BlueDiver Dot ANA12 Screen IgG Kit (IVD)

BlueDiver Dot ANA12 Screen IgG is an Immunodot kit intended for the detection in human sera of IgG autoantibodies against Sm, RNP (68kD/A/C), Sm/RNP, SSA/Ro 60kD, SSB(La), Jo-1, Scl-70, PM-Scl 100, Ku, CENP-A/B, PCNA and Mi-2 antigens. Each kit contains 24 tests.

ANA12_Screen_IgG_DIV_Protocol.pdf

BlueDiver Dot 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 BlueDiver Dot are automated on the BlueDiver Instrument. The complete processing time lasts just 1 hour. The results can be interpretated by sight or a semi-quantification can be obtained thanks to the BlueScan scanner and the Dr DOT software (minimum version 3).