HELIOS Automated ifa system

STANDARDIZE PROCESSING AND READING
  • Wide range of tissue and cell-based slides for detection of all major autoantibodies
  • Vacuum sealed slides for long shelf-life
  • Traceability via barcoded slides and unique numbers
  • IFA method enables high sensitivity
  • Automation friendly standardized reagents and protocols
  • Easy handling: Vials fit directly in the HELMED and HELIOS
  • Suitable for automated reading with HELIOS
  • Pattern library, including ICAP nomenclature, for better evaluation
Reagents
Helios
Helios

Overview

HELIOS is a revolutionary system that automates the complete pipetting and image capturing of IFA (immunofluorescence) tests.It is the first and only system to automate this process completely from beginning to end – offering unparalleled process control, traceability, standardization, ease of use, and maximum efficiency by requiring technical intervention only for expert review.

HELIOS SOFTWARE HIGHLIGHTS

The HELIOS processor is capable of performing all IFA processing and reading automatically.

The HELIOS uses the robust and widely adopted HELMED IFA Software, which is compatible with most IFA test kits, regardless of their manufacturer. However, non-AESKU slides will be processed without reading.

This module starts automatically after slide processing is complete or can be used independently from other modules. The well imaging positions and image number is user configurable for all AESKUSLIDES tests, prior to reading. A Pre-Classification suggestion ( + or – ) is performed for each image for AESKUSLIDES ANA HEp2, ANCA, and nDNA.

All IFA analysis data can be loaded and evaluated patient by patient. The evaluation process is complemented by the AESKU pattern library. The “show all negatives” option displays all pre-classified negative results, helping to save reporting time by automatically releasing the negative results with the push of a button. The “sample overview” option allows all results related to one sample to be compared side by side. Activating the pattern recognition tool give the Helios the ability to autonomously suggest the most probable IFA patterns for Hep-2, ANCA, and nDNA.

This module is used to manage pre-classification settings and user rights.

The LIS Module sends all classified results to the LIS. ASTM standard connection configuration is done via a user-friendly interface.

New Features

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.

“These are 3rd and 4th FDA cleared assays on the HELIOS, after ANA HEp-2 [in 2016] and nDNA [cleared last month], thanks to our great Regulatory Affairs team at AESKU. With four kits, the HELIOS has the largest FDA cleared IFA menu of any platform and is the only sample-in/result-out system, with half the footprint. Through integrated design and pattern recognition software, the HELIOS system solves the subjectivity, labor, and traceability problems of IFA so laboratories can use the highest quality tests and ultimately improve patient outcomes.” said Dr. Matthias, founder and CEO of the AESKU.GROUP.

The HELIOS is a revolutionary platform that both processes and analyzes patient samples in a single run. It is the first and only clinical platform to offer this level of IFA automation, overcoming the previous limitations of IFA testing and letting users return to the gold-standard method for Autoimmunity screening. Over 300 HELIOS systems are in clinical use worldwide, in over 40 countries including the USA.

The HELIOS system and its FDA cleared kits will be displayed at the American Association of Clinical Chemistry meeting.

nDNA (Crithidia luciliae) now FDA cleared with HELIOS System

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.

“Laboratories have continued to return to IFA testing ever since the 2009 ACR position statement, which asserts that IFA is the Gold Standard for systemic autoimmune disease screening. The HELIOS improves traceability and turnaround time and eliminates the subjectivity and laborintensiveness of immunofluorescence assays, so labs can follow the ACR recommendations and ultimately improve the quality of patient testing.” said Dr. Matthias, founder and CEO of the AESKU.GROUP.

“Laboratories performing IFA will be able to screen for ANA’s and then reflex to a very specific assay to detect anti-dsDNA antibodies using the most automated system on the market: the HELIOS. This a great tool to help clinicians diagnose Lupus patients. We look forward to making this kit available on the HELIOS to US clinical laboratories with the help of Grifols, our exclusive distribution partner in the US.” said Bruno Larida, Vice-President AESKU. INC.

The HELIOS is a revolutionary platform that both processes and analyzes patient immunofluorescence (IFA) samples in a single run. It is the first and only clinical platform to offer this level of IFA automation, overcoming the previous limitations of IFA testing and letting users return to the gold-standard method for Autoimmunity screening. Over 300 HELIOS systems are in clinical use worldwide, in over 40 countries.

Press - nDNA (Crithidia luciliae) now FDA cleared with HELIOS System

Kimberly Pacella, Director of Clinical Operations at HNL in Allentown, PA chose the HELIOS to address a surge in IFA orders: “In order to absorb all that volume without adding staffing, we need to be able to do things more efficiently. This [HELIOS] will absolutely help with that.” said Pacella.

The HELIOS system and its FDA cleared kits will be displayed at the American Association of Clinical Chemistry meeting and is available in the U.S.

New Multi-Rack

High flexibility, accepts most tubes

  • Tube diameters ranging from 11-13 mm and lengths from 55-100 mm
  • Multi-rack sample tube capacity: 106
  • The design of the rack and the clamping of the sample tubes increases the overall stability
  • Position numbers are clearly printed and easy to read
  • The tubes are clamped in the holders to avoid rotation during the reading process of the sample barcodes
  • In addition, the use of small control tubes with flat bottoms is also possible

The new HELIOS Multi-Rack is an optional accessory, not included in the HELIOS, sold separately.

Estimated Endpoint Titer Option

Saves Time and Reagents

Easier to find the target dilution – less dilution steps needed. The endpoint titer is defined as the highest dilution in which staining intensity is still detectable. It is an important indicator for the classification of immunofluorescence images. After the first screening run, a titration of positive samples is strongly recommended. The HELIOS EPT Plus offers the possibility to estimate an endpoint titer for wells that were pre-classified as positive in a previous screening mode run. Supported by this endpoint titer estimation, the next dilution steps can easily be selected during the user classification process.

The HELIOS Endpoint Titer is a preinstalled option. Activation only on customer request, activation key sold separately.

Pattern Recognition Add-ons

The pattern recognition Add-ons give the HELIOS the ability to autonomously provide a suggestion of the most probable IFA pattern by analyzing captured IFA images.Rheumatology Pattern Plus Add-on:

This Add-on is able to recognize the following ANA HEp2 IFA patterns:

  • Centromere
  • Cytoplasmic
  • Homogeneous
  • Nuclear membrane
  • Nuclear Dots
  • Nucleolar
  • Speckled (granular)

Vasculitis Pattern Plus Add-on:

This Add-on is able to recognize the following ANCA IFA patterns:

  • P-ANCA
  • C-ANCA
  • A-ANCA (X-ANCA)
  • Undefined positive

DNA Pattern Plus Add-on: This Add-on is able to descriminate postive/negative nDNA samples.

The HELIOS Pattern Recognition Add-ons are preinstalled options. Activation only on customer request, activation key sold separately

Improved Tissue Processing

As an optional feature tissues can be now processed up to 70 % faster with increased quality. The improved tissue processing is an additional feature.