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.
Study Type
OBSERVATIONAL
Enrollment
600
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
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