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POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test

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: NCT05119530
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Therma Bright Inc

Tracking Information
First Submitted Date November 11, 2021
First Posted Date November 15, 2021
Last Update Posted Date January 11, 2022
Actual Study Start Date December 6, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 11, 2021)
Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test [ Time Frame: 1 day ]
To establish the performance characteristics of the AcuVid COVID-19 Rapid Antigen Saliva Test in a point-of-care (POC) CLIA Waived setting with lay users (no laboratory experience) testing a participant that has self-collected a saliva specimen. Clinical accuracy of the AcuVid Test will be compared to RT-PCR test results. Accuracy refers to the (PPA, positive percent agreement (sensitivity) and (NPA, negative percent agreement (specificity) between the results of the AcuVid Test and the comparator RT-PCR test.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
Official Title U.S. POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
Brief Summary

The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect.

The AcuVid COVID-19 Rapid Antigen Saliva Test performance will be compared to a high sensitivity FDA EUA approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) swab results will be collected from subjects by healthcare providers at CLIA Waived COVID-19 Testing Centers, and on the same day the subjects will also provide saliva samples which will be tested and interpreted by the healthcare providers.

This prospective, observational, study will test up to 300 participants to establish the performance characteristics of the AcuVid test on saliva specimens.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Study population will come from individuals visiting COVID-19 testing Centers for the purpose of obtaining a COVID-19 RT-PCR test results. Individuals will be approached to determine eligibility and obtain consent after they have provided a NP swab sample for their COVID-19 RT-PCR test.
Condition COVID-19
Intervention Diagnostic Test: AcuVid COVID-19 Rapid Antigen Saliva Test
The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 11, 2021)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participant is willing to sign verbal informed consent form.
  • Age ≥12 and parents or legal guardians must consent as required by law.
  • Participant is attending COVID-19 testing centre to provide a nasopharyngeal swab sample.
  • Participant is willing to provide a self-collected saliva sample.

Exclusion Criteria:

  • Participant has previously tested positive for COVID-19 within the past 90 days.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hazel Flores 909-462-4161 hazel@covidclinic.org
Contact: Angela Hall 949-287-8191 angela@covidclinic.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05119530
Other Study ID Numbers TB20-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Therma Bright Inc
Original Responsible Party Same as current
Current Study Sponsor Therma Bright Inc
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Therma Bright Inc
Verification Date December 2021