data of the Sona Saliva C-19 Rapid self test and the comparator arm is to obtain data from the primary care route using approved RT-PCR testing.

Diagnostic Test: Sona Saliva C-19 Rapid Self-test
Rapid Antigen diagnostic device performance comparative to RT-PCR




Primary Outcome Measures :
  1. Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity) [ Time Frame: 35 days from last patient enrolment ]
    Calculate the performance of the Sona Saliva C-19 Rapid Self Test when compared to RT- PCR



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged ≥ 18+ years
  2. Presenting at designated NS Health Central Zone COVID-19 PCR testing sites.
  3. Receiving a RT-PCR COVID-19 test as per standard of care (nasopharyngeal/mid-turbinate swabs).
  4. Unvaccinated, partially vaccinated, fully vaccinated and fully vaccinated-boosted patients
  5. Provide written informed consent..
  6. Patients may have recently been exposed, in close contact, show no symptoms or may be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 6 days:

    1. Fever as self-described or measured ≥ 38 °C (100.4°F)
    2. Chills
    3. Cough
    4. Shortness of Breath
    5. Congestion or Runny Nose
    6. Difficulty Breathing
    7. Muscle or Body Aches
    8. Vomiting
    9. Diarrhoea
    10. New loss of sense of taste or smell
    11. General malaise All patients in whom a test result (positive or negative) is obtained from both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test, will be included in the performance analysis.

Exclusion Criteria:

All patients from whom a non-valid result is obtained from either or both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test will be excluded in the analysis for sensitivity and specificity and will be noted as a test error.

Any rapid tests that produced an invalid test result will be noted as a test error and secondary analysis will be conducted on this cohort of patients to understand any underlying causation.

Patients recruited into the study that are recorded to have consumed anything orally within 30 minutes of conducting a rapid self-test, as per the warnings laid out in the IFU, may be excluded from the analysis to mitigate any interference risks relating to test outcome.

Also, the following:

  1. Patients unable to provide a saliva sample for rapid testing
  2. Patients unable to provide written consent.
  3. Patients previously enrolled in the study
  4. Patients undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection

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): NCT05256589


Contacts
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Contact: Glenn Patriquin, MD +1 902-473-7493 glenn.patriquin@nshealth.ca

Sponsors and Collaborators
Sona Nanotech Inc
Nova Scotia Health Authority
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Responsible Party: Sona Nanotech Inc
ClinicalTrials.gov Identifier: NCT05256589    
Other Study ID Numbers: DHF009 - NSHCT
First Posted: February 25, 2022    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sona Nanotech Inc:
Antigen
COVID19
Rapid Test
Saliva
Self-test
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases