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Tracing the Virus - AESKULISA SARS-CoV-2 Antibody Tests

A secure future thanks to quantitative SARS-CoV-2 AESKULISA tests

Corona Virus In the current situation, it is hardly necessary to argue about the urgent need for an effective and robust vaccine to treat COVID-19, because our society and humanity itself are in a state of emergency. However, not only a vaccine is urgently needed, but the success of vaccination must also be verified using quantitative tests. Quantitative tests react to neutralizing antibodies, i.e., antibodies responding to a pathogen and breaking it down, make it possible to determine the success of an immune response and a vaccination in everyday practice.

For the determination of an immune reaction, the examination of immunoglobulins, so-called antibodies, has been established for years. Since protein structures on the surface of a pathogen (bacterium, virus) are specific, i.e., unique for individual structures, the immune system forms the appropriate antibody; it is possible to examine different antibodies for confirmation and infection. In the case of SARS-CoV-2 viruses, the nucleocapsid protein (N) and the spike protein (S1) are suitable.

AESKU offers six different immunoassays:

AESKULISA^® SARS-CoV-2 NP IgM/ IgA / IgG

AESKULISA^®SARS-CoV-2 NP IgA, IgG, and IgM tests are qualitative and quantitative immunoassays for the detection of human IgM, IgA, and IgG antibodies in serum or plasma directed against SARS-CoV-2 in highly conserved nucleocapsid protein (NP). The nucleocapsid protein is very reactive and stimulates a strong immune response. This potent immune response provides a very sensitive detection of antibodies, which allows a clear differentiation between positive and negative samples.

They are, therefore, ideal for IgM, IgG, and IgA detection for screening and diagnosis. Due to the high sensitivity and the strong conservation of the nucleocapsid protein in the coronavirus family, the risk of cross-reaction with antibodies against SARS-CoV-1 is increased. Since antibodies against the nucleocapsid protein have no neutralizing effect, they are not suitable for determining the immune status, the so-called antibody titer.

AESKULISA^®SARS-CoV-2 NP IgA Antibodytest (Nucleocapsid Protein)
recommended for the detection of acute infections.

AESKULISA^®SARS-CoV-2 NP IgG Antibodytest (Nucleocapsid Protein)
allows the confirmation of pathogen contact and the immune status's determination.

AESKULISA^®SARS-CoV-2 NP IgM Antibodytest (Nucleocapsid Protein)
allows determining the first specific reaction of the immune system.

AESKU uses immunogenic nucleocapsid proteins of SARS-CoV-2 expressed in insect cells for the sensitive detection of IgM, IgA, and IgG antibodies.

AESKULISA^®

Sensitivity

Specificity

SARS-CoV-2 NP IgA

98.3 %

> 99 %

SARS-CoV-2 NP IgG

95.2 %

> 99 %

Table 1: Sensitivity and specificity of AESKULISA® SARS-CoV-2 NP IgA
and IgG immunoassays were assessed by the analysis of 76 serum samples from healthy blood donors (2018) and 20 individuals with clinically confirmed COVID19 using the clinical findings as a reference.

AESKULISA^® SARS-CoV-2 S1 IgM/ IgA / IgG

AESKULISA^®SARS-CoV-2 S1 IgA, IgG, and IgM tests are qualitative and quantitative immunoassays for the detection of human IgM, IgA, and IgG antibodies in serum or plasma directed against SARS-CoV-2 by the highly specific spike protein (S1). The spike protein has the advantage over the nucleocapsid protein that is highly specific for the SARS-CoV-2 virus.

Resulting in a much lower risk of cross-reactions with antibodies against other members of the coronavirus family. IgG antibodies react against the receptor-binding domain (RBD) on the spike proteins. They are considered to be neutralizing and, therefore, suitable for monitoring the antibody titer of patients.

AESKULISA^®SARS-CoV-2 S1 IgA Antibodytest (Spike Protein)
recommended for the detection of acute infections.

AESKULISA^®SARS-CoV-2 S1 IgG Antibodytest (Spike Protein)
allows the confirmation of pathogen contact and the determination of the immune status. It can be used to detect and monitor the antibody titer of a patient.

AESKULISA^®SARS-CoV-2 S1 IgM Antibodytest (Spike Protein)
allows determining the first specific reaction of the immune system.

Asset 1 2 Test Kit Components

Aluminium-sealed and coated MTP with breakable cavities
4 Calibrators (A – D), Calibrator B = cut off Calibrator
Positive and Negative Control
Sample Dilution Buffer (5x conc.; for IgM detection incl. Rf Absorbent)
Wash Buffer (50x conc.)
Conjugate (anti-human IgG / IgA / IgM conjugated to POD)
Substrate (TMB) and „Stop Solution“
Quality Control Certificate and Instruction Manual

The AESKULISA SARS-CoV-2 immunoassays offer the end-user many unique advantages. These set them apart from the test kits of competitors:

Use of the immunogenic nucleocapsid protein for the detection of IgA and IgG antibodies directed against SARS-CoV-2
Standardized processing of IgA, IgG and IgM AESKULISA® with short incubation times (30 min, 30 min, 30 min) and consistent incubation temperatures
Optimized for incubation at room temperature
Combination of different AESKULISA^® in one test run
Ready-to-use, colored, barcoded and interchangeable reagents for quality assured handling in routine laboratories
Cost efficiency by the use of breakable microtiter strips and a minimum number of calibrators and controls
Positive and negative controls according to modern quality management guidelines
Exact quantification of the pathogen-specific IgA, IgG and IgM antibody activity by use of the precise 4 parameter logistic (4 PL) function and 4-point calibration
Use of Cal B as cut off calibrator for qualitative data evaluation
Fast evaluation of measurement signals using standard software solutions
Excellent diagnostic efficiency with high sensitivity and specificity guaranteed by carefully selected antigens
High precision and linearity within wide measurement ranges guaranteed by a superior principle for antibody quantification
CE certified
Compatibility with conventional ELISA washer and reader systems
Complete automation on Triturus®, SQII, DSX and comparable instruments
Triturus^®, SQII, DSX and comparable instruments can be optimally networked using HERA- the AESKU laboratory automation manager

TRACING THE VIRUS

AESKULISA SARS-CoV-2 IgM

AESKULISA SARS-CoV-2 IgA

AESKULISA SARS-CoV-2 IgG