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
disease or bronchiectasis. An immunoglobulin washout period of four to six months is necessary to enable an accurate assessment. Prophylactic antibiotics may be considered to cover the period of IVIg cessation. Patients may qualify for further IVIg therapy: under other immunodeficiency criteria (e.g. common variable immunodeficiency [CVID]) depending on the results of subsequent immune evaluation; or rarely under specific antibody deficiency following re-emergence of severe significant infection requiring hospitalisation. In principle, IVIg should only be continued or renewed if there is a demonstrated clinical benefit. Note that re-vaccination with pneumococcal polysaccharide vaccine is not recommended because of safety concerns, and the potential persistent purulent suppurative otitis media threatening long-term hearing) AND A trial cessation of therapy will be undertaken next September or October to undertake an immunological re-evaluation, unless a period of cessation of intravenous immunoglobulin (IVIg) for the purpose of immunological evaluation is medically contraindicated on safety grounds (such as a patient with neutropenia, on immunosuppressant medication or with clinically active bronchiectasis and/or suppurative lung disease*). *Please note: a diagnosis of bronchiectasis and/or suppurative lung disease must be consistent with the position statement of the Thoracic Society of Australia and New Zealand and the Australian Lung Foundation (Chang et al 2010). Life-threatening infection or a series of significant infections following trial-off Ig therapy