helios new offen schraeg cropped

FDA clears Automated Vasculitis Test from AESKU

AESKU Receives FDA 510(k) Clearance for Anti-Neutrophil Cytoplasmic Antibody (ANCA) test to aid in the Diagnosis of ANCA Associated Vasculitides with the HELIOS Automated immunofluorescence assay (IFA) System

(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.

nDNA (Crithidia luciliae) now FDA cleared with HELIOS

AESKU Receives FDA 510(k) Clearance for nDNA (Crithidia luciliae) with the HELIOS AUTOMATED IFA SYSTEM

(Wendelsheim, Germany / Oakland, California,) AESKU.GROUP received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES nDNA (Crithidia luciliae) with the new HELIOS AUTOMATED IFA SYSTEM. The kit is the second FDA cleared immunofluorescence assay on the HELIOS, after ANA HEp-2 (cleared in 2016), and will be followed by ANCA and tissue section slides.

HELIOS automated IFA System - now FDA cleared

helios fda closed image AESKU receives FDA 510(k) Clearance for HELIOS automated IFA System with AESKUSLIDES ANA HEp-2-Gamma

NEW | Pattern Recognition

The pattern recognition Add-ons give the HELIOS the ability to autonomously provide a suggestion of the most propable IFA pattern by analysing captured IFA images.

Read more...

NEW | Estimated Endpoint Titer

The Estimated Endpoint Titer option saves time and reagents. This option makes it easier to find the target solution and less dilution steps are needed.

The endpoint titer is defined as the highest dilution in which staining intensity is still detectable.

HELIOS HTC Module

Teaser HELIOS HTC Module

HELIOS HTC MODULE - STANDARDIZE YOUR IFA ENVIRONMENT

IFA instructions for use often include recommendations for reagent temperatures and for incubation humidity because the micro-climates in clinical laboratories vary, and sometimes can fall out of range.

The World Health Organization (WHO) has guidelines for temperature and humidity in the working environment, and the International Standards Organization (ISO) and the US Food and Drug Administration (FDA) both provide humidity and temperature ranges for clinical laboratories.

These regulations describe the optimal range for temperature as 20-25 degrees Celsius. Humidity should be 35-50 percent. IFA standardization is a major concern across laboratories, and many standardization initiatives such as the GEAI, Easy Group, and ICAP have been launched to address this issue. Having consistent humidity and temperature helps laboratories improve the accuracy and reproducibility of their results.

Asset 4 To account for micro-climate variation and deliver more comparable results to our customers, a new optional module has been developed for the HELIOS. This new accessory lets technicians regulate and control IFA temperature and humidity.

The "humidity and temperature control" (HTC) add-on also enables testing with a wide range of automated infectious disease substrates, including EBV, HSV, Adenovirus, and Borrelia.

helios htc image The final appearance of the HTC module may vary in colour and shape depending on the stage of development

General Specifications

Incubation up to 37°C
Set and maintain optimal humidity point
Sample-ring moves every 10 seconds during incubation to guarantee environmental homogeneity
Sample Capacity: Up to 190 barcoded samples
Sample Identification: Built-in multi-type barcode reader for sample detection and identification
Slide Capacity: Up to 20 slides
IFA test capacity: Up to 4 different tests with four different conjugates per run

For more information about the new HELIOS HTC module and our new Infectious Serology IFA Products powered by AESKU.BION please check the new IFA Productline Flyer.

AESKU IFA Product Line FlyerDownload as PDF

helios new offen schraeg cropped

FDA clears Automated Vasculitis Test from AESKU

AESKU Receives FDA 510(k) Clearance for Anti-Neutrophil Cytoplasmic Antibody (ANCA) test to aid in the Diagnosis of ANCA Associated Vasculitides with the HELIOS Automated immunofluorescence assay (IFA) System

(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.

nDNA (Crithidia luciliae) now FDA cleared with HELIOS

AESKU Receives FDA 510(k) Clearance for nDNA (Crithidia luciliae) with the HELIOS AUTOMATED IFA SYSTEM

(Wendelsheim, Germany / Oakland, California,) AESKU.GROUP received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES nDNA (Crithidia luciliae) with the new HELIOS AUTOMATED IFA SYSTEM. The kit is the second FDA cleared immunofluorescence assay on the HELIOS, after ANA HEp-2 (cleared in 2016), and will be followed by ANCA and tissue section slides.

HELIOS automated IFA System - now FDA cleared

helios fda closed image AESKU receives FDA 510(k) Clearance for HELIOS automated IFA System with AESKUSLIDES ANA HEp-2-Gamma

NEW | Pattern Recognition

The pattern recognition Add-ons give the HELIOS the ability to autonomously provide a suggestion of the most propable IFA pattern by analysing captured IFA images.

Read more...

NEW | Estimated Endpoint Titer

The Estimated Endpoint Titer option saves time and reagents. This option makes it easier to find the target solution and less dilution steps are needed.

The endpoint titer is defined as the highest dilution in which staining intensity is still detectable.

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You can hover the Mouse-pointer over the red dots ( ico 5 ) in the interactive HELIOS picture to activate detailed information regarding the serveral HELIOS features.

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Did you know?

You can hover the Mouse-pointer over the red dots ( ico 5 ) in the interactive HELMED picture to activate detailed information regarding the serveral HELMED features.