5012 – Anti-Phospholipid 10 Dot

Highlights

• Detection of IgG antibodies against IgG and/or IgM antibodies against phospholipids and serum proteins
• Line immunoassay for simultaneous multi-antigen testing
• Quality assured handling in routine laboratories
• Ready-to-use test strips (exception: buffer), color- and barcoded reagents
• Aids in the diagnosis of anti-phospholipid antibody syndrome (APAS) in conjunction with other clinical and laboratory findings
• Differentiates antibodies against phospholipids only versus those requiring ß2-GP I cofactor
• High precision and reproducibility within the measurement range
• CE marked
• Automatable

Intended Purpose

The Anti-Phospholipid 10 Dot is a qualitative line immunoassay for the determination of IgG or IgM antibodies against phospholipids and serum proteins in human serum. The Anti-Phospholipid 10 Dot is intended as an aid in the diagnosis of anti-phospholipid antibody syndrome (APAS) in conjunction with other clinical and laboratory findings. It provides fast and reliable information to support diagnosis in patients. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Anti-phospholipid antibody syndrome (APAS), an autoimmune disorder evident by clinical symptoms such as thrombocytopenia, arterial (venous) thrombosis, and recurrent fetal loss, as well as systemic lupus erythematosus (SLE), is characterized by the presence of autoantibodies reactive to negatively charged phospholipids.

The detection of such autoantibodies is well established and plays an essential role in the diagnostics of systemic autoimmune diseases.

Role of Phospholipids and Cofactor Proteins

In autoimmune patients, phospholipid antibodies seem to recognize phospholipids associated with plasma protein cofactors, e.g., beta-2-glycoprotein-I (β2GPI), a serum protein with a molecular weight of ca. 50 kDa, that affects platelet aggregation and coagulation. Negatively charged phospholipids such as cardiolipin interact with the positively charged fifth domain of β2GPI, an interaction that leads to conformational changes of the protein and the creation of new epitopes recognized by autoimmune phospholipid autoantibodies. Consequently, clinicians most commonly rely on anti-cardiolipin antibodies for the diagnosis of APAS. However, antibodies against other phospholipids are also clinically relevant. In particular, physicians use them for differential diagnosis when anti-cardiolipin antibody results are negative, thereby improving diagnostic accuracy.

Publications

• Emmenegger et al., (2023) Antiphospholipid antibodies are enriched post-acute COVID-19 but do not modulate the thrombotic risk
• Alijotas-Reig et al., (2023) Thrombosis and Hyperinflammation in COVID-19 Acute Phase Are Related to Anti-Ph.serine and Anti-Ph.inositol AbsPositivity
• Anunciación-Llunell et al., (2022) Differences in APS Abs Profile between Patients with Obstetric and Thrombotic APS
• Tkachenko et al., (2020) Profiling of non-criteria APS Abs in patients with SLE-differentiation of thrombotic SLE patients and risk of recurrence of thrombos
• Volkov et al., (2020) Profiles of criteria and non‑criteria APS Abs are associated with clinical phenotypes of the APS
• Park et al., (2019) Thrombotic Risk of Non-Criteria APL Measured by LIA_Superiority of aPS and aPA Abs
• Thaler et al., (2019) Evaluation of the sens. and spec. of a novel LIA for the detection of criteria and non-criteria APS Abs in comparison to established ELISAs
• Nalli et al., (2018) APS IgG Abs detected by LIA differentiate patients with APS and other autoimmune diseases
• Roggenbuck et al., (2016) Antiphospholipid antibodies detected by line immunoassay differentiate among patients with APS, with infections and asymptomatic carriers
• Egerer et al., (2011) Single-step autoAb profiling in APS using a multi-LIA