BlueDot ENA 6 IgG Kit (IVD)

BlueDOT ENA 6 IgG is an Immunodot kit intended for the detection in human sera of IgG autoantibodies against Sm, Sm/RNP, SSA (Ro), SSB (La), Jo-1 and Scl-70 antigens. Each kit contains 24 tests.

ENA6_IgG_Protocol.pdf

BlueDot kits are composed of 24 nitrocellulose strips on which the antigens have been coated in a dot-shaped format. One strip allows the testing of one patient for many different autoantibodies in the same run. The test is based on a classical Enzyme ImmunoAssays (EIA).

In addition to the antigens, each strip possesses two built-in reactive controls :

• The first one, the Reaction Control (RC), controls the validity of the test : its coloration proves that the clinician has added the patient serum and that the test has functioned correctly.
• The second one, the Cut-Off Control (CO), allows the interpretation of the test : any color intensity equal to or below that of the cut-off is considered negative, any color intensity superior to that of the cut-off is considered positive.

The results can be interpretated by sight or a semi-quantification can be obtained thanks to the Dr DOT software.