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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 VirusIn 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 (Nukleocapsid Protein)
recommended for the detection of acute infections.
AESKULISA® SARS-CoV-2 NP IgG Antibodytest (Nukleocapsid Protein)
allows the confirmation of pathogen contact and the immune status's determination.
AESKULISA® SARS-CoV-2 NP IgM Antibodytest (Nukleocapsid 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
> 95%
> 98%
SARS-CoV-2 NP IgG
> 99 %
> 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 2Test 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

Read more...

 

Best Paper Award AESKUMEDLAB 2020 - AESKU.GROUP highlights from the premier global laboratory and diagnostics conference in Dubai

Thanks to all the visitors, partners, and friends who visited us during the 2020 MEDLAB conference. AESKU had our full line of innovative automation platforms on display. We were highlighting our ability to be a complete laboratory solutions provider, helping us expand our business into many new countries. Read more...

 

AACC 2019: Setting a Higher standardBest Paper Award AESKU

It was a successful year for AESKU at this AACC. We announced the 400th placement of our HELIOS All-in-One IFA device, and officially introduced three products - the HELIOS HTC, AESQC IFA, and our own HERA automation management software. Read more...

 

mbl bion logoAESKU.GROUP Completes Acquisition of MBL Bion

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Spotlights on! Presenting the new AESKU.GROUP image film

See our company philosophy and an overview of our products in just a few short minutes.

 

AESKU.GROUP Company Image 2019

 

Helios Chosen In Automation and Modernization Initiative at Hospital Vicente Corral Moscoso, Cuenca-Ecuador

aesku modernization ecuadorTuesday April 10th, 2018, was the official start date for the HELIOS system at the Vicente Corral Moscoso Regional Hospital in the city of Cuenca, Ecuador.

This public-sector hospital has been named ‘number one in service’ in its region.

Its clinical lab performs high-complexity routine, emergency and outpatient testing 24 hours a day, 7 days a week while serving as a reference location for a network of six area labs and the Teofilo Davila de Machala, Isidro Ayora de Loja, and Jose Carrasco Arteaga of the IESS – Cuenca Hospitals. Read more...

 

Best Paper Award AESKU

Best Review Paper Award goes to…

Prof. Aaron Lerner, Dr. Sandra Neidhöfer and Dr. Torsten Matthias received the Best Review Paper Award 2018 from the journal Microorganism with “The Gut Microbiome Feelings of the Brain: A Perspective for Non-Microbiologists Microorganisms”. Read more...

 

 

aesku dr ed chan

ICAP Compliant IFA QC now available from AESKU

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QCs in IFA are not only important as part of assay quality management, but now as IFA readers are becoming standard devices in laboratories, assuring their ability to read patterns in a standardized manner has also become important.

The AESQC IFA product line allows laboratories to compare IFA reader performance to a set of controls validated and standardized to the ICAP nomenclature. Read more...

 

helios ssm picture

Complete IFA Automation with HELIOS is a ‘Dream Come True’ for SSM Health

Wesley Badley, Clinical Laboratory Supervisor at St. Anthony’s Hospital in Oklahoma City, Oklahoma, had an IFA problem. His lab performs ANA testing for the hospital, off-site SSM facilities and affiliated rheumatologists.

“The main reason we were looking at the HELIOS was our sheer volume,” said Badley. “We couldn’t afford in our facility to sit around and have one full FTE be dedicated to doing manual IFA, ANA; it just wasn’t feasible. Also, just finding qualified technicians is a very hard thing to do in our area. Having people there that can read ANAs and read those patterns was hard.” Read more...

 

aesqc com webportal s

AESQC.com Web Portal, a Quality Control Resource, now Available from AESKU

AESKU announces the launch of AESQC.com, an online Quality Control resource providing lot-specific information, including pattern images, to help laboratories improve their Immunofluorescence Assay quality. Read more...

 

image latam meeting 2018 web s

2nd Latin American Workshop, 2018

From 24th to 27th of September 2018, AESKU organized the second Latin America workshop in Cancun (Mexico).

We were delighted with the overall response and welcomed 26 participants from Colombia, Panama, Cuba, Costa Rica, Ecuador, Mexico, Peru, Bolivia, El Salvador, Paraguay, Spain and Brazil.

Read more...

 

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Since 2014, the Stifterverband acknowledges research companies that embrace their special responsibility for state and society with the "Innovative through Research" seal. Now Aesku.Diagnostics has received the award for its research competence and innovative abilities. Read more...

 

aesqc ifa promo image

ICAP Compatible IFA Quality Controls Now Available from AESKU

AESKU announces a new ICAP compatible Immunofluorescence Assay (IFA) Quality Control (QC) product line and supporting Quality Assurance tool, AESQC.com, to help laboratories identify, correct, and prevent analytical failure prior to releasing results. Read more...

 

AESKU.GROUP Lab Automation - Worldwide Installations Overview

1
Installations worldwide
1
HELMED IFA & ELISA
1
HELIOS IFA
1
HELIA BLOT
1
Countries with Installations

 

HELIOS Introduction (English Language)

 

FDA clears Automated Vasculitis Test from AESKU

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(Wendelsheim, Germany / Oakland, California) AESKU.GROUP – a science-focused manufacturer of autoimmune, allergy, and infectious disease diagnostics – received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES ANCA Ethanol, and ANCA Formalin with the new HELIOS AUTOMATED IFA SYSTEM. Next to be submitted are esophageal and tissue section slides. Read more...