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AESKULISA®
Reference:
30-7115US
Designation:
ANA HEp-2
Intended use:

AESKULISA® ANA HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and specific antigens. The test collectively detects, in one well, total ANAs against double-stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.

Method:
ELISA
Conjugate:
IgG
Analysis:
Qualitative
Cut Off:
Cut-off control
Calibration:
CDC sera
Provisions:
1 x 96
Kit-Configuration:
Single
Registration:
FDA-cleared
Coated Antigens:
Lysed Hep2 cells
AESKULISA®

30-7115US

ANA HEp-2

Image may differ
Intended use:

AESKULISA® ANA HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and specific antigens. The test collectively detects, in one well, total ANAs against double-stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.

Method:
ELISA
Conjugate:
IgG
Analysis:
Qualitative
Cut Off:
Cut-off control
Calibration:
CDC sera
Provisions:
1 x 96
Kit-Configuration:
Single
Registration:
FDA-cleared
Coated Antigens:
Lysed Hep2 cells
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