Evaluation of commercial herpes simplex virus IgG and IgM enzyme immunoassays.

Serological methods are used widely for the determination of herpes simplex virus (HSV) IgG and IgM antibodies in virological laboratories. The present study evaluates the automated performance of the Virion\Serion (Würzburg, Germany) and Orgentec (Mainz, Germany) enzyme-linked immunosorbent assays (ELISA) for the determination of HSV type-common and type-specific IgG and IgM antibodies. Two hundred sixty-three sera from HSV-negative children, healthy blood donors as well as patients without and with acute HSV infections were included. The Serion ELISAs classic HSV 1+2, HSV 1 and HSV 2 IgG showed sensitivities between 89.1% and 98.0% and specificities from 82.8% to 100%. Sensitivities of the Orgentec ELISAs Anti-HSV-1 and Anti-HSV-2 IgG were calculated as 91.0-96.0% and 88.5-95.4% accompanied by specificities between 93.1% and 100%. The HSV type-common Serion IgM ELISA revealed also a high sensitivity and specificity. However, the single-type HSV-1 and HSV-2 IgM ELISAs from both companies did not detect reliably HSV-1- and HSV-2-specific IgM antibodies. In conclusion, the automated performance of Serion ELISAs classic HSV 1+2, HSV 1 and HSV 2 IgG as well Orgentec ELISAs Anti-HSV-1 and Anti-HSV-2 IgG provide highly dependable results for identifying HSV-1 and HSV-2 IgG-positive or -negative individuals. While HSV type-common IgM ELISAs can be useful to confirm acute newly acquired HSV infections, the use of single-type IgM ELISAs on the basis of whole-virus antigen is dispensable.

Evaluation of three commercial varicella-zoster virus IgG enzyme-linked immunosorbent assays in comparison to the fluorescent-antibody-to-membrane-antigen test.

Commercial serologic assays for varicella-zoster virus (VZV), which enable reliable determination of VZV immune status and are amenable to automation, are needed. The present study compares the automated performance of the VZV whole-cell enzyme-linked immunosorbent assay (ELISA) Enzygnost anti-VZV/IgG, the Euroimmun anti-VZV ELISA (IgG) based on highly purified viral proteins, and the VZV glycoprotein (gp)-based Serion ELISA Classic VZV IgG. The fluorescent-antibody-to-membrane-antibody (FAMA) test was used as a reference. A total of 638 serum samples from VZV-negative children, blood donors, varicella vaccinees, and bone marrow transplant recipients were included. The Enzygnost anti-VZV/IgG and the Serion ELISA Classic VZV IgG showed sensitivities of 99.6% and 99.2%, respectively, and the Euroimmun anti-VZV ELISA (IgG) had a significantly lower sensitivity of 90.5%. Specificity was calculated as 100% for both the Euroimmun anti-VZV ELISA (IgG) and for the Enzygnost anti-VZV/IgG, and the Serion ELISA Classic VZV IgG had a significantly lower specificity of 89.4%. Quantitative results of all ELISAs correlated well, but there was a poor quantitative correlation between the ELISAs and FAMA. In conclusion, this study does not show any superiority of a gp- and a protein-based ELISA compared to a whole-cell ELISA for the automated detection of VZV-specific IgG. The automated performance of the Enzygnost anti-VZV/IgG assay correlated best with the FAMA reference assay.

Serological response to influenza A H1N1 vaccine (Pandemrix®) and seasonal influenza vaccine 2009/2010 in renal transplant recipients and in hemodialysis patients.

In the present study, antibody response to seasonal influenza vaccination and to the adjuvanted one-shot influenza A H1N1 vaccine (Pandemrix(®)) was investigated in 57 hemodialysis (HD) patients and 48 renal transplant (RT) recipients. Specific antibodies were measured by hemagglutination inhibition (HI) test using a pandemic H1N1 strain and a seasonal H3N2 virus. HI titers of ≥1:40 were considered as protective. Hemodialysis patients showed seroprotection against pandemic H1N1 in 35.1%, against seasonal influenza in 36.8% and against both in 14.0%. In comparison, renal transplant recipients developed protective antibody titers against the pandemic H1N1 virus in 47.9%, against the seasonal H3N2 strain in 31.3% and against both in 18.8%. HD patients and renal transplant recipients younger than 60 years developed protective antibody response to the pandemic influenza H1N1 vaccine in 50.0% of the HD patients and 55.2% of the RT recipients and against seasonal influenza in 45.0/20.7% (HD/RT) of the cases. Patients aged ≥60 years showed seroprotection against pandemic influenza in 27.0/36.8% (HD/RT) and against seasonal influenza in 32.4/47.4% (HD/RT). Side effects were reported in only four patients. In hemodialysis patients and renal transplant recipients, vaccination against pandemic H1N1 and seasonal influenza is well tolerated. However, more than a half of these patients did not develop seroprotective antibody levels. Thus, new vaccines and altered vaccination regimes are likely necessary to achieve relevant antibody levels in these patient groups.