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Zenit PRO

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

More needles
for higher speed Two dispensing needles and one aspiration needle increase preparation speed
Multiple run
Up to 18 slides can be simultaneously loaded to be processed. 
Wash station
A wash station ensures both internal and external cleaning of the three needles eliminating carryover
Automated coverslipping and mounting
The system automatically mounts each processed slide. A suction pad places the coverslip and seals the slide, avoiding the formation of air bubbles
Automated slide delivery
A precision clamp delivers the mounted slide onto the microscope precision stage for automated scanning of each well
Automated slide reader
The motorized microscope drives to the substrate positions, autofocuses and scan each well
Slide parking rack
After termination of the reading procedure, a precision clamp delivers the slide into a parking rack to await removal by the operator. Up to 18 slides can be stacked in this area
In-built touch screen monitor
On-board digital archive
Bar code readers for full traceability of sample and slide

The Zenit brand: a leading presence with complete coverage in the autoimmunity field

Autoimmunity has been our focus since 1998.
Extensive research and a proven track record of accuracy and reliability have allowed us to expand our early experience into an international organization with a comprehensive offering including IFA, ELISA, CLIA, microarray, genetic testing, biomonitoring, with the smallest instrument range coupled with the widest possible array of antigens, both human recombinant and human purified, to cover all diagnostic needs. Our goal is to continue developing solutions for the clinic and laboratory that improve the diagnosis, prognosis, monitoring and treatment of autoimmune diseases.


Evolving scenarios and innovative perspectives

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.


Main features and benefits

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

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 intervention, 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 of pre-defined images only partially covering the area of 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

Full screen view of the IFA test:
The digitized image is displayed and can be navigated with the virtual microscope tool that allows the user to have a broad view of the substrate at multiple magnifications.


From assay to answer

Results are interpreted and validated by the operator, using the touch screen monitor, or remotely at another station within the laboratory using a powerful yet intuitive software interface. Customizable views facilitate navigation.

1. Multiview
for visualization and analysis of multiple wells of the same patient’s sample on the same slide (different dilutions)
2. Send to LIS
Sends results directly to LIS as soon as each well is validated and before the session is archived
3. Patient info Shows the Patient card with relevant info
4. Results Gives an indication of the Slide/well and performs an automatic diagnosis (Pos/Unc/Neg) giving an Index value as result
5. Patterns The list of all the possible patterns associated to the specific substrate analysed is shown
6. Extra tests
To select additional IFA/non IFA tests

History/Patient
To evaluate on the screen multiple tests (digital wells) of the same patient (different dilutions, different tests, both of the same session or from the archive)

Smart analysis software for meaningful data

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.

Add confidence to your results

The system includes the automatic classification of positive/negative results for Zenit ANA HEp-2 tests and the identifìcation of nine different HEp-2 patterns: Homogeneous, Fine speckled, Coarse speckled, Nucleola, Centromere, Few nucleolar dots, Multiple nuclear dots, Ribosomal-like, Mitochondrial-like. Patterns can be recognized 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 classifìer. The system includes the automatic classification of positive/negative results and Pattern recognition (c-ANCA, p-ANCA, Others) for Zenit ANCA tests and the automatic positive/negative classification for Zenit nDNA Crithidia Luciliae tests.