Abstract
Availability of a sensitive and a reliable test for anticardiolipin autoantibodies (aCL) is important in diagnosis and follow-up of the patients. This study presents the data on the assay protocol, analytical validation (detection limit, precision, linearity) and reference ranges for the ELISA aCL IgG and IgM assays developed at INEP. The determined characteristics of the assays, as well as the reference ranges, being 0-5.9 MPL U/mL for aCL IgM and 0-10.5 GPL U/mL for aCL IgG, are comparable to the assay from Axis-Shield Diagnostics Limited used as accepted procedure in the absence of the reference one. The tests described here can be included in to the standard laboratory panel for autoimmune conditions.
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