Approximately 85-90% of patients with myasthenia gravis (MG) express antibodies to the acetylcholine receptor (AChR), which can be divided into binding, blocking, and modulating antibodies. Binding antibody can activate complement and lead to loss of AChR. Blocking antibody may impair binding of acetylcholine to the receptor, leading to poor muscle contraction. Modulating antibody causes receptor endocytosis resulting in loss of AChR expression, which correlates most closely with clinical severity of disease. Approximately 10-15% of individuals with confirmed myasthenia gravis have no measurable binding, blocking, or modulating antibodies.
Statement B: Compliance Statement B
: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.