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GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST

For professionals only

 Published in July 2021 

 

How does it work? 

GENmonitorCOVID-19 NEUTRALISING Ab RAPID TEST is an excellent IVD product for the qualitative detection of IgG antibodies against the SARS-CoV-2 Spike protein. This CE-certified diagnostic device detects the antibodies in human plasma, serum, or whole blood samples. For professional in-vitro use only.

GENIUS Pharmaceutical AG - GENmonitor - COVID-19 NEUTRALISING Ab RAPID TEST

SPIKE PROTEIN & NEUTRALISING ANTIBODIES

Since the arrival of the first vaccines against SARS-CoV-2 virus the nature of serological tests supporting the COVID-19 emergency has changed. At first the aim was to track down the spread of the virus among the population. However, over time it has become increasingly important to support the ongoing vaccination campaigns. 

 

GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST is a rapid device for the qualitative detection of IgG antibodies against the SARS-CoV-2 Spike protein in human serum, blood, and plasma samples. 

 

One of the most important proteins involved in the virus infection process is the Spike protein, which covers the whole virus’ surface. It is divided into two portions: one contains a region known as RBD (Receptor Binding Domain) which allows the virus to bind to the host cell by adhering to the ACE2 receptor; while the other allows the virus to enter the cell subsequently. This evidence allows to assume that an antibody capable of inhibiting the interaction between the Spike protein and the ACE2 receptor would potentially prevent coronavirus infection and the associated disease. 

GENIUS Pharmaceutical AG - GENmonitor - Spike Protein

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PRINCIPLE AND TEST PERFORMANCE

GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST is a lateral flow immunochromatographic rapid test able to detect IgG antibodies against Spike protein, which are recognised on the one hand by a specific antigen and, on the other, by a specific antibody (IgG) present in the Test line region. 

 

During the test, the anti-SARS-CoV-2 Spike/RBD IgG antibodies react with the nanoparticles present in the test buffer. Then the mixture chromatographically migrates by capillarity to the top of the test strip membrane, interacting with the Test line region and resulting in the appearance of a colored line if the sample contains anti-SARS-CoV-2 Spike/RBD IgG antibodies. If these antibodies are not present in the specimen, no colored line will appear in the Test line region, indicating a negative result. A colored line will always appear in the Control (C) line region, as procedural control, indicating that the test has been properly performed and that all the components have worked as intended. 

TECH SPECS

Different studies* were conducted to evaluate the use of GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST in order to determine the post-vaccination seroconversion rate. 

Data have been obtained starting from 14 days after the end of the vaccination cycle. Overall accuracy 96.5%, (95% CI: 94.9-98.13%), Sensitivity 92.6% (95% CI: 87.4-97.9%) and Specificity 97.4% (95% CI: 95.9-99.0%).

*Q8R318 Study Report – Italian National Cancer Institute (Milan, Italy), Interuniversity Center for Research on Influenza and other Transmissible infections (Genova, Italy), Pharmacological Research Institute Mario Negri (Bergamo, Italy) and PRIMA Lab SA (Balerna, Switzerland); May 2021. Q8R334 und Q8R335 Study Report. PRIMA Lab SA (Balerna, Switzerland); June 2021

POSSIBLE TEST METHODS

DETECTION OF THE ACUTE INFECTION

GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST

An active infection can be proven in the first three weeks after occurrence by PCR or rapid antigen test.

Used to support the vaccination campaign, in order to check the immune response of vaccinated subjects and on recovered persons after the 3rd and 6th week from symptoms onset.

HOW DOES THE TEST WORK?

GENIUS Pharmaceutical AG - GENmonitor - Test Work 1

1. Take the sample.

Take a blood sample Add two drops of the after the prick in the diluent and wait for 10 finger. Alternatively, a minutes, before you can laboratory micropipette see a result. can be used. 

2. Deposit it into the sample well.

3. Add the diluent.

Add two drops of the after the prick in the diluent and wait for 10 finger. Alternatively, a minutes, before you can laboratory micropipette see a result. 

RESULTS INTERPRETATION

Positive Result: Two colored lines appear, one in the Control Line region (C) and another line in the Test line region (T). This result means that the test has identified the presence of IgG against SARS-CoV-2 Spike protein. The color intensity of the control and test lines may vary depending on the concentration of antibodies against SARS-CoV-2 Spike protein present in the sample. Therefore, any color shade in the T region must be considered as positive.

 

Negative Result: No line appears in the Test line region (T). The test did not detect the presence of IgG against SARS-CoV-2 Spike protein in the sample. IgG is either not present or is present in very low concentrations not detectable by this diagnostic device.

 

GENmonitor NEUTRALISING Ab RAPID TEST is not conclusive for the diagnosis of ongoing infection, as the absence of antibodies does not exclude the possibility of an early-stage infection. 

GENIUS Pharmaceutical AG - GENmonitor - Test Work 4

10 MINUTES

Study abstract

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