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Development of an automatic rapid test system for blood diagnostics and immunoassays

AESKU. Group has received funding from the European Union's Fund for Region Growth 2014 – 2020 Program to develop an automated platform for the automation of Point-Of-Care (POC) Tests. Read more...

 

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AESKU.RAPID SARS-CoV-2 Antigen Rapid Test

The AESKU.RAPID SARS-CoV-2 Rapid Test is based on immunochromatographic polymer technology combined with the sandwich principle for the qualitative detection of the nucleocapsid protein antigen in human nasal swab specimens. The specimen is placed in the test device's specimen well with colored polymer-labeled monoclonal SARS-CoV-2 antibody 1 and mixed along the nitrocellulose membrane chromatographed.

If SARS-CoV-2 antigens are present in the sample, they bind to the SARS-CoV-2 antibody 1.The mixture then binds to the immobilized SARS-CoV-2 antibody 2 on the nitrocellulose membrane. The resulting complex of antibody 1, antigen, and antibody 2 forms the colored test line. The test device's control line is coated with secondary antibodies, which, under normal test procedure, a colored strip is drawn.

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AESKU.RAPID Test Procedure

 

AESKU.RAPID SARS-CoV-2 Test Procedure Hide Article

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AESKU.RAPID SARS-CoV-2  Rapid Test (5 Tests)

AESKU.RAPID SARS-CoV-2 is a patient-specific antigen rapid test for the direct detection of SARS-CoV-2 NP antigen in human nasal swab specimens.
REF 840003: 5 individually sealed test cassettes per kit box.
AESKU.RAPID SARS-CoV-2  Rapid Test (20 Tests)

AESKU.RAPID SARS-CoV-2 is a patient-specific antigen rapid test for the direct detection of SARS-CoV-2 NP antigen in human nasal swab specimens.
REF 840001: 20 individually sealed test cassettes per kit box.

Test Kit Components

Test Kit Components

  • Test tubes
  • Extraction buffer
  • SARS-CoV-2 antigen test cassette (individually sealed)
  • Specimen swabs
  • Instructions for use
  • Quick guide

 

ESfEQA Evaluation Study: AESKU SARS-CoV-2 Antigen Rapid Test Performance

 
Sensitivity
Specificity
AESKU.RAPID SARS-CoV-2 Rapid Test
100% Ct Value ≤ 30.0
(95% Cl 95% - 100%)
98%
(95% Cl 95% - 99%)

 

ESfEQA Evaluation Study: AESKU SARS-CoV-2 Antigen Rapid Test vs. Realtime PCR

 
 RT-PCR Positive
RT-PCR Negative
RT-PCR Total
 AESKU.RAPID Positive
105
4
109
 AESKU.RAPID Negative
4
218
222
AESKU.RAPID Total
109
222
331

Positive test results confirm the presence of viral antigens. Negative test results do not completely rule out COVID-19. However, a clinical history of the patient is still necessary to determine the infection status. The samples were tested in parallel with the RT-PCR test of a leading European manufacturer.

 

 

AESKU.RAPID SARS-CoV-2 Product Highlights

 

  • Antigen rapid test for the direct detection of SARS-CoV-2 NP antigen
  • Rapid test result after 15 minutes
  • Lateral-Flow principle based
  • Test material: minimally invasive nasal swab (2.5 cm depth)
  • Very high sensitivity: 100% Ct-Value ≤ 29.9, 93% Ct-Value ≥ 30.0
  • Very high specificity 98%
  • Detection limit of 50 TCID50/ml
  • No cross-reactivity
  • The rapid antigen test is stable for up to 18 months at 4 - 30°C
  • Test performance at room temperature (15 - 30°C)
  • Each test individually in a sealed foil pouch
  • Pack sizes:5 Tests, including consumables or 20 Tests, including consumables
  • CE certified

 

 

New study - SARS-CoV-2 immunity after infection or not? Hide Article

A study by Long et al., recently published in the renowned scientific journal "Nature" (https://doi.org/10.1038/s41591-020-0965-6), strongly emphasizes why it is necessary, during and after the corona pandemic, to use readily available and efficiently performed antibody tests such as enzyme-linked immunosorbent assays (ELISA).

In the study mentioned above, Chinese researchers around Long and Huang compared samples from the megacity Chongqing. They examined samples of 74 patients with and without symptoms. After an infection, the body generates an immune response to eliminate a pathogen. The immune system first produces IgM and IgA antibodies. Once the pathogen is recognized and fought, IgG antibodies are produced. IgG antibodies offer some protection against future SARS-CoV-2 infections and are detected in the blood as so-called antibody titers. These IgG antibodies form the memory of the immune system for many years. Vaccines work similarly by teaching the immune system to produce antibodies to protect against specific pathogens.

Quantitative antibody tests that target neutralizing antibodies are among the most important tools for clinicians to determine a titer that reflects the value of a protective immune response to infection. Thus, the titer required for an effective vaccine can easily be determined using our SRS-CoV-2 AESKULISAs.

Long et al. have investigated this fact by measuring IgM and IgG levels in patient samples using ELISA. Even though the sample of patients is small, the study shows no insignificant decrease in antibodies in the patient group with mild to mild symptoms. Only 62.2 percent of patients in the group without symptoms still had antibodies in their blood a few weeks after infection. In the group of symptomatic patients, 78.4 percent still had antibodies in their blood.

After approximately eight weeks, follow-up examinations showed that the antibody concentration in the blood of the symptom-free patients decreased by 81.1 percent. In the group of symptomatic patients, the decrease was only 62.2 percent. The group of Long and Huang also identified patients positive for SARS-CoV-2 by ELISA, who had previously been categorized as negative by RT-PCR. An examination of the samples for cytokines involved in the immune reaction, including G- and M-CSF, IL2, IL6, CCL2, IFN-γ, shows that patients with symptoms had a higher value of these proteins, which indicates a stronger immune response.

Even though the study mentioned above only involved a comparatively small sample, the results cast doubt on previous assumptions that strong symptoms represent a high risk of infection and that anyone who has survived an infection is immune to future infections.

At Imperial College London, Professor Altmann confirms the present study, stating that most infected people show only mild or no symptoms at all. The crucial question is whether they have sustained protective immunity. For him, it is an essential but also worrying point, that many patients in the study showed a significant drop in antibody concentration only 6-7 weeks after the disease's onset. Long et al. write that the decrease in IgG and neutralizing antibodies in early convalescence will influence the immune strategy and serological investigations.

That is precisely where AESKU sees the primary clinical utility of its quantitaive AEKULISA SARS-CoV-2 tests and offers six different kits for detection and monitoring of the immune status.

 

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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 IgA* / IgG* / IgM*

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 IgA, IgG, and IgM 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 IgGAntibodytest (Nucleocapsid Protein)
allows the confirmation of pathogen contact and the immune status's determination.
AESKULISA® SARS-CoV-2 NP IgMAntibodytest (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 %
SARS-CoV-2 NP IgM*
95.7 %
> 99 %

Table 1: Sensitivity and specificity of AESKULISA® SARS-CoV-2 NP IgA, IgG 
and IgM 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 IgA/ IgG / IgM

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.
AESKULISA®
Sensitivity
Specificity
SARS-CoV-2 S1 IgA
94.6 %
> 99 %
SARS-CoV-2 S1 IgG
98.6 %
> 99 %
SARS-CoV-2 S1 IgM
> 99 %
> 99 %

Table 2: Sensitivity and specificity of AESKULISA® SARS-CoV-2 S1 IgA/IgG/IgM

* Submitted for EUA

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 or S1 domain of the spike protein for the detection of IgA, IgG or IgM 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

AESKU.GROUP finalized acquisition of immunofluorescence assay specialist MBL Bion, expanding IFA product menu and production operations.

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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

 

DST LogoAESKU.GROUP übernimmt DST Diagnostische Systeme & Technologien GmbH

Wendelsheim / Schwerin - AESKU.GROUP, Innovationsführer in der Autoimmundiagnostik übernimmt den Allergiespezialisten DST Diagnostische Systeme & Technologien GmbH und erweitert somit das eigene Produktportfolio um den Diagnostikbereich Allergie und Nahrungsmittelunverträglichkeiten.

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...

 

 

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ICAP Compliant IFA QC now available from AESKU

AESKU is introducing a new Immunofluorescence Assay (IFA) Quality Control product line – AESQC IFA – that complies with International Consensus on Antinuclear Antibody Patterns (ICAP) nomenclature.

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...

 

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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...

 

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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...