COVID-19 Testing Results in 15 Minutes

Accurate detection of IgM and IgG patient-generated antibodies with the rapid, point-of-contact CE-IVD test

COVID-19 Immunoassay Quick Facts

> The COVID-19 Rapid Point-of-Contact CE-IVD Test Cassette is a qualitative, membrane-based immunoassay for the detection of IgG and IgM patient-generated antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens.

> SARS-CoV-2 is the causative viral agent of the disease COVID-19. It is primarily transmitted through respiratory droplets, and enters into cells via the ACE2 receptor found on alveolar epithelial cells (among other cell types).

> Symptoms of COVID-19 may appear as early as 2 days after initial infection, or as late as 14 days. There is variation in the severity of symptoms and in their duration and time of onset. Further information is available at the CDC website (cdc.gov).

COVID-19 vs Flu & Common Cold Symptoms

Fig 1. Symptom information adapted from CDC, WHO, & HSE guidelines.

Detecting COVID-19

Fig 3. Detection methods for COVID-19 by diagnostic and specimen types.

Fig 2. One test cassette unit.

IgG vs. IgM Responses in Viral Infections

Fig 4. A typical antibody response curve; the time course of COVID-19 isotype switching is currently being elucidated.

> The test detects the presence of patient-generated antibodies against SARS-CoV-2, the virus which causes the disease COVID-19. The test can detect two types of antibody isotypes: IgG and IgM. IgM antibodies are the first antibodies to appear in response to a novel antigen. They imply a more recently initiated infection.

> IgG antibodies have a higher affinity for the target antigen, meaning they are able to bind the substance which caused the immune response with more specificity. IgG antibodies are generated later in the course infection.

> IgM and IgG antibodies can both be present in a sample. This implies that the conversion from a primarily IgM to IgG response is underway. A sample can be positive if there are IgM, IgG, or both IgM and IgG antibodies present.

Accurate Detection of Patient-Generated Antibodies in 15 minutes

The COVID-19 Rapid Point-of-Contact CE-IVD Test Cassette is a qualitative, membrane-based immunoassay for the detection of IgG and IgM patient-generated antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens.

The test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the test cassette. The mixture then migrates laterally across the membrane through capillary action and reacts with the anti-human IgM in IgM test line region. If the specimen contains IgM antibodies to SARS-CoV-2, a coloured line will appear in M test line region. Similarly, anti-human IgG coats the IgG test line region. If specimen contains IgG antibodies to SARS-CoV-2, the conjugate-specimen complex reacts with anti-human IgG. A coloured line appears in G test line region as a result.