Products - Autoimmune - Rheumatology - Systemic lupus erythematous (SLE)

Systemic lupus erythematous (SLE)

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Information

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease belonging to the group of connective tissue diseases.

Diagnostic Guidelines

The classification criteria of the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) revised in 2019 contain 7 clinical and 3 immunological categories with the individual parameters weighted using a point system. A case is classified as SLE if the entry criterion of a positive ANA test is fulfilled and the total score is at least 10.

Antibodies against double-stranded DNA (dsDNA) are the main focus of serological SLE diagnostics. These antibodies can be found in 60% to 90% of patients, depending on the activity of the disease. In rare cases, anti-dsDNA antibodies are found in patients with other autoimmune diseases (e.g., autoimmune hepatitis) or infections and 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 an exclusive marker of SLE, provided they are detected using a test system with a target antigen free of histone H1, Scl-70 and other non-histone proteins. Anti-Sm antibodies are also highly specific markers but occur a lot less frequently. Anti-Sm and anti-dsDNA antibodies each have a high weighting of 6 points in the classification criteria.

Various test methods are available for the routine detection of antibodies against dsDNA: enzyme immunotests (ELISA, EUROASSAY, EUROLINE), Farr RIA and the Crithidia luciliae immunofluorescence test (CLIFT). The various test systems differ, sometimes greatly, regarding their sensitivity and specificity. The conventional CLIFT, for example, shows a particularly high disease specificity, while the IIFT Crithidia luciliae sensitive was developed with a focus on high sensitivity.

Thanks to the use of highly purified nucleosomes as a linking substance, the performance data of the Anti-dsDNA-NcX ELISA are significantly higher than those of the conventional Anti-dsDNA ELISA. Because of their strong adhesive ability, even a very low concentration of these nucleosomes is suited to coupling isolated dsDNA to the surface of a microplate well. False positive reactions due to conventional linking substances such as poly-L lysine and protamine sulphate are avoided.

In a clinical comparative study of 564 patients with rheumatic diseases (of these 207 with SLE), the Anti-dsDNA-NcX ELISA yielded an 8% higher sensitivity than the Anti-dsDNA RIA (Biesen et al., Arthritis Res Ther (2011) 13:R26). Nevertheless, different test methods identify different SLE subgroups, so different test systems should be combined to increase the serological detection rate.

Systemic lupus erythematous (SLE) products

For Research Use Only. Not For Use In Diagnostic Procedures.
The individual product regulatory statements may vary, please refer to the instructions for use for more information.

wdt_ID Method Parameter Substrate Species/ Antigen
284 IFA cell nuclei (ANA) EUROPattern
cell nuclei (ANA)
HEp-2 cells
liver
(2 BIOCHIPs per field)
human
monkey
285 IFA cell nuclei
(ANA global test)
HEp-2 cells
liver
(2 BIOCHIPs per field)
human
monkey
286 IFA EUROPLUS ANA Mosaic 10
cell nuclei (ANA)
SS-A + SS-B
2 BIOCHIPs per field:
HEp-2 cells
SS-A+SS-B BIOCHIPs
human
287 IFA cell nuclei (ANA) EUROPattern
cell nuclei (ANA)
HEp-20-10 cells
liver
(2 BIOCHIPs per field)
human
monkey
288 IFA cell nuclei
(ANA global test)
HEp-20-10 cells
liver
(2 BIOCHIPs per field)
human
monkey
289 IFA 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
290 IFA 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
291 IFA 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
292 IFA cell nuclei (ANA)
cell nuclei (ANA)
HEp-20-10 cells
liver
(2 BIOCHIPs per field)
human
rat
293 IFA cell nuclei (ANA) HEp-2 cells human
294 IFA cell nuclei (ANA)
EUROPattern
HEp-2 cells human
295 IFA cell nuclei (ANA) HEp-20-10 cells human
296 IFA cell nuclei (ANA)
EUROPattern
HEp-20-10 cells human
297 ELISA histones antigen-coated
microplate wells
native, highly purified histones,
bovine thymus
298 IFA antibodies against cell nuclei
(ANA control), homogeneous pattern
299 IFA test performance control
(ANA homogeneous, IgG)
300 IFA antibodies against cell nuclei (ANA control), homogeneous pattern,
control serum with indication of titer, reference serum W 1064 (66/233)
301 IFA antibodies against cell nuclei,
aliquots from positive control for ANA diagnostics
(20 different fluorescence patterns)
302 IFA antibodies against cell nuclei (ANA control),
homogeneous pattern, control serum with indication of titer
303 IFA antibodies against cell nuclei (ANA control),
homogeneous pattern, for EUROPattern
304 ELISA double-stranded DNA
(dsDNA)
antigen-coated
microplate wells
highly purified genomic
double-stranded
305 RIA double-stranded DNA (dsDNA)
precipitation
labelled antigen plasmid DNA
306 IFA antibodies against dsDNA
(dsDNA ab control)
307 IFA dsDNA flagellates Crithidia luciliae
308 IFA dsDNA
EUROPattern
flagellates Crithidia luciliae
Method Parameter Substrate Species/ Antigen
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