Clinical information
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease belonging to the group of connective tissue diseases. The classification criteria of the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR), revised in 2019, contain 7 clinical and 3 immunological categories, with each parameter 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 also 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 also an exclusive marker of SLE, provided that they are determined using a test system with a target antigen that is free of histone H1, Scl-70 and other non-histone proteins.
Anti-Sm antibodies are also highly specific markers but much rarer. Anti-Sm and anti-dsDNA antibodies each have a high weighting of 6 points in the classification criteria.
Diagnostics
Various test methods are available for the routine detection of antibodies against dsDNA: enzyme immunotests, such as ELISA or EUROLINE, and the Crithidia luciliae immunofluorescence test (CLIFT) The 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 linking substance, the performance data of the Anti-dsDNA-NcX ELISA are significantly higher than those of conventional anti-dsDNA ELISAs. 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.
| Technology | Parameter | Substrate | Species | Calibration | Ig Class | Format | Order No. |
|---|---|---|---|---|---|---|---|
| IIFT | cell nuclei (ANA) |
HEp-2 cells (1 BIOCHIP per field) |
human | IgG IgG IgG IgG |
10 x 50 120 x 10 20 x 05 20 x 10 |
FA 1520-1050-R FA 1520-12010-R FA 1520-2005-R FA 1520-2010-R |
|
| IIFT | cell nuclei (ANA) |
HEp-20-10 cells (1 BIOCHIP per field) |
human | IgG IgG IgG IgG |
10 x 50 120 x 10 20 x 05 20 x 10 |
FA 1522-1050-R FA 1522-12010-R FA 1522-2005-R FA 1522-2010-R |
|
| ChLIA | IDS SS-A/Ro 52 kDa | antigenic coated magnetic particles | SS-A/Ro 52 kDa |
quantitative |
50 x 01 |
IS-AI11031 | |
| IIFT |
antibodies against cell nuclei (ANA control), homogeneous pattern |
IgG |
05 x 02 |
CA 1570-0502 | |||
| IIFT |
antibodies against dsDNA (dsDNA ab control) |
IgG |
05 x 02 |
CA 1572-0502 | |||
| IIFT |
cell nuclei (ANA global test) |
HEp-2 cells liver (2 BIOCHIPs per field) |
human monkey |
IgG IgG IgG IgG IgG IgG IgG |
10 x 05 10 x 10 10 x 50 120 x 10 20 x 05 20 x 10 24 x 50 10 x 05 10 x 10 10 x 50 20 x 05 20 x 10 |
FA 1510-1005-1 FA 1510-1010-1 FA 1510-1050-1 FA 1510-12010-1 FA 1510-2005-1 FA 1510-2010-1 FA 1510-2450-1 FB 1510-1005-1 FB 1510-1010-1 FB 1510-1050-1 FB 1510-2005-1 FB 1510-2010-1 |
|
| IIFT |
cell nuclei (ANA) mitochondria (AMA) |
HEp-2 cells kidney (2 BIOCHIPs per field) |
human rat |
IgG IgG |
10 x 05 10 x 10 10 x 05 10 x 10 |
FA 1510-1005-2 FA 1510-1010-2 FB 1510-1005-2 FB 1510-1010-2 |
|
| IIFT |
cell nuclei (ANA global test) |
HEp-20-10 cells liver (2 BIOCHIPs per field) |
human monkey |
IgG IgG IgG IgG IgG IgG IgG |
10 x 05 10 x 10 10 x 50 120 x 10 20 x 05 20 x 10 24 x 50 10 x 05 10 x 10 10 x 50 20 x 05 20 x 10 |
FA 1512-1005-1 FA 1512-1010-1 FA 1512-1050-1 FA 1512-12010-1 FA 1512-2005-1 FA 1512-2010-1 FA 1512-2450-1 FB 1512-1005-1 FB 1512-1010-1 FB 1512-1050-1 FB 1512-2005-1 FB 1512-2010-1 |
|
| IIFT |
cell nuclei (ANA) mitochondria (AMA) |
HEp-20-10 cells kidney (2 BIOCHIPs per field) |
human rat |
IgG IgG IgG |
10 x 05 10 x 10 10 x 50 10 x 05 10 x 10 10 x 50 |
FA 1512-1005-2 FA 1512-1010-2 FA 1512-1050-2 FB 1512-1005-2 FB 1512-1010-2 FB 1512-1050-2 |
|
| IIFT | cell nuclei (ANA) | HEp-2 cells | human | IgG IgG IgG IgG IgG IgG |
10 x 05 10 x 10 10 x 50 120 x 10 20 x 05 20 x 10 10 x 05 10 x 10 10 x 50 20 x 05 20 x 10 |
FA 1520-1005 FA 1520-1010 FA 1520-1050 FA 1520-12010 FA 1520-2005 FA 1520-2010 FB 1520-1005 FB 1520-1010 FB 1520-1050 FB 1520-2005 FB 1520-2010 |
|
| IIFT | cell nuclei (ANA) | HEp-20-10 cells | human | IgG IgG IgG IgG |
10 x 05 10 x 10 20 x 05 20 x 10 10 x 05 10 x 10 20 x 05 20 x 10 |
FA 1522-1005 FA 1522-1010 FA 1522-2005 FA 1522-2010 FB 1522-1005 FB 1522-1010 FB 1522-2005 FB 1522-2010 |
|
| IIFT | dsDNA | flagellates | Crithidia luciliae | IgG IgG IgG IgG |
10 x 05 10 x 10 20 x 05 20 x 10 10 x 05 10 x 10 20 x 05 20 x 10 |
FA 1572-1005 FA 1572-1010 FA 1572-2005 FA 1572-2010 FB 1572-1005 FB 1572-1010 FB 1572-2005 FB 1572-2010 |
|
| IIFT | dsDNA (sensitive) | flagellates | Crithidia luciliae | IgG IgG IgG IgG |
10 x 05 10 x 10 20 x 05 20 x 10 |
FA 1572-1005-1 FA 1572-1010-1 FA 1572-2005-1 FA 1572-2010-1 |
|
| IIFT |
cell nuclei (ANA) EUROPattern cell nuclei (ANA) |
HEp-2 cells liver (2 BIOCHIPs per field) |
human monkey |
IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI |
10 x 05 10 x 10 120 x 10 20 x 05 20 x 10 24 x 50 10 x 50 20 x 10 |
FC 1510-1005-1 FC 1510-1010-1 FC 1510-12010-1 FC 1510-2005-1 FC 1510-2010-1 FC 1510-2450-1 FW 1510-1050-1 FW 1510-2010-1 |
|
| IIFT |
cell nuclei (ANA) EUROPattern cell nuclei (ANA) |
HEp-20-10 cells liver (2 BIOCHIPs per field) |
human monkey |
IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI |
10 x 05 10 x 10 10 x 50 120 x 10 20 x 05 20 x 10 24 x 50 10 x 05 10 x 10 10 x 50 20 x 10 |
FC 1512-1005-1 FC 1512-1010-1 FC 1512-1050-1 FC 1512-12010-1 FC 1512-2005-1 FC 1512-2010-1 FC 1512-2450-1 FW 1512-1005-1 FW 1512-1010-1 FW 1512-1050-1 FW 1512-2010-1 |
|
| IIFT |
cell nuclei (ANA) EUROPattern mitochondria (AMA) |
HEp-20-10 cells kidney (2 BIOCHIPs per field) |
human rat |
IgG PI IgG PI IgG PI |
10 x 05 120 x 10 |
FC 1512-1005-2 FC 1512-12010-2 FC 1512-2450-2 |
|
| IIFT |
cell nuclei (ANA) EUROPattern |
HEp-2 cells | human | IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI |
10 x 05 10 x 10 10 x 50 120 x 10 20 x 05 20 x 10 24 x 50 10 x 05 10 x 10 10 x 50 20 x 05 20 x 10 |
FC 1520-1005 FC 1520-1010 FC 1520-1050 FC 1520-12010 FC 1520-2005 FC 1520-2010 FC 1520-2450 FW 1520-1005 FW 1520-1010 FW 1520-1050 FW 1520-2005 FW 1520-2010 |
|
| IIFT |
cell nuclei (ANA) EUROPattern |
HEp-20-10 cells | human | IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI IgG PI |
10 x 05 10 x 10 10 x 50 120 x 10 20 x 05 20 x 10 10 x 05 20 x 05 20 x 10 |
FC 1522-1005 FC 1522-1010 FC 1522-1050 FC 1522-12010 FC 1522-2005 FC 1522-2010 FW 1522-1005 FW 1522-2005 FW 1522-2010 |
|
| IIFT |
dsDNA EUROPattern |
flagellates | Crithidia luciliae | IgG EB IgG EB IgG EB IgG EB |
10 x 05 10 x 10 20 x 05 20 x 10 |
FC 1572-1005 FC 1572-1010 FC 1572-2005 FC 1572-2010 |
|
| IIFT |
dsDNA (sensitive) EUROPattern |
flagellates | Crithidia luciliae | IgG EB IgG EB IgG EB IgG EB IgG EB |
10 x 05 10 x 10 120 x 10 20 x 05 20 x 10 |
FC 1572-1005-1 FC 1572-1010-1 FC 1572-12010-1 FC 1572-2005-1 FC 1572-2010-1 |
|
| ELISA | Anti-Histones ELISA (IgG) |
antigen-coated microplate wells |
native, highly purified histones, bovine thymus |
2/20/200 RU/ml | IgG |
96 x 01 |
EA 1560-9601 G |
| ELISA |
Anti-dsDNA ELISA (IgG) double-stranded DNA |
antigen-coated microplate wells |
highly purified genomic double-stranded DNA |
10/100/800 IU/ml | IgG |
96 x 01 |
EA 1571-9601 G |
| ELISA | Anti-dsDNA-NcX ELISA (IgG) |
antigen-coated microplate wells |
highly purified genomic double-stranded DNA, complexed with nucleosomes |
10/100/800 IU/ml | IgG |
96 x 01 |
EA 1572-9601 G |
| ELISA | Anti-Nucleosomes ELISA (IgG) |
antigen-coated microplate wells |
native, nucleosomes, calf thymus |
2/20/200 RU/ml | IgG |
96 x 01 |
EA 1574-9601 G |
| ELISA |
Anti-ENA SLE Profile 2-ELISA (IgG) (dsDNA, histones, nucleosomes, nRNP/Sm, Sm, SS-A, SS-B, Scl-70 separately) |
antigen-coated microplate wells |
see individual ELISA | semi-quantitative | IgG |
12 x 08 |
EA 1590-1208-12 G |
| ELISA |
Anti-ENA ProfilePlus 2 ELISA (IgG) (ribosomal P-proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromeres, separately) |
antigen-coated microplate wells |
see individual ELISA | semi-quantitative | IgG |
12 x 08 |
EA 1590-1208-2 G |
| ELISA |
ANA Screen 11 ELISA (IgG) (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 |
see individual ELISA | semi-quantitative | IgG |
96 x 01 |
EA 1590-9601-11 G |
| ELISA |
ANA Screen 9 ELISA (IgG) (antigen mixture: PCNA, PM-Scl, ribosomal P-proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1) |
antigen-coated microplate wells |
see individual ELISA | semi-quantitative | IgG |
96 x 01 |
EA 1590-9601-14 G |
| ELISA |
ANA Screen ELISA (IgG) (antigen mixture: dsDNA, histones, ribosomal P-proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromeres) |
antigen-coated microplate wells |
see individual ELISA | semi-quantitative | IgG |
96 x 01 |
EA 1590-9601-8 G |
| ELISA |
Anti-ENA Pool ELISA (IgG) (antigen mixture: nRNP/Sm, Sm, SS-A, SS-B, Scl-70, ribosomal P-proteins, Ro-52) |
antigen-coated microplate wells |
see individual ELISA | semi-quantitative | IgG |
96 x 01 |
EA 1590-9601-9 G |
| ELISA | Anti-Sm ELISA (IgG) |
antigen-coated microplate wells |
native, U2-, U4-, U5-, U6-nRNP, incl. B, B', D, E, F, G, calf thymus |
2/20/200 RU/ml | IgG |
96 x 01 |
EA 1593-9601 G |
| EUROLINE |
EUROLINE ANA Profile 23 (IgG) (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 | IgG IgG IgG |
16 x 01 50 x 01 64 x 01 |
DL 1590-1601-23 G DL 1590-5001-23 G DL 1590-6401-23 G |
||
| EUROLINE |
EUROLINE ANA Profile 3 (IgG) (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 | IgG IgG IgG |
16 x 01 50 x 01 64 x 01 |
DL 1590-1601-3 G DL 1590-5001-3 G DL 1590-6401-3 G |
||
| EUROLINE |
EUROLINE ANA Profile 3 plus DFS70 (IgG) (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 | IgG IgG IgG |
16 x 01 50 x 01 64 x 01 |
DL 1590-1601-30 G DL 1590-5001-30 G DL 1590-6401-30 G |
||
| EUROLINE |
EUROLINE ANA Profile et Mi-2 et Ku (IgG) (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 | IgG IgG |
16 x 01 64 x 01 |
DL 1590-1601-31 G DL 1590-6401-31 G |
||
| EUROLINE |
EUROLINE ANA Profile et Mi-2, Ku, DFS70 (IgG) (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 | IgG IgG IgG |
16 x 01 50 x 01 64 x 01 |
DL 1590-1601-33 G DL 1590-5001-33 G DL 1590-6401-33 G |
||
| EUROLINE |
EUROLINE ANA Profile 5 (IgG) (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 | IgG IgG |
16 x 01 64 x 01 |
DL 1590-1601-5 G DL 1590-6401-5 G |
||
| EUROLINE |
EUROLINE ANA-Profile 1 (IgG) (nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, CENP B, dsDNA, nucleosomes, histones, ribosomal P-proteins separately) |
EUROLINE | IgG IgG IgG |
16 x 01 50 x 01 64 x 01 |
DL 1590-1601-8 G DL 1590-5001-8 G DL 1590-6401-8 G |
||
| ChLIA | IDS ANA Screen | antigenic coated magnetic particles | dsDNA, Centromere B, SS-A/Ro (60 kDa and 52 kDa), SS-B/La, Sm, U1-snRNP (70 kDa, A and C), Scl-70, Jo-1 |
qualitative |
100 x 01 |
IS-AI10011 | |
| ChLIA | IDS ENA Screen | antigenic coated magnetic particles | SS-A/Ro (60 kDa and 52 kDa), SS-B/La, Sm, U1-snRNP (70 kDa, A and C), Scl-70, Jo-1 |
qualitative |
100 x 01 |
IS-AI10021 | |
| ChLIA | IDS ANA Screen Control Set | 3 x 1.5 ml Control 1/2 | human serum |
2 concentrations |
IS-AI10301 | ||
| ChLIA | IDS dsDNA IgG | antigenic coated magnetic particles | dsDNA |
quantitative |
100 x 01 |
IS-AI11011 | |
| ChLIA | IDS SS-A/Ro | antigenic coated magnetic particles | SS-A/Ro |
quantitative |
50 x 01 |
IS-AI11021 | |
| ChLIA | IDS SS-A/Ro 60 kDa | antigenic coated magnetic particles | SS-A/Ro 60 kDa |
quantitative |
50 x 01 |
IS-AI11041 | |
| ChLIA | IDS SS-B/La | antigenic coated magnetic particles | SS-B/La |
quantitative |
50 x 01 |
IS-AI11051 | |
| ChLIA | IDS Sm | antigenic coated magnetic particles | Sm |
quantitative |
50 x 01 |
IS-AI11061 | |
| ChLIA | IDS U1-snRNP | antigenic coated magnetic particles | U1-snRNP (70 kDa, A, C) |
quantitative |
50 x 01 |
IS-AI11071 | |
| ChLIA | IDS ANA Control Set | 3 x 1.5 ml Control 1/2 | human serum |
2 concentrations |
IS-AI11301 | ||
| ELISA | Anti-ribosomal P Proteins ELISA (IgG) |
antigen-coated microplate wells |
native, P0/P1/P2 of the 60S ribosomal subunit, calf thymus |
2/20/200 RU/ml | IgG |
96 x 01 |
EA 1641-9601 G |
| ChLIA |
Nu.Q® NETs H3.1 nucleosome |
Antibody-coated magnetic particles | H3.1 nucleosome |
quantitative |
100 x 01 |
2001-02-011 | |
| IIFT | dsDNA (sensitive) EUROPattern |
flagellates (1 BIOCHIP per field) |
Crithidia luciliae | IgG IgG IgG IgG |
24 x 50 120 x 10 20 x 05 20 x 10 |
FC 1572-12010-1-R FC 1572-2005-1-R FC 1572-2010-1-R |
|
| IIFT | dsDNA (sensitive) |
flagellates (1 BIOCHIP per field) |
Crithidia luciliae | IgG IgG |
20 x 05 20 x 10 |
FA 1572-2005-1-R FA 1572-2010-1-R |
|
| IIFT | dsDNA |
flagellates (1 BIOCHIP per field) |
Crithidia luciliae | IgG IgG |
20 x 05 20 x 10 |
FA 1572-2005-R FA 1572-2010-R |
|
| IIFT | dsDNA EUROPattern |
flagellates (1 BIOCHIP per field) |
Crithidia luciliae | IgG IgG |
20 x 05 20 x 10 |
FC 1572-2005-R FC 1572-2010-R |
|
|
* For research use only, not for in vitro diagnostic use in the sense of EU directive 98/79/EC. 1 Product manufactured by third party. Please contact your local Euroimmun representative for more information. | |||||||