specialist, but Clinical immunologist must make the diagnosis. (A) Diagnosis must be Yes Which Clinical immunologist if a For existing IgG Subclass patients, verified Specialty clinical immunologist did confirmation of the diagnosis is required not make the diagnosis by a second immunologist. (A) Exclusion Criteria Unchanged Isolated IgG subclass deficiency in the Isolated IgG subclass deficiency in the absence of absence of evidence of specific evidence of specific antibody deficiency. antibody deficiency. Low trial total IgG. This should be considered under primary or secondary immunodeficiency. Low total IgG. This should be considered under primary or secondary immunodeficiency. Indications Prevention of infections in individuals with History of abnormally frequent and/or persistent indications are recommended. The bacterial infections associated with a second indication is required for re-entry frequent infections who have demonstrated of confirmed SAD patients that have a demonstrated failure to mount a IgG ‘normal’ failure to mount protective IgG antibody antibody response to pneumococcal life threatening infection while on responses to vaccine antigen challenge polysaccharides or protein antigens, such as off therapy. A re-entry path is needed as despite normal total serum IgG levels. tetanus toxoid, after vaccine challenge in a revaccination is contraindicated. patient with a normal serum total IgG The third indication is to cover existing concentration. IgG subclass patients to enable reassessment and requalification. (A) Life-threatening infection or a series of serious Some states have reasonable numbers of infections following trial-off Ig therapy in IgG subclass patients that have not been patients with proven specific antibody deficiency. re-evaluated under earlier changes to the Criteria - this will be required during transfer to the Ig system unless there is Patients currently receiving immunoglobulin presence of active suppurative lung therapy for a diagnosis of IgG subclass deficiency disease (which is now required to comply are eligible for continued therapy, but a with the position statement of the diagnosis of specific antibody deficiency should
specialist, but Clinical immunologist must make the diagnosis. (A) Diagnosis must be verified Yes Which Specialty Clinical immunologist if a clinical immunologist did not make the diagnosis For existing IgG Subclass patients, confirmation of the diagnosis is required by a second immunologist. (A) Exclusion Criteria Isolated IgG subclass deficiency in the absence of evidence of specific antibody deficiency. Low total IgG. This should be considered under primary or secondary immunodeficiency. Isolated IgG subclass deficiency in the absence of evidence of specific antibody deficiency. Low total IgG. This should be considered under primary or secondary immunodeficiency. Unchanged Indications Prevention of infections in individuals with frequent infections who have demonstrated failure to mount protective IgG antibody responses to vaccine antigen challenge despite normal total serum IgG levels. History of abnormally frequent and/or persistent bacterial infections associated with a demonstrated failure to mount a ‘normal’ IgG antibody response to pneumococcal polysaccharides or protein antigens, such as tetanus toxoid, after vaccine challenge in a patient with a normal serum total IgG concentration. Life-threatening infection or a series of serious infections following trial-off Ig therapy in patients with proven specific antibody deficiency. Patients currently receiving immunoglobulin therapy for a diagnosis of IgG subclass deficiency are eligible for continued therapy, but a diagnosis of specific antibody deficiency should indications are recommended. The second indication is required for re-entry of confirmed SAD patients that have a life threatening infection while on off therapy. A re-entry path is needed as revaccination is contraindicated. The third indication is to cover existing IgG subclass patients to enable reassessment and requalification. (A) Some states have reasonable numbers of IgG subclass patients that have not been re-evaluated under earlier changes to the Criteria - this will be required during transfer to the Ig system unless there is presence of active suppurative lung disease (which is now required to comply with the position statement of the trial
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