The information to be found in this section is intended for the exclusive use of healthcare professionals.
Vasculitis kit at a glance: Zenit RA PR3
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.