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

MethodParameterSubstrateSpecies 
IIFTcell nuclei
(ANA global test)
HEp-2 cells
liver
(2 BIOCHIPs per field)
human
monkey
Details
IIFTcell 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
humanDetails
IIFTcell 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
humanDetails
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 cellshumanDetails
cell nuclei (ANA)
EUROPattern
HEp-2 cellshumanDetails
cell nuclei (ANA)HEp-20-10 cellshumanDetails
cell nuclei (ANA)
EUROPattern
HEp-20-10 cellshumanDetails
EUROLINEpositive control serum: IgG, human, 100x concentrated
for DL 1530-X G
Details
EUROLINEMyositis Profile
(Mi-2, Ku, PM-Scl, Jo-1, PL-7,
PL-12, Ro-52 separately)
EUROLINEDetails
EUROLINEMyositis Profile 3
(Mi-2, Ku, PM-Scl100, PM-Scl75, Jo-1, SRP,
PL-7, PL-12, EJ, OJ, Ro-52 separately)
EUROLINEDetails
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
ELISAhistonesantigen-coated
microplate wells
Details
IIFTantibodies 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
ELISAdouble-stranded DNA
(dsDNA)
antigen-coated
microplate wells
Details
RIAdouble-stranded DNA (dsDNA)
precipitation
labelled antigenDetails
IIFTantibodies against dsDNA
(dsDNA ab control)
Details
ELISAdsDNA-NcXantigen-coated
microplate wells
Details
dsDNAflagellatesCrithidia luciliaeDetails
dsDNA
EUROPattern
flagellatesCrithidia luciliaeDetails
dsDNA (sensitive)flagellatesCrithidia luciliaeDetails
dsDNA (sensitive)
EUROPattern
flagellatesCrithidia luciliae
Details
antibodies against dsDNA (dsDNA ab control)
control serum with indication of titer
Details
ELISAnucleosomesantigen-coated
microplate wells
Details
single-stranded DNA
(ssDNA)
antigen-coated
microplate wells
Details
IIFTantibodies against cell nuclei
(ANA control), nucleolar pattern
Details
ELISAPM-Sclantigen-coated
microplate wells
Details
IIFTantibodies against cell nuclei
(ANA control), granular pattern
Details
EUROLINEpositive control serum: IgG, human, 100x concentrated
for DL 1590-X G
Details
EUROASSAYAnti-ENA ProfilePlus
(nRNP/Sm, Sm, SS-A, SS-B, Scl-70,
Jo-1 separately)
EUROASSAY strip
with antigens
Details
EUROLINEAnti-ENA ProfilePlus 1
(nRNP/Sm, Sm, SS-A, Ro-52, SS-B,
Scl-70, Jo-1 separately)
EUROLINEDetails
ELISAAnti-ENA ProfilePlus 1 (nRNP/Sm,
Sm, SS-A, SS-B, Scl-70, Jo-1 separately)
antigen-coated
microplate wells
Details
ELISAANA 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
EUROASSAYAnti-ENA ProfilePlus with AMA M2
(nRNP/Sm, Sm, SS-A, SS-B, Scl-70,
Jo-1, AMA M2 separately)
EUROASSAY strip
with antigens
Details
ELISAAnti-ENA ProfilePlus 2 (ribosomal
P-proteins, nRNP/Sm, Sm, SS-A, SS-B,
Scl-70, Jo-1, centromeres, separately)
antigen-coated
microplate wells
Details