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Trial record 1 of 1 for:    Acuvid | Recruiting, Not yet recruiting Studies | Covid

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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  : Not yet recruiting

First Posted  : November 15, 2021

Last Update Posted  : November 15, 2021

See Contacts and Locations

Sponsor:

Therma Bright Inc

Information provided by (Responsible Party):

Therma Bright Inc

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Study Description

 

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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.

Condition or disease	Intervention/treatment
COVID-19	Diagnostic Test: AcuVid COVID-19 Rapid Antigen Saliva Test

Study Design

 

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Study Type  :	Observational
Estimated Enrollment  :	300 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Official Title:	U.S. POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
Estimated Study Start Date  :	November 2021
Estimated Primary Completion Date  :	December 2021
Estimated Study Completion Date  :	December 2021

Groups and Cohorts

 

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Intervention Details:

• 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

Outcome Measures

 

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Primary Outcome Measures  :

1. 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.

Eligibility Criteria

 

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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.

Ages Eligible for Study:	12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

 

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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): NCT05119530

Contacts

Contact: Hazel Flores	909-462-4161	[e-mail]
Contact: Angela Hall	949-287-8191	[e-mail]

Sponsors and Collaborators

Therma Bright Inc

More Information

 

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Responsible Party:	Therma Bright Inc
ClinicalTrials.gov Identifier:	NCT05119530     History of Changes
Other Study ID Numbers:	TB20-03
First Posted:	November 15, 2021    Key Record Dates
Last Update Posted:	November 15, 2021
Last Verified:	November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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

[Skipabeat22]

Interesting to say the least... "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." So what does CLIA Waived mean: Every laboratory system, examination and assay is categorized for its

[moonball32]

Excellent post, thank you

[Bakunin6]

Bewildering that a 15 minute at home spit test does not excite the masses. The fda is in a hurry, the people are clamoring for it, yet the share price flat lines for months...guess I'll buy more