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Zenit G-Sight

The information to be found in this section is intended for the exclusive use of healthcare professionals.

WHAT IS ZENIT G-SIGHT


Zenit G-Sight is the novel A. Menarini Diagnostics automated system for image acquisition and interpretation of cell- or tissue-based indirect immunofluorescence (IIF) tests.

Components of this compact benchtop instrument include:

  • a state-of-the-art automated fluorescence microscope with LED light source
  • a motorized scanning stage for substrate slides
  • a highly sensitive CCD camera
  • an innovative software for digital image generation and analysis

Zenit G Sight performs:


  • Fully automated image acquisition of cell- or tissue-based IIF tests
  • Semi-quantitative analysis and intelligent pattern recognition for ANA HEp-2 assays
  • Digitization for other IIF substrates
  • Analysis and intelligent pattern recognition for other IIF substrates available soon

LISTING

  • Zenit G-Sight analyzer | code 42251
  • Zenit G-Sight Enjoy | code 42677
  • Zenit G-Sight full viewer license | code 42679
  • Zenit G-Sight additional working station MAC | code 4267
  • Zenit G-Sight OBJ.20x | code 42678

ZENIT G-SIGHT AT A GLANCE

  • Compact benchtop system
  • Fully automated image acquisition of cell- or tissue-based indirect immunofluorescence (IIF) tests
  • Semi-quantitative analysis and intelligent pattern recognition for ANA HEp-2 assays
  • Digitization for other IIF substrates
  • Analysis and intelligent pattern recognition for other IIF substrates available soon
  • High workload management
  • Data storage and retrieval
  • Online remote access and file sharing

WHY AUTOMATE IIF FOR AUTOIMMUNE DISORDER DIAGNOSTICS

Clarification of suspected rheumatic symptoms is mainly achieved by the serological assessment/detection of disease-specific autoantibodies (e.g., anti-nuclear antibodies, ANAs).

Despite the development of enzyme-linked immunosorbent immunoassay (ELISA) and other alternative methods or technologies, screening for ANAs by IIF assays remains the gold standard method in the current diagnostic approach to systemic rheumatic disorders such as systemic lupus erythematosus (SLE), Sjögren’s syndrome (SS), progressive systemic sclerosis (PSS), dermatomyositis-polymyositis (DM/PM) or mixed connective-tissue disease (MCTD).

International guidelines recommend that ANA screening be performed on human epithelial (HEp-2) cells. Other cell substrates such as Crithidia luciliae (for the detection of autoantibodies to dsDNA) and human granulocytes (for the detection of anti-neutrophil cytoplasmic autoantibodies, ANCA) are routinely employed in cell-based IIF procedures.

Since autoantibodies produce characteristic fluorescence patterns whose analysis depends on the knowledgeability and the subjective interpretations of investigators, high intra- and interlaboratory variability represents a major problem in autoimmune diseases diagnostics.

The increase in workload and the need for standardized and reproducible evaluation of cell-based IIF assays have guided autoimmunity laboratories on the road to automation.

The new Zenit G Sight system from A. Menarini Diagnostics was specifically designed to overcome IIF-specific issues, making it particularly suited for the automated serological diagnosis of autoimmune diseases in a routine laboratory setting.

IIF ASSAY TPROCEDURE

The principal steps of the method are:
Serum sample dilution (for example 1:80) and incubation with substrate fixed on glass slides for 30 min in a moisture chamber at RT  
Incubation with fluorescein isothiocyanate (FITC)-conjugated sheep anti human Ig for 30 min at RT  
Assessment: visual or automated analysis of slides  

IIF PATTERNS*

         
Homogeneous/Peripheral Nucleolar Speckled Centromere Cytoplasmic/Mitochondrial


* ANA fluorescence patterns on HEp-2 cells are shown because this is the most widely used test for visual/automated screening of rheumatic diseases

WHY CHOOSE ZENIT G-SIGHT OVER A CLASSICAL CELL-BASED IIF ASSAY?

IIF assay is a low-cost, simple and rapid method for routine autoimmune screening; however, it has several disadvantages, which can be easily resolved with Zenit G Sight.

Classical cell-based IIF assay
  • Subjective analysis
  • Limited number of samples
  • Time-consuming sample screening
  • Fluorochrome decay
  • Organized archiving space required
  • Difficult to exchange results with other labs
vs Zenit G Sight system
  • Objective quantification and pattern recognition
  • High workload management
  • Efficient automated +/- sera discrimination
  • Digitized image data
  • File storage and easy retrieval of previous reports
  • Online access and data exchange

ZENIT G-SIGHT IS:

- Valuable and accurate
giving clinicians a precious aid for diagnosis by providing a full quantitative/qualitative report on autoantibody serological status
- Reliable
providing results that are reproducible and comparable within and between laboratories
- Cost-effective
alleviating the heavy workload of laboratories with large sample numbers, maximizing efficiency and optimizing human resources
- Secure
safeguarding results and improving data management

WHAT ARE THE KEY FEATURES OF ZENIT G-SIGHT

Hardware components are fully controlled by software and mainly involved in the digital image acquisition process.

Fluorescence microscope
Zenit G Sight microscope is equipped with a high-performance autofocus mechanism (5 to 13 focusing points per well) and supplied with two objectives (4x, 40x) on a revolving turret. Additional objectives can be provided on request (the revolving turret can accommodate 6 objectives).
LED light source
LED illumination technology has numerous advantages over conventional light sources: for example it delivers highly focused light, generates little heat and is virtually maintenance free (long-life light source). Morevover, LED light sources do not photobleach FITC as fast as mercury lamps do.

HARDWARE COMPONENTS

Scan stage
Zenit G Sight’s XY-motorized scan stage holds up to 5 slides (containing various number of wells) and is equipped with a barcode reader. For maximizing accuracy, a large area is scanned (from 1 to 220 fields per well), therefore the average scanning time for a 14-well slide may vary from 30 to 60 minutes.

Digital camera
The high-sensitivity CCD camera of the Zenit G Sight system captures clear, high-contrast fluorescence images.
 

WHAT ARE THE KEY FEATURES OF ZENIT G-SIGHT?

 The innovative Zenit G Sight software is the central component of the system. It guarantees optimal image capture and processing, fully automated analysis of immunofluorescence signals and efficient data storage and management. In addition, Zenit G Sight software manages and controls the entire experimental workflow. 

DIGITAL IMAGE ACQUISITION 

Zenit G Sight software automatically reads out images and generates editable high-resolution Jpeg2000 files (30-50 MB per well). Enlarged images can subsequently be obtained by means of digital magnification.

 

IMAGE INTERPRETATION / EVALUATION 

Zenit G Sight software processes the fluorescence signals and ensures an objective reading: it automatically analyzes signal intensity and distribution in each sample.
A cut-off level was set in order to minimize the risk of “false negatives”. After the positive-negative differentiation step, a mathematical algorithm automatically assigns the observed fluorescence, for example, to one of the five basic patterns in the case of HEp-2 substrate.
The system can also give a semi-quantitative result on a positive identification criteria basis (for the HEp-2 cells, the dsDNA-mAb33 Cat. Number 33300 vial 10000 IU correlated with WHO standard Wo/80 has been used as reference material, to estimate the Absolute concentration/fluorescent emission rate).


SOFTWARE
 Image storage
Once the manual validation process is completed, Zenit G Sight software proceeds with immunofluorescence image archiving. The system provides sufficient data storage capacity for about 5000 slides*.

Data retrieval and sharing
The Zenit G Sight software database search option allows easy retrieval of previous results.
Online data access and exchange are also possible.

Workflow management
The intuitive, user-friendly interface of Zenit G Sight software accompanies the operator step by step through the entire autoantibody detection process:
 

1. Worksheet loading (automatic or manual)** The worksheet contains the number of slides to process, the test to be carried out for each slide and sample data (for each well: patient identification number, patient details, antibody title etc…).
2. Scanning and automatic analysis of samples After slides are placed on the stage, the system automatically acquires images and proceeds to analyze them using a specific algorithm to discriminate between positive and negative samples and assign a pattern to each well.
3. Validation The operator examine every digital image and navigate the virtual slide. Moreover the diagnosis provided by the system can be confirmed or modified based on the clinical and laboratory history of the patient.
4. Report (to print or as an export file) The system allows report printing and creation of an output worksheet file containing the pattern and associated diagnosis for every well.


* depends on the HDD capacity;
** Zenit G Sight can be connected to LIS and to all Zenit series A. Menarini Diagnostics liquid handling systems for the automatic preparation of IIF slides