THROMBOSIS PRODUCT HIGHLIGHTS

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Vanessa Chapman
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1 PRODUCT HIGHLIGHTS AESKU.DIAGNOSTICS has extensive experience and know-how in the Anti-Phospholipid Syndrome (APS) field and offers the most comprehensive panel of anti-phospholipid tests, employing highly purified, native human ß2-GP-1 antigens and bovine phospholipids, available in different kit formats and immunoglobulins. Two major serological parameters for diagnosis, anti-cardiolipin and anti-ß2-gp-1 antibodies are well established. Despite some contradictory results, a number of studies indicate that there is a sub-group of APS patients with a clear clinical picture of APS but without detectable Cardiolipin / ß2-GP-1 antibodies or LA. There is, however, increasing evidence from a number of studies that testing a profile of various phospholipids, rather than restriction to cardiolipin and ß2-GP-1, increases both the sensitivity and specificity of the laboratory diagnosis. Why choose Cardiolipin and ß2-GP-1 tests? Kit format flexibility: ACA and ß2-GP-1 kits allow the separated as well as combined detection of ACA and ß2-GP-1 antibodies of the IgG, IgM and IgA isotype. Kit conjugate flexibility: Combined detection of all isotypes can be performed with the ACA-Check and ß2-GP-1 Check. The ACA and ß2-GP-1 GM kit format include the individual IgG and IgM conjugates within the same kit for a cost effective and convenient handling. Usage of native human ß2 -GP-1 instead of bovine. Addition of ß2-GP-1 during coating. Coating with a defined and reproducible ratio of cardiolipin to ß2-GP-1 is ensured. Optical density Optical density ensity IgG 2 1,8 1,6 1,4 1,2 1 0,8 0,6 0,4 0,2 0 0,00 20,00 40,00 60,00 80,00 100,00 HCAL concentration (ng/ml) IgG 2,5 2 1,5 1 0,5 3,5 3,0 2,5 2,0 IgM 0 0,00 50,00 100,00 150,00 200,00 EY2C9 concentration (ng/ml) IgM Testing of monoclonal antibodies HCAL and EY2C9 (Sapporo-Standards) on Cardiolipin-GM Test IgG Dedicated phospholipids dilution and wash buffers are not necessary: THE ONE AESKU CONCEPT. 0, HCAL concentration (ng/ml) IgG Calibration of Cardiolipin IgG, IgM and IgA against the Harris sera (GPL and MPL units). Calibration of Cardiolipin IgG against the UK NEQAS standard preparation 97/514. Optical Density 3,5 3,0 2,5 2,0 1,5 1,0 IgM Standardization of Cardiolipin-GM and ß2-GP-1-GM using the Sapporo monoclonal antibodies (Sapporo standards). Reporting units can be converted to ng/ml EY2C9 concentration (ng/ml) IgM Testing of monoclonal antibodies HCAL and EY2C9 (Sapporo-Standards) on ß2-GP-1-GM tests 24

PRODUCT HIGHLIGHTS Phospholipid screening tests are highly sensitive

are the ideal tools for the reliable differential diagnosis of APS, as

diagnostic workflow for APS Suspected APS Cardiolipin, ß2-GP1 (IgG,

negative positive borderline Repeated testing after 12 weeks

borderline positive negative positive positive negative Repeated

No APS Diagnosis: APS Diagnosis: APS No APS A definite clinical

2 PRODUCT HIGHLIGHTS Phospholipid screening tests are highly sensitive for a rapid and reliable combined determination of the most important antiphospholipid antibodies. AESKULISA S Phospholipid profiles, employing eight different antigens, are the ideal tools for the reliable differential diagnosis of APS, as certain antibody patterns can be correlated with distinct clinical manifestations of the APS. All phospholipids are also available as single tests for a cost-effective therapy monitoring. Phospholipid - 8Profile APS - Profile Thrombo - Profile Proposed diagnostic workflow for APS Suspected APS Cardiolipin, ß2-GP1 (IgG, IgM) and / or Phospholipid Screen and / or Lupus anticoagulant negative positive borderline Repeated testing after 12 weeks Prothrombin Annexin V Laminin Phospholipid-Screen and/or Profile borderline positive negative positive positive negative Repeated testing after 12 weeks positive Increased risk of reproductive failure No APS Diagnosis: APS Diagnosis: APS No APS A definite clinical diagnosis should not be based on the results of the performed tests alone, but should be made by the physician after all clinical and laboratory findings have been evaluated. The diagnosis is to be verified using different diagnostic methods. 25

REF 3216 Phospholipid- Screen IgG/M-HRP Cut-off: Cut-off calibrator Screening-Check Each well with native human ß2-glycoprotein I and cardiolipin, phosphatidyl-choline, -ethanolamine, -inositol,

3 REF 3216 Phospholipid- Screen IgG/M-HRP Cut-off: Cut-off calibrator Screening-Check Each well with native human ß2-glycoprotein I and cardiolipin, phosphatidyl-choline, -ethanolamine, -inositol, -serine and sphingomyelin (ELISA) for the combined qualitative determination of IgG and IgM autoantibodies to phospholipids (SCREENING) in REF 3219 Phospholipid- Screen-A IgA-HRP Screening-A Each well with native human ß2-glycoprotein I and cardiolipin, phosphatidyl-choline, -ethanolamine, -inositol, -serine and sphingomyelin autoantibodies to phospholipids (SCREENING) in REF 3224 Phospholipid- Screen-GM Screening-GM Each well with native human ß2-glycoprotein I and cardiolipin, phosphatidyl-choline, -ethanolamine, -inositol, -serine and sphingomyelin (ELISA) for the separate quantitative and qualitative determination of IgG and/or IgM autoantibodies to phospholipids (SCREENING) in REF 3222 Phospholipid- 8Pro-A IgA-HRP Cut-off Calibrator: antigen specific Profile-A ß2-glycoprotein I, cardiolipin+ ß2-glycoprotein I, cardiolipin, phosphatidyl-choline, -ethanolamine, -inositol, -serine and sphingomyelin (ELISA) for the qualitative determination of 8 different IgA anti-phospholipid autoantibodies (PROFILE) in REF 3232 Phospholipid- 8Pro-GM Cut-off Calibrator: antigen specific Profile-GM ß2-glycoprotein I, cardiolipin + ß2-glycoprotein I, cardiolipin, phosphatidyl-choline, -ethanolamine, -inositol, -serine and sphingomyelin (ELISA) for the separate qualitative determination of 8 different IgG and/or IgM anti- phospholipid autoantibodies (PROFILE) in 26

4 REF 3230 Thrombo-Profile Profile-GM and cardiolipin, phosphatidylserine, -inositol and phosphatidic acid as well as mixtures thereof of IgG and/or IgM autoantibodies in to ß2-gly- coprotein I, cardiolipin, phosphatidyl-serine, -inositol, phosphatidic acid, a mixture of all phospholipids and a mixture of all phospholipids without additional ß2-glycoprotein I coating REF 3234 APS-Profile-GM Cut-off Calibrator: antigen specific Profile-GM Human prothrombin, thrombin, cardiolipin, phosphatidyl-choline -ethanolamine, -inositol, -serine and sphingomyelin (ELISA) for the separate qualitative determination of 8 different IgG and/or IgM antiphospholipid autoantibodies (PROFILE) in REF 3202 Cardiolipin- Check IgA/G/M-HRP + cardiolipin (ELISA) for the combined quantitative of IgA, IgG and IgM autoantibodies to the cardiolipin-ß2- glycoprotein I complex in human REF 3203 Cardiolipin-A IgA-HRP APL/ml APL/ml + cardiolipin autoantibodies to the cardiolipin-ß2- glycoprotein I complex REF 3204 Cardiolipin-GM GPL/M- PL/ml GPL/MPL/ml + cardiolipin to the cardiolipin-ß2- glycoprotein I complex in human 27

5 REF 3215 ß2-Glyco- Check IgA/G/M-HRP (ELISA) for the combined quantitative of IgA, IgG and IgM autoantibodies to ß2-glycoprotein I in REF 3205 ß2-Glyco-A IgA-HRP autoantibodies to ß2- glycoprotein I in REF 3206 ß2-Glyco-GM (ELISA) for the separate quantitative and qualitative determination of IgG and/or IgM autoantibodies to ß2-glycoprotein I in REF 3223 Serine- Prothrombin Check IgG/M-HRP Native human prothrombinphosphatidylserine complex (ELISA) for the combined quantitative of IgG and IgM autoantibodies to the prothrombinphophatidylserine-complex in REF 3227 Serine- Prothrombin-A IgA-HRP Native human prothrombinphosphatidylserine complex autoantibodies to the prothrombin-phosphatidylserine-complex in 28

6 REF 3226 Serine- Prothromin-GM Native human prothrombin-phosphatidylserine complex to the prothrombinphosphatidylserine-complex in REF 3211 Prothrombin- Check IgG/M-HRP Native human prothrombin (ELISA) for the combined quantitative of IgG and IgM autoantibodies to prothrombin in human REF 3210 Prothrombin-A IgA-HRP Native human prothrombin autoantibodies to prothrombin in REF 3229 Prothrombin- GM Native human prothrombin to prothrombin in human REF 3244 Cardiolipin-GM GPL/MPL/ml GPL/MPL/ml + cardiolipin to the cardiolipin-ß2- gylcoprotein I complex in human 29

7 REF 3225 Thrombin- Check IgA/G/M-HRP Native human thrombin (ELISA) for the combined quantitative of IgA, IgG and IgM autoantibodies to thrombin in human REF 3213 Thrombin-A IgA-HRP Native human thrombin autoantibodies to thrombin in REF 3228 Thrombin-GM Native human thrombin to thrombin in human REF 3207 Serine-GM + phosphatidylserine to phosphatidylserine in REF 3208 Inositol-GM + phosphatidylinositol to phosphatidylinositol in 30

8 REF 3236 Ethanolamine-A IgA-HRP + phosphatidylethanolamine autoantibodies to phosphatidyl-ethanolamine in human REF 3209 Ethanolamine- GM + phosphatidylethanolamine to phosphatidylethanol-amine in REF 3254 Glycerol-A IgA-HRP + phosphatidylglycerol autoantibodies to phosphatidylglycerol in REF 3255 Glycerol-GM + phosphatidylglycerol to phosphatidylglycerol in REF 3231 Phosphatidic acid-gm + phosphatidic acid to phosphatidic acid in 31

9 REF 3212 Choline-GM + phosphatidylcholine to phosphatidylcholine in REF 3214 Sphingomyelin-GM + sphingomyelin to sphingomyelin in REF 3240 Annexin V-GM Native human annexin V to annexin V in human REF 3235 Laminin IgG-HRP Single-G Native human laminin-1 qualitative determination of IgG autoantibodies against laminin-1 in REF 3290 HiT II IgG-HRP Single-G HiT II complex qualitative determination of IgG autoantibodies that cause heparin induced thrombocytopenia type II in human 32

10 REF 3291 HiT II Check Ig A/G/M-HRP HiT II complex (ELISA) for the combined quantitative of IgA, IgG and IgM autoantibodies that cause heparin induced thrombocytopenia type II in 33

Antiphospholipid Syndrome

Antiphospholipid Syndrome EliA Cardiolipin and EliA β2-glycoprotein I Fully Automated Testing for Antiphospholipid Syndrome (APS) Testing for APS according to classification criteria determination of anti-β2-glycoprotein