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LAPL-GM-300
A NEW SET OF CALIBRATORS FOR ANTICARDIOLIPIN ANTIBODIES
Effective January 31st 2013, a new set of IgG and IgM calibrators LAPL-GM-300 for anticardiolipin antibodies has been released.
It replaces the former set of calibrators LAPL-GM-200 which are no longer available.
This new set of calibrators LAPL-GM-300 has been extensively evaluated and correlated against the LAPL-GM-200 and the original “Harris” calibrators, including linearity, recovery, commutability, and stability studies.
APL ELISA™ IgG AP Kit and APL ELISA™ IgM AP Kit
Intended Use
The APL ELISA™ IgG AP Kit and APL ELISA™ IgM AP Kit are semi quantitative enzyme linked immunosorbent assays (ELISA) for use as an aid in diagnosing the Antiphospholipid Syndrome (APS) in patients presenting with thrombosis, pregnancy losses and/or thrombocytopenia. It enables measurement of IgG or IgM anticardiolipin antibody levels in human serum or plasma.
Explanation of the Test
Introduction
The anticardiolipin test was devised to help in the diagnosis of patients with the Antiphospholipid Syndrome. The Antiphospholipid Syndrome is a disorder of recurrent venous thrombosis, pregnancy losses, and thrombocytopenia associated with positive anticardiolipin and/or lupus anticoagulant tests. Both the anticardiolipin and lupus anticoagulant tests detect antibodies which bind phospholipids. These antibodies are heterogeneous, and the two tests do not necessarily identify the same antibodies. Hence, both tests should be performed in individuals suspected of having the Antiphospholipid Syndrome.
The APL ELISA™ IgG Kit and APL ELISA™ IgM Kit are calibrated using standard anticardiolipin units (GPL or MPL units respectively) and can be used to detect IgG or IgM isotypes. In addition to the APL ELISA™ IgG or IgM Calibrator, an APL ELISA™ IgG or IgM Positive Control (each with a defined range of positivity) and an APL ELISA™ Negative Control are included as in-house controls so that operators can determine whether a particular run is acceptable.
Principle
A standard indirect enzyme linked immunoassay (ELISA) technique has been employed in this assay. Calibrators, controls and sera are incubated in polystyrene microwell strips coated with the APL ELISA™ Cardiolipin Antigen. This process allows IgG or IgM anticardiolipin antibodies in patient sera or plasma to react with the APL ELISA™ Cardiolipin Antigen. Washing removes any unbound protein. Antibodies specific for anti-human IgG or IgM labeled with alkaline phosphatase conjugate are added. After an additional washing, a measurable color reaction ensues with the addition of an alkaline phosphatase substrate, which undergoes a color change in the presence or absence of cardiolipin antibody and is determined by comparing the sample optical density with that of a five point calibration curve. Results are reported in GPL or MPL units.
Features
- Number of determinations 40, if samples were run in duplicates
- Most reagents in ready-to-use form
- Total run time = 1.5 to 2 hours
- 5 point calibration curve
- Includes Positive and Negative Controls