Anti-cardiolipin IgM, IgA, and IgG Reporting
Effective September 3, 2020, Cleveland Clinic Laboratories will report Anti-cardiolipin IgM, IgA, and IgG semi-quantitative enzyme immunoassays with updated reference ranges.
This change is in accordanceÂ with the manufacturerâ€™s instructions (Inova Diagnostics), as approved by the FDA.
Anti-cardiolipin antibody testing aids in diagnosing antiphospholipid syndrome or assessing the risk of thrombosis in individuals with systemic lupus erythematosus, among others. In addition to reference range changes, the manufacturer has recently replaced the serum calibrators and controls prepared from patientsâ€™ sera used in the anti-cardiolipin IgM kit with a monoclonal recombinant antibody suspended in negative human serum. This change will improve performance, stability, and lot-to-lot consistency.
Changes to Reference Ranges
< 12.5 MPL
12.5 â€“ 20 MPL
> 20 MPL (98.2thÂ percentile)
< 12.0 APL
12 â€“ 20 APL
> 20 APL (100th percentile)
< 15.0 GPL
15 â€“ 20 GPL
> 20 GPL (98.6th percentile)
Cardiolipin Antibodies (CARDIO) is a panel consisting of the above three tests.
Hypercoagulation Diagnostic Interpretive Panel (HYPER) will be impacted by the changes to the above three tests.
Lupus Anticoagulant Diagnostic Interpretive Panel (LUPUSP) will be impacted by the changes to the above three tests.
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