Austria

Rheumatoid Arthritis: Zenit RA CCP

Download Instruction For Use*:

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.

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