Special Communication
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 accordance with the manufacturer’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 patients’ 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
Cardiolipin IgM Antibodies (CARDIM)
Negative:
< 12.5 MPL
Indeterminate:
12.5 – 20 MPL
Positive:
> 20 MPL (98.2th percentile)
Cardiolipin IgA Antibodies (CARDIA)
Negative:
< 12.0 APL
Indeterminate:
12 – 20 APL
Positive:
> 20 APL (100th percentile)
Cardiolipin IgG Antibodies (CARDIG)
Negative:
< 15.0 GPL
Indeterminate:
15 – 20 GPL
Positive:
> 20 GPL (98.6th percentile)
Panels Affected
Cardiolipin Antibodies (CARDIO)
Cardiolipin Antibodies (CARDIO) is comprised of the three tests listed above.
Hypercoagulation Diagnostic Interpretive Panel (HYPER)
This panel will be impacted by the changes to the above three tests.
Lupus Anticoagulant Diagnostic Interpretive Panel (LUPUSP)
This panel will be impacted by the changes to the above three tests.