Clinical Performance Evaluation of KnowNow SARS-CoV-2 Test for the Detection of COVID-19 Antigen
1 other identifier
observational
600
0 countries
N/A
Brief Summary
This is an international, multicentre, non-interventional, observational study to assess the clinical diagnostic performance of a rapid, point of care (POC) COVID-19 (SARS-CoV-2) antigen In vitro diagnostic (IVD), The KnowNow SARS-CoV-2 Rapid Antigen Test, using saliva samples when compared to reverse transcription polymerase chain reaction (RT-PCR) as the standard detection of COVID-19 infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedFebruary 25, 2021
January 1, 2021
7 months
January 22, 2021
February 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Assess clinical diagnostic performance of the KnowNow SARS-CoV-2 Rapid Antigen Test
This includes determination of the sensitivity/positive percent agreement (PPA), specificity/negative percent agreement (NPA), positive predicted value (PPV) and negative predictive value (NPV).
6 months
Secondary Outcomes (2)
Efficacy to assess the test compared to the reference test method
6 months
Usability Questionnaire to evaluate the use of the test with 2 saliva collection methods
6 months
Interventions
KnowNow SARS-CoV-2 Rapid Antigen Test for the detection of Covid-19 in saliva, as compared to high sensitivity reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swabs as the reference test method
Eligibility Criteria
Male or female aged 18 years or over (or age of adult consent in some states within the United States) with suspected COVID -19 infection.
You may qualify if:
- Male or female aged 18 years or over (or age of adult consent in some states within the United States).
- Suspected COVID-19 infection and / or presenting with at least 1 recognised symptom Fever or chills. ie: Cough. Shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat
- Be willing and able to comply with study procedures.
- Be able to give written informed consent.
You may not qualify if:
- Inability to give written informed consent.
- Vaccinated against SARS-CoV-2
- Adults unable to undertake the requirements of the nasopharyngeal or saliva sample collection for physical or psychological reasons
- Subjects with other significant disease, condition, or at the Clinician's discretion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vatic Ltd.lead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alex Sheppard, BA
Vatic Ltd.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2021
First Posted
February 1, 2021
Study Start
February 15, 2021
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
February 25, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share