Autoimmunity  ENA 6 parameters profile
ENA 6 parameters profile |
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The device ENA6PRO.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the qualitative determination of IgG autoantibodies against Ro/SSA, La/SSB, RNP-68, Sm, Scl-70, Jo-1 in human plasma and sera.
For in vitro diagnostic use only.
Microplates are coated by strips with ENA recombinant or purified Antigens specific: Ro/SSA, La/SSB, RNP-68, Sm, Scl-70, Jo-1.
| Position |
Autoantigen |
Composition |
| A |
Human Serum Albumin |
Negative Control |
| B |
SSA |
Rec Ag |
| C |
SSB |
Rec Ag
|
| D |
RNP-68 |
Rec Ag
|
| E |
Sm |
Native Ag |
| F |
Scl-70 |
Rec Ag
|
| G |
Jo-1 |
Rec Ag
|
| H |
hIgG |
Positive Control |
In the 1st incubation, the solid phase is treated with diluted samples and anti nuclear IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti nuclear IgG are detected by the addition of anti hIgG antibody, labelled with peroxidase (HRP).
The enzyme captured on the solid phase, acting on the substrate/chromogen mixture, generates an optical signal that is proportional to the amount of anti nuclear IgG antibodies present in the sample. The presence of IgG in the sample may therefore be determined by means of a cut-off value able to discriminate between negative and positive samples.Controls are included to provide an internal check of the analytical system.
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