Search

ZusammenfassungDie Erfassung von Daten zu SARS-CoV-2-Testungen in Deutschland sind für die Einschätzung des Infektionsgeschehens im Rahmen der COVID-19-Pandemie von zentraler Bedeutung. Am Robert Koch-Institut (RKI) werden dazu die Daten aus verschiedenen Systemen zur Erfassung von Labortestungen zusammengeführt. In diesem Beitrag werden zunächst bedeutsame Aspekte der Testverfahren erläutert. Nachfolgend werden die unterschiedlichen Systeme zur Erfassung von Labortestungen erläutert und Testzahlen aus der RKI-Testlaborabfrage und der laborbasierten Surveillance SARS-CoV‑2 sowie die Abrechnungsdaten der kassenärztlichen Vereinigungen zu SARS-CoV-2-Labortestungen dargestellt.Mit der RKI-Testlaborabfrage und der laborbasierten Surveillance SARS-CoV‑2 stand früh in der Pandemie eine Surveillance zur Verfügung, mit der unter den teilnehmenden Laboren Daten zu durchgeführten Testungen und Testkapazitäten ausgewertet werden können. Durch die Erfassung von positiven und negativen Testergebnissen sind Aussagen zur Gesamtzahl der durchgeführten Testungen sowie dem Anteil der positiven Testergebnisse möglich. Während die aggregierten Testzahlen bundesweit weitestgehend repräsentativ sind, ist die Repräsentativität auf Bundesland- und Landkreisebene aber nicht immer gegeben. Die Abrechnungsdaten der Kassenärztlichen Vereinigungen können die Labordaten im Nachhinein ergänzen. Sie erlauben eine retrospektive Einschätzung der Gesamtzahl von SARS-CoV-2-Tests in Deutschland, da die Leistungen der vertragsärztlichen Versorgung aller gesetzlich Krankenversicherten (ca. 85 % der Bevölkerung) enthalten sind.Die verschiedenen Systeme zur Erfassung von Labortestungen ergänzen sich gegenseitig. Die Auswertungen fließen in die Maßnahmenempfehlungen zur Pandemiebewältigung ein.

Serological methods to differentiate between recently acquired and established HIV-1 infections are a useful tool in the HIV-surveillance to characterize the epidemic, identify groups at risk and assess HIV-preventive interventions. Therefore, an avidity-based, modified BioRad Genscreen™ HIV-1/2 assay (BRAEUR) was evaluated according to the avidity-based, modified BioRad HIV-1/2 Plus O protocol (BRAUSA). Overall, 692 well defined samples (82.5% B and 17.5% non-B subtypes) from recent (

Die Erfassung von Daten zu SARS-CoV-2-Testungen in Deutschland sind für die Einschätzung des Infektionsgeschehens im Rahmen der COVID-19-Pandemie von zentraler Bedeutung. Am Robert Koch-Institut (RKI) werden dazu die Daten aus verschiedenen Systemen zur Erfassung von Labortestungen zusammengeführt. In diesem Beitrag werden zunächst bedeutsame Aspekte der Testverfahren erläutert. Nachfolgend werden die unterschiedlichen Systeme zur Erfassung von Labortestungen erläutert und Testzahlen aus der RKI-Testlaborabfrage und der laborbasierten Surveillance SARS-CoV‑2 sowie die Abrechnungsdaten der kassenärztlichen Vereinigungen zu SARS-CoV-2-Labortestungen dargestellt. Mit der RKI-Testlaborabfrage und der laborbasierten Surveillance SARS-CoV‑2 stand früh in der Pandemie eine Surveillance zur Verfügung, mit der unter den teilnehmenden Laboren Daten zu durchgeführten Testungen und Testkapazitäten ausgewertet werden können. Durch die Erfassung von positiven und negativen Testergebnissen sind Aussagen zur Gesamtzahl der durchgeführten Testungen sowie dem Anteil der positiven Testergebnisse möglich. Während die aggregierten Testzahlen bundesweit weitestgehend repräsentativ sind, ist die Repräsentativität auf Bundesland- und Landkreisebene aber nicht immer gegeben. Die Abrechnungsdaten der Kassenärztlichen Vereinigungen können die Labordaten im Nachhinein ergänzen. Sie erlauben eine retrospektive Einschätzung der Gesamtzahl von SARS-CoV-2-Tests in Deutschland, da die Leistungen der vertragsärztlichen Versorgung aller gesetzlich Krankenversicherten (ca. 85 % der Bevölkerung) enthalten sind. Die verschiedenen Systeme zur Erfassung von Labortestungen ergänzen sich gegenseitig. Die Auswertungen fließen in die Maßnahmenempfehlungen zur Pandemiebewältigung ein. The collection of data on SARS-CoV‑2 tests is central to the assessment of the infection rate in the context of the COVID-19 pandemic. At the Robert Koch Institute (RKI), data collected from various laboratory data recording systems are consolidated. First, this article aims to exemplify significant aspects regarding test procedures. Subsequently the different systems for recording laboratory tests are described and test numbers from the RKI test laboratory query and the laboratory-based SARS-CoV‑2 surveillance as well as accounting data from the Association of Statutory Health Insurance Physicians for SARS-CoV‑2 laboratory tests are shown. Early in the pandemic, the RKI test laboratory query and the laboratory-based SARS-CoV‑2 surveillance became available and able to evaluate data on performed tests and test capacities. By recording the positive and negative test results, statements about the total number of tests and the proportion of positive test rates can be made. While the aggregate test numbers are largely representative nationwide, they are not always representative at the state and district level. The billing data of the Association of Statutory Health Insurance Physicians can complement the laboratory data afterwards. In addition, it can provide a retrospective assessment of the total number of SARS-CoV‑2 numbers in Germany, because the services provided by statutory health insurers (around 85% of the population in Germany) are included. The various laboratory data recording systems complement one another and the evaluations flow into the recommended measures for the pandemic response.

Estimating the number of persons tested for HIV in Germany is challenging. HIV testing can be reimbursed by statutory health insurance (SHI) under certain circumstances. This study aimed to use SHI physician claims data to determine the number of persons tested in the outpatient sector.The Central Research Institute for Ambulatory Health Care in Germany (Zi) aggregated a dataset of persons tested for HIV among all SHI insurees. Descriptive analysis differentiated between screening and confirmatory HIV tests. Time trends were explored using linear regression. Insurees with confirmatory tests were compared to newly diagnosed HIV (ndHIV) cases.Between 2010 and 2015, 1.7% of insurees were annually screened by SHI physicians. Screening tests increased significantly between 2010 and 2015. Among persons screened, 82.5% were women and of those 81.2% had a screening test during pregnancy. Confirmatory tests were performed on 16,034 insurees (0.3% with screening test; 51.2% men). A total of 18,446 (82.8% men) ndHIV cases were notified between 2010 and 2015.For the first time, the number of persons with HIV tests in the SHI sector was estimated. The high number of screened women is due to tests during pregnancy. The higher number of ndHIV cases indicates an unknown number of persons tested at other testing sites.

HIV-1 genotyping of larger pol-fragments from dried serum/plasma spots (DSS/DPS) is often hindered by RNA-degradation during transportation at ambient temperature. We evaluated an in-house HIV-1 DSS/DPS-genotyping assay designed in two shorter overlapping fragments covering all resistance mutations in protease and reverse transcriptase. Validation criteria such as specificity, detection limit, accuracy, reproducibility and storage conditions were assessed using reference plasma samples prepared as DPS and clinical DSS from the German molecular HIV-1 surveillance processed under real-life transportation conditions. The specificity was 100% for both samples types, and the experimental DPS detection limit of 1000 copies/ml yielded a 98.7% (3,329/3373) success rate for DSS (including all subtypes) above this detection limit. Accuracy for DPS compared to the gold standard was 99.1% and the reproducibility was 100% for DPS replicates and 99.9% for DSS pairs. Storage of DPS at room temperature was possible for 90 or 30 days and at −20 °C for at least 180 or 90 days at viral loads of 10,000 or 1000 copies/ml, respectively. The HIV-1 pol-genotyping assay presented here is a sensitive, robust and subtype generic tool for a large-scale population-based HIV-1 drug resistance surveillance for the use of DSS/DPS.

Today's consumer virtual reality (VR) devices have reached a level of complexity that necessitates innovative solutions, interaction designs, and the potential for greater user immersion. For example, the advanced interaction website developer Leap Motion presented the following introduction of their groundbreaking VR device: "Until the rise of virtual reality, we lived on the edge of a digital universe that was trapped behind glass screens. Now the glass is breaking. The digital is taking substance in our reality. But VR and AR is (sic) still largely unexplored."

HIV-1 non-B infections have been increasing in Europe for several years. In Germany, subtype A belongs to the most abundant non-B subtypes showing an increasing prevalence of 8.3% among new infections in 2016. Here we trace the origin and examine the current spread of the German HIV-1 subtype A epidemic. Bayesian coalescence and birth-death analyses were performed with 180 German HIV-1 pol sequences and 528 related and publicly available sequences to reconstruct the population dynamics and fluctuations for each of the transmission groups. Our reconstructions indicate two distinct sources of the German subtype A epidemic, with an Eastern European and an Eastern African lineage both cocirculating in the country. A total of 13 German-origin clusters were identified; among these, 6 clusters showed recent activity. Introductions leading to further countrywide spread originated predominantly from Eastern Africa when introduced before 2005. Since 2005, however, spreading introductions have occurred exclusively within the Eastern European clade. Moreover, we observed changes in the main route of subtype A transmission. The beginning of the German epidemic (1985 to 1995) was dominated by heterosexual transmission of the Eastern African lineage. Since 2005, transmissions among German men who have sex with men (MSM) have been increasing and have been associated with the Eastern European lineage. Infections among people who inject drugs dominated between 1998 and 2005. Our findings on HIV-1 subtype A infections provide new insights into the spread of this virus and extend the understanding of the HIV epidemic in Germany. IMPORTANCE HIV-1 subtype A is the second most prevalent subtype worldwide, with a high prevalence in Eastern Africa and Eastern Europe. However, an increase of non-B infections, including subtype A infections, has been observed in Germany and other European countries. There has simultaneously been an increased flow of refugees into Europe and especially into Germany, raising the question of whether the surge in non-B infections resulted from this increased immigration or whether German transmission chains are mainly involved. This study is the first comprehensive subtype A study from a western European country analyzing in detail its phylogenetic origin, the impact of various transmission routes, and its current spread. The results and conclusions presented provide new and substantial insights for virologists, epidemiologists, and the general public health sector. In this regard, they should be useful to those authorities responsible for developing public health intervention strategies to combat the further spread of HIV/AIDS.

To enable an up-to-date molecular analysis of human immunodeficiency virus (HIV) genotypes circulating in Germany we have established a surveillance system based on recently acquired HIV infections. New HIV infections are reported to the Robert Koch Institute as a statutory duty for anonymous notification. In 2013 and 2014, a dried serum spot (DSS) sample was received from 6,371 newly diagnosed HIV-cases; their analysis suggested that 1,797 samples originated from a recent infection. Of these, 809 were successfully genotyped in the pol region to identify transmitted drug resistance (TDR) mutations and to determine the HIV-1 subtype. Total TDR was 10.8%, comprising 4.3% with mono-resistance to nucleoside reverse transcriptase inhibitors (NRTIs), 2.6% to non-NRTIs, 3.0% to protease inhibitors and 0.6% and 0.2%, respectively, with dual- and triple-class resistances. HIV-1 subtype B was most prevalent with 77.0%. Non-B infections were identified more often in men and women with heterosexual transmission compared with intravenous drug users or men who have sex with men (79% and 76%, 33%, 12%; all p

Background Molecular surveillance of newly diagnosed HIV-infections is important for tracking trends in circulating HIV-variants, including those with transmitted drug resistances (TDR) to sustain ART efficacy. Methods Dried serum spots (DSS) are received together with the statutory notification of a new diagnosis. 'Recent infections' (

Genital chlamydia infections are the most frequently diagnosed bacterial sexually transmitted infection (STI) worldwide. Infections with chlamydia trachomatis are not notifiable in Germany. Since 2002, a STI sentinel surveillance including 243 sentinel sites has been set up in Germany. Between January 2003 and June 2006, 6.7% of 46,168 chlamydia tests were positive. Of the 1547 positive patients, 64.3% were women and the median age was 26 years. In this group, 60.4% of women and 29.3% of men were of non-German origin. Heterosexual contacts were stated as the possible source of infection for 42.9% of men and 26.4% of women. A total of 16.1% men and 38.6% women reportedly "always" used condoms with others than their permanent partner. The awareness of chlamydia infections needs to be improved among physicians, patients and the general population.

BACKGROUND: The variety and limitations of current laboratory methods for estimating HIV-incidence has driven attempts to improve and standardize the performance of serological 'Tests for Recent HIV-Infections' (TRI). Primary and follow-up HIV-1 positive plasma samples from individuals with well-defined dates of infection collected as part of the German Seroconverter Cohort provided specimens highly suitable for use in comparing the performance of three TRIs: the AWARE™ BED™ EIA HIV-1 Incidence test (BED-CEIA), Genetic systems HIV-1/HIV-2 Plus O EIA antibody avidity-based assay (BioRad Avidity) and Sedia™ HIV-1 LAg Avidity EIA (LAg Avidity). METHODS: The evaluation panel included 180 specimens: 44 from antiretroviral (ARV)-naïve individuals with recently acquired HIV-infection (≤ 130 days; 25 B and 19 non-B subtypes) and 136 from long-term (>12 months) infected individuals [101 ARV-naïve subtype B, 16 non-B subtypes, 14 ARV-treated individuals, 5 slow progressors (SLP)]. RESULTS: For long-term infected, ARV-naïve individuals the false recent rates (FRR) of both the BioRad and LAg Avidity assays were 2% (2/101 for subtype B) and 6% (1/16 for subtype 'non-B'), while the FRR of the BED-CEIA was 7% (7/101 for subtype B) and 25% (4/16 for subtype 'non-B') (all p>0.05). Misclassification of ARV-treated individuals and SLP was rare by LAg (1/14, 0/5) and BioRad Avidity assays (2/14, 1/5) but more frequent by BED-CEIA (5/14, 3/5). Among recently-infected individuals (subtype B), 60% (15/25) were correctly classified by BED-CEIA, 88% (22/25) by BioRad Avidity and significantly fewer by LAg (48%, 12/25) compared to BioRad Avidity (p = 0.005) with a higher true-recency rate among non-B infections for all assays. CONCLUSIONS: This study using well-characterized specimens demonstrated lower FRRs for both avidity methods than with the BED-CEIA. For recently infected individuals the BioRad Avidity assay was shown to give the most accurate results.

Objectives: We aimed at comparing the long term clinical outcome of SES and PES in routine clinical practice. Background: Although sirolimus-eluting stents (SES) more effectively reduce neointimal hyperplasia than paclitaxel-eluting stents (PES), uncertainty prevails whether this difference translates into differences in clinical outcomes outside randomized controlled trials with selected patient populations and protocol-mandated angiographic follow-up. Methods: Nine hundred and four consecutive patients who underwent implantation of a drug-eluting stent between May 2004 and February 2005: 467 patients with 646 lesions received SES, 437 patients with 600 lesions received PES. Clinical follow-up was obtained at 2 years without intervening routine angiographic follow-up. The primary endpoint was a composite of death, myocardial infarction (MI), or target vessel revascularization (TVR). Results: At 2 years, the primary endpoint was less frequent with SES (12.9%) than PES (17.6%, HR = 0.70, 95% CI 0.50–0.98, P = 0.04). The difference in favor of SES was largely driven by a lower rate of target lesion revascularisation (TLR; 4.1% vs. 6.9%, P = 0.05), whereas rates of death (6.4% vs. 7.6%, P = 0.49), MI (1.9% vs. 3.2%, P = 0.21), or definite stent thrombosis (0.6% vs. 1.4%, P = 0.27) were similar for both stent types. The benefit regarding reduced rates of TLR was significant in nondiabetic (3.6% vs. 7.1%, P = 0.04) but not in diabetic patients (5.6% vs. 6.1%, P = 0.80). Conclusions: SES more effectively reduced the need for repeat revascularization procedures than PES when used in routine clinical practice. The beneficial effect is maintained up to 2 years and may be less pronounced in diabetic patients.

Background Chlamydia trachomatis (CT) infections are not reportable in Germany and limited data on CT-prevalence among women is available. In 2008 an opportunistic CT-screening programme for women Methods In September 2010 voluntary laboratory-based sentinel surveillance system was implemented and is collecting retrospective (from 2008) and prospective data on CT-tests together with information on age and test reason (TR). We calculated positivity rates (PR) by age-group and TR over years. We used Chi2 and two-sample t-test, accordingly. We estimated coverage of OCS by extrapolating the proportion of CT-tests attributable to OCS to the respective German population. Results As of 10.04.2015 data from 24 laboratories were available for analysis. Overall 93% (3,440,131) of all tests (3,701,288) were among women. Among those 24% were attributable to OCS, 36% to screening in pregnancy, 25% to diagnostic testing, and in 15% the TR was unknown. The coverage of OCS increased over time from 8% in 2008 to 11% in 2009, and 12% in 2014. PR was highest in age-groups 15–19 (6.75%) and 20–24 (5.93%) years compared to age-groups Conclusion The proportion of young women testing positive for CT is high despite gradual but slight decrease in PR among 15–24 years old women. OCS coverage in Germany is low and did not increase substantially in the last years. OCS should be promoted among the target population and physicians. Awareness campaigns for young women should be implemented. Respective regulations should be expanded and remuneration for counselling to physicians for OCS offered. Disclosure of interest statement Chlamydia trachomatis laboratory sentinel is funded by German Federal ministry of health. No conflicts of interest.

Background/objectives: Increases in STIs have been reported from the United States and Europe. Since 2001, only syphilis and HIV are notifiable in Germany. A sentinel surveillance system has been set up to assess the occurrence and trends of STIs and identify risk groups. Methods: Through the sentinel system data are collected from local health offices (LHO), hospital based STI clinics and private practitioners (dermato-venerology, urology, gynaecology, or HIV). For every newly diagnosed laboratory confirmed infection of HIV, gonorrhoea, chlamydia, syphilis, or trichomoniasis physicians complete a standardised questionnaire regarding diagnosis, source of infection, and demographic information. Patients complete a questionnaire about sexual risk behaviour. The patient form is matched with the diagnosis form using a unique identifier number. Characteristics of sentinel patients were compared with those reported through the HIV and syphilis national notification system. Results: 58 LHO, 14 hospital based STI clinics, and 160 private practitioners (53.1% dermato-venerologists) from all federal states participated in the study. 176 (75.9%) sentinel sites are located in cities of >100 000 inhabitants. From 1 March 2003–29 February 2004, a total of 1833 STIs have been reported, among them 452 chlamydia, 321 syphilis (10.9% of notified syphilis), 343 gonorrhoea, 269 HIV (15.7% of notified HIV). 925 (50.5%) of the patients were male, the median age was 31 years. Female patients were more often of foreign origin (χ2 test; 70.0% v 26.3%; p

Triosephosphate isomerase (TIM), from the hyperthermophilic bacterium Thermotoga maritima, has been shown to be covalently linked to phosphoglycerate kinase (PGK) forming a bifunctional fusion protein with TIM as the C-terminal portion of the subunits of the tetrameric protein (Schurig et al., EMBO J 14:442-451, 1995). To study the effect of the anomalous state of association on the structure, stability, and function of Thermotoga TIM, the isolated enzyme was cloned and expressed in Escherichia coli, and compared with its wild-type structure in the PGK-TIM fusion protein. After introducing a start codon at the beginning of the tpi open reading frame, the gene was expressed in E.c.BL21(DE3)/ pNBTIM. The nucleotide sequence was confirmed and the protein purified as a functional dimer of 56.5 kDa molecular mass. Spectral analysis, using absorption, fluorescence emission, near- and far-UV circular dichroism spectroscopy were used to compare the separated Thermotoga enzyme with its homologs from mesophiles. The catalytic properties of the enzyme at approximately 80 degrees C are similar to those of its mesophilic counterparts at their respective physiological temperatures, in accordance with the idea that under in vivo conditions enzymes occupy corresponding states. As taken from chaotropic and thermal denaturation transitions, the separated enzyme exhibits high intrinsic stability, with a half-concentration of guanidinium-chloride at 3.8 M, and a denaturation half-time at 80 degrees C of 2 h. Comparing the properties of the TIM portion of the PGK-TIM fusion protein with those of the isolated recombinant TIM, it is found that the fusion of the two enzymes not only enhances the intrinsic stability of TIM but also its catalytic efficiency.

Background Sexual transmitted infections (STIs) have increased in Germany and other countries in Europe since the mid-nineties. To obtain a better picture of diagnostic methods used in STI testing institutions in Germany, we performed a nationwide survey amongst STI specialists in order to evaluate the quality of STI reports and provide recommendations to harmonize and possibly improve STI diagnostics in Germany. Methods We asked sentinel physicians and randomly chosen gynaecologists, urologists and dermato-venerologists, about the diagnostic methods used in 2005 to diagnose HIV, chlamydia (CT), gonorrhoea (GO) and syphilis (SY) in a national cross-sectional survey in order to recognize potential problems and provide recommendations. Results A total of 739/2287 (32%) physicians participated. Of all participants, 80% offered tests for HIV, 84% for CT, 83% for GO and 83% for SY. Of all participants who performed HIV testing, 90% requested an antibody test, 3% a rapid test and 1% a nucleic acid amplification test (NAAT). For CT testing, NAAT was used in 33% and rapid tests in 34% of participants. GO resistance testing was performed by 31% of the participants. SY testing was performed in 98% by serology. Conclusions Diagnostic methods for STI vary highly among the participants. Diagnostic guidelines should be reviewed and harmonised to ensure consistent use of the optimal STI diagnostic methods.