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Zenit RA

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

The fully automated immunoassay analyzer that best fits your needs in autoimmunity.

Zenit RA easily detects the most common autoantibodies in autoimmune diseases, providing clinically useful data in a short time. The flexibility of its work modalities makes it particularly well adapted to determining antigenic specificities in daily practice.

Zenit RA is the exclusive new addition to A. Menarini Diagnostics Zenit series. It is magnetic microparticle-based and uses chemiluminescent detection (acridinium) to provide the high degree of precision and rapidity of analysis that your autoimmunity laboratory routine demands:

  • Accurate, standardized and reproducible results
  • First result within 25 minutes
  • Throughput: 70 results/hour
Zenit RA provides maximum flexibility and operational readiness in autoimmunity testing:

  • Up to 15 different simultaneous immunoassays
  • True walk-away operation
  • Continuous access to samples, reagents, consumables and parts
  • STAT priority function for urgent samples
  • Continuous loading of bar-coded samples and reagents
It brings a higher degree of versatility to autoimmune diagnostics:

  • Consolidated 25-test autoimmunity menu
  • Calibration stable for 3 weeks for all reagents
  • Capacity and automation for medium to large laboratories
  • AVAILABLE TESTS: Connective Tissue diseases

    ANA screening

    Connective tissue diseases (CTD): Zenit ANA Screen

    Download Instruction For Use*: Download PDF

    Code: 41411
    Parameter/assay principle: Quantitative detection of IgG antibodies to dsDNA, centromere B, SS-A/Ro (60 kDa and 52 kDa), SS-B/La, Sm, U1-snRNP (70 kDa, A and C), Scl-70 and Jo-1
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: -
    Results (Index): Negative <1.0 | Positive ≥1.0 
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: -
    Precision: Intra-assay CV% ≤4.8 | Inter-assay CV% ≤8.6
    Relative specificity§ **: 96.0%
    Relative sensitivity§ **: 96.0%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit.

    ** versus a commercial ELISA method

    ENA screening

    Connective tissue diseases (CTD): Zenit ENA Screen

    Download Instruction For Use*: Download PDF

    Code: 41412
    Parameter/assay principle: Quantitative detection of IgG antibodies to SS-A/Ro (60 kDa and 52 kDa), SS-B/La, Sm, U1-snRNP (70 kDa, A and C), Scl-70 and Jo-1
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: -
    Results (Index): Negative <1.0 | Positive ≥1.0 
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: -
    Precision: Intra-assay CV% ≤4.3 | Inter-assay CV% ≤8.2
    Relative specificity§: 94.4%
    Relative sensitivity§: 98.3%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit.

    anti-DsDNA

    Connective tissue diseases (CTD): Zenit RA dsDNA IgG

    Download Instruction For Use*: Download PDF
    Code: 41413
    Parameter/assay principle: Quantitative detection of IgG antibodies to dsDNA
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-600 IU/mL
    Results (IU/mL): Negative <30 | Doubtful 30-50 | Positive >50 
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: 24.2 IU/mL
    Precision: Intra-assay CV% ≤4.1 | Inter-assay CV% ≤5.7
    Relative specificity§: 98.2%
    Relative sensitivity§: 89.3%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit.

    anti-SS-A

    Connective tissue diseases (CTD): Zenit RA SS-A/Ro

    Download Instruction For Use*: Download PDF

    Code: 41414
    Parameter/assay principle: Quantitative detection of IgG antibodies to SS-A/Ro
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-640 AU/mL
    Results (AU/mL): Negative <10 | Positive ≥10 
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: 4.5 AU/mL
    Precision: Intra-assay CV% ≤3.2 | Inter-assay CV% ≤9.2
    Relative specificity§: 98.3%
    Relative sensitivity§: 100%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

    anti-SS-B

    Connective tissue diseases (CTD): Zenit RA SS-B/La

    Download Instruction For Use*: Download PDF

    Code: 41415
    Parameter/assay principle: Quantitative detection of IgG antibodies to SS-B/La
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-640 AU/mL
    Results (AU/mL): Negative <10 | Positive ≥10
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: 7.0 AU/mL
    Precision: Intra-assay CV% ≤3.6 | Inter-assay CV% ≤9.1
    Relative specificity§: 96.6%
    Relative sensitivity§: 86.7%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

    anti-Sm

    Connective tissue diseases (CTD): Zenit RA Sm

    Download Instruction For Use*: Download PDF

    Code: 41416
    Parameter/assay principle: Quantitative detection of IgG antibodies to Sm
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-320 AU/mL
    Results (AU/mL): Negative <10 | Positive ≥10 
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: 3.5 AU/mL
    Precision: Intra-assay CV% ≤3.3 | Inter-assay CV% ≤8.5
    Relative specificity§: 99.5%
    Relative sensitivity§: 93.3%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

    anti-RNP

    Connective tissue diseases (CTD): Zenit RA U1-snRNP

    Download Instruction For Use*: Download PDF

    Code: 41417
    Parameter/assay principle: Quantitative detection of IgG antibodies to U1-snRNP
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-240 AU/mL
    Results (AU/mL): Negative <10 | Positive ≥10 
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: 3.5 AU/mL
    Precision: Intra-assay CV% ≤6.1 | Inter-assay CV% ≤9.9
    Relative specificity§: 92.8%
    Relative sensitivity§: 100%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit.

    anti-Scl70

    Connective tissue diseases (CTD): Zenit RA Scl-70

    Download Instruction For Use*: Download PDF

    Code: 41418
    Parameter/assay principle: Quantitative detection of IgG antibodies to Scl-70
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-640 AU/mL
    Results (AU/mL): Negative <10 | Positive ≥10
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: 5.0 AU/mL
    Precision: Intra-assay CV% ≤9.5 | Inter-assay CV% ≤8.7
    Relative specificity§: 99.5%
    Relative sensitivity§: 100% 

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit.

    anti-Jo1

    Connective tissue diseases (CTD): Zenit RA Jo-1

    Download Instruction For Use*: Download PDF 

    Code: 41419
    Parameter/assay principle: Quantitative detection of IgG antibodies to Jo-1
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-400 AU/mL
    Results (AU/mL): Negative <10 | Positive ≥10 
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: 4.5 AU/mL
    Precision: Intra-assay CV% ≤6.2 | Inter-assay CV% ≤5.1
    Relative specificity§100%
    Relative sensitivity§81.8% 


    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit.

    anti-Centromere

    Connective tissue diseases (CTD): Zenit RA Centromere B

    Download Instruction For Use*: Download PDF

    Code: 41431
    Parameter/assay principle: Quantitative detection of IgG antibodies to centromere B
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-640 AU/mL
    Results (AU/mL): Negative <10 | Positive ≥10 
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: 7.2 AU/mL
    Precision: Intra-assay CV% ≤9.8 | Inter-assay CV% ≤8.8
    Relative specificity:§ 98.1%
    Relative sensitivity:§ 97.9% 


    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

    AVAILABLE TESTS: Inflammatory Bowel diseases

    anti-tTG IgG

    Inflammatory bowel diseases (IBD): Zenit RA t-TG IgG

    Download Brochure: Download PDF 

    Code: 41423
    Parameter/assay principle: Quantitative detection of IgG antibodies to tissue transglutaminase
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range : 0-200 AU/mL
    Results (AU/mL): Negative <10 | Positive ≥10
    Clinical specificity: 96.2%
    Clinical sensitivity: 59.7%
    Limit of detection: 8.3 AU/mL
    Precision: Intra-assay CV% ≤ 8.3 | Inter-assay CV% ≤ 6.0
    Relative specificity§90.1%
    Relative sensitivity§78.8% 


    For optimal results the use of Zenit RA t-TG IgG Control set (cod. 41455) is recommended

    anti-tTg IgA

    Inflammatory bowel diseases (IBD): Zenit RA t-TG IgA

    Download Brochure: Download PDF 

    Code: 41422
    Parameter/assay principle: Quantitative detection of IgA antibodies to tissue transglutaminase | Estimation of total IgA concentrations (valuable in IgA anti-tTG negative samples)
    Number of tests:100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume:4 µL
    Incubation time:10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board:8 weeks
    Measuring range: 0-200 AU/mL
    Results (AU/mL)* : Negative for IgA anti-tTG 0.8-9.9 | Possible IgA deficiency < 0.8 (<25 mg/dL) | Positive for IgA anti-tTG ≥ 10
    Clinical specificity: 96.7%
    Clinical sensitivity: 98.4%
    Limit of detection: 4.7 AU/mL**
    Precision: Intra-assay CV% ≤ 6.7 | Inter-assay CV% ≤ 4.4
    Relative specificity§89.2%
    Relative sensitivity§98.0%

     

    *for Zenit RA t-TG IgA kit data refer to total IgA levels; **refers to IgA anti-tTG; §versus a commercial ELISA method
    For optimal results the use of Zenit RA Celiac Control set (cod. 41452) is recommended.


    anti-Deamidated Gliadin IgG

    Inflammatory bowel diseases (IBD): Zenit RA deamidated Gliadin IgG

    Download Instruction For Use*: Download PDF 

    Code: 41421
    Parameter/assay principle: Quantitative detection of IgG antibodies to deamidated gliadin peptides
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-200 AU/mL
    Results (AU/mL)**: Negative < 10 | Positive ≥ 10
    Clinical specificity: 96.2%
    Clinical sensitivity : 72.6%
    Limit of detection: 6.0 AU/mL
    Precision: Intra-assay CV% ≤ 4.4 | Inter-assay CV% ≤ 6.8
    Relative specificity§92.0%
    Relative sensitivity§ : 97.1% 

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

    **for Zenit RA t-TG IgA kit data refer to total IgA levels; **refers to IgA anti-tTG; §versus a commercial ELISA method
    For optimal results the use of Zenit RA Celiac Control set (cod. 41452) is recommended.


    anti-Deamidated Gliadin IgA

    Inflammatory bowel diseases (IBD): Zenit RA deamidated Gliadin IgA

    Download Instruction For Use*: Download PDF

    Code: 41420
    Parameter/assay principle: Quantitative detection of IgA antibodies to deamidated gliadin peptides
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range : 0-200 AU/mL
    Results (AU/mL)**: Negative <10 | Positive ≥10
    Clinical specificity: 94.4%
    Clinical sensitivity: 77.4%
    Limit of detection: 5.2 AU/mL
    Precision: Intra-assay CV% ≤ 5.7 | Inter-assay CV% ≤ 6.2
    Relative specificity§97.2%
    Relative sensitivity§92.9%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit.
    **for Zenit RA t-TG IgA kit data refer to total IgA levels.
    For optimal results the use of Zenit RA Celiac Control set (cod. 41452) is recommended

    AVAILABLE TESTS: Anti-phospoholid syndrome

    anti-Cardiolipin IgG

    Anti-phospoholid syndrome: anti-Cardiolipin IgG

    Download Instruction For Use*: Download PDF

    Code: 41424
    Parameter/assay principle: Quantitative determination of the specific β2-glycoprotein I dependent anti-cardiolipin IgG antibodies in samples of human serum or plasma
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-640 GPL U/ml.
    Results (AU/mL)**: Negative < 10 | Positive ≥ 20
    Clinical specificity: 93.7%
    Clinical sensitivity : 84,4%
    Limit of detection: 10.8 GPL U/ml
    Precision: Intra-assay CV% ≤ 6,2% | Inter-assay CV% ≤ 11,0%
    Relative specificity§: 98,2%
    Relative sensitivity§ : 95,2%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

     

    anti-Cardiolipin IgM

    Anti-phospoholid syndrome: anti-Cardiolipin IgM

    Download Instruction For Use*: Download PDF

    Code: 41425
    Parameter/assay principle: Quantitative determination of the specific β2-glycoprotein I dependent anti-cardiolipin IgM antibodies in samples of human serum or plasma
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-640 MPL U/ml.
    Results (AU/mL)**: Negative < 10 | Positive ≥ 10
    Clinical specificity: 97.5%
    Clinical sensitivity : 39,7%
    Limit of detection: 6.8 MPL U/ml
    Precision: Intra-assay CV% ≤ 6,7% | Inter-assay CV% ≤ 9,3%
    Relative specificity§: 95,4%
    Relative sensitivity§ : 92,3%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

     

    anti-B2GP1 IgG

    Anti-phospoholid syndrome: anti-B2GP1 IgG

    Download Instruction For Use*: Download PDF

    Code: 41426
    Parameter/assay principle: Quantitative determination of the specific IgG antibodies directed againstβ2-glycoprotein I in samples of human serum or plasma
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0.0 – 867 AU/ml.
    Results (AU/mL)**: Negative < 10 | Positive ≥ 20
    Clinical specificity: 94,9%
    Clinical sensitivity : 83,8%
    Limit of detection: 8.1 AU/ml.
    Precision: Intra-assay CV% ≤ 5,3% | Inter-assay CV% ≤ 10,5%
    Relative specificity§: 93,0%
    Relative sensitivity§ : 98,8%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit


    anti-B2GP1 IgM

    Anti-phospoholid syndrome: anti-B2GP1 IgM

    Download Instruction For Use*: Download PDF

    Code: 41427
    Parameter/assay principle: Quantitative determination of the specific IgM antibodies directed againstβ2-glycoprotein I in samples of human serum or plasma 
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: is: 0.0 – 300 AU/ml.Results (AU/mL)**: Negative < 10 | Positive ≥ 10
    Clinical specificity: 96,0%
    Clinical sensitivity : 32,4%
    Limit of detection: 3,7 AU/ml.
    Precision: Intra-assay CV% ≤ 4,9% | Inter-assay CV% ≤ 7,6%
    Relative specificity§: 95,9%
    Relative sensitivity§ : 95,5%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit


    AVAILABLE TESTS: Autoimmune Liver Diseases

    anti_LKM1

    Liver diseases kit at a glance: Zenit RA anti LKM-1

    Download Instruction For Use*: Download PDF

    Code: 46315
    Parameter/assay principle: Quantitative detection of IgG against Liver Kidney Microsomes antigen type 1
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 10 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0.0 – 300 AU/mL.
    Results (AU/mL): Negative < 15 Positive >= 15
    Relative specificity**: 97,6 %
    Relative sensitivity**: 100 %


    *The content of this file is for informational purposes only.The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit
    **versus a commercial ELISA method

    anti_AMA M2

    Zenit RA Anti-Mitochondrial Antibodies (M2)

    Download Instruction For Use*:
     Download PDF

    Code: 46316
    Parameter/assay principle: Quantitative detection of IgG antibodies to against Anti-Mitochondrial Antibodies
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 10 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-1000 AU/mL 
    Results (AU/mL): Negative < 10 Positive >= 10
    Relative specificity**: 97.4 %
    Relative sensitivity**: 88.9 %


    *The content of this file is for informational purposes only.The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit
    **versus a commercial ELISA method

    AVAILABLE TESTS: IRheumatoid Arthritis

    anti-CCP

    Rheumatoid Arthritis: Zenit RA CCP

    Download Instruction For Use*: Download PDF

    Code: 41430
    Parameter/assay principle: Quantitative detection of IgG antibodies to cyclic citrullinated peptide (CCP) 2nd Generation
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-320 AU/mL
    Results (AU/mL)**: Negative < 5 | Positive ≥ 5
    Clinical specificity: -
    Clinical sensitivity: -
    Limit of detection: 2.1 AU/mL
    Precision: Intra-assay CV% ≤ 4.8 | Inter-assay CV% ≤ 5.6
    Relative specificity*: 97.4%
    Relative sensitivity*: 95.7%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

    **versus a commercial ELISA method
    For optimal results the use of Zenit RA CCP Control set (cod. 41451) is recommended.

    AVAILABLE TESTS: Vasculitis

    anti-MPO

    Vasculitis kit at a glance: Zenit RA MPO

    Download Instruction For Use*: Download PDF

    Code: 41428
    Parameter/assay principle: Quantitative detection of IgG antibodies to myeloperoxidase (MPO)
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-860 AU/mL 
    Results (AU/mL): Negative < 10 | Positive >20 | Doubtful 10-20
    Clinical specificity: 95.2%
    Clinical sensitivity: 84.4%
    Limit of detection: 3.8 AU/mL
    Precision: Intra-assay CV% ≤ 4.3 | Inter-assay CV% ≤ 9.0
    Relative specificity**: 95.2%
    Relative sensitivity**: 93.2%

    *The content of this file is for informational purposes only.The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

    **versus a commercial ELISA method
    For optimal results the use of Zenit RA ANCA/GBM Control set (cod. 41449) is recommended.


    anti-PR3

    Vasculitis kit at a glance: Zenit RA PR3

    Download Instruction For Use*: Download PDF

    Code: 41429
    Parameter/assay principle: Quantitative detection of IgG antibodies to proteinase 3 (PR3)
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 6 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-1000 AU/mL
    Results (AU/mL): Negative < 10 | Positive > 20 | Doubtful 10-20
    Clinical specificity: 94.0% 
    Clinical sensitivity: 78.0%
    Limit of detection: 7.3 AU/mL
    Precision: Intra-assay CV% ≤ 3.5 | Inter-assay CV% ≤ 8.9
    Relative specificity**: 98.3%
    Relative sensitivity**: 97.8%

    *The content of this file is for informational purposes only. The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

    **versus a commercial ELISA method
    For optimal results the use of Zenit RA ANCA/GBM Control set (cod. 41449) is recommended.


    anti-GBM

    Vasculitis kit at a glance: Zenit RA anti GBM

    Download Instruction For Use*: Download PDF

    Code: 43735
    Parameter/assay principle: Quantitative detection of IgG antibodies to Basal Glomerular Membrane (GBM)
    Number of tests: 50
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 4 µL
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0-1000 AU/mL 
    Results (AU/mL): Negative < 40 | Positive >40 |

    Precision: Intra-assay CV% ≤ 4.3 | Inter-assay CV% ≤ 9.0
    Relative specificity**: 98.4%
    Relative sensitivity**: 90.9%

    *The content of this file is for informational purposes only.The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit

    **versus a commercial ELISA method
    For optimal results the use of Zenit RA ANCA/GBM Control set (cod. 41449) is recommended.


    AVAILABLE TESTS: Autoimmune Thyroiditis

    anti Tg

    Autoimmune Thyroiditis kit at a glance: Zenit RA anti TG

    Download Instruction For Use*: Download PDF

    Code: 47745
    Parameter/assay principle: Quantitative detection of of specific IgG class antibodies acting against human thyroglobulin,(TG)
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 10 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0.0 – 5500 IU/mL 
    Results (AU/mL):
    < 50 The sample must be considered to be negative for the presence of anti-thyroglobulin antibodies
    50 ÷ 75 The sample must be considered to be uncertain for the presence of anti-thyroglobulin antibodies
    > 75 The sample must be considered to be positive for the presence of anti-thyroglobulin antibodies

    Relative specificity**: 97,0 %
    Relative sensitivity**: 94,1 %


    *The content of this file is for informational purposes only.The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit
    **versus a commercial method

    anti TPO

    Autoimmune Thyroiditis kit at a glance: Zenit RA anti TPO

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    Code: 47746
    Parameter/assay principle: Quantitative detection of of specific IgG class antibodies acting against Thyroid peroxidase (TPO)
    Number of tests: 100
    Sample type: Serum or plasma (EDTA, Heparin)
    Sample volume: 10 µl
    Incubation time: 10 + 10 minutes
    Stability of calibration: 3 weeks
    Cartridge stability on board: 8 weeks
    Measuring range: 0.0 – 1300 IU/mL
    Results (AU/mL):
    < 15 The sample must be considered to be negative for the presence of anti-TPO antibodies
    15 ÷ 25 The sample must be considered to be uncertain for the presence of anti-TPO antibodies
    > 25 The sample must be considered to be positive for the presence of anti-TPO antibodies

    Relative specificity**: 97,2 %
    Relative sensitivity**: 93,8 %


    *The content of this file is for informational purposes only.The latest, updated version of the IFU, to which you should always refer, is the one accompanying the product and is to be found on the disk inside the product kit
    **versus a commercial method