The information to be found in this section is intended for the exclusive use of healthcare professionals.
Anti-phospoholid syndrome: anti-B2GP1 IgG
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