The Anti-PR3 ELISA by ORGENTEC is an indi- rect enzyme immunoassay for the quantitative serological detection of autoantibodies against proteinase 3 (PR3), a lysosomal enzyme of neutrophil granulocytes and monocytes. The Anti-PR3 assay is an important element in the diagnosis of Wegener’s granulomatosis.
Autoantibodies against PR3 play a critical role in the diagnosis of this life-threatening disease. At present, a combination of indirect immunofluo- rescence (IFT) and an antigenspecific ELISA is currently recommended for the detection of these antibodies.
The Anti-PR3 hs now represents an innovative ELISA whose unusually high sensitivity of 96 % and simultaneously high specificity of 99 % pro- vide outstanding diagnostic significance in ANCA diagnosis. In addition, the results of the Anti-PR3 hs correlate very well with those of indirect immunofluorescence. |
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| Tests |
12 x 8 determinations
12 or 24 Alegria® test strips |
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| Calculation |
quantitative |
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| Range |
Anti-PR3: 0-100 U/ml
Anti-PR3 hs: 0-200 U/ml |
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| Cut-off |
Anti-PR3: 5 U/ml
Anti-PR3 hs: 10 U/ml |
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| Sensitivity |
0.5 U/ml |
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| Calibration |
arbitrary |
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| Substrate |
TMB (450 nm) |
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| Antigens |
Proteinase 3 (human) |
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