This company has received FDA 510(k) clearance of a new kit format for both its anti-Cardiolipin (aCL) and anti-Phosphatidylserine (aPS) ELISA assays. Testing for all three isotypes (IgG, IgM and IgA) is available with the choice of either performing the assay with a single-point calibrator or utilizing a multi-point four-calibrator linear regression analysis. This multi-point format offers three individual human-source samples as calibrators with the sample diluent used as a zero point (fourth calibrator). Since both the aCL and aPS assays test for heterogeneous antibodies, the use of individual human-source samples as calibrators provides good representation of true reactivity and recovery.
Keywords: antiphospholipid, autoimmune, control