The information to be found in this section is intended for the exclusive use of healthcare professionals.
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
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.
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
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
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
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.
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.
Download Instruction For Use*: Download PDF
*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 optimal results the use of Zenit RA t-TG IgG Control set (cod. 41455) is recommended
*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.
**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.
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%
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%
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%
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%
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 %
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 %
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%
**versus a commercial ELISA method For optimal results the use of Zenit RA CCP Control set (cod. 41451) is recommended.
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.
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%
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%
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 %
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 information contained in this section is intended for the exclusive use of healthcare professionals.
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