Stability assessment of anti-bacterial antibodies in immunoglobulin G-depleted serum with validated immunoassays.

Aim: To investigate the stability of the anti-pneumococcal (PCP) and anti-haemophilus type B (Hib) immunoglobulins (IgGs) in human IgG-depleted serum samples frozen at -20°C. Materials & methods: Modified commercially available immunoassays (ELISAs) were bioanalytically validated. These ELISAs were used to measure levels of the two anti-bacterial IgG in samples kept at -20°C for up to 15 months. Human IgG-depleted serum was spiked with GAMMAGARD Liquid to obtain those samples. Results: Both ELISAs passed the validation test. Anti-PCP IgG and anti-Hib IgG were shown to be stable for at least 15 months at -20°C. Conclusion: These data confirm the stability of anti-bacterial IgG in human IgG-depleted serum and support the common practice of testing frozen samples.

Immunodeficiency disorders can prevent your body from fighting infections. These disorders make it easier to catch viruses and bacterial infections caused by so-called pathogens. Patients suffering from immunodeficiencies are treated throughout their lives with antibodies purified from human plasma. This immunoglobulin replacement therapy, which helps to avoid infections, provides specific antibodies directed against these pathogens. An antibody is a protein produced by the body's immune system to detect (bind) antigens and to help eliminating harmful substances. Little is known about the stability of such specific antibodies in samples taken from patients during clinical studies carried out to improve the replacement therapy. We investigated the stability of two such antibodies using a standard technique for their measurement. In a process termed validation, these methods were demonstrated to deliver accurate and precise results. For the stability study, we prepared human serum (= the liquid part of human blood) samples with specific antibodies levels expected in samples from patients on replacement therapy. These samples were kept frozen at -20°C for up to 15 months. The data obtained on analysis of the frozen samples showed the adequate stability of both antibodies directed against important pathogen. This stability confirms a common testing practice applied for samples obtained in clinical studies where usually such samples are not tested immediately but are stored frozen and tested in batches. In particular, the data for the two anti-bacterial antibodies support the storage of such samples for at least 15 months at -20°C before testing.

Successful discontinuation of immunoglobulin G replacement at age 10 in a patient with immunoglobulin G2 deficiency.

CONTEXT: Immunoglobulin G2 deficiency that persists beyond the age of 6 years is likely to be permanent. CASE REPORT: We report on a young Japanese female, diagnosed as having immunoglobulin G2 deficiency and low anti-pneumococcal immunoglobulin G2 antibody levels when 3 years old, with a subsequent medical history of frequent respiratory infections and asthma. Monthly intravenous immunoglobulin replacement therapy was started at 4 years of age. After 8 years of age, an anti-pneumococcal immunoglobulin G2 trough level could be maintained with administration intervals longer than 6 weeks, and after 9 years and 10 months of age, therapy was discontinued. The frequency of hospital admissions was reduced by the introduction of the replacement therapy (from 8.4 times/year before the introduction to 1.1 times/year during the therapy). The patient was also able to discontinue daily medications for asthma, and serum immunoglobulin G2 was maintained at a normal level even after the cessation of replacement therapy. CONCLUSION: Termination of immunoglobulin replacement therapy in a patient with a symptomatic immunoglobulin G2 deficiency is possible, even for a child older than 6 years.