Austria

Connective tissue diseases (CTD): Zenit RA dsDNA IgG

Download Instruction For Use*:

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.

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