An observational study in Covid19, sponsored by Vatic Ltd.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by Vatic Ltd. · Observational
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.
The KnowNow SARS-CoV-2 Rapid Antigen Test which uses saliva and is a lateral flow diagnostic device that can detect the SARS-CoV-2 specific Antigens that are present on the surface of the virus. The KnowNow test is an affordable, user friendly, and point of care device that can be mass produced as part of a multipronged strategy to address the global COVID-19 pandemic.
A saliva sample is collected from someone with suspected COVID-19 and mixed with a running buffer. The mixture is added to the sample pad of the KnowNow test, from where it migrates through the lateral flow strip. If COVID-19 Antigens are present, they bind to capture proteins on a test line and are made visible by secondary reagents within the device. The test result is visually assessed after 15-30 minutes and provides a binary positive (two lines) or negative (one line) result. Levels of COVID-19 Antigen differ dependent on disease progression. A visible test line (marked T) indicates the presence of COVID-19 Antigen in sufficient quantity in the collected sample to be detected. The appearance of the control line (marked C) confirms that the test has been performed correctly.
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's planned enrollment of 600 is above the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Vatic Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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).
Time frame: 6 months
Efficacy to assess the test compared to the reference test method
* Calculated Sensitivity/PPA, Specificity/NPA, PPV and NPV of the KnowNow SARS-CoV-2 Rapid Antigen Test compared to RT-PCR as SOT in individuals with and without COVID-19 symptoms. * Calculated Sensitivity/PPA, Specificity/NPA, PPV and NPV of the KnowNow SARS-CoV-2 Rapid Antigen Test compared to RT-PCR as the reference method in individuals with and without COVID-19 symptoms. * Calculated Sensitivity/PPA between the KnowNow SARS-CoV-2 Rapid Antigen Test and RT-PCR tests stratified using cycle threshold (CT) values.
Time frame: 6 months
Usability Questionnaire to evaluate the use of the test with 2 saliva collection methods
Evaluation of the 2 saliva collection methods by a patient questionnaire with responses recorded by a healthcare provider. responses are on a numerical scale graded 1 to 9. 1 = 'hard' to 9 which is 'easy'.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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