Multicentric Analysis of the Species Distribution and Antifungal Susceptibility of Clinical Isolates from Aspergillus Section Circumdati.

The clinical involvement and antifungal susceptibility of Aspergillus section Circumdati are poorly known. We analyzed 52 isolates, including 48 clinical isolates, belonging to 9 species inside the section Circumdati. The whole section exhibited, by the EUCAST reference method, a poor susceptibility to amphotericin B, but species/series-specific patterns were observed for azole drugs. This underlines the interest in getting an accurate identification inside the section Circumdati to guide the choice of antifungal treatment in clinical practice.

[Biobanks, translational research and medical informatics]. / Biobanken, translationale Forschung und Medizininformatik.

When we think of medical research, one intuitively associates it with the analysis of study data collected for a specific research question or with the secondary use of patient data from routine care. However, these are not the only sources for answering scientific questions. Especially for translational research, tissue and liquid samples such as blood, DNA or other body fluids provide essential insights into disease pathogenesis, development of new therapies and treatment decisions. Access to these biomedical materials is provided by so-called biobanks. By collecting, characterizing, documenting and, if necessary, processing human biospecimens in accordance with high quality standards, they can support research of the causes of diseases, early diagnosis and the targeted treatment of diseases, or make a significant contribution to the investigation of common diseases.

[Requirements for a cross-location biobank IT infrastructure : Survey of stakeholder input on the establishment of a biobank network of the German Biobank Alliance (GBA)]. / Anforderungen an eine standortübergreifende Biobanken-IT-Infrastruktur : Erhebung des Stakeholderinputs zum Aufbau eines Biobankennetzwerks der German Biobank Alliance (GBA).

BACKGROUND: The large number of biobanks within Germany results in a high degree of heterogeneity with regard to the IT components used at the respective locations. Within the German Biobank Alliance (GBA), 13 biobanks implement harmonized processes for the provision of biomaterial and accompanying data. OBJECTIVES: The networking of the individual biobanks and the associated harmonisation of the IT infrastructure should facilitate access to biomaterial and related clinical data. METHODS: For this purpose, the relevant target groups were first identified in order to determine their requirements for IT solutions to be developed in a workshop. RESULTS: Of the seven identified interest groups, three were initially invited to a first round of discussions. The stakeholder input expressed resulted in a catalogue of requirements with regard to IT support for (i) a sample and data request, (ii) the handling of patient consent and inclusion, and (iii) the subsequent evaluation of the sample and data request. CONCLUSIONS: The next step is to design the IT solutions as prototypes based on these requirements. In parallel, further user groups are being surveyed in order to be able to further concretise the specifications for development.

Performance of hepatitis B surface antigen tests with the first WHO international hepatitis B virus genotype reference panel.

BACKGROUND: Standardization of hepatitis B surface antigen (HBsAg) tests is indispensable for consistent quality and comparability. Ideally, the assays should detect all known hepatitis B virus (HBV) genotypes equally well. OBJECTIVE: Development of an HBV genotype reference panel for HBsAg assays representing the most prevalent HBV subgenotypes to address commutability and traceability of the heat-inactivated 2nd WHO International Standard (IS) for HBsAg in relation to native HBsAg and to HBV genotypes. STUDY DESIGN: An HBV panel of 15 non-inactivated lyophilized specimens representing the subgenotypes A1, A2, B1, B2, C2, D1-D3, E, F2, and H was evaluated in parallel to the IS by 15 laboratories using 19 different HBsAg tests and tree unitages. The virus content of the samples was reduced by ultracentrifugation and dilution to <2×10(4) IU HBV DNA/mL. RESULTS: Twenty-two qualitative and 6 quantitative data sets were evaluated. Overall, the results demonstrated consistent detection of HBV genotypes by the majority of tests with a mean potency variability relative to the IS of 36%. Some assays showed significant genotype-dependent differences in analytical sensitivity. Some tests were more sensitive with the IS, others less. On average, one IU HBsAg corresponded to 0.88±0.20 ng HBsAg protein. CONCLUSIONS: The panel was accepted by the WHO as the "1st International Reference Panel for HBV genotypes for HBsAg-based assays". The panel is a helpful complementation to the IS to validate HBV genotype specific analytical test sensitivities.

Deficiencies in the standardization and sensitivity of diagnostic tests for hepatitis B virus.

The patterns of hepatitis B virus (HBV) markers described in textbooks apply to acute and chronic infection with wild-type HBV. Deviations from these patterns occur in the very early phase, in low-level (or occult) infection and under immunosuppression. Variability may originate from the virus, the host or the test kits. In order to obtain a reliable diagnosis under these conditions, tests for all three markers of HBV infection have to be applied: HBsAg, HBV DNA and anti-HBc. All tests should be as sensitive as feasible, but even then occult infection may be missed. Reliable detection of occult or mutated HBV is particularly important in blood and organ donors and in patients before or with immunosuppression.

Hepatitis C virus transmission by a blood donation negative in nucleic acid amplification tests for viral RNA.

Hepatitis C virus (HCV) was transmitted by transfusion of a platelet concentrate made from an anti-HCV and HCV-PCR-negative blood donation. Even a negative nucleic acid amplification test cannot completely prevent transmission of HCV.

HIV risk behaviour in Irish intravenous drug users.

The aim of the study was to measure HIV prevalence and risk behaviour in 185 Irish Intravenous Drug Misusers. Information was obtained by application of a standardised WHO questionnaire covering HIV risk behaviour in the preceding 6 months. HIV serostatus was obtained by saliva/blood sample testing. One hundred and 3 (55.7 per cent) shared and 114 (61.6 per cent) lent used injecting equipment in the previous 6 months. 97 (94.2 per cent) of those who shared always cleaned the needles before use but only 48 (49.5 per cent) of these always cleaned in an efficient manner. One hundred and 14 (79.2 per cent) males and 28 (68.3 per cent) females reported heterosexual activity in the preceding 6 months. On examination sexual risk behaviour was found to be high. 50.5 per cent of males and 63 per cent of females never used condoms with regular partners. 32.6 per cent of males never used condoms with casual partners. The large majority of partners of male I.D.U'.s (both regular and casual) were non injectors. Therefore there is potential for sexual spread of HIV into the non-injecting heterosexual population. Conversely the vast majority of partners of female IDU's were injectors. This suggests that female IDU's are at higher risk of HIV infection than their male counterparts. HIV prevalence in the study group was 8.4 per cent. Implications of results for future intervention are discussed.

[Radiochemical purity studies on 10 radiopharmaceuticals]. / Radiochemische Reinheitsuntersuchungen an zehn Radiopharmaka.

Ten radiopharmaceuticals in frequent clinical use were examined for their radiochemical purity. Thin-layer chromatography, paper chromatography and electrophoresis were used. The activity of the separated components was measured in a gamma sample changer. The assumed chemical identity of the radiochemical impurities was evaluated by comparing the results with data described in the literature. For all radiopharmaceuticals tested, the radiochemical purity was found to be not lower than the value claimed by the manufacturer and to be in accordance with the requirements of the European Pharmacopoeia as far as those pharmaceuticals are listed therein.