Clinical information
ANCA often occur in autoimmune vasculitides of the small blood vessels – especially in granulomatosis with polyangiitis (GPA, Wegener’s granulomatosis), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA, Churg–-Strauss syndrome), which are collectively referred to as ANCA-associated vasculitides (AAV) according to the classification system of the Chapel Hill Consensus Conference. The most important target antigens of the vasculitis-associated ANCA are proteinase 3 (PR3) and myeloperoxidase (MPO). Antibodies against PR3 are most frequently found in patients with GPA (up to 90 %), while MPO ANCA have been reported in MPA (40 % – 80 %) and EGPA (20 % – 70 %). Another form of vasculitis of the small blood vessels is anti-GBM disease (Goodpasture syndrome), which affects the glomerular and, in some cases, also the pulmonary capillaries. Characteristic autoantibodies are directed against the glomerular basement membrane (GBM). Up to 35 % of anti-GBM positive samples are also ANCA positive. Due to clinical overlap of AAV and anti-GBM disease, it is recommended to investigate both anti-GBM antibodies and ANCA in patients with corresponding kidney damage.
Diagnostics
AAV diagnostics relies predominantly on the monospecific detection of antibodies against proteinase 3 (PR3) and myeloperoxidase (MPO), as well as the detection of ANCA using IIFT. According to the international consensus of 2017, the use of high-quality monospecific assays is particularly recommended for the detection of PR3 and MPO in the context of GPA, MPA and EGPA diagnostics.
With the innovative Anti-PR3-hn-hr ELISA, consisting of a mixture of human native (hn) and human recombinant (hr) PR3, as well as the Anti-MPO ELISA with highly purified human MPO, EUROIMMUN offers high-quality test systems to support the diagnosis in suspected AAV. Especially the Anti-PR3-hn-hr ELISA is characterised by a very good specificity (99 %) and a significantly higher sensitivity (94%) compared to ELISAs using native antigens (88 % and 78 %, respectively).
EUROIMMUN offers BIOCHIPs consisting of ethanol (EOH)- and formaldehyde (HCHO)-fixed human granulocytes, which represent the standard substrate for IIFT diagnostics. Further EUROIMMUN-exclusive BIOCHIPs, e. g. HEp-2 cells with sedimented granulocytes, further increase the diagnostic certainty. The EUROPLUS technique allows the combination of conventional cell culture substrates with defined, purified single antigens (PR3, MPO, GBM) on one test field. This considerably simplifies the interpretation of the immunofluorescence patterns.
By means of IIFT, two ANCA types can be displayed: One is the cytoplasmic type (cANCA), which is associated with GPA and is almost always directed against PR3, and the other is the perinuclear type (pANCA), which indicates a spectrum of different diseases. The main target antigen of pANCA is mainly MPO in MPA and EGPA. In addition, there are atypical ANCA (also called xANCA or DNA-ANCA), which are particularly associated with chronic inflammatory bowel diseases (CIBD) and liver diseases (primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)). Prominent representatives of these ANCA include those directed against DNA-linked lactoferrin, cathepsin G, lysozyme or BPI. Positive IIFT results should always be interpreted in combination with a monospecific anti-PR3 and anti-MPO test (e. g. ChLIA or ELISA). Since not all cANCA and pANCA are positive in the monospecific test, only a combination of IIFT and ChLIA/ELISA achieves high specificity and sensitivity for ANCA detection. EUROIMMUN offers ELISA, EUROLINE, ChLIA and IIFT test systems for the detection of ANCA and antibodies against PR3, MPO and GBM.
| Technology | Parameter | Substrate | Species | Calibration | Ig Class | Format | Order No. |
|---|---|---|---|---|---|---|---|
| ChLIA | IDS GBM | antigenic coated magnetic particles | NC1?3(IV) |
quantitative |
50 x 01 |
IS-AI17031 | |
| ChLIA | Anti-GBM ChLIA (IgG) | Antigen-coated magnetic particles | quantitative | IgG |
100 x 1 |
LA 1251-10010 G | |
| ChLIA | Control set Anti-GBM ChLIA (IgG) | 2 x 0.4 ml control 1/2 | IgG |
02 x 02 |
LR 1251-20210 G | ||
| EUROLINE |
EUROLINE Anti-MPO, -PR3 and -GBM (IgG) myeloperoxidase proteinase 3 (PR3) glomerular basement membrane |
EUROLINE | IgG IgG |
16 x 01 64 x 01 |
DL 1200-1601-3 G DL 1200-6401-3 G |
||
| ChLIA | IDS ANCA/GBM Control Set | 3 x 1.5 ml Control 1/2 | human serum |
2 concentrations |
IS-AI17301 | ||
| IIFT |
antibodies against granulocyte cytoplasm, cytoplasmic pattern (cANCA control, PR3 ab control) |
IgG |
05 x 02 |
CA 1200-0502 | |||
| IIFT |
antibodies against granulocyte cytoplasm, perinuclear pattern (pANCA control) |
IgG |
05 x 02 |
CA 1210-0502 | |||
| IIFT |
antibodies against granulocyte cytoplasm, perinuclear pattern (pANCA control, MPO ab control) |
IgG |
05 x 02 |
CA 1211-0502 | |||
| IIFT |
cytoplasm of granulocytes (cANCA, pANCA), nuclei of granulocytes (GS-ANA) |
granulocytes, ethanol-fixed |
human | IgG IgG IgG IgG |
10 x 05 10 x 10 180 x 10 20 x 05 10 x 05 10 x 10 20 x 05 |
FA 1200-1005 FA 1200-1010 FA 1200-18010 FA 1200-2005 FB 1200-1005 FB 1200-1010 FB 1200-2005 |
|
| IIFT |
granulocytes (cANCA, pANCA) |
granulocytes, formaldehyde-fixed |
human | IgG IgG |
10 x 05 10 x 10 10 x 05 10 x 10 |
FA 1201-1005 FA 1201-1010 FB 1201-1005 FB 1201-1010 |
|
| IIFT |
Granulocyte Mosaic 13 cANCA, pANCA, GS-ANA cell nuclei (ANA), cANCA, pANCA cANCA, pANCA |
3 BIOCHIPs per field: granulocytes (EOH) HEp-2+granulocytes (EOH) granulocytes (HCHO) |
human human 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 1201-1005-13 FA 1201-1010-13 FA 1201-1050-13 FA 1201-12010-13 FA 1201-2005-13 FA 1201-2010-13 FB 1201-1005-13 FB 1201-1010-13 FB 1201-1050-13 FB 1201-2005-13 FB 1201-2010-13 |
|
| IIFT |
Granulocyte Mosaic 15 cANCA, pANCA, GS-ANA cell nuclei (ANA), cANCA, pANCA |
2 BIOCHIPs per field: granulocytes (EOH) HEp-2+granulocytes (EOH) |
human 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 1201-1005-15 FA 1201-1010-15 FA 1201-2005-15 FA 1201-2010-15 FB 1201-1005-15 FB 1201-1010-15 FB 1201-2005-15 FB 1201-2010-15 |
|
| IIFT |
Granulocyte Mosaic 2 cANCA, pANCA, GS-ANA cANCA, pANCA |
2 BIOCHIPs per field: granulocytes (EOH) granulocytes (HCHO) |
human 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 1201-1005-2 FA 1201-1010-2 FA 1201-2005-2 FA 1201-2010-2 FB 1201-1005-2 FB 1201-1010-2 FB 1201-2005-2 FB 1201-2010-2 |
|
| IIFT |
EUROPLUS Granulocyte Mosaic 22 cANCA, pANCA, GS-ANA cANCA, pANCA pANCA: myeloperoxidase (MPO) cANCA: proteinase 3 (PR3) |
4 BIOCHIPs per field: granulocytes (EOH) granulocytes (HCHO) MPO BIOCHIPs PR3 BIOCHIPs |
human human |
IgG IgG IgG |
10 x 05 10 x 10 20 x 05 10 x 05 10 x 10 |
FA 1201-1005-22 FA 1201-1010-22 FA 1201-2005-22 FB 1201-1005-22 FB 1201-1010-22 |
|
| IIFT |
EUROPLUS Granulocyte Mosaic 25 cANCA, pANCA, GS-ANA cell nuclei (ANA), cANCA, pANCA cANCA, pANCA glomerular basement membrane (GBM) pANCA: myeloperoxidase (MPO) cANCA: proteinase 3 (PR3) |
6 BIOCHIPs per field: granulocytes (EOH) HEp-2+granulocytes (EOH) granulocytes (HCHO) GBM BIOCHIPs MPO BIOCHIPs PR3 BIOCHIPs |
human human human |
IgG IgG IgG IgG |
10 x 05 10 x 10 20 x 05 20 x 10 10 x 05 20 x 05 20 x 10 |
FA 1201-1005-25 FA 1201-1010-25 FA 1201-2005-25 FA 1201-2010-25 FB 1201-1005-25 FB 1201-2005-25 FB 1201-2010-25 |
|
| IIFT |
EUROPLUS Granulocyte Mosaic 32 cANCA, pANCA, GS-ANA cANCA, pANCA cell nuclei (ANA), cANCA, pANCA pANCA: myeloperoxidase (MPO) cANCA: proteinase 3 (PR3) |
5 BIOCHIPs per field: granulocytes (EOH) granulocytes (HCHO) HEp-2+granulocytes (EOH) MPO BIOCHIPs PR3 BIOCHIPs |
human human 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 1201-1005-32 FA 1201-1010-32 FA 1201-2005-32 FA 1201-2010-32 FB 1201-1005-32 FB 1201-1010-32 FB 1201-2005-32 FB 1201-2010-32 |
|
| IIFT |
cytoplasm of granulocytes (cANCA, pANCA), nuclei of granulocytes (GS-ANA) EUROPattern |
granulocytes, ethanol-fixed |
human | 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 1200-1005 FC 1200-1010 FC 1200-12010 FC 1200-2005 FC 1200-2010 |
|
| IIFT |
granulocytes (cANCA, pANCA) EUROPattern |
granulocytes, formaldehyde-fixed |
human | IgG EB IgG EB IgG EB |
10 x 05 10 x 10 20 x 05 |
FC 1201-1005 FC 1201-1010 FC 1201-2005 |
|
| IIFT |
Granulocyte Mosaic 13 EUROPattern cANCA, pANCA, GS-ANA, EUROPattern cell nuclei (ANA), cANCA, pANCA cANCA, pANCA, EUROPattern |
3 BIOCHIPs per field: granulocytes (EOH) HEp-2+granulocytes (EOH) granulocytes (HCHO) |
human human human |
IgG EB IgG EB IgG EB 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 24 x 50 10 x 05 20 x 10 |
FC 1201-1005-13 FC 1201-1010-13 FC 1201-12010-13 FC 1201-2005-13 FC 1201-2010-13 FC 1201-2450-13 FW 1201-1005-13 FW 1201-2010-13 |
|
| IIFT |
Granulocyte Mosaic 15 EUROPattern cANCA, pANCA, GS-ANA, EUROPattern cell nuclei (ANA), cANCA, pANCA |
2 BIOCHIPs per field: granulocytes (EOH) HEp-2+granulocytes (EOH) |
human human |
IgG EB IgG EB IgG EB IgG EB IgG EB |
10 x 05 10 x 10 10 x 50 20 x 10 10 x 05 |
FC 1201-1005-15 FC 1201-1010-15 FC 1201-1050-15 FC 1201-2010-15 FW 1201-1005-15 |
|
| IIFT |
Granulocyte Mosaic 2 EUROPattern cANCA, pANCA, GS-ANA, EUROPattern cANCA, pANCA, EUROPattern |
2 BIOCHIPs per field: granulocytes (EOH) granulocytes (HCHO) |
human human |
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 1201-1005-2 FC 1201-1010-2 FC 1201-12010-2 FC 1201-2005-2 FC 1201-2010-2 |
|
| IIFT |
EUROPLUS Granulocyte Mosaic 22 EUROPattern cANCA, pANCA, GS-ANA, EUROPattern cANCA, pANCA, EUROPattern pANCA: myeloperoxidase (MPO), EUROPattern cANCA: proteinase 3 (PR3), EUROPattern |
4 BIOCHIPs per field: granulocytes (EOH) granulocytes (HCHO) MPO BIOCHIPs PR3 BIOCHIPs |
human human |
IgG EB IgG EB IgG EB |
10 x 05 10 x 10 20 x 10 |
FC 1201-1005-22 FC 1201-1010-22 FC 1201-2010-22 |
|
| IIFT |
EUROPLUS Granulocyte Mosaic 25 EUROPattern cANCA, pANCA, GS-ANA, EUROPattern cell nuclei (ANA), cANCA, pANCA cANCA, pANCA, EUROPattern glom. basement membrane (GBM), EUROPattern pANCA: myeloperoxidase (MPO), EUROPattern cANCA: proteinase 3 (PR3), EUROPattern |
6 BIOCHIPs per field: granulocytes (EOH) HEp-2+granulocytes (EOH) granulocytes (HCHO) GBM BIOCHIPs MPO BIOCHIPs PR3 BIOCHIPs |
human human human |
IgG EB IgG EB IgG EB IgG EB IgG EB IgG EB |
10 x 05 10 x 10 20 x 05 20 x 10 10 x 05 20 x 10 |
FC 1201-1005-25 FC 1201-1010-25 FC 1201-2005-25 FC 1201-2010-25 FW 1201-1005-25 FW 1201-2010-25 |
|
| IIFT |
EUROPLUS Granulocyte Mosaic 32 EUROPattern cANCA, pANCA, GS-ANA, EUROPattern cANCA, pANCA, EUROPattern cell nuclei (ANA), cANCA, pANCA pANCA: myeloperoxidase (MPO), EUROPattern cANCA: proteinase 3 (PR3), EUROPattern |
5 BIOCHIPs per field: granulocytes (EOH) granulocytes (HCHO) HEp-2+granulocytes (EOH) MPO BIOCHIPs PR3 BIOCHIPs |
human human human |
IgG EB IgG EB 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 10 x 05 10 x 10 |
FC 1201-1005-32 FC 1201-1010-32 FC 1201-12010-32 FC 1201-2005-32 FC 1201-2010-32 FW 1201-1005-32 FW 1201-1010-32 |
|
| ELISA |
ANCA-Profile ELISA (IgG) (proteinase 3, MPO, elastase, cathepsin G, BPI, lactoferrin separately) |
antigen-coated microplate wells |
native, human neutrophil granulocytes recombinant, human c-DNA expressed in human cell line |
semi-quantitative | IgG |
12 x 08 |
EA 1200-1208-1 G |
| ELISA |
Anti-PR3-hn-hr ELISA (IgG) cANCA: proteinase 3 |
antigen-coated microplate wells |
hn: native, human neutrophil granulocytes hr: recombinant, human c-DNA expressed in human cell line |
2/20/200 RU/ml | IgG |
96 x 01 |
EA 1201-9601-2 G |
| ELISA |
Anti-MPO ELISA (IgG) pANCA: myeloperoxidase |
antigen-coated microplate wells |
native, human neutrophil granulocytes |
2/20/200 RU/ml | IgG |
96 x 01 |
EA 1211-9601 G |
| EUROLINE |
positive control serum: IgG, human, 100x concentrated for DL 1200-X G |
IgG |
05 x 07 |
CL 1200-0507-2 G | |||
| EUROLINE |
EUROLINE Anti-MPO, -PR3 (IgG) myeloperoxidase proteinase 3 |
EUROLINE | IgG IgG |
16 x 01 64 x 01 |
DL 1200-1601-2 G DL 1200-6401-2 G |
||
| ChLIA | IDS MPO | antigenic coated magnetic particles | MPO |
quantitative |
50 x 01 |
IS-AI17011 | |
| ChLIA | IDS PR3-II | antigenic coated magnetic particles | PR3 |
quantitative |
50 x 01 |
IS-AI1702II1 | |
| ChLIA | Anti-PR3 ChLIA (IgG) | Antigen-coated magnetic particles | quantitative | IgG |
100 x 1 |
LA 1201-10010 G | |
| ChLIA | Anti-Myeloperoxidase ChLIA (IgG) | Antigen-coated magnetic particles | quantitative | IgG |
100 x 1 |
LA 1211-10010 G | |
| ChLIA | Control set Anti-PR3 ChLIA (IgG) | 2 x 0.4 ml control 1/2 | IgG |
02 x 02 |
LR 1201-20210 G | ||
| ChLIA | Control set Anti-Myeloperoxidase ChLIA (IgG) | 2 x 0.4 ml control 1/2 | IgG |
02 x 02 |
LR 1211-20210 G | ||
| ELISA |
sCD163 determination in urine |
antibody-coated microplate wells |
soluble CD163 | 0-12 ng/ml |
96 x 01 |
EQ 6851-9601-U | |
|
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