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
IIFT
cell nuclei (ANA) EUROPattern
cell nuclei (ANA)
HEp-2 cells
liver
(2 BIOCHIPs per field)
human
monkey
IIFT
EUROPLUS ANA Mosaic 10
cell nuclei (ANA)
SS-A + SS-B
2 BIOCHIPs per field:
HEp-2 cells
SS-A+SS-B BIOCHIPs

human
IIFT
cell nuclei
(ANA global test)
HEp-20-10 cells
liver
(2 BIOCHIPs per field)
human
monkey
IIFT
cell nuclei (ANA) EUROPattern
cell nuclei (ANA)
HEp-20-10 cells
liver
(2 BIOCHIPs per field)
human
monkey
IIFT
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
IIFT
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
IIFT
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
IIFT
cell nuclei (ANA)
cell nuclei (ANA)
HEp-20-10 cells
liver
(2 BIOCHIPs per field)
human
rat
IIFT
cell nuclei (ANA)
HEp-2 cells
human
IIFT
cell nuclei (ANA)
EUROPattern
HEp-2 cells
human
IIFT
cell nuclei (ANA)
HEp-20-10 cells
human
IIFT
cell nuclei (ANA)
EUROPattern
HEp-20-10 cells
human
ELISA
histones
antigen-coated
microplate wells
IIFT
antibodies against cell nuclei
(ANA control), homogeneous pattern
IIFT
test performance control
(ANA homogeneous, IgG)
IIFT
antibodies against cell nuclei (ANA control), homogeneous pattern,
control serum with indication of titer, reference serum W 1064 (66/233)
IIFT
antibodies against cell nuclei,
aliquots from positive control for ANA diagnostics
(20 different fluorescence patterns)
IIFT
antibodies against cell nuclei (ANA control),
homogeneous pattern, control serum with indication of titer
IIFT
antibodies against cell nuclei (ANA control),
homogeneous pattern, for EUROPattern
ELISA
double-stranded DNA
(dsDNA)
antigen-coated
microplate wells
RIA
double-stranded DNA (dsDNA)
precipitation
labelled antigen
plasmid DNA
IIFT
antibodies against dsDNA
(dsDNA ab control)
ELISA
dsDNA-NcX
antigen-coated
microplate wells
IIFT
dsDNA
flagellates
Crithidia luciliae
IIFT
dsDNA
EUROPattern
flagellates
Crithidia luciliae
IIFT
dsDNA (sensitive)
flagellates
Crithidia luciliae
IIFT
dsDNA (sensitive)
EUROPattern
flagellates
Crithidia luciliae
IIFT
antibodies against dsDNA (dsDNA ab control)
control serum with indication of titer
ELISA
nucleosomes
antigen-coated
microplate wells
EUROLINE
Anti-ENA ProfilePlus 1
(nRNP/Sm, Sm, SS-A, Ro-52, SS-B,
Scl-70, Jo-1 separately)
EUROLINE
EUROLINE
ANA Profile 23
(nucleosomes, dsDNA, histones, SS-A, Ro-52,
SS-B, nRNP/Sm, Sm, Mi-2 alpha, Mi-2 beta, Ku, CENP A,
CENP B, Sp100, PML, Scl-70, PM-Scl100, PM-Scl75,
RP11, RP155, gp210, PCNA, DFS70 separately)
EUROLINE
EUROLINE
ANA Profile 3
(nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, PM-Scl,
Jo-1, CENP B, PCNA, dsDNA, nucleosomes,
histones, ribosomal P-proteins, AMA M2 separately)
EUROLINE
EUROLINE
ANA Profile 3 plus DFS70
(nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, PM-Scl,
Jo-1, CENP B, PCNA, dsDNA, nucleosomes, histones,
ribosomal P-proteins, AMA M2, DFS70 separately)
EUROLINE
EUROLINE
ANA Profile et Mi-2 et Ku
(Mi-2, Ku, nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70,
PM-Scl, Jo-1, CENP B, PCNA, dsDNA, nucleosomes,
histones, ribosomal P-proteins, AMA M2 separately)
EUROLINE
EUROLINE
dsDNA, nucleosomes, histones, DFS70
EUROLINE
EUROLINE
ANA Profile et Mi-2, Ku, DFS70
(Mi-2, Ku, nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70,
PM-Scl100, Jo-1, CENP B, PCNA, dsDNA,
nucleosomes, histones, ribosomal P-proteins,
AMA M2, DFS70 separately)
EUROLINE
EUROLINE
Cytoplasm profile
(AMA M2, M2-3E, ribosomal P-proteins, Jo-1
SRP, PL-7, PL-12, EJ, OJ, Ro-52 separately)
EUROLINE
EUROLINE
ANA Profile 5
(nRNP/Sm, Sm, RNP70, RNPA, RNPC, SS-A,
Ro-52, SS-B, Scl-70, PM-Scl, Jo-1, CENP B,
PCNA, dsDNA, nucleosomes, histones,
ribosomal P-proteins, AMA M2 separately)
EUROLINE
EUROLINE
ANA Profile 1
(nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70,
Jo-1, CENP B, dsDNA, nucleosomes, histones,
ribosomal P-proteins separately)
EUROLINE
IIFT
antibodies against Sm
ELISA
Sm
antigen-coated
microplate wells
IIFT
antibodies against PCNA (cyclin I)
ELISA
ribosomal P-proteins
antigen-coated
microplate wells
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