CLIA Beta 2 Glycoprotein IgG

Description

Support for the Diagnosis of Antiphospholipid Syndrome (APS) and Other Autoimmune Diseases

Cardiolipin, a phospholipid, is a major structural component of the inner mitochondrial membrane and is also present in the plasma membrane of certain prokaryotes. Because antibodies directed against cardiolipin alone commonly occur in infectious diseases, diagnostic assays therefore utilize a complex epitope composed of cardiolipin and β2-glycoprotein I.

The diagnosis of APS is based on a combination of clinical manifestations (such as a history of thrombosis, spontaneous miscarriage, thrombocytopenia, or stroke) and laboratory findings (including the presence of IgM/IgG autoantibodies against cardiolipin and β2-glycoprotein I, detection of lupus anticoagulant antibodies, and abnormalities in coagulation testing).

Technical data

• Assay time: 40 min
• Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
• Sample matrix: Serum, Plasma
• Sample volume: 10 μL
• Measuring range: 0–300 IU/ml
• Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: The kits are CE-IVD certified and intended for professional use.

Specifications

• Catalog Number: CL-BGG100
• Size: 100 tests
• Regulatory status: CE IVD
• Clinical topic: Immunology & Autoimmune Diseases
• Diagnostic panel: Antiphospholipid Syndrome
• Producer: TestLine Clinical Diagnostics s.r.o.

References

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• Sammaritano LR. Antiphospholipid syndrome. Best Pract Res Clin Rheumatol. 2020 Feb;34(1):101463. doi: 10.1016/j.berh.2019.101463. Epub 2019 Dec 19. PMID: 31866276.
• Schreiber K, Sciascia S, de Groot PG, Devreese K, Jacobsen S, Ruiz-Irastorza G, Salmon JE, Shoenfeld Y, Shovman O, Hunt BJ. Antiphospholipid syndrome. Nat Rev Dis Primers. 2018 Jan 11;4:17103. doi: 10.1038/nrdp.2017.103. Erratum in: Nat Rev Dis Primers. 2018 Jan 25;4:18005. doi: 10.1038/nrdp.2018.5. PMID: 29321641.
• Fauchais AL, Lambert M, Launay D, Michon-Pasturel U, Queyrel V, Nguyen N, Hebbar M, Hachulla E, Devulder B, Hatron PY. Antiphospholipid antibodies in primary Sjögren’s syndrome: prevalence and clinical significance in a series of 74 patients. Lupus. 2004;13(4):245-8. doi: 10.1191/0961203304lu1006oa. PMID: 15176660.
• Ortel TL. Antiphospholipid syndrome: laboratory testing and diagnostic strategies. Am J Hematol. 2012 May;87 Suppl 1(Suppl 1):S75-81. doi: 10.1002/ajh.23196. Epub 2012 Mar 31. PMID: 22473619; PMCID: PMC4848066.
• Gómez-Puerta JA, Cervera R. Diagnosis and classification of the antiphospholipid syndrome. J Autoimmun. 2014 Feb-Mar;48-49:20-5. doi: 10.1016/j.jaut.2014.01.006. Epub 2014 Jan 24. PMID: 24461539.
• Meroni PL, Borghi MO, Raschi E, Tedesco F. Pathogenesis of antiphospholipid syndrome: understanding the antibodies. Nat Rev Rheumatol. 2011 Jun;7(6):330-9. doi: 10.1038/nrrheum.2011.52. Epub 2011 May 10. PMID: 21556027.
• Petri M. Antiphospholipid syndrome. Transl Res. 2020 Nov;225:70-81. doi: 10.1016/j.trsl.2020.04.006. Epub 2020 May 12. PMID: 32413497; PMCID: PMC7487027.
• Barbhaiya M, Zuily S, Naden R, Hendry A, Manneville F, Amigo MC, Amoura Z, Andrade D, Andreoli L, Artim-Esen B, Atsumi T, Avcin T, Belmont HM, Bertolaccini ML, Branch DW, Carvalheiras G, Casini A, Cervera R, Cohen H, Costedoat-Chalumeau N, Crowther M, de Jesús G, Delluc A, Desai S, Sancho M, Devreese KM, Diz- Kucukkaya R, Duarte-García A, Frances C, Garcia D, Gris JC, Jordan N, Leaf RK, Kello N, Knight JS, Laskin C, Lee AI, Legault K, Levine SR, Levy RA, Limper M, Lockshin MD, Mayer-Pickel K, Musial J, Meroni PL, Orsolini G, Ortel TL, Pengo V, Petri M, Pons-Estel G, Gomez-Puerta JA, Raimboug Q, Roubey R, Sanna G, Seshan SV, Sciascia S, Tektonidou MG, Tincani A, Wahl D, Willis R, Yelnik C, Zuily C, Guillemin F, Costenbader K, Erkan D; ACR/EULAR APS Classification Criteria Collaborators. 2023 ACR/EULAR antiphospholipid syndrome classification criteria. Ann Rheum Dis. 2023 Oct;82(10):1258-1270. doi: 10.1136/ard-2023-224609. Epub 2023 Aug 28. PMID: 37640450.