SLE
Clinical information
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease belonging to the collagenosis group. Diagnosis is based on 11 criteria defined by the American College of Rheumatology (ACR) and modified in 1997. If 4 of 11 criteria are present, the probability of SLE is between 80 and 90%.
Antibodies against dsDNA are the main focus in the serological diagnosis of SLE. These antibodies can be found in 60 to 90% of patients, depending on the activity of the disease. Anti-dsDNA antibodies are in rare cases also found in patients with other autoimmune diseases (e.g. autoimmune hepatitis) or infections as well as in clinically healthy persons. 85% of people in the latter group develop SLE within 5 years of initial detection of anti-dsDNA. However, SLE cannot be excluded if anti-dsDNA antibodies are not detected.
Antibodies against nucleosomes are also an exclusive marker of SLE, provided that they are determined using an advanced test system with a target antigen that is free of histone H1, Scl-70 and other non-histone proteins.
Diagnostics
Various test methods are available for the routine detection of autoantibodies against dsDNA: enzyme immunotests (ELISA, EUROASSAY, EUROLINE), Farr RIA and the Crithidia luciliae immunofluorescence test (CLIFT). The various test systems differ, sometimes greatly, in sensitivity and specificity. Conventional CLIFT shows a particularly high disease specificity, while the IIFT Crithidia luciliae sensitive is a very sensitive test.
Using an innovative biological preparation, scientists at EUROIMMUN have developed a new test system: the Anti-dsDNA-NcX ELISA, which surpasses by far the diagnostic quality characteristics of all conventional anti-dsDNA ELISA. The secret of the innovation lies in the use of highly purified nucleosomes as the new linking substance. Since nucleosomes have a strong adhesive ability, even the smallest concentration of these is highly suited to coupling isolated dsDNA to the surface of a microplate well. Poly-L-lysine and protamine sulphate are now obsolete, and many false positive reactions can be avoided. In a clinical comparative study of 378 patients with rheumatic diseases (of these 209 with SLE), the Anti-dsDNA-NcX ELISA yielded an 8% higher sensitivity than the anti-dsDNA RIA (Farr assay), demonstrating its superior capabilities.
Nevertheless, different test methods identify different SLE subgroups. To increase the serological detection rate different test systems should be combined.

Selected Products
Method | Parameter | Substrate | Species | |
---|---|---|---|---|
IIFT | cell nuclei (ANA global test) | HEp-2 cells liver (2 BIOCHIPs per field) | human monkey | Details |
IIFT | cell nuclei (ANA) EUROPattern cell nuclei (ANA) | HEp-2 cells liver (2 BIOCHIPs per field) | human monkey | Details |
EUROPLUS ANA Mosaic 10 cell nuclei (ANA) SS-A + SS-B | 2 BIOCHIPs per field: HEp-2 cells SS-A+SS-B BIOCHIPs | human | Details | |
IIFT | cell nuclei (ANA) mitochondria (AMA) | HEp-2 cells kidney (2 BIOCHIPs per field) | human rat | Details |
ANA Mosaic 2 EUROPattern cell nuclei (ANA), EUROPattern mitochondria (AMA) | 2 BIOCHIPs per field: HEp-2 cells kidney | human rat | Details | |
cell nuclei (ANA global test) | HEp-20-10 cells liver (2 BIOCHIPs per field) | human monkey | Details | |
cell nuclei (ANA) EUROPattern cell nuclei (ANA) | HEp-20-10 cells liver (2 BIOCHIPs per field) | human monkey | Details | |
EUROPLUS ANA Mosaic 10A cell nuclei (ANA) SS-A + SS-B | 2 BIOCHIPs per field: HEp-20-10 cells SS-A+SS-B BIOCHIPs | human | Details | |
cell nuclei (ANA) mitochondria (AMA) | HEp-20-10 cells kidney (2 BIOCHIPs per field) | human rat | Details | |
cell nuclei (ANA) EUROPattern mitochondria (AMA) | HEp-20-10 cells kidney (2 BIOCHIPs per field) | human rat | Details | |
EUROPLUS ANA Mosaic 20A cell nuclei (ANA) cell nuclei (ANA) SS-A + SS-B ribosomal P-proteins + Jo-1 | 4 BIOCHIPs per field: HEp-20-10 cells liver SS-A+SS-B BIOCHIPs rib. P-prot.+Jo-1 BIOCHIPs | human monkey | Details | |
EUROPLUS ANA Mosaic 22A cell nuclei (ANA) cell nuclei (ANA) nRNP/Sm + Sm + SS-A SS-B + Scl-70 + Jo-1 | 4 BIOCHIPs per field: HEp-20-10 cells liver nRNP/Sm+Sm+SS-A BIOCHIPs SS-B+Scl-70+Jo-1 BIOCHIPs | human monkey | Details | |
cell nuclei (ANA) cell nuclei (ANA) | HEp-20-10 cells liver (2 BIOCHIPs per field) | human rat | Details | |
cell nuclei (ANA) | HEp-2 cells | human | Details | |
cell nuclei (ANA) EUROPattern | HEp-2 cells | human | Details | |
cell nuclei (ANA) | HEp-20-10 cells | human | Details | |
cell nuclei (ANA) EUROPattern | HEp-20-10 cells | human | Details | |
EUROLINE | positive control serum: IgG, human, 100x concentrated for DL 1530-X G | Details | ||
EUROLINE | Myositis Profile (Mi-2, Ku, PM-Scl, Jo-1, PL-7, PL-12, Ro-52 separately) | EUROLINE | Details | |
EUROLINE | Myositis Profile 3 (Mi-2, Ku, PM-Scl100, PM-Scl75, Jo-1, SRP, PL-7, PL-12, EJ, OJ, Ro-52 separately) | EUROLINE | Details | |
Autoimmune Inflammatory Myopathies 16 Ag (Mi-2 alpha, Mi-2 beta, TIF1g, MDA5, NXP2, SAE1, Ku, PM-Scl100, PM-Scl75, Jo-1, SRP, PL-7, PL-12, EJ, OJ, Ro-52 separately) | Details | |||
Autoimmune Inflammatory Myopathies 16 Ag et cN-1A (Mi-2 alpha, Mi-2 beta, TIF1g, MDA5, NXP2, SAE1, Ku, PM-Scl100, PM-Scl75, Jo-1, SRP, PL-7, PL-12, EJ, OJ, Ro-52, cN-1A separately) | Details | |||
positive control serum: IgG, human, 100x concentrated for DL 1532 G | Details | |||
Systemic Sclerosis Profile (Nucleoli) (Scl-70, CENP A, CENP B, RP11, RP155, fibrillarin, NOR90, Th/To, PM-Scl100, PM-Scl75, Ku, PDGFR, Ro-52 separately) | Details | |||
ELISA | histones | antigen-coated microplate wells | Details | |
IIFT | antibodies against cell nuclei (ANA control), homogeneous pattern | Details | ||
test performance control (ANA homogeneous, IgG) | Details | |||
antibodies against cell nuclei, aliquots from positive control for ANA diagnostics (20 different fluorescence patterns) | Details | |||
antibodies against cell nuclei (ANA control), homogeneous pattern, control serum with indication of titer | Details | |||
antibodies against cell nuclei (ANA control), homogeneous pattern, for EUROPattern | Details | |||
ELISA | double-stranded DNA (dsDNA) | antigen-coated microplate wells | Details | |
RIA | double-stranded DNA (dsDNA) precipitation | labelled antigen | Details | |
IIFT | antibodies against dsDNA (dsDNA ab control) | Details | ||
ELISA | dsDNA-NcX | antigen-coated microplate wells | Details | |
dsDNA | flagellates | Crithidia luciliae | Details | |
dsDNA EUROPattern | flagellates | Crithidia luciliae | Details | |
dsDNA (sensitive) | flagellates | Crithidia luciliae | Details | |
dsDNA (sensitive) EUROPattern | flagellates | Crithidia luciliae | Details | |
antibodies against dsDNA (dsDNA ab control) control serum with indication of titer | Details | |||
ELISA | nucleosomes | antigen-coated microplate wells | Details | |
single-stranded DNA (ssDNA) | antigen-coated microplate wells | Details | ||
IIFT | antibodies against cell nuclei (ANA control), nucleolar pattern | Details | ||
ELISA | PM-Scl | antigen-coated microplate wells | Details | |
IIFT | antibodies against cell nuclei (ANA control), granular pattern | Details | ||
EUROLINE | positive control serum: IgG, human, 100x concentrated for DL 1590-X G | Details | ||
EUROASSAY | Anti-ENA ProfilePlus (nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1 separately) | EUROASSAY strip with antigens | Details | |
EUROLINE | Anti-ENA ProfilePlus 1 (nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1 separately) | EUROLINE | Details | |
ELISA | Anti-ENA ProfilePlus 1 (nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1 separately) | antigen-coated microplate wells | Details | |
ELISA | ANA screen 11 (antigen mixture: PCNA, PM-Scl, ribosomal P-proteins, nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, centromeres) | antigen-coated microplate wells | Details | |
Anti-ENA SLE Profile 2 (dsDNA, histones, nucleosomes, nRNP/Sm, Sm, SS-A, SS-B, Scl-70 separately) | antigen-coated microplate wells | Details | ||
ANA screen 9 (antigen mixture: PCNA, PM-Scl, ribosomal P-proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1) | antigen-coated microplate wells | Details | ||
EUROASSAY | Anti-ENA ProfilePlus with AMA M2 (nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, AMA M2 separately) | EUROASSAY strip with antigens | Details | |
ELISA | Anti-ENA ProfilePlus 2 (ribosomal P-proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromeres, separately) | antigen-coated microplate wells | Details |