AN INNOVATIVE OPERATING PRINCIPLE
CLIA (Chemiluminescence enzyme immunoassay) based tecnology

The assay is based on a two-step indirect chemiluminescent method that generates quantitative results. This particular technique uses autoantigen-coated magnetic particles as solid phase and an antibody labeled with a dimethyl acridinium ester (DMAE) as detection marker. The use of high quality antigens and large coated surfaces provides excellent sensitivity in Zenit RA immunoassays.

1. In the first incubation phase, specific autoantibodies present either in the sample, calibrators or controls bind to the immobilized antigen
2. In the second incubation phase the DMAE conjugate reacts with the coated magnetic particle-autoantibody complexes
3. Non-bound material is washed away after every incubation step
4. Chemiluminescence is activated by the addition of trigger solutions:
   A (hydrogen peroxide) and B (an alkaline solution), resulting in oxidation of the ester to an excited form. Return to a stable state is accompanied by the emission of light, which is measured and expressed in Relative Light Units (RLU)
5. The signal is directly proportional to the concentration of specific autoantibodies in the samples, calibrators or controls

AN OPTIMIZED WORKFLOW
Let’s push the start button…

1. Samples and reagents are aspirated using a probe equipped to detect liquid level using capacitance. The sample and reagents are pipetted in accordance with the validated parameters for each assay and transferred into a cuvette where the reaction takes place
2. Reaction cuvettes are then incubated on the carousel at 37°C for 10 minutes
3. The probe is rinsed internally and externally between each sample to eliminate any risk of contamination
4. The cuvettes are transferred to the washing module where magnets hold the solid phase (magnetic particles) during washing
5. Conjugate is added to the cuvettes and they are transferred to the carousel for another incubation at 37°C for 10 minutes
6. After this last incubation step, another washing is performed in the washing module as mentioned earlier
7. The cuvette is then transferred to the luminometer where trigger reagents are added to produce luminescence
8. When measurement is complete, cuvettes are automatically ejected into a re-usable solid waste tray

THE KEY FEATURES AT A GLANCE

Flexibility

• Various work modalities: Random access, batch mode and STAT priority function for urgent samples
• Up to 15 different simultaneous immunoassays
• Continuous access to samples, reagents, consumables and parts
• 64 positions for samples, controls or calibrators
• Several disciplines can be processed in one run (Autoimmunity but also Infectiology)
• Patient-specific test profiles
• On-board dilution and pre-treatment of samples
• Calibration stable for 2 weeks
• Asynchronous management of samples
• Reagent cartridges on board in a refrigerated area
• Primary and secondary tubes accepted: 5, 7, 10 ml tubes and pediatric micro-cups
• Reflex testing capability

Accuracy, Reproducibility…

• Highly reliable results:
  • Stored master curve
  • 2-point recalibration method
  • Use of coated-microparticles instead of classical coated-cuvettes (providing more uniform and extensive coating)

…and quality/safety of the results

• Flashing light drawer-system (to prevent interruption of procedures and safeguard results)
• One cuvette per test (to avoid potential cross contamination)
• Probe rinsing between each sample
• Clot detection system

Efficiency

• Short time to first result: within 25 minutes
• High throughput: 70tests/hour
• Continuous loading of bar-coded samples and reagents for peak workloads
• Workload management for optimal throughput: ideal for labs performing 50 to 400tests per day
• Sample volumes as low as 4 μl in some assays
• Calibrators and controls included
• Ready to use reagent cartridges

Simplicity

• Load and walk away (960 cuvettes on board, automatic cuvette loader, ancillary reagents on board for more than 1000 tests)
• Intuitive user interface
• Barcode reading for all reagents and samples

Computerized functionality

The analyzer is connected to a computer via an Ethernet link.
Workflow is programmed with dedicated software that performs the following functions:

• Management of reagent, calibrator and control lots
• Quality controls (Levey-Jennings and Westgard)
• Management of ancillary reagents
• Full traceability of samples, reagents and operators
• Transfer of results to a centralized computer system
• Automatic wakeup and shutdown
• Remote maintenance connection

Lab-Friendly design

• Small size (L 105 cm x H 70 cm x W 75 cm)
• Benchtop
• Flashing light drawer-system