Publikationen

@article{Ignatius.2016,

title = {Highly specific detection of Cryptosporidium spp. oocysts in human stool samples by undemanding and inexpensive phase contrast microscopy},

author = {R Ignatius and T Klemm and S Zander and J B Gahutu and P Kimmig and F P Mockenhaupt and T Regnath},

doi = {10.1007/s00436-015-4859-3},

year  = {2016},

date = {2016-01-01},

journal = {Parasitology research},

volume = {115},

number = {3},

pages = {1229--1234},

abstract = {To compare phase contrast microscopy (PCM) of unstained slides for the detection of Cryptosporidium spp. oocysts with a commercially available enzyme immunoassay (EIA) for the detection of cryptosporidial antigen in human stool samples, we prospectively analysed by both methods 463 fresh human stool samples obtained from diarrhoeic patients between July and October 2014. Compared with the EIA, the sensitivity, specificity, positive and negative predictive value of PCM were 88.9 % (95 % confidence interval (CI), 66.0-98.1 %), 100 % (95 % CI, 99.0-100 %), 100 % (95 % CI, 77.3-100 %) and 99.6 % (95 % CI, 98.3-100 %), respectively. Additionally, we retrospectively examined with PCM 65 fixed stool samples that had been collected in 2010 from mostly asymptomatic Rwandan children textless5 years of age; 14 of these samples had previously yielded positive results with a highly sensitive real-time (RT)-PCR. PCM detected cryptosporidia in 5/14 RT-PCR-positive samples, and notably, also in one of 51 RT-PCR-negative samples, which was subsequently confirmed by acid-fast staining. Positive and negative percent agreement of PCM with RT-PCR were 35.7 % (95 % CI, 16.2-61.4 %) and 98.0 % (95 % CI, 88.7-100 %), respectively. Positive PCM results were associated with higher RT-PCR cycle threshold values (p = 0.044). In conclusion, PCM offers a highly specific, undemanding and inexpensive method for the laboratory diagnosis of acute human cryptosporidiosis independent of the causative Cryptosporidium species.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Eggers.2016b,

title = {Neuer Wirksamkeitsbereich begrenzt viruzid PLUS -- was ist das?},

author = {M Eggers},

url = {http://www.zbmed.de/ccmedimages/2016/ZBMED-2017135155-3.pdf},

issn = {0172-3790},

year  = {2016},

date = {2016-01-01},

journal = {Hygiene + Medizin},

volume = {41},

number = {12},

pages = {319},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Geipel.2016,

title = {Stellungnahme zum Thema Zika-Virusinfektion},

author = {A Geipel and M Enders and I Mylonas},

doi = {10.1016/S0140­6736(16)30253­7.},

issn = {0016-0237},

year  = {2016},

date = {2016-01-01},

journal = {Frauenarzt},

volume = {57},

number = {6},

pages = {614--617},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Bottcher.2016,

title = {Recombinant Enterovirus A71 Subgenogroup C1 Strains, Germany, 2015},

author = {S B\"{o}ttcher and P E Obermeier and K Neubauer and S Diedrich},

doi = {10.3201/eid2210.160357},

issn = {1080-6040},

year  = {2016},

date = {2016-01-01},

urldate = {2016-01-01},

journal = {Emerging Infectious Diseases},

volume = {22},

number = {10},

pages = {1843--1846},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Rabenau.2016,

title = {2. Mitteilung des DVV/GfV-Fachausschusses Virusdesinfektion zur DVV/RKI-Leitlinie in der Fassung vom 01.12.2014 : Erl\"{a}uterung zur Bedeutung, Anwendung und Berechnung des textquotedblLarge-Volume-Platingstextquotedbl (LVP)},

author = {H F Rabenau and I Schwebke and J Bl\"{u}mel and M Eggers and I Rapp and J Steinmann and H Willkommen},

doi = {10.1007/s00103-016-2325-8},

issn = {1436-9990},

year  = {2016},

date = {2016-01-01},

journal = {Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz},

volume = {59},

number = {4},

pages = {540--542},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Regnath.2016,

title = {Antimicrobial resistance of Neisseria gonorrhoeae isolates in south-west Germany, 2004 to 2015: increasing minimal inhibitory concentrations of tetracycline but no resistance to third-generation cephalosporins},

author = {T Regnath and T Mertes and R Ignatius},

url = {https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2016.21.36.30335},

doi = {10.2807/1560-7917.ES.2016.21.36.30335},

year  = {2016},

date = {2016-01-01},

journal = {Eurosurveillance},

volume = {21},

number = {36},

pages = {30335},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Enders.2016b,

title = {Kinderkrankheiten und Schwangerschaft -- Mumps, Masern und R\"{o}teln},

author = {M Enders and M Biber and S Exler},

doi = {10.1007/s00129-016-3912-3},

issn = {0017-5994},

year  = {2016},

date = {2016-01-01},

journal = {Der Gyn\"{a}kologe},

volume = {49},

number = {8},

pages = {575--581},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Luthgens.2016,

title = {Comment on "The importance of determining the limit of detection of non-invasive prenatal testing methods"},

author = {K L\"{u}thgens and A Binder and D Biskup},

doi = {10.1002/pd.4854},

issn = {0197-3851},

year  = {2016},

date = {2016-01-01},

journal = {Prenatal diagnosis},

volume = {36},

number = {9},

pages = {896--897},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Schalasta.2016b,

title = {Performance of the New Aptima HCV Quant Dx Assay in Comparison to the Cobas TaqMan HCV2 Test for Use with the High Pure System in Detection and Quantification of Hepatitis C Virus RNA in Plasma or Serum},

author = {G Schalasta and A Speicher and A B\"{o}rner and M Enders},

doi = {10.1128/JCM.03236-15},

issn = {0095-1137},

year  = {2016},

date = {2016-01-01},

journal = {Journal of clinical microbiology},

volume = {54},

number = {4},

pages = {1101--1107},

abstract = {Quantitating the level of hepatitis C virus (HCV) RNA is the standard of care for monitoring HCV-infected patients during treatment. The performances of commercially available assays differ for precision, limit of detection, and limit of quantitation (LOQ). Here, we compare the performance of the Hologic Aptima HCV Quant Dx assay (Aptima) to that of the Roche Cobas TaqMan HCV test, version 2.0, using the High Pure system (HPS/CTM), considered a reference assay since it has been used in trials defining clinical decision points in patient care. The assays' performance characteristics were assessed using HCV RNA reference panels and plasma/serum from chronically HCV-infected patients. The agreement between the assays for the 3 reference panels was good, with a difference in quantitation values of textless0.5 log. High concordance was demonstrated between the assays for 245 clinical samples (kappa = 0.80; 95% confidence interval [CI], 0.720 to 0.881); however, Aptima detected and/or quantitated 20 samples that HPS/CTM did not detect, while Aptima did not detect 1 sample that was quantitated by HPS/CTM. For the 165 samples quantitated by both assays, the values were highly correlated (R= 0.98;Ptextless 0.0001). The linearity of quantitation from concentrations of 1.4 to 6 log was excellent for both assays for all HCV genotypes (GT) tested (GT 1a, 1b, 2b, and 3a) (R(2)textgreater 0.99). The assays had similar levels of total and intra-assay variability across all genotypes at concentrations from 1,000 to 25 IU/ml. Aptima had a greater analytical sensitivity, quantitating more than 50% of replicates at 25-IU/ml target. Aptima showed performance characteristics comparable to those of HPS/CTM and increased sensitivity, making it suitable for use as a clinical diagnostic tool on the fully automated Panther platform.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Schalasta.2016c,

title = {Comparative evaluation of the Aptima HIV-1 Quant Dx assay and COBAS TaqMan HIV-1 v2.0 assay using the Roche High Pure System for the quantification of HIV-1 RNA in plasma},

author = {G Schalasta and A B\"{o}rner and A Speicher and M Enders},

doi = {10.1515/cclm-2015-0522},

issn = {1434-6621},

year  = {2016},

date = {2016-01-01},

journal = {Clinical chemistry and laboratory medicine},

volume = {54},

number = {3},

pages = {493--499},

abstract = {BACKGROUND: Quantification of human immunodeficiency virus type 1 (HIV-1) RNA in plasma has become the standard of care in the management of HIV-infected patients. There are several commercially available assays that have been implemented for the detection of HIV-1 RNA in plasma. Here, the new Hologic Aptima(R) HIV-1 Quant Dx assay (Aptima HIV) was compared to the Roche COBAS(R) TaqMan(R) HIV-1 Test v2.0 for use with the High Pure System (HPS/CTM). METHODS: The performance characteristics of the assays were assessed using commercially available HIV reference panels, dilution of the WHO 3rd International HIV-1 RNA International Standard (WHO-IS) and plasma from clinical specimens. Assay performance was determined by linear regression, Deming correlation analysis and Bland-Altman analysis. RESULTS: Testing of HIV-1 reference panels revealed excellent agreement. The 61 clinical specimens quantified in both assays were linearly associated and strongly correlated. CONCLUSIONS: The Aptima HIV assay offers performance comparable to that of the HPS/CTM assay and, as it is run on a fully automated platform, a significantly improved workflow},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Luthgens.2016b,

title = {Unterschiedliche Nachweisgrenzen immunologischer Tests auf Blut im Stuhl unterstreichen die Notwendigkeit der Standardisierung und Qualit\"{a}tssicherung},

author = {Kai L\"{u}thgens and S Albert and H Brenner},

doi = {10.1055/s-0041-106854},

year  = {2016},

date = {2016-01-01},

journal = {Zeitschrift fur Gastroenterologie},

volume = {54},

number = {4},

pages = {299--303},

abstract = {BACKGROUND 

 

Immunological fecal occult blood tests (FIT) are superior in detecting colorectal cancer and its precursors compared to conventional Guajac-based tests. Besides quantitative, laboratory-based FITs qualitative, office-based FITs are increasingly employed. Studies have shown major variation of these tests with respect to sensitivity and specificity, which is most probably caused by different detection limits. In the present study we therefore determined and compared the detection limits and other criteria of commercial FITs. 

 

METHODS 

 

We determined the detection limits for 21 qualitative and one quantitative FIT using commercial control solutions with defined hemoglobin (Hb) concentrations. These detection limits were compared with the manufacturers' data. 

 

RESULTS 

 

The detection limits of the tests showed a wide range of 2 to over 60 µg Hb per gram stool. In many cases the detection limits we determined were not in accordance with the manufacturers' data. Two tests didn't show a positive reaction even with the highest hemoglobin concentration of 440 ng/mL. On the other hand one test showed a positive reaction even at the lowest hemoglobin concentration of 25 ng/mL. 

 

CONCLUSION 

 

The large differences in the detection limits found in this study are consistent with observations of large variation of sensitivity and specificity of qualitative FITs in screening practice. Proper clinical validation of each FIT is to be required before admission for colorectal cancer screening. An additional regular quality control, i. e. by means of external quality control measures and documentation of results of colonoscopies following positive tests results, should be mandatory.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Eggers.2016,

title = {Viruzidie 4.0},

author = {M Eggers },

url = {http://www.zbmed.de/ccmedimages/2016/ZBMED-2016101851511-17.pdf},

issn = {0943-674X},

year  = {2016},

date = {2016-01-01},

journal = {Der Mikrobiologe},

volume = {26},

number = {3},

pages = {122},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Enders.2015,

title = {Reply to "Better method for evaluating a new laboratory test for syphilis"},

author = {M Enders and M Gleich and A M\"{u}hlbacher and T Sakuldamrongpanich and A Turhan and R Sert\"{o}z and S Semprini and V Sambri},

doi = {10.1128/CVI.00109-15},

issn = {1556-6811},

year  = {2015},

date = {2015-01-01},

journal = {Clinical and vaccine immunology : CVI},

volume = {22},

number = {5},

pages = {607--608},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Enders.2015b,

title = {Performance evaluation of the Elecsys syphilis assay for the detection of total antibodies to Treponema pallidum},

author = {M Enders and A Hunjet and M Gleich and R Imdahl and A M\"{u}hlbacher and H Schennach and K Chaiwong and T Sakuldamrongpanich and A Turhan and R Sertoz and E Wolf and W Mayer and C Tao and L L Wang and S Semprini and V Sambri},

doi = {10.1128/CVI.00505-14.},

issn = {1556-6811},

year  = {2015},

date = {2015-01-01},

journal = {Clinical and vaccine immunology : CVI},

volume = {22},

number = {1},

pages = {17--26},

abstract = {Syphilis is a health problem of increasing incidence in recent years that may have severe complications if not diagnosed and treated at an early stage. There are many diagnostic tests available for syphilis, but there is no gold standard, and diagnosis therefore usually relies upon a combination of tests. In this multicenter study, we evaluated the treponemal Elecsys syphilis assay for use in the diagnosis of syphilis in routine samples, i.e., when syphilis is suspected or during antenatal or blood donation screening. The sensitivity and specificity of the Elecsys syphilis assay were compared head to head with those of other treponemal assays used in routine clinical practice and were assessed in potentially cross-reactive samples from patients with Epstein-Barr virus, HIV, and Lyme disease. In a total of 8,063 syphilis-negative samples collected from routine diagnostic requests and blood donations, the Elecsys syphilis assay had a specificity of 99.88%. In 928 samples previously identified as syphilis positive, the sensitivity was 99.57 to 100% (the result is presented as a range depending on whether four initially indeterminate samples are included in the assessment). The specificity of the Elecsys syphilis assay in patients with other infections was 100%; no false-positive samples were identified},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Schofer.2015,

title = {S2k guideline "Diagnosis and therapy of syphilis"--short version},

author = {H Sch\"{o}fer and T Weberschock and Wolfgang Br\"{a}uninger and Viviane Bremer and A Dreher and Martin Enders and S Esser and O Hamouda and H J Hagedorn and W Handrick and W Krause and C Mayr and D M\"{u}nstermann and A Nast and F Ochsendorf and U Petry and A Potthoff and H Prange and S Rieg and P Schneede and A Sing and J Weber and T A Wichelhaus and Norbert Brockmeyer},

doi = {10.1111/ddg.12574},

issn = {1610-0379},

year  = {2015},

date = {2015-01-01},

journal = {Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG},

volume = {13},

number = {5},

pages = {472--480},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{DesinfektionsmittelKommissiondesVAH.2015,

title = {Desinfektion von Wickeltischen in Einrichtungen zur Kinderbetreuung: Fragen und Antworten},

author = {Desinfektionsmittel-Kommission des VAH},

url = {http://www.zbmed.de/ccmedimages/2015/ZBMED-20155235153-2.pdf},

issn = {0172-3790},

year  = {2015},

date = {2015-01-01},

journal = {Hygiene + Medizin},

volume = {40},

number = {5},

pages = {205},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Eggers.2015,

title = {Povidone-iodine hand wash and hand rub products demonstrated excellent in vitro virucidal efficacy against Ebola virus and modified vaccinia virus Ankara, the new European test virus for enveloped viruses},

author = {M Eggers and M Eickmann and K Kowalski and J Zorn and K Reimer},

doi = {10.1186/s12879-015-1111-9},

issn = {1471-2334},

year  = {2015},

date = {2015-01-01},

journal = {BMC infectious diseases},

volume = {15},

pages = {375},

abstract = {BACKGROUND 

 

The recent Ebola virus (EBOV) epidemic highlights the need for efficacious virucidal products to help prevent infection and limit the spread of Ebola virus disease. However, there is limited data on the efficacy of virucidal products against EBOV, because the virus has a high biosafety level and is only available in a few laboratories worldwide. The virucidal efficacy of antiseptics and disinfectants can be determined using the European Standard EN14476:2013/FprA1:2015. Modified vaccinia virus Ankara (MVA) was introduced in 2014 as a reference virus for the claim 'virucidal active against enveloped viruses for hygienic hand rub and hand wash'. For EBOV, also an enveloped virus, the suitability of MVA as a surrogate needs to be proven. The aim of this study was to test the in vitro efficacy of four povidone iodine (PVP-I) formulations against EBOV: 4% PVP-I skin cleanser; 7.5% PVP-I surgical scrub; 10% PVP-I solution; and 3.2% PVP-I and 78% alcohol solution. The formulations were tested with MVA to define the test conditions, and as a secondary objective the suitability of MVA as a surrogate for enveloped viruses like EBOV was assessed. 

 

METHODS 

 

According to EN14476, a standard suspension test was used for MVA. Large-volume plating was used for EBOV to increase test sensitivity and exclude potential after-effects. All products were tested under clean (0.3 g/L BSA) and dirty (3.0 g/L BSA + 3.0 mL/L erythrocytes) conditions with MVA for 15, 30, and 60 s. The concentration-contact time values obtained with MVA were verified for EBOV. 

 

RESULTS 

 

Viral titres of MVA and EBOV were reduced by textgreater99.99% to textgreater99.999% under clean and dirty conditions after application of the test products for 15 seconds. 

 

CONCLUSIONS 

 

All products showed excellent virucidal efficacy against EBOV, demonstrating the important role PVP-I can play in helping to prevent and limit the spread of Ebola virus disease. The efficacy against both test viruses after 15 s is helpful information for the implementation of guidance for people potentially exposed to EBOV, and confirms the excellent virucidal efficacy of PVP-I against enveloped viruses. MVA was found to be a suitable surrogate for enveloped viruses like EBOV.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Eggers.2015b,

title = {Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA)},

author = {M Eggers and M Eickmann and J Zorn},

doi = {10.1007/s40121-015-0091-9},

issn = {2193-8229},

year  = {2015},

date = {2015-01-01},

journal = {Infectious diseases and therapy},

volume = {4},

number = {4},

pages = {491--501},

abstract = {INTRODUCTION 

 

Since the first case of Middle East Respiratory Syndrome coronavirus (MERS-CoV) infection was reported in 2012, the virus has infected more than 1300 individuals in 26 countries, and caused more than 480 deaths. Human-to-human transmission requires close contact, and has typically occurred in the healthcare setting. Improved global awareness, together with improved hygiene practices in healthcare facilities, has been highlighted as key strategies in controlling the spread of MERS-CoV. This study tested the in vitro efficacy of three formulations of povidone iodine (PVP-I: 4% PVP-I skin cleanser, 7.5% PVP-I surgical scrub, and 1% PVP-I gargle/mouthwash) against a reference virus (Modified vaccinia virus Ankara, MVA) and MERS-CoV. 

 

METHODS 

 

According to EN14476, a standard suspension test was used to assess virucidal activity against MVA and large volume plating was used for MERS-CoV. All products were tested under clean (0.3~g/L bovine serum albumin, BSA) and dirty conditions (3.0~g/L BSA~+~3.0~mL/L erythrocytes), with application times of 15, 30, and 60~s for MVA, and 15~s for MERS-CoV. The products were tested undiluted, 1:10 and 1:100 diluted against MVA, and undiluted against MERS-CoV. 

 

RESULTS 

 

A reduction in virus titer of $geq$4 log10 (corresponding to an inactivation of $geq$99.99%) was regarded as evidence of virucidal activity. This was achieved versus MVA and MERS-CoV, under both clean and dirty conditions, within 15~s of application of each undiluted PVP-I product. 

 

CONCLUSION 

 

These data indicate that PVP-I-based hand wash products for potentially contaminated skin, and PVP-I gargle/mouthwash for reduction of viral load in the oral cavity and the oropharynx, may help to support hygiene measures to prevent transmission of MERS-CoV. 

 

FUNDING 

 

Mundipharma Research GmbH \& Co.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Hassel.2015,

title = {Transmission patterns of human enterovirus 71 to, from and among European countries, 2003 to 2013},

author = {C Hassel and A Mirand and A Lukashev and E Terletskaia-Ladwig and A Farkas and I Schuffenecker and S Diedrich and H P Huemer and C Archimbaud and H Peigue-Lafeuille and C Henquell and J-L Bailly},

doi = {10.2807/1560-7917.ES.2015.20.34.30005},

year  = {2015},

date = {2015-01-01},

journal = {Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin},

volume = {20},

number = {34},

pages = {30005},

abstract = {Enterovirus 71 (EV-71) is involved in epidemics of hand, foot, and mouth disease (HFMD) and has been reported to occur with severe neurological complications in eastern and south-east Asia. In other geographical areas, the transmission of this virus is poorly understood. We used large sequence datasets (of the gene encoding the viral protein 1, VP1) and a Bayesian phylogenetic approach to compare the molecular epidemiology and geographical spread patterns of EV-71 subgenogroups B4, B5, C1, C2, and C4 in Europe relative to other parts of the world. For the study, European countries considered were European Union (EU) Member States and Iceland, Norway and Switzerland. Viruses of the B4, B5, and C4 subgenogroups circulate mainly in eastern and south-east Asia. In Europe sporadic introductions of these subgenogroups are observed, however C1 and C2 viruses predominate. The phylogenies showed evidence of multiple events of spread involving C1 and C2 viruses within Europe since the mid-1990s. Two waves of sporadic C2 infections also occurred in 2010 and 2013. The 2007 Dutch outbreak caused by C2 and the occurrence of B5 and C4 infections in the EU between 2004 and 2013 arose while the circulation of C1 viruses was low. A transmission chain involving a C4 virus was traced from Japan to the EU and then further to Canada between 2001 and 2006. Recent events whereby spread of viruses have occurred from, to, and within Europe appear to be involved in the long term survival of EV-71, highlighting the need for enhanced surveillance of this virus.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Rabenau.2015,

title = {Leitlinie der Deutschen Vereinigung zur Bek\"{a}mpfung der Viruskrankheiten (DVV) e. V. und des Robert Koch-Instituts (RKI) zur Pr\"{u}fung von chemischen Desinfektionsmitteln auf Wirksamkeit gegen Viren in der Humanmedizin : Fassung vom 1. Dezember 2014},

author = {H F Rabenau and I Schwebke and J Bl\"{u}mel and Maren Eggers and D Glebe and I Rapp and A Sauerbrei and E Steinmann and J Steinmann and H Willkommen and P Wutzler},

doi = {10.1007/s00103-015-2131-8},

issn = {1436-9990},

year  = {2015},

date = {2015-01-01},

urldate = {2015-01-01},

journal = {Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz},

volume = {58},

number = {4-5},

pages = {493--504},

keywords = {},

pubstate = {published},

tppubtype = {article}

}