Human plasma proteins are important for therapy or prophylaxis of human diseases. Due to the preparation of human plasma proteins from human plasma pools and risk of contamination with human viruses, different viral reduction treatments such as: pasteurization, solvent/detergent, dry heat treatment, steam treatment, beta-propiolactone/UV and nanofiltration have been implemented. As pasteurization can be performed for liquid protein, this method (a 10-hour heat treatment of the aqueous solutions at 60°C) was introduced into the manufacturing procedure of IGM-enriched immunoglobulin, to improve its safety further. The efficiency of this method for inactivation of viruses was evaluated by the use of Foot-and-Mouth Disease Virus (a non-enveloped virus) and Infectious Bovine Rhinotracheitis (IBR) Virus (a lipid-enveloped virus). Pasteurization inactivated Foot-and-Mouth Disease Virus by 7 log10 and for IBR Virus by 5log10. These findings show a significant added measure of virus safety associated with pasteurization of IGM-enriched immunoglobulin preparation.

Background and objective: Brucellosis is an important public health problem that occurs worldwide. Its clinical manifestations can be quite varied and definitive signs to indicate the diagnosis can be lacking and the clinical diagnosis must usually supported by the results of bacteriologic and / or serologic tests. According to recent reports in Iran our city "Hamedan" is a one of the cities with high incidence of brucellosis (incidence=107.5/100000 per year).Materials & methods: In this diagnostic study, patients with clinical diagnosis of brucellosis that had referred to Sina hospital were evaluated. A combination of infection diseases specialist clinical diagnosis and positive Wright test (Wright test ≥ 1/80) or positive 2ME test (2me ≥1/40) defined as a gold standard for diagnosis of brucellosis. Control's group was medical students and some of their families that have negative Wright and 2me tests and clinical diagnosis of brucellosis.Results: Over a one-year period, we had 200 patients (120 male and 80 female) with clinical features suggestive of brucellosis and 200 medical students and some of their families as a control group. The average age in patients was 38.74 years (min=6, max=76, SD=17.3) and in control group was 33.38 years (min=6, max=70, SD=14.5). All the 200 controls had a negative Wright and 2ME test results. The sensitivity and specificity of the ELISA were 92% and 100% respectively. The positive and negative predictive values were 100% and 92.5% respectively.Conclusion: The ELISA is a rapid, reliable, easy to perform and sensitive test in the diagnosis of brucellosis. It saves laboratory cost and time.  

Background/objectives: HIGM syndrome is a rare kind of primary Immunodeficiency disease (PID) characterized by normal to the increased serum IGM and very low or undetectable IgG, IgA, and IgE. Broad spectrum of clinical manifestations and laboratory findings are observed in the HIGM patients including hematologic problem and malignancy. This study was conducted to assess demographic data, clinical manifestation, and immunological findings in the HIGM patients. Methods: Lab findings and clinical presentations data of 79 Iranian patients diagnosed with HIGM syndrome were collected. All the patients were classified into two different groups including the patients with hematological problems and those without hematological problems. Results: Hematologic problems were observed in 34 patients (43%, 23 males and 11 females). The most common hematologic problems types were anemia and leukemia (33 and 25%, respectively). Also, 19 patients (24. 1%) had a family history of PID. Significant data that were higher in the patients with hematologic problems, were the oral ulcer (p=0. 037), failure to thrive (p=0. 022), recurrent diarrhoea (p=0. 021), chronic diarrhoea (p=0. 022), urinary tract infections (p=0. 037), anemia (p=0. 000), neutropenia (p=0. 000), thrombocytopenia (p=0. 001), gastrointestinal problem (p=0. 011), neurologic problem (p=0. 000), multiple site problem (p=0. 000), platelet count (p=0. 005), and IgG level (p=0. 048). Conclusions: The association between HIGM syndrome and hematologic problems could lead to severe clinical disorders. Therefore, it is necessary for immunologists to be aware of these situations.

Background: Brucellosis is an important common disease with many complications. Early diagnosis of the disease is very important. The present study was designed to compare the diagnostic value of ELISA test (IGM, IgG) with serologic agglutination tests (Wright and Coombs Wright) in brucellosis patients in Kashan during 2004. Materials and Methods: This case control study was conducted on 31 brucellosis patients. Using 5 cc venous blood, the ELISA, Wright and Coombs Wright tests were performed before and 3 months after the treatment. The results were analyzed concerning the determination of specificity and sensitivity of the tests. Results: The sensitivity of ELISA for IGM and IgG was 100%. Specificity of the test was 63.3% and 72.7%; respectively. Also, while the positive predictive value of both tests was 100% the negative predictive values were 83.6% and 86.9%; respectively. Conclusion: Regarding the sensitivity and specificity the ELISA test could be considered as a reliable and appropriate test in diagnosis of brucellosis.

Viral safety of human plasma products plays a key role in their safe uses. Solvent- detergent (SD) virus-inactivation method has gained widespread popularity in the manufacture of biological products. This treatment which inactivates lipid-enveloped viruses effectively consists of incubation of a plasma protein solution in the presence of a non-volatile organic solvent and a detergent. In this study, IGM-enriched immunoglobulin was incubated at 24 °C for 6 h under slow stirring in the presence of tri(nbutyl) phosphate (0.3% w/w ) as solvent and tween 80 (1% w/w) as detergent. After completion of the inactivation process and removal of the solvent-detergent, the ability of SD-treatment to remove Infectious Bovine Rhinotracheitis (IBR) virus (a lipid-enveloped virus) and Foot-and-Mouth Disease virus (a non-enveloped virus) were evaluated by virus spiking studies using a scaled down process. Reduction factor of 4 log was obtained for the SD-treatment of IGM-enriched immunoglobulin spiked with IBR virus. No virus inactivation was observed in the SD-treated IGM-enriched immunoglobulin, spiked with Foot-and-Mouth Disease virus. It was concluded that treatment of IGM-enriched immunoglobulin with TNBP-TWEEN 80 may be considered as an efficient lipid-enveloped virus inactivation step in the manufacture of this product.

Background/objectives: hyper-IGM (HIGM) syndrome is characterized by normal to increased serum IGM, as well as very low or undetectable IgG, IgA, and IgE. HIGM (also known as class-switch recombination (CSR) defects) patients indicate different clinical manifestations such as autoimmune disorders. The present study aimed to evaluate demographic data, clinical manifestation, and immunological findings in HIGM patients. Methods: Clinical features and immunological data were collected from medical records belonged to the 79 Iranian HIGM patients diagnosed in Children’ s Medical Center in Iran. To compare clinical records and laboratory data, all HIGM patients were classified into two different groups as follows: patients with autoimmune disease and patients without autoimmune diseases. Results: A total of 79 patients (60 male and 19 female) with median (IQR) age of 12 years old at the time of the study were enrolled (6-22. 45). Autoimmunity diseases were seen in 19 patients (23. 75%, 3 females and 16 males). Among the noninfectious manifestations, the hepatomegaly and spelenomegaly were significantly higher in the patients with autoimmunity (p= 0. 006), compared to the patients without autoimmunity (p=0. 006). The most common autoimmune presentations among HIGM patients were ITP (32%), juvenile rheumatoid arthritis (16%), autoimmune hemolytic anemia (11%), Sclerosing cholangitis (11%), Gullain-Barré syndrome, Evans syndrome, diabetes mellitus, and chrohn’ s disease. Conclusions: The relationship between HIGM syndrome and autoimmunity disorders could lead to sever clinical complications. Therefore, we suggested that immunologists should be aware of this complications.

Laboratory diagnosis of acute measles is usually achieved by serology assays for measle-specific IGM antibody. For comparison of measle-specific IGM antibody in saliva and serum, 95 paired blood and saliva samples were collected 1-14 days after the onset of rash. The specimens were tested for specific IGM antibody by an IGM antibody-capture Enzyme Immunoassay (EIA). Measles IGM antibody was detected in 89 (93.7%) of serum samples and in 85(89.5%) of saliva specimens. Of the 6(6.3%) serum samples that were IGM antibody-negative, 2 (2.1%) of the paired saliva samples were IGM antibody-positive. The sensitivity and specificity of saliva testing compared with serum was 95.5% and 66.7% respectively. Positive predictive value (PPV) and negative predictive value (NPV) of saliva testing were 97.7% and 50.0% respectively and the accuracy of saliva testing was 93.7%. Our results indicate that saliva samples provided Enzyme Immunoassay results that were in good agreement with results from serum samples. Salivary IGM antibody detection is a suitable non-invasive method for diagnosing recent measles infections and epidemiological studies, especially in children.

X-linked immunodeficiency with hyper-IGM (XHIGM or HIGM1) is a rare form of primary immunodeficiency disease caused by mutations in the gene that codes for CD40 ligand (CD40L, also known as gp39, TNFSF5 and CD154). CD40L is expressed on activated CD4+T cells and interacts with CD40 on the surface of B cells. This interaction induces B cells to undergo immunoglobulin (Ig) class-switching from IGM to IgG, IgA, and IgE. Patients with XHIGM exhibit profoundly depressed B-cell activation, fail to form germinal centers, have markedly reduced levels of IgG, IgA, and IgE but have normal or elevated levels of IGM. Because CD40L is required in the functional maturation of T lymphocytes and macrophages, patients with XHIGM also have a variable defect in T-lymphocyte and macrophage effector function. The range of clinical findings of XHIGM varies, even within the same family. Patients with XHIGM have increased susceptibility to infection with a wide variety of bacteria, viruses, fungi, and parasites. XHIGM usually presents in infancy with recurrent upper and lower respiratory tract bacterial infections, opportunistic infections, and recurrent or protracted diarrhea caused by Cryptosporidium parvum which is associated with failure to thrive. Neutropenia, thrombocytopenia, and anemia are common. Malignancies, Significant neurologic complications, oral ulcers, autoimmune and/or inflammatory disorders, such as sclerosing cholangitis, liver diseases including hepatitis, primary cirrhosis and carcinomas and tumors of the gastrointestinal tract have been reported.