The B-cell Immunodeficiency Profile measures circulating B-cells (CD19), their surface immunoglobulins (Total Ig, IgG, IgD, IgM, and IgA) and a common HLA class II antigen. The percentage of lymphocytes expressing CD19, various immunoglobulin fractions and HLA-DR may be altered in certain immunologic abnormalities. For example, HLA-DR is absent on B-cells in the bare lymphocyte syndrome (MHC Class II Deficiency).
Compliance Statement A
: Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. 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. This test should not be regarded as investigational or for research use.