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Quantitative
nAb test QT

Quantitative nAb test QT

GENmonitor™ NEUTRALISING Ab RAPID TEST QT

For professionals only

 Published in August 2021 

 

How does it work?  

GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT is an excellent IVD product for the quantitative 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. 

SPIKE PROTEIN & NEUTRALISING ANTIBODIES

COVID-19-20P_BOX_QT_3D_ersatz

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.

 

With our test, you can very quickly determine whether your patients have neutralising antibodies against a renewed COVID-19 disease in their blood due to a vaccination or an infection they have overcome, and in what concentration. Of growing importance is the question of the titer of these antibodies: firstly, because of testing, immune protection and its refreshment as needed. Secondly, to control the general vaccination success with regard to herd immunity. And thirdly, to use vaccine shortages where really necessary through a clever vaccination strategy. 

The GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT is a rapid test for the quantitative quantitative detection of IgG antibodies against the the SARS-CoV-2 spike protein in human serum serum, blood and plasma samples. One of the important viral proteins involved in the process of viral infection is the so-called spike protein. This covers the entire surface of the virus. The spike protein comprises two components (S1 and S2 sub-units). The first component contains an area known as the RBD (Receptor Binding Domain), which enables the virus to bind to the host cell by attaching to 

 the ACE2 receptor; the second component enables the virus to enter the cell in a subsequent phase. This principle of action leads to the that an antibody that can inhibit the interaction between the spike protein and the the ACE2 receptor could potentially prevent coronavirus infection and prevent coronavirus infection and, consequently, the associated disease. associated disease. 

GENIUS Pharmaceutical AG - GENmonitor - Spike Protein

SMART ANALYSER PLATFORM

The GENmonitor COVID-19 NEUTRALISING Ab RAPID TEST QT is aimed at medical professionals with the aim of analysing very quickly whether your patients/clients have neutralising antibodies against a renewed COVID-19 disease in their blood due to a vaccination or an infection they have overcome, and in what concentration. Our Smart Analyzer platform is used for this purpose. Within 10 minutes, it carries out a fully automated, quantitative determination of the neutralising antibodies at the point of care in the doctor’s practice and transfers these values to the practice information system. information system. 

TEST PRINCIPLE

For the evaluation of quantitative rapid tests such as the GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT, the Smart Analyser platform is required, otherwise all components to perform the test are included. to perform the test are included. GENIUS Pharma offers two very high quality point-of-care measuring devicesthe small and handy GENmonitor™ Smart Analyser (igloo) and the larger GENmonitor™ Pro analyser. 

The target analyte of the GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT, i.e. the IgG antibodies against the SARS-CoV-2 virus contained in the patient’s blood, binds on the one hand to the specific surrogate virus antigen (i.e. to the RBD part of the virus spike protein, S1) on the test strip, and on the other hand to specific antibodies present in the area of the test line, which selectively recognise human IgG. 

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 QT in order to determine the post-vaccination seroconversion rate. 

genius-pharmaceutical-ag-genmonitor-symptoms-tech-specs-en

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 

8 FACTS ABOUT THE GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT

With the progressive number of vaccinated and recovered individuals against, respectively, COVID-19, a new issue is coming to the fore: active immune protection against SARS-CoV-2, which can be measured by neutralising antibodies (NAb). GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT is a quantitative rapid test that, in combination with one of our high-quality meters, detects within 10 minutes the concentration of neutralising antibodies in a human blood, plasma, or serum sample that a patient has after a full vaccination or COVID-19 infection. Neutralising antibodies can prevent viral infection by binding to the spike protein. 

 

As specialists in IVD diagnostics, we would like to give you the freedom to evaluate the determination of NAb directly and easily and to bill yourself without detours via laboratories or long waiting times with the GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT and one of our high-quality measuring instruments. In addition, we have summarised the eight most important facts about the testing of about the testing of antibodies. 

1. Neutralising antibodies (NAb)

Are a subgroup of the IgG antibodies which, through antibodies that can prevent a viral infection by binding to the spike protein. They indicate the immune status after vaccination or after surviving a COVID-19 infection. infection. 

5. Reliability

The GENmonitor™ COVID-19 NEUTRALISING Ab. RAPID TEST QT is very reliable with a sensitivity of 96.5% and a specificity of 97.4%. and a specificity of 97.4%. Our test is designed for the well-known vaccines Pfizer BioNTech, Moderna and AstraZeneca vaccines, and the efficacy is also supported by studies*. 

2. Quantitative determination of antibodies

This test method measures the concentration of neutralising antibodies (NAb) in the blood to assess the actual immune protection of patients. This analysis of SARSCoV-2 by rapid test is new and distinguishes the GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT from the qualitative antibody tests that have been antibody tests that have been available on the market for some time. 

6. laboratory is not necessary

The GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT is very easy to use. All the necessary components for carrying out the test are included in the scope of delivery. For the evaluation you need one of our innovative Point-of- Care measuring devices. 

3. Significance

The quantitative measurement of neutralising antibodies is increasing in the pandemic environment: because the immune protection of patients can be tested and refreshed if the levels are too low. Because the general success of vaccination can be monitored (keyword herd immunity). And last but not least, because the vaccine can be used efficiently through clever vaccination strategies. Vaccination is carried out when it is really necessary, and not before. 

7. Our measuring instruments

Each of our instruments is a high-precision minilab for quantitative test evaluation. We offer two different devices. The Smart Analyser and the Pro Analyser. 

4. Performance

Small prick in the finger and collection of 10 ul blood, serum or plasma from the fingertip. 

8. the billing

The GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT can be billed in the Federal Republic of Germany according to GOÄ 4400 (factor 1.15 = € 20.11), or GOÄ 4405 (factor 1.15 = € 53.62). Immunity tests such as the test for neutralising antibodies are not reimbursed by the GKV but are paid for privately or as or as an IGeL service. 

OUR MEASURING DEVICES FOR YOUR PRACTICE/ SALES PREMISES

A readout device is required to perform quantitative rapid tests, otherwise all components to perform the GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT are included. Genius Pharma has two high-quality point-of-care meters to choose from. The small and handy Smart Analyser and the larger GENmonitor™ Pro Analyser. 

THE COMPACT ONE

Smart Analyser
Point-of-Care

The Smart Analyser is our handy and small measuring device. With a ledQTich 8.5 cm height and a diameter of 9 cm, this peck is a very precise a very precise quantitative instant diagnostician. The very very high measuring accuracy and handiness, as well as easy handling, makes it a valuable device with which you can with which you can evaluate important patient-oriented in your practice. You can pay for these either either privately via the GOÄ or as an IGeL service. 

THE PROFESSIONAL

GENmonitor™
Pro Analyser

Analyser_Pro

The GENmonitor™ Pro Analyser is our large point-of-care measuring device with integrated thermal printer, touchscreen and a wide range of interfaces to external devices (USB, Ethernet, LAN, RS232c, ID card). This easy-to-use measuring device with touch screen and a memory for up to 10’000 patient records patient records, measures 33x25x16 cm and weighs 2.5 kg. weighs 2.5 kg. The GENmonitor™ Pro analyser is a fluorescence immunoassay for the quantitative and qualitative and qualitative detection of neutralising antibodies against SARS-CoV-2 in human whole blood, serum or plasma samples. 

SM-1

Quick / Determine immune status in 10 minutes

SM-2

Qualitative / Swiss Quality product

SM-3

Profitable / Self without detours via a laboratory

SM-4

Reliable / Short Delivery routes from Swiss manufacture

BILLING INFORMATION

The GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST QT can be billed in the Federal Republic of Germany according to GOÄ 4400 (factor 1.15 = € 20.11), or GOÄ 4405 (factor 1.15 = € 53.62). Immunity tests such as the test for neutralising antibodies are not yet reimbursed by the GKV, but are billed privately or as IGeL services. 

POSSIBLE TEST METHODS

DETECTION OF THE ACUTE INFECTION

GENmonitor™ COVID-19 NEUTRALISING Ab RAPID TEST+QT

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 a blood sample after pricking the finger. Alternatively, a laboratory micropipette can be used. 

2. Drop the sample into the sample well of the cassette. 

3. Add 2 drops of diluent and prepare the test cassette immediately for the measuring instrument. 

4. Insert the test cassette into the analyser and start the measuring process.

Result after 10 min

DESCRIPTION OF THE POSSIBLE ANALYSIS VALUES

NEGATIVE

The displayed result is either “Negative” or “Value below test minimum”. This result indicates that the test has not detected the presence of antibodies or that antibodies are present at a concentration below 22.5 BAU/ mL. 

IgG

Analyse-Werte-1

IgG

Analyse-Werte-2

POSITIVE - LOW ANTIBODY LEVEL

The result displayed is ” Few “. This result means that the test has detected the presence of antibodies at a concentration between 22.5 and 135.5 BAU/ mL. 

IgG

Analyse-Werte-3

POSITIVE - MODERATE LEVEL

The result displayed is “Moderate”. This result indicates that the tst has detected the presence of antibodies at a concentration between 135.5 and 511 BAU/ mL. 

IgG

Analyse-Werte-4

POSITIVE - HIGH LEVEL

The result displayed is “Very High”. This result indicates that the test has detected the presence of antibodies at a concentration above 511 BAU/ mL. 

IgG

Analyse-Werte-5

Study abstract

Open PDF file

Contact Info

Further informations

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