SPECIFICATION

Code	Description
ANA-17-A	Mi-2、Ku、nRNP/Sm、Sm、 SSA/60kd、SSA/52kd、SSB、Scl-70、PM/Scl、Jo-1、CENP B、PCNA、dsDNA、nucleosome、 histone、P0、AMA M2
ANA-15M-A	Mi-2、nRNP/Sm、Sm、 SSA/60kd、SSA/52kd、SSB、Scl-70、Jo-1、CENP B、PCNA、dsDNA、nucleosome、histone、P0、AMA M2
ANA-15K-A	nRNP/Sm、Sm、 SSA/60kd、SSA/52kd、SSB、Scl-70、PM/Scl、Jo-1、CENP B、PCNA、dsDNA、nucleosome、histone、P0、AMA M2
ANA-13-A	nRNP/Sm、Sm、SSA/60kd、SSA/52kd、SSB、Scl-70、Jo-1、CENP B、dsDNA、nucleosome、histone、P0、AMA M2
ANA-12-A	nRNP/Sm、Sm、 SSA/60kd、SSA/52kd、SSB、Scl-70、Jo-1、CENP B、dsDNA、nucleosome、histone、P0
ANA-9N-A	nRNP/Sm、Sm、SSA/60kd、SSA/52kd、SSB、Scl-70、Jo-1、nucleosome、P0
ANA-9D-A	nRNP/Sm、Sm、SSA/60kd、SSA/52kd、SSB、Scl-70、Jo-1、CENP B、dsDNA
ANA-8N-A	nRNP/Sm、Sm、SSA、SSB、Scl-70、Jo-1、nucleosome、P0
ANA-8D-A	nRNP/Sm、Sm、SSA、SSB、Scl-70、Jo-1、CENP B、dsDNA
ANA-7-A	nRNP/Sm、Sm、SSA/60kd、SSA/52kd、SSB、Scl-70、Jo-1
ANA-5-A	Mi-2、Ku、nRNP/Sm、PM/Scl、Jo-1

INTENDED USE

SDR LIA ANA is for the qualitative measurement of 17 kinds of IgG class antinuclear antibodies against Mi-2、Ku、nRNP/Sm、Sm、SSA/60kd、SSA/52kd、SSB、 Scl-70、PM/Scl、Jo-1、CENP B、PCNA、dsDNA、nucleosome、histone、P0 and AMA M2 in human serum. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of autoimmune disease.

Antinuclear antibodies (ANA) are autoantibodies of different specificity directed against antigens of the cell nucleus. In general ANA can be divided into antibodies aiming at extractable nuclear antigens(ENA), nonextractable nuclear antigens and cytoplasmatically located antigens.

The detection of ANA and ENA antibodies is important for diagnosis of collagenosis especially of systemic lupus erythematosus (SLE) and the “mixed connective tissue disease (MCTD)” that is strongly associated with SLE, and other rheumatic diseases also.

In principle every rheumatic disease is related to a characteristic ANA antibody pattern. The ANA Profile Line Immunoassay has been developed to detect such antibody profiles.

PRINCIPLE

The test is based on the principle of the line immune assay (LIA).

Nuclear and associated cytosolic antigens are applied as lines on a nitrocellulose membrane. The nitrocellulose membrane is blocked to prevent unspecific reactions. During incubation of a strip with diluted patient samples, autoantibodies present in the sample will bind to the antigens on the strip. For the detection of the bound antibodies, an alkaline phosphatase labeled anti-human IgG antibody is used. After addition of the substrate solution, the appearance of purple blue lines indicates the existence of (auto) antibodies against the respective antigens

斯德润诊断

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies