INTRODUCTION

APS DIAGNOSIS

Simultaneous detection of anti-cardiolipin, anti-ß2Glycoprotein I and anti-prothrombin

International Consensus Statement on Classification Criteria for APS⁽¹⁾ (IgG and/or IgM)

• Clinical criteria
  • Vascular thrombosis
  • Pregnancy morbidity
• Laboratory criteria
  • Lupus anticoagulant
  • Anticardiolipin IgG or IgM antibody
  • Anti-ß2glycoprotein I IgG or IgM antibody

In addition, multivariate analysis revealed that IgG anti-prothrombin antibodies are associated with a significant elevated risk for fetal loss in APS patients⁽²⁾.

(1) Journal of Thrombosis and Haemostasis 2006; 4: 295-306
(2) American Journal of Reproductive Immunology 2003; 49: 51-56

PRODUCT ADVANTAGES

Correlates to the international standard

Cardiolipin is calibrated against SAPPORO standards [KOIKE MAb HCAL (IgG) and EY2C9 (IgM)].

Results given in

• International unit for anticardiolipin
  • GPL/mL, MPL/mL
  • µg/mL
• Arbitrary Unit for anti-ß2glycoprotein I and anti-prothrombin
  • AU/mL

Cut off at 15 GPL/mL or MPL/mL, 15 AU/mL.

PERFORMANCE

The study was performed on up to 130 samples against a marketed ELISA (FDA & CE).

Results

HANDELSFORM