Autoantibodies against Cell Nuclei (ANA)

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Indirect Immunfluorescence Test: New Cell Line from EUROIMMUN, HEp-20-10

HEp-2010: antibodies against spindle fibers.
  • Screening test for detection of antibodies against cell nuclei.
  • Indications: rheumatic diseases.
  • Initial dilution 1 : 100; conjugate class anti-human IgG, FITC-labelled.
  • Compared to standard HEp-2 cells, HEp-20-10 cells demonstrate 10-fold more mitotic cells. Antibodies against mitotic-specific structures (centromeres, spindle fibers, midbody, centrioles, NOR) can be more easily identified than with conventional preparations.
  • At the same time, the cell line HEp-20-10 offers the full antigen spectrum for cell nuclei antibody diagnostics.
  • The BIOCHIP with HEp-20-10 can be supplemented with additional substrates, for example, primate liver (ANA; Order No. FA 1512-####-1 G) as well as rat kidney and rat stomach (Order No. FA 1802-####-3 G).

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Indirect Immunofluorescence Test: EUROPLUS™ ANA Mosaic 20

EUROPLUS™ ANA Mosaic 20 (HEp-2 cells, primate liver, SS-A+SS-b BIOCHIPs, rib. P-prot.+Jo-1 BIOCHIPs: antibodies against SS-A/SS-B.
  • Screening testfor the detection of antibodies against cell nuclei (ANA).
  • Indications: rheumatic diseases.
  • Initial dilution 1 : 100; conjugate class anti-human IgG, FITC-labelled.
  • Using HEp-2 cells many antibodies against cell nuclei can be analyzed, e.g. antibodies against DNA, histones, RNA, nRNP, Sm, SS-A, SS-B, nuclear dots, centromeres, nuclear membrane, nucleoli (PM-Scl, fibrillarin, RNA polymerase I, NOR), Scl-70, cyclin I and II, spindle fibers, midbody, centrioles.
  • In addition, cytoplasmic autoantibodies are identified with HEp-2 cells: antibodies against ribosomes, Jo-1, mitochondria, Golgi apparatus, actin etc.
  • The primate liver permits the verification of results between both substrates, makes the pre-differentiation of a large number of ANA possible, and helps to establish titer levels. Moreover, the primate liver often contains additional antigens, allowing the identification of further autoantibodies: antibodies against LMA, LSP, endomysium, bile ducts and endothelium cells, as well as cANCA und pANCA.
  • The EUROPLUS™ system is a monospecific test that can be used to confirm the presence of autoantibodies against cell nuclei and cytoplasm components with one and the same test kit. The following antigens are currently available as EUROPLUS™ BIOCHIPs: SS-A, SS-B, nRNP/Sm, Sm, Jo-1, ribosomal P-proteins.

EUROLINE: ANA Profile 3

Incubated EUROLINE ANA Profile 3.
  • Differentiation of antibodies against cell nuclei (ANA).
  • Indications: Sharp syndrome (MCTD), systemic lupus erythematosus, Sjögren’s syndrome, progressive systemic sclerosis, poly/dermatomyositis, PBC.
  • Serum dilution 1 : 100; conjugate class anti-human IgG, AP-labelled.
  • With the EUROLINE ANA-Profile 3, fifteen autoantibodies can be determined: antibodies against nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, PM-Scl, Jo-1, centromere protein B, PCNA, dsDNA, nucleosomes, histones, ribosomal P-proteins, AMA M2.
  • Antibodies against SS-A are characteristic markers for SLE and Sjögren’s syndrome. In contrast, antibodies against Ro-52 also occur in patients with other autoimmune diseases.
  • Native antigens, purified by affinity chromatography (exception: centromere protein B, PM-Scl, Ro-52, PCNA).
  • Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan.

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EUROLINE: Myositis Profile

Incubated EUROLINE Myositis Profile.
  • Differentiation of myositis-associated antibodies against cell-nuclear and cytoplasmic antigens.
  • Indications: poly/dermatomyositis.
  • Serum dilution 1 : 100, conjugate class anti-human IgG, AP-labelled.
  • With the EUROLINE Myositis Profile, seven autoantibodies can be determined: antibodies against Mi-2, Ku, PM-Scl, Jo-1, PL-7, PL-12 and Ro-52.
  • Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan.

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Microplate ELISA: ANA Screen, Anti-ENA PoolPlus

Incubate ELISA ANA Screen (antigen mixture of dsDNA, histones, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, ribosomal P-proteins, centromere).
  • Screening test for predifferentiation of antibodies against cell nuclei (ANA) and cytoplasm components.
  • Indications: Sharp syndrome (MCTD), systemic lupus erythematosus, Sjögren's syndrome, progressive systemic sclerosis, polymyositis/dermatomyositis.
  • Serum dilution 1 : 200, conjugate class anti-human IgG, POD-labelled.
  • One microplate well incubated per patient.
  • 1-point calibration, semiquantitative.
  • Native antigens (exception: centromere, recombinant).
  • The ANA Screen ELISA supplements the gold standard immunofluorescence. It is based on a mixture of 10 highly purified antigens, which provide higher sensitivity and specificity than the undefined cell extracts used by other manufacturers.
  • Two ELISAs with different antigen combinations, adapted to particular indications or for follow-up of immunofluorescence patterns, are available.

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Microplate ELISA: SLE Profile 1/2, Anti-ENA ProfilePlus 1/2

Incubated ELISA Anti-ENA ProfilePlus 2 (antigens: ribosomal P-proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromere).
  • Differentiation of antibodies against cell nuclei (ANA) and cytoplasm components.
  • Indications: Sharp syndrome (MCTD), systemic lupus erythematosus, Sjögren's syndrome, progressive systemic sclerosis, polymyositis/dermatomyositis.
  • Serum dilution 1 : 200; conjugate class anti-human IgG, POD-labelled.
  • 8 or 6 relevant antibodies can be detected simultaneously.
  • 1-point calibration, semiquantitive. Calibrator pool and negative controls each on a separate microplate strip (SLE Profiles and Anti-ENA ProfilePlus 2) or on the same microplate strip as the patient serum.
  • Native antigens (exception: Ro-52, centromere and PM-Scl, recombinant).
  • In total 4 different ELISAs with different antigen combinations, adapted to particular indications or for follow-up of immunofluorescence patterns, are available.

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Microplate ELISA: ANA Single-Antigen ELISAs


Incubated ELISA Anti-SS-A, Anti-SS-B
  • Differentiation of antibodies against cell nuclei (ANA) and cytoplasm components.
  • Indications: rheumatic diseases.
  • Serum dilution 1 : 200; conjugate class anti-human IgG, POD-labelled.
  • Antibodies against cell nuclei components can be determined quantitatively in RU/ml.
  • 3-point calibration, quantitative.
  • Identical incubation conditions and times: all single-antigen tests can be combined with each other on one microplate.
  • Native antigens (exceptions: centromere and PM-Scl, recombinant).
  • Single-antigen ELISAs available for detection of antibodies against cell nuclei and cytoplasm antigens: ssDNA, nucleosomes, dsDNA, histones, ribosomal P proteins, PM-Scl, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromere.
  • ANA VarioProfile: ELISA test kits (total 12 strips, maximum 4 different microplate strips) can be individually put together from 14 different antigen-coated microplate strips: ssDNA, nucleosomes, dsDNA, histones, ribosomal P-proteins, PM-Scl, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromere, AMA M2.

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Determination of Autoantibodies

  • AAb against Cell Nuclei (ANA)
  • AAb against dsDNA
  • AAb against CCP
  • AAb against Liver Antigens
  • AAb against Neuronal Antigens
  • AAb in Diabetes mellitus
  • AAb against Granulocytes (ANCA)
  • Ab against Endomysium and Gliadin
Infectious SerologyAllergology

FDA cleared : For In vitro Diagnostic use :

Autoimmune serology

Infectious serology

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