This test has CE Marking for professional use only. The Novacheck COVID-19 quick test identifies the body’s response to the corona virus after the onset of infection and gives a qualitative yes / no result within 15 minutes. Implementing rapid screening for COVID-19 saves a lot of time and cost compared to laboratory screening and will help control the spreaad of the virus by identifying the infection quickly and accurately.
The test kit is easy to use, just like a blood glucose test, it just needs a drop of blood sample from finger. In additon to whole blood, the test kit can also be run with serum or plasma samples.
Diagnosing viral infections currently relies on two major methodologies:
Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) and serological immunoassays that dettect viral-specific antibodies (IgM and IgG) for antigens. Although, RT-qPCR is a highly sensitive test for SARS-CoV-2 (the virus that causes COVID-19) it has its limitations. RT-qPCR requires high-quality nasopharyngeal swabs containing sufficients amount of viral RNA. This can be a challenge because the amount the of viral RNA not only varies tremendously between patients, it can also varies within the same patient depending on the timing of the test and the start of the infection and/or the onset of symptoms. In addition, nasopharyngeal swabs are not only very unpleasant to the patient, the sampling techniques vary significantly from nurse to nurse.
Without sufficient viral RNA RT-qPCR can return a false negative test result. RT- qPCR also requires highly trained personnel to perform complex RNA extraction step and PCR. Normally, this would not be a problem when testing a few thousand samples. RT-qPCR becomes an issue when dealing with a global pandemic with potentially millions of people to test. This leads to delyas in testing as medical facilities become overwhelmed with requests.
The present IgM/IgG serological assay is designed to complement RT-qPCR in the diagnosis of SARS-CoV-2 infetioncs. Table 1 shows the clinical interpretation of all possible scenarios that can be encountered when testing a patient with both RT-qPCR and an IgM/IgG serological test.