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Zenit PRO

Fully automated IFA analyzer

A different way to be unique

Total automation

Unparalleled performance

Enhanced standardization

     

Evolving scenarios and innovative perspectives

Download Zenit PRO Brochure:

     
     

Autoimmune diseases and the role of IFA

The impact of autoimmune diseases has grown exponentially both from a clinical and a diagnostic point of view over the past few decades. The knowledge of the pathogenic mechanisms underlying autoimmune diseases contributed to identify new autoantibodies and new diagnostic/prognostic assays have been developed.

Antinuclear antibodies (ANA) are important elements in the diagnosis of a variety of autoimmune diseases, especially ANA-associated rheumatic diseases (AARD), and indirect immunofluorescence (IFA), although it has been in use for over 50 years, is still the recommended method to screen for ANAs. Specifically, according to the recommendations of the American College of Rheumatology, ANA Task Force, the IFA assay on human epidermoid laryngeal carcinoma (HEp-2) cells represents the gold standard for ANA testing.

Nevertheless, performing ANA testing with IFA is time-consuming, labor intensive and burdened by some unfavorable features, such as the need for expert reading by skilled operators, a high rate of subjectivity and the low degree of standardization.

Laboratories that are testing on autoimmunity have made strides in automation over the past decade; technological solutions have been developed and automated reading systems have been made more and more reliable to achieve improved sensitivity and specificity, to obtain reproducible results and guarantee analytical precision.

In order to further improve standardization of the whole IFA procedure, A.Menarini Diagnostics has developed Zenit PRO, the brand new all-in-one system for the total automation of IFA: not only are reading and interpretation automatically performed but also the slide preparation, thus reducing the effects caused by less trained personnel and differences which might show up in different laboratories.

With Zenit PRO you will achieve a new level of standardization, increase efficiency and productivity with a remarkable impact on the overall laboratory management for improved health outcomes.

   

A generation ahead in IFA automation

   

The evolution of standardization

Zenit PRO is the new high-performance A.Menarini Diagnostics fully automated system which streamlines the whole IFA protocol, from slide processing to reading and interpretation of results. The system integrates an enhanced module that ensures the complete slide preparation, from serum dilution to coverslipping, with an on-board reading unit which provides unparalleled accuracy and allows automated whole well digitization for a better interpretation of Zenit IFA tests.

What makes Zenit PRO different are the image autofocusing technology, the software algorithms for IFA detection and pattern recognition, run-time, types of recognized ANA IFA patterns, and its ability to analyze different kinds of IFA substrate. Thus, Zenit PRO is able to overcome the drawbacks of manual ANA IFA analysis, and it efficiently contributes to the harmonization of the HEp-2 IFA analysis.

An advanced intelligent software orchestrates multiple processes into a seamless, fully automated continuous access system.

   

Main features and benefits

  • Automated IFA slide preparation and coverslip mounting
  • Walkaway process with continuous access
  • Whole well scanning
  • Navigable well
  • High throughput
  • Reduction of intra- and inter-laboratory variability
  • Full traceability
  • Reduction of operating costs
   

TECHNICAL DATA

Slide processing

Pumps:

 

1 peristaltic pump and 2x1,25 ml syringe pumps

Traceability:

 

Samples: Linear barcode reader with focal adjustment

Slides: Data matrix 2D barcode reader

Slide capacity:

 

18

Sample capacity:

 

160

Dilution cuvettes:

 

288 (3x96-well consumable plates, 1.2 ml volume)

Probes:

 

3 (2 dispensing needles + 1 aspiration needle)

Slide washing:

 

Continuous flow or multi drop

External tanks:

 

2x2l Buffers; 1x5l Wash; 1x5l Waste with level sensor

Slide reading

Microscope:

 

Epi-fluorescent microscope

Excitation:

 

450-490 nm

Fluorescence:

 

520 nm

Objectives:

 

4x for pre-focus, 20x for acquisition (10x, 40x optional).

Resolution: 0.50 micron per pixel at 20x

Optical source:

 

Blue high power LED 480 nm

Image compression:

 

JPEG-2000

Scanning speed (at 20x):

 

ANA, nDNA, ANCA: < 30 sec per well

Tissues:

 

< 2,5 min per well

Image and data processing

Integrated visual display unit on board:

 

15’’ touch screen full HD monitor

Integrated elaboration unit On board:

 

2 hard disks 1TB RAID 10 (1 TB to store data).

Operating system: Windows 10

Bidirectional communication:

 

HL7, XML

Environmental setting - Working session

Temperature:

 

20-35 °C

Humidity:

 

10% - 60% non condensing

Power supply, Entry level:

 

AC 110-120 V or 220-240V 50-50 Hz

Transport/Storage

Size:

 

WHD 120x70x90 cm

Weight:

 

Approx 150 kg

Temperature:

 

From -20 to 60 °C

Humidity:

 

90% RH max. (non condensing)

Optional Modules

Remote station

 

Client access to archive and validation modules

ANA HEp-2 pattern recognition:

 

Homogeneous, Fine speckled, Coarse speckled, Nucleolar, Centromere, Few nuclear dots, Multiple nuclear dots, Ribosomal-like, Mitochondrial-like.

Mitoses recognition on identified patterns.

Smart ANCA analysis software:

 

ANCA positive/negative classification and pattern recognition (c-ANCA, p-ANCA, other-ANCA)

Smart nDNA analysis software:

 

nDNA positive/negative classification

Smart EMA analysis software:

 

EMA positive/negative classification

   

LEARN MORE

Driving standardization through automation

Integrated slide processing that changes the way IFA is performed

A. Menarini Diagnostics brought engineering and capability to the lab by simply developing the sole system that ensures the complete preparation of the IFA slide, from serum dilution to coverslipping, minimizing operator intervention all along a high-volume testing procedure. The Zenit PRO automated liquid handling system eliminates the inconsistency of human ntervention, maximizing the accuracy of the overall IFA process and ensuring accurate sample dispensation, controlled incubation conditions and efficient washing.

  • Up to 160 tubes: 8 racks with 20 tubes each
  • Up to 288 cuvettes: 3 x 96-well consumable plates, 1.2 ml volume
  • Up to 20 slots for controls
  • Up to 9 slots for conjugate and mounting medium
  • Up to 4 slots for diluent

Advanced and powerful information management for results that matter

As smart and simple as you want it to be

Zenit PRO offers powerful analytics and a simple and intuitive user interface that simplify workflows and enable meaningful analysis of results to efficiently achieve diagnostic goals even from the most challenging assays. Simply powerful The system can process and scan a number of cellular substrates and provides whole well digitization of any IFA Zenit test: it performs the analysis on the whole well and not just on a limited number ofpre-defined images only partially covering the areaof interest.
This feature offers several advantages:

  • As the number of counted and analyzed cells is fairly large (greater than 3.000 for each well), the results are more reliable and consistent
  • Results are robust even in the presence of microbubbles or damaged areas in the well
  • High sensitivity thanks to the possibility to adjust cell count and cell identification to detect rare patterns or a pattern displayed by a few cells only.

Add confidence to your results

The system includes the automatic classification of positive/negative results for Zenit ANA HEp-2

tests and the identification of a number of cellular patterns even in mixed cases. The software measures the intensity of fluorescence for each positive test and provides a pattern suggestion based on a wide database of reference images used to train a state of the art classifier.

Additional recognition software modules

Zenit ANA HEp-2 pattern recognition

Homogeneous, Fine speckled, Coarse speckled, Nucleola, Centromere,Few nucleolar dots, Multiple nuclear dots, Ribosomal-like, Mitochondrial-like, Mitoses recognition on identified pattern

Smart ANCA analysis software

ANCA positive/negative classification and pattern recognition (c-ANCA, p-ANCA, Other ANCA)

Smart nDNA analysis software

nDNA positive/negative classification

Smart EMA analysis software

EMA positive/negative classification

   

From assay to answer