2020
Anderson, DE; Sivalingam, V; Kang, A Eng Zheng; Ananthanarayanan, A; Arumugam, H; Jenkins, TM; Hadjiat, Y; Eggers, M
In: Infectious diseases and therapy, Bd. 9, Nr. 3, S. 669–675, 2020.
@article{Anderson.2020,
title = {Povidone-Iodine Demonstrates Rapid In Vitro Virucidal Activity Against SARS-CoV-2, The Virus Causing COVID-19 Disease},
author = {DE Anderson and V Sivalingam and A Eng Zheng Kang and A Ananthanarayanan and H Arumugam and TM Jenkins and Y Hadjiat and M Eggers},
doi = {10.1007/s40121-020-00316-3},
year = {2020},
date = {2020-01-01},
journal = {Infectious diseases and therapy},
volume = {9},
number = {3},
pages = {669\textendash675},
abstract = {INTRODUCTION
As of 22 June 2020, Severe Acute Respiratory Syndrome (SARS)-coronavirus (CoV)-2 has infected more than 8.95 million people worldwide, causing textgreater 468,000 deaths. The virus is transmitted through respiratory droplets and physical contact from contaminated surfaces to the mucosa. Hand hygiene and oral decontamination among other measures are key to preventing the spread of the virus. We report the in vitro virucidal activity of topical and oral povidone-iodine (PVP-I) products against SARS-CoV-2.
METHODS
Suspension assays were used to assess the virucidal activity of PVP-I against SARS-CoV-2. Products were tested at a contact time of 30~s for virucidal activity. Viral titres were calculated using the Spearman-K\"{a}rber method and reported as median tissue culture infectious dose (TCID50)/mL.
RESULTS
All four products [antiseptic solution (PVP-I 10%), skin cleanser (PVP-I 7.5%), gargle and mouth wash (PVP-I 1%) and throat spray (PVP-I 0.45%)] achieved $geq$ 99.99% virucidal activity against SARS-CoV-2, corresponding to $geq$ 4 log10 reduction of virus titre, within 30~s of contact.
CONCLUSION
This study provides evidence of rapid and effective virucidal activity of PVP-I against SARS-CoV-2. PVP-I-based products are widely available for medical and personal use for hand hygiene and oral decontamination, and could be readily integrated into coronavirus disease, COVID-19, infection control measures in hospital and community settings.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
INTRODUCTION
As of 22 June 2020, Severe Acute Respiratory Syndrome (SARS)-coronavirus (CoV)-2 has infected more than 8.95 million people worldwide, causing textgreater 468,000 deaths. The virus is transmitted through respiratory droplets and physical contact from contaminated surfaces to the mucosa. Hand hygiene and oral decontamination among other measures are key to preventing the spread of the virus. We report the in vitro virucidal activity of topical and oral povidone-iodine (PVP-I) products against SARS-CoV-2.
METHODS
Suspension assays were used to assess the virucidal activity of PVP-I against SARS-CoV-2. Products were tested at a contact time of 30~s for virucidal activity. Viral titres were calculated using the Spearman-Kärber method and reported as median tissue culture infectious dose (TCID50)/mL.
RESULTS
All four products [antiseptic solution (PVP-I 10%), skin cleanser (PVP-I 7.5%), gargle and mouth wash (PVP-I 1%) and throat spray (PVP-I 0.45%)] achieved $geq$ 99.99% virucidal activity against SARS-CoV-2, corresponding to $geq$ 4 log10 reduction of virus titre, within 30~s of contact.
CONCLUSION
This study provides evidence of rapid and effective virucidal activity of PVP-I against SARS-CoV-2. PVP-I-based products are widely available for medical and personal use for hand hygiene and oral decontamination, and could be readily integrated into coronavirus disease, COVID-19, infection control measures in hospital and community settings.
As of 22 June 2020, Severe Acute Respiratory Syndrome (SARS)-coronavirus (CoV)-2 has infected more than 8.95 million people worldwide, causing textgreater 468,000 deaths. The virus is transmitted through respiratory droplets and physical contact from contaminated surfaces to the mucosa. Hand hygiene and oral decontamination among other measures are key to preventing the spread of the virus. We report the in vitro virucidal activity of topical and oral povidone-iodine (PVP-I) products against SARS-CoV-2.
METHODS
Suspension assays were used to assess the virucidal activity of PVP-I against SARS-CoV-2. Products were tested at a contact time of 30~s for virucidal activity. Viral titres were calculated using the Spearman-Kärber method and reported as median tissue culture infectious dose (TCID50)/mL.
RESULTS
All four products [antiseptic solution (PVP-I 10%), skin cleanser (PVP-I 7.5%), gargle and mouth wash (PVP-I 1%) and throat spray (PVP-I 0.45%)] achieved $geq$ 99.99% virucidal activity against SARS-CoV-2, corresponding to $geq$ 4 log10 reduction of virus titre, within 30~s of contact.
CONCLUSION
This study provides evidence of rapid and effective virucidal activity of PVP-I against SARS-CoV-2. PVP-I-based products are widely available for medical and personal use for hand hygiene and oral decontamination, and could be readily integrated into coronavirus disease, COVID-19, infection control measures in hospital and community settings.
Boursillon, D; Kocics, J; Eggers, M; Elts, B
Reiniger mit Zusatz von Mikroorganismen (MARP) Artikel
In: Hygiene + Medizin, Bd. 45, Nr. 7/8, S. 98–101, 2020.
@article{Boursillon.2020,
title = {Reiniger mit Zusatz von Mikroorganismen (MARP)},
author = {D Boursillon and J Kocics and M Eggers and B Elts},
year = {2020},
date = {2020-01-01},
journal = {Hygiene + Medizin},
volume = {45},
number = {7/8},
pages = {98--101},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Eggers, M; Hitz, DA; Elts, B
Reinigung von Oberflächen - Eine mikrobiologische Untersuchung und Bewertung der Reinigung in öffentlichen Bereichen Artikel
In: Hygiene + Medizin, Bd. 45, Nr. 7-8, S. D102–D106, 2020.
@article{Eggers.2020,
title = {Reinigung von Oberfl\"{a}chen - Eine mikrobiologische Untersuchung und Bewertung der Reinigung in \"{o}ffentlichen Bereichen},
author = {M Eggers and DA Hitz and B Elts},
year = {2020},
date = {2020-01-01},
journal = {Hygiene + Medizin},
volume = {45},
number = {7-8},
pages = {D102--D106},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Eggers, M; Rabenau, H; Blümel, J; Fickenscher, H; Geisel, B; Glebe, D; Hengel, H; Marschang, R; Reiche, S; Steinmann, E; Steinmann, J; Schwebke, I
In: Epidemiologisches Bulletin, Nr. 36, S. 3–14, 2020.
@article{Eggers.2020b,
title = {Einsatz geeigneter Desinfektionsmitteln bei gentechnisch ver\"{a}nderten Viren und viralen Vektoren -- Stellungnahme der Kommission f\"{u}r Virusdesinfektion der Deutschen Vereinigung zur Bek\"{a}mpfung der Viruskrankheiten (DVV) e. V. und der Gesellschaft f\"{u}r Virologie (GfV) e. V},
author = {M Eggers and H Rabenau and J Bl\"{u}mel and H Fickenscher and B Geisel and D Glebe and H Hengel and R Marschang and S Reiche and E Steinmann and J Steinmann and I Schwebke},
doi = {10.25646/7030},
year = {2020},
date = {2020-01-01},
journal = {Epidemiologisches Bulletin},
number = {36},
pages = {3--14},
abstract = {Im Epidemiologischen Bulletin 36/2020 haben Mitglieder der Kommission f\"{u}r Virusdesinfektion der DVV/GfV eine \"{U}bersicht h\"{a}ufig verwendeter gentechnisch ver\"{a}nderter Organismen zusammengestellt, davon ausgehend werden Aspekte der Auswahl und Anwendung von Desinfektionsmitteln n\"{a}her er\"{o}rtert. Dabei wurden neben Vertretern von Bundesoberbeh\"{o}rden, wie des FLI, des PEI und des RKI, auch Vertreter des \"{O}GD und virologischer Institute aus Universit\"{a}ten einbezogen.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Im Epidemiologischen Bulletin 36/2020 haben Mitglieder der Kommission für Virusdesinfektion der DVV/GfV eine Übersicht häufig verwendeter gentechnisch veränderter Organismen zusammengestellt, davon ausgehend werden Aspekte der Auswahl und Anwendung von Desinfektionsmitteln näher erörtert. Dabei wurden neben Vertretern von Bundesoberbehörden, wie des FLI, des PEI und des RKI, auch Vertreter des ÖGD und virologischer Institute aus Universitäten einbezogen.
Elts, B; Rager, A-M; Boursillon, D; Eggers, M
Aufbereitung von Reinigungstextilien in der Krankenhausreinigung Artikel
In: Hygiene + Medizin, Bd. 45, Nr. 7/8, S. D80–D89, 2020.
@article{Elts.2020,
title = {Aufbereitung von Reinigungstextilien in der Krankenhausreinigung},
author = {B Elts and A-M Rager and D Boursillon and M Eggers},
year = {2020},
date = {2020-01-01},
journal = {Hygiene + Medizin},
volume = {45},
number = {7/8},
pages = {D80--D89},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Kramer, A; Eggers, M
Prävention respiratorischer Virusinfektionen durch viruzide Schleimhautantiseptik bei medizinischem Personal und in der Bevölkerung Artikel
In: Hygiene + Medizin, Bd. 45, Nr. 9, S. D118–D124, 2020.
@article{Kramer.2020,
title = {Pr\"{a}vention respiratorischer Virusinfektionen durch viruzide Schleimhautantiseptik bei medizinischem Personal und in der Bev\"{o}lkerung},
author = {A Kramer and M Eggers},
year = {2020},
date = {2020-01-01},
journal = {Hygiene + Medizin},
volume = {45},
number = {9},
pages = {D118\textendashD124},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Rabenau, HF; Schwebke, I; Blümel, J; Eggers, M; Rapp, I; Steinmann, J; Willkommen, H
In: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, Bd. 63, Nr. 5, S. 657–659, 2020.
@article{Rabenau.2020b,
title = {Comment on the significance, application and determination of the large volume plating (LVP) 2. Communication of the DVV/GfV Virus Disinfection Expert Committee on the DVV/RKI Guideline in the version of December 1st, 2014},
author = {HF Rabenau and I Schwebke and J Bl\"{u}mel and M Eggers and I Rapp and J Steinmann and H Willkommen},
doi = {10.1007/s00103-020-03117-8},
year = {2020},
date = {2020-01-01},
journal = {Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz},
volume = {63},
number = {5},
pages = {657--659},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Russcher, A; Enders, A; de Brouwer, CS; Oepkes, D; Hahn, R; Enders, M; Kroes, AC M; Vossen, A CTM
In: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, Bd. 129, S. 104482, 2020.
@article{Russcher.2020,
title = {Diagnosis of intrauterine parvovirus B19 infection at birth - Value of DNA detection in neonatal blood and dried blood spots},
author = {A Russcher and A Enders and CS de Brouwer and D Oepkes and R Hahn and M Enders and AC M Kroes and A CTM Vossen},
doi = {10.1016/j.jcv.2020.104482},
year = {2020},
date = {2020-01-01},
journal = {Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology},
volume = {129},
pages = {104482},
abstract = {BACKGROUND
Diagnosis of congenital viral infection at birth is generally attempted by direct detection of the virus by PCR in various neonatal materials. How to reliably diagnose intrauterine infection with parvovirus B19 (B19 V) at birth is unknown.
OBJECTIVES
To evaluate the performance of B19 V DNA detection in cord blood (CB) or neonatal dried blood spots (DBS) in diagnosing fetal infection.
STUDY DESIGN
Two cohorts of children diagnosed prenatally with an intrauterine B19 V infection were included in this study. CB samples of intrauterine B19 V infections that were sent to a reference laboratory for congenital infections in Stuttgart, Germany in the period 1995-2014 were tested in triplicate for B19 V DNA by quantitative PCR. DBS from children with intrauterine B19 V infection that underwent IUT at the LUMC, Leiden, the Netherlands in the period 2009-2014 were tested for B19 V DNA by quantitative B19 V PCR in triplicate.
RESULTS
Fourteen of twenty (70 %) CB samples tested positive for B19 V DNA. The positivity rate was 40 % (4/10) in those with a prenatal diagnosis textless20 weeks gestation. When intrauterine B19 V infection was diagnosed thereafter, 100 % (10/10) samples were B19 V DNA positive. Of the thirteen available DBS, twelve (92 %) tested positive. Viral load in CB and DBS corresponded inversely with time from fetal diagnosis to birth.
CONCLUSION
B19 V DNA can be detected in neonatal blood samples of children following intrauterine B19 V infection, although the possibility of false-negatives, even in severe infections, should be considered. B19 V viral load at birth correlates with timing of infection.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND
Diagnosis of congenital viral infection at birth is generally attempted by direct detection of the virus by PCR in various neonatal materials. How to reliably diagnose intrauterine infection with parvovirus B19 (B19 V) at birth is unknown.
OBJECTIVES
To evaluate the performance of B19 V DNA detection in cord blood (CB) or neonatal dried blood spots (DBS) in diagnosing fetal infection.
STUDY DESIGN
Two cohorts of children diagnosed prenatally with an intrauterine B19 V infection were included in this study. CB samples of intrauterine B19 V infections that were sent to a reference laboratory for congenital infections in Stuttgart, Germany in the period 1995-2014 were tested in triplicate for B19 V DNA by quantitative PCR. DBS from children with intrauterine B19 V infection that underwent IUT at the LUMC, Leiden, the Netherlands in the period 2009-2014 were tested for B19 V DNA by quantitative B19 V PCR in triplicate.
RESULTS
Fourteen of twenty (70 %) CB samples tested positive for B19 V DNA. The positivity rate was 40 % (4/10) in those with a prenatal diagnosis textless20 weeks gestation. When intrauterine B19 V infection was diagnosed thereafter, 100 % (10/10) samples were B19 V DNA positive. Of the thirteen available DBS, twelve (92 %) tested positive. Viral load in CB and DBS corresponded inversely with time from fetal diagnosis to birth.
CONCLUSION
B19 V DNA can be detected in neonatal blood samples of children following intrauterine B19 V infection, although the possibility of false-negatives, even in severe infections, should be considered. B19 V viral load at birth correlates with timing of infection.
Diagnosis of congenital viral infection at birth is generally attempted by direct detection of the virus by PCR in various neonatal materials. How to reliably diagnose intrauterine infection with parvovirus B19 (B19 V) at birth is unknown.
OBJECTIVES
To evaluate the performance of B19 V DNA detection in cord blood (CB) or neonatal dried blood spots (DBS) in diagnosing fetal infection.
STUDY DESIGN
Two cohorts of children diagnosed prenatally with an intrauterine B19 V infection were included in this study. CB samples of intrauterine B19 V infections that were sent to a reference laboratory for congenital infections in Stuttgart, Germany in the period 1995-2014 were tested in triplicate for B19 V DNA by quantitative PCR. DBS from children with intrauterine B19 V infection that underwent IUT at the LUMC, Leiden, the Netherlands in the period 2009-2014 were tested for B19 V DNA by quantitative B19 V PCR in triplicate.
RESULTS
Fourteen of twenty (70 %) CB samples tested positive for B19 V DNA. The positivity rate was 40 % (4/10) in those with a prenatal diagnosis textless20 weeks gestation. When intrauterine B19 V infection was diagnosed thereafter, 100 % (10/10) samples were B19 V DNA positive. Of the thirteen available DBS, twelve (92 %) tested positive. Viral load in CB and DBS corresponded inversely with time from fetal diagnosis to birth.
CONCLUSION
B19 V DNA can be detected in neonatal blood samples of children following intrauterine B19 V infection, although the possibility of false-negatives, even in severe infections, should be considered. B19 V viral load at birth correlates with timing of infection.
Stenger, T; Ledo, A; Ziller, C; Schub, D; Schmidt, T; Enders, M; Gärtner, BC; Sester, M; Meyer, T
Timing of Vaccination after Training: Immune Response and Side Effects in Athletes Artikel
In: Medicine and science in sports and exercise, Bd. 52, Nr. 7, S. 1603–1609, 2020.
@article{Stenger.2020,
title = {Timing of Vaccination after Training: Immune Response and Side Effects in Athletes},
author = {T Stenger and A Ledo and C Ziller and D Schub and T Schmidt and M Enders and BC G\"{a}rtner and M Sester and T Meyer},
doi = {10.1249/MSS.0000000000002278},
year = {2020},
date = {2020-01-01},
journal = {Medicine and science in sports and exercise},
volume = {52},
number = {7},
pages = {1603--1609},
abstract = {OBJECTIVES
Influenza vaccination was used to assess whether induction of immunity or side effects are influenced by the timing of the last training session before vaccination.
METHODS
Forty-five healthy athletes (36 male, 23 $pm$ 8 yr, $geq$5 training sessions per week, predominantly national competition level) were vaccinated with the tetravalent influenza vaccine; blood samples were collected immediately before and 1, 2, and 26 wk after vaccination. Athletes were randomly assigned to vaccination within 2 h after the last training session versus after 24-26 h. Influenza-specific T cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies (IgA, IgG, IgM) were quantified by enzyme-linked immunosorbent assay and neutralization assay. Participants documented resulting side effects and training restrictions using a standardized diary.
RESULTS
Both groups showed an increase in influenza-reactive CD4 T-cell levels, which peaked 1 wk after vaccination (fold changes to baseline; median (interquartile range), 3.7 (3.0-5.4; P textless 0.001) in the 2-h group; 4.6 (2.8-7.4; P textless 0.001) in the 26-h group) with no difference between groups (P = 0.52). Influenza-specific antibodies showed a significant increase after vaccination in both groups (at least 1.4-fold, each P textless 0.001, no group differences; P = 0.24-0.97 for different antibody types). Only antibodies toward the Brisbane strain showed a trend toward significant differences in neutralization titers between groups (4-fold (2-17.8) in the 2-h group, 16-fold (4-32.9) in the 26-h group; P = 0.06), whereas other specificities did not differ (P = 0.16-0.72). No intergroup differences were found for side effects; no athlete reported a loss of training time due to the vaccination or its side effects.
CONCLUSION
Infection prophylaxis in elite athletes by influenza vaccination seems to be effective and safe. Timing of vaccination after prior training does not seem to require specific constraints.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
OBJECTIVES
Influenza vaccination was used to assess whether induction of immunity or side effects are influenced by the timing of the last training session before vaccination.
METHODS
Forty-five healthy athletes (36 male, 23 $pm$ 8 yr, $geq$5 training sessions per week, predominantly national competition level) were vaccinated with the tetravalent influenza vaccine; blood samples were collected immediately before and 1, 2, and 26 wk after vaccination. Athletes were randomly assigned to vaccination within 2 h after the last training session versus after 24-26 h. Influenza-specific T cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies (IgA, IgG, IgM) were quantified by enzyme-linked immunosorbent assay and neutralization assay. Participants documented resulting side effects and training restrictions using a standardized diary.
RESULTS
Both groups showed an increase in influenza-reactive CD4 T-cell levels, which peaked 1 wk after vaccination (fold changes to baseline; median (interquartile range), 3.7 (3.0-5.4; P textless 0.001) in the 2-h group; 4.6 (2.8-7.4; P textless 0.001) in the 26-h group) with no difference between groups (P = 0.52). Influenza-specific antibodies showed a significant increase after vaccination in both groups (at least 1.4-fold, each P textless 0.001, no group differences; P = 0.24-0.97 for different antibody types). Only antibodies toward the Brisbane strain showed a trend toward significant differences in neutralization titers between groups (4-fold (2-17.8) in the 2-h group, 16-fold (4-32.9) in the 26-h group; P = 0.06), whereas other specificities did not differ (P = 0.16-0.72). No intergroup differences were found for side effects; no athlete reported a loss of training time due to the vaccination or its side effects.
CONCLUSION
Infection prophylaxis in elite athletes by influenza vaccination seems to be effective and safe. Timing of vaccination after prior training does not seem to require specific constraints.
Influenza vaccination was used to assess whether induction of immunity or side effects are influenced by the timing of the last training session before vaccination.
METHODS
Forty-five healthy athletes (36 male, 23 $pm$ 8 yr, $geq$5 training sessions per week, predominantly national competition level) were vaccinated with the tetravalent influenza vaccine; blood samples were collected immediately before and 1, 2, and 26 wk after vaccination. Athletes were randomly assigned to vaccination within 2 h after the last training session versus after 24-26 h. Influenza-specific T cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies (IgA, IgG, IgM) were quantified by enzyme-linked immunosorbent assay and neutralization assay. Participants documented resulting side effects and training restrictions using a standardized diary.
RESULTS
Both groups showed an increase in influenza-reactive CD4 T-cell levels, which peaked 1 wk after vaccination (fold changes to baseline; median (interquartile range), 3.7 (3.0-5.4; P textless 0.001) in the 2-h group; 4.6 (2.8-7.4; P textless 0.001) in the 26-h group) with no difference between groups (P = 0.52). Influenza-specific antibodies showed a significant increase after vaccination in both groups (at least 1.4-fold, each P textless 0.001, no group differences; P = 0.24-0.97 for different antibody types). Only antibodies toward the Brisbane strain showed a trend toward significant differences in neutralization titers between groups (4-fold (2-17.8) in the 2-h group, 16-fold (4-32.9) in the 26-h group; P = 0.06), whereas other specificities did not differ (P = 0.16-0.72). No intergroup differences were found for side effects; no athlete reported a loss of training time due to the vaccination or its side effects.
CONCLUSION
Infection prophylaxis in elite athletes by influenza vaccination seems to be effective and safe. Timing of vaccination after prior training does not seem to require specific constraints.
Rager, A; Eggers, M; Eilts, B; Klingshirn, A
In: Hauswirtschaft und Wissenschaft, Bd. 68, S. 1, 2020.
@article{Rager.2020,
title = {Entwicklung eines neuen Bioindikatorsystems zur Pr\"{u}fung der Hygienewirkung von Geschirrsp\"{u}lverfahren unter besonderer Ber\"{u}cksichtigung von englumigem Sp\"{u}lgut},
author = {A Rager and M Eggers and B Eilts and A Klingshirn},
doi = {10.23782/HUWtextunderscore 10textunderscore 2020},
year = {2020},
date = {2020-01-01},
journal = {Hauswirtschaft und Wissenschaft},
volume = {68},
pages = {1},
abstract = {Die Aufbereitung von Sp\"{u}lgut aus hygienisch sensiblen Bereichen stellt Einrichtungen wie z. B. Kindertagesst\"{a}tten und Pflegeheime vor Herausforderungen. In Einrichtungen, in denen Menschen mit noch nicht vollst\"{a}ndig ausgebildeter oder eingeschr\"{a}nkter Immunabwehr untergebracht sind, ist die Gew\"{a}hrleistung von hygienisch einwandfreiem Sp\"{u}lgut zur Vermeidung der \"{U}bertragung von Krankheitserregern sicherzustellen. Der Einsatz von Haushaltsgeschirrsp\"{u}lern in hygienisch sensiblen Bereichen wird von \"{U}berwachungsbeh\"{o}rden daher kritisch betrachtet. Mittels eines neuentwickelten Bioindikatorsystems soll die hygienische Aufbereitung von v. a. englumigem Sp\"{u}lgut in Geschirrsp\"{u}lmaschinen in diesen Einrichtungen untersucht werden.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Die Aufbereitung von Spülgut aus hygienisch sensiblen Bereichen stellt Einrichtungen wie z. B. Kindertagesstätten und Pflegeheime vor Herausforderungen. In Einrichtungen, in denen Menschen mit noch nicht vollständig ausgebildeter oder eingeschränkter Immunabwehr untergebracht sind, ist die Gewährleistung von hygienisch einwandfreiem Spülgut zur Vermeidung der Übertragung von Krankheitserregern sicherzustellen. Der Einsatz von Haushaltsgeschirrspülern in hygienisch sensiblen Bereichen wird von Überwachungsbehörden daher kritisch betrachtet. Mittels eines neuentwickelten Bioindikatorsystems soll die hygienische Aufbereitung von v. a. englumigem Spülgut in Geschirrspülmaschinen in diesen Einrichtungen untersucht werden.
Ledo, A; Schub, D; Ziller, C; Enders, M; Stenger, T; Gärtner, BC; Schmidt, T; Meyer, T; Sester, M
In: Brain, behavior, and immunity, Bd. 83, S. 135-145, 2020.
@article{Ledo.2020,
title = {Elite athletes on regular training show more pronounced induction of vaccine-specific T-cells and antibodies after tetravalent influenza vaccination than controls},
author = {A Ledo and D Schub and C Ziller and M Enders and T Stenger and BC G\"{a}rtner and T Schmidt and T Meyer and M Sester},
doi = {10.1016/j.bbi.2019.09.024},
year = {2020},
date = {2020-01-01},
journal = {Brain, behavior, and immunity},
volume = {83},
pages = {135-145},
abstract = {Compliance of elite athletes with vaccination recommendations is low mainly based on concerns about side-effects and perceived poor vaccine efficacy due to continued physical training. We therefore employed seasonal influenza vaccination to investigate the effect of regular physical training on vaccine-induced cellular and humoral immunity in elite athletes and controls. Lymphocyte subpopulations and vaccine-specific T-cells were quantified and functionally characterized from 45 athletes and 25 controls before, and 1, 2 and 26 weeks after vaccination. Moreover, influenza-specific antibodies and their neutralizing function were quantified. Both groups showed a significant increase in vaccine-reactive CD4 T-cell levels which peaked one week after vaccination (p textless 0.0001). The increase was significantly more pronounced in athletes (4.1-fold) compared to controls (2.3-fold; p = 0.0007). The cytokine profile changed from multifunctional T-cells co-producing IFNtextgreekg, IL-2 and TNFtextgree\k{a} to cells with restricted cytokine expression. This change in functionality was associated with a significant increase in CTLA-4 expression (p textless 0.0001), which again was more pronounced in athletes. Likewise, the increase in neutralizing antibodies was stronger in athletes (p = 0.004 for H1N1; p = 0.032 for H3N2). In conclusion, both groups mounted a strong vaccine-specific cellular and humoral immunity after standard vaccination. The more pronounced increase in specific T-cells and neutralizing antibodies indicates that high frequency and intensity of training enhance vaccine-responses in elite athletes.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Compliance of elite athletes with vaccination recommendations is low mainly based on concerns about side-effects and perceived poor vaccine efficacy due to continued physical training. We therefore employed seasonal influenza vaccination to investigate the effect of regular physical training on vaccine-induced cellular and humoral immunity in elite athletes and controls. Lymphocyte subpopulations and vaccine-specific T-cells were quantified and functionally characterized from 45 athletes and 25 controls before, and 1, 2 and 26 weeks after vaccination. Moreover, influenza-specific antibodies and their neutralizing function were quantified. Both groups showed a significant increase in vaccine-reactive CD4 T-cell levels which peaked one week after vaccination (p textless 0.0001). The increase was significantly more pronounced in athletes (4.1-fold) compared to controls (2.3-fold; p = 0.0007). The cytokine profile changed from multifunctional T-cells co-producing IFNtextgreekg, IL-2 and TNFtextgreeą to cells with restricted cytokine expression. This change in functionality was associated with a significant increase in CTLA-4 expression (p textless 0.0001), which again was more pronounced in athletes. Likewise, the increase in neutralizing antibodies was stronger in athletes (p = 0.004 for H1N1; p = 0.032 for H3N2). In conclusion, both groups mounted a strong vaccine-specific cellular and humoral immunity after standard vaccination. The more pronounced increase in specific T-cells and neutralizing antibodies indicates that high frequency and intensity of training enhance vaccine-responses in elite athletes.
2019
Eggers, M
Correction to: Infectious Disease Management and Control with Povidone Iodine Artikel
In: Infectious diseases and therapy, Bd. 8, Nr. 4, S. 595, 2019.
@article{Eggers.2019b,
title = {Correction to: Infectious Disease Management and Control with Povidone Iodine},
author = {M Eggers},
doi = {10.1007/s40121-019-00263-8},
year = {2019},
date = {2019-12-01},
journal = {Infectious diseases and therapy},
volume = {8},
number = {4},
pages = {595},
abstract = {In the original publication, Figure~1 was incorrectly published. The correct figure is given here.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
In the original publication, Figure~1 was incorrectly published. The correct figure is given here.
Eggers, M
Infectious Disease Management and Control with Povidone Iodine Artikel
In: Infectious diseases and therapy, Bd. 8, Nr. 4, S. 581-593, 2019.
@article{Eggers.2019,
title = {Infectious Disease Management and Control with Povidone Iodine},
author = {M Eggers},
doi = {10.1007/s40121-019-00260-x},
year = {2019},
date = {2019-08-01},
journal = {Infectious diseases and therapy},
volume = {8},
number = {4},
pages = {581-593},
abstract = {With reports of vancomycin-resistant enterococci recently emerging in hospital settings, renewed focus is turning to the importance of multifaceted infection prevention efforts. Careful compliance with established hygiene practices by healthcare workers together with effective antiseptic options is essential for the protection of patients from infectious agents. For over 60~years, povidone iodine (PVP-I) formulations have been shown to limit the impact and spread of infectious diseases with potent antiviral, antibacterial and antifungal effects. In addition to a lack of reported resistance, the benefits of PVP-I include an excellent safety profile and a broad spectrum of effect due to its multimodal action. Studies have shown that hand washing with PVP-I-based antiseptics is effective for the decontamination of skin, while PVP-I mouthwashes and gargles significantly reduce viral load in the oral cavity and the oropharynx. The importance of PVP-I has been emphasised by its inclusion in the World Health Organization's list of essential medicines, and high potency for virucidal activity has been observed against viruses of significant global concern, including hepatitis A and influenza, as well as the Middle-East Respiratory Syndrome and Sudden Acute Respiratory Syndrome coronaviruses. Together with its diverse applications in antimicrobial control, broad accessibility across the globe, and outstanding safety and tolerability profile, PVP-I offers an affordable, potent, and widely available antiseptic option.Funding Mundipharma Singapore Holding Pte Limited.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
With reports of vancomycin-resistant enterococci recently emerging in hospital settings, renewed focus is turning to the importance of multifaceted infection prevention efforts. Careful compliance with established hygiene practices by healthcare workers together with effective antiseptic options is essential for the protection of patients from infectious agents. For over 60~years, povidone iodine (PVP-I) formulations have been shown to limit the impact and spread of infectious diseases with potent antiviral, antibacterial and antifungal effects. In addition to a lack of reported resistance, the benefits of PVP-I include an excellent safety profile and a broad spectrum of effect due to its multimodal action. Studies have shown that hand washing with PVP-I-based antiseptics is effective for the decontamination of skin, while PVP-I mouthwashes and gargles significantly reduce viral load in the oral cavity and the oropharynx. The importance of PVP-I has been emphasised by its inclusion in the World Health Organization's list of essential medicines, and high potency for virucidal activity has been observed against viruses of significant global concern, including hepatitis A and influenza, as well as the Middle-East Respiratory Syndrome and Sudden Acute Respiratory Syndrome coronaviruses. Together with its diverse applications in antimicrobial control, broad accessibility across the globe, and outstanding safety and tolerability profile, PVP-I offers an affordable, potent, and widely available antiseptic option.Funding Mundipharma Singapore Holding Pte Limited.
Exler, S; Daiminger, A; Grothe, M; Schalasta, G; Enders, G; Enders, M
In: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, Bd. 117, S. 33–36, 2019.
@article{Exler.2019,
title = {Primary cytomegalovirus (CMV) infection in pregnancy: Diagnostic value of CMV PCR in saliva compared to urine at birth},
author = {S Exler and A Daiminger and M Grothe and G Schalasta and G Enders and M Enders},
doi = {10.1016/j.jcv.2019.05.015},
year = {2019},
date = {2019-05-01},
journal = {Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology},
volume = {117},
pages = {33--36},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Kohmer, N; Nagel, A; Berger, A; Enders, M; Hamprecht, K; Korn, K; Kortenbusch, M; Überla, K; Rabenau, H F
Laboratory diagnosis of congenital CMV infection in newborns: Impact of pre-analytic factors Artikel
In: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, Bd. 115, S. 32–36, 2019.
@article{Kohmer.2019,
title = {Laboratory diagnosis of congenital CMV infection in newborns: Impact of pre-analytic factors},
author = {N Kohmer and A Nagel and A Berger and M Enders and K Hamprecht and K Korn and M Kortenbusch and K \"{U}berla and H F Rabenau},
doi = {10.1016/j.jcv.2019.03.017},
year = {2019},
date = {2019-04-01},
journal = {Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology},
volume = {115},
pages = {32--36},
abstract = {BACKGROUND
To identify infants with congenital cytomegalovirus (cCMV) saliva polymerase chain reaction (PCR) is an ideal screening method. However, there are only few data on the influence of pre-analytic factors on the analytical sensitivity of the CMV PCR.
OBJECTIVES
This study aimed to evaluate the performance of different swabbing materials, transport time and initial virus concentration regarding to the efficacy of recovery of CMV-DNA.
STUDY DESIGN
Two CMV suspensions containing a high or low concentration of the laboratory strain AD 169 were prepared as test samples. Sampling was simulated by immersion of different swabs in these CMV suspensions and storing the swabs dry or in specified transport media. Transport conditions were modeled by storing the samples for defined time periods prior to DNA extraction and quantitative PCR analyses. Parallel analyses in two different laboratories allowed determination of lab to lab consistency.
RESULTS
The duration of storage under the conditions analysed did not have a major effect on the recovery efficiency for the swabbing materials tested. With exception of flocked dry swabs, all tested swabbing materials demonstrated good recovery of CMV DNA. The flocked swab/eNAT system showed the best overall performance.
CONCLUSIONS
All tested swabbing materials (with exception of the flocked dry swabs) seem to be well suited for recovery of CMV DNA and appropriate for use for the diagnosis of cCMV infection in symptomatic cases and in general cCMV screening programs of newborns.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND
To identify infants with congenital cytomegalovirus (cCMV) saliva polymerase chain reaction (PCR) is an ideal screening method. However, there are only few data on the influence of pre-analytic factors on the analytical sensitivity of the CMV PCR.
OBJECTIVES
This study aimed to evaluate the performance of different swabbing materials, transport time and initial virus concentration regarding to the efficacy of recovery of CMV-DNA.
STUDY DESIGN
Two CMV suspensions containing a high or low concentration of the laboratory strain AD 169 were prepared as test samples. Sampling was simulated by immersion of different swabs in these CMV suspensions and storing the swabs dry or in specified transport media. Transport conditions were modeled by storing the samples for defined time periods prior to DNA extraction and quantitative PCR analyses. Parallel analyses in two different laboratories allowed determination of lab to lab consistency.
RESULTS
The duration of storage under the conditions analysed did not have a major effect on the recovery efficiency for the swabbing materials tested. With exception of flocked dry swabs, all tested swabbing materials demonstrated good recovery of CMV DNA. The flocked swab/eNAT system showed the best overall performance.
CONCLUSIONS
All tested swabbing materials (with exception of the flocked dry swabs) seem to be well suited for recovery of CMV DNA and appropriate for use for the diagnosis of cCMV infection in symptomatic cases and in general cCMV screening programs of newborns.
To identify infants with congenital cytomegalovirus (cCMV) saliva polymerase chain reaction (PCR) is an ideal screening method. However, there are only few data on the influence of pre-analytic factors on the analytical sensitivity of the CMV PCR.
OBJECTIVES
This study aimed to evaluate the performance of different swabbing materials, transport time and initial virus concentration regarding to the efficacy of recovery of CMV-DNA.
STUDY DESIGN
Two CMV suspensions containing a high or low concentration of the laboratory strain AD 169 were prepared as test samples. Sampling was simulated by immersion of different swabs in these CMV suspensions and storing the swabs dry or in specified transport media. Transport conditions were modeled by storing the samples for defined time periods prior to DNA extraction and quantitative PCR analyses. Parallel analyses in two different laboratories allowed determination of lab to lab consistency.
RESULTS
The duration of storage under the conditions analysed did not have a major effect on the recovery efficiency for the swabbing materials tested. With exception of flocked dry swabs, all tested swabbing materials demonstrated good recovery of CMV DNA. The flocked swab/eNAT system showed the best overall performance.
CONCLUSIONS
All tested swabbing materials (with exception of the flocked dry swabs) seem to be well suited for recovery of CMV DNA and appropriate for use for the diagnosis of cCMV infection in symptomatic cases and in general cCMV screening programs of newborns.
Kagan, K O; Enders, M; Schampera, M S; Baeumel, E; Hoopmann, M; Geipel, A; Berg, C; Goelz, R; de Catte, L; Wallwiener, D; Brucker, S; Adler, S P; Jahn, G; Hamprecht, K
In: Ultrasound in obstetrics & gynecology, Bd. 53, Nr. 3, S. 383–389, 2019.
@article{Kagan.2019b,
title = {Prevention of maternal-fetal transmission of CMV by hyperimmunoglobulin (HIG) administered after a primary maternal CMV infectionin early gestation},
author = {K O Kagan and M Enders and M S Schampera and E Baeumel and M Hoopmann and A Geipel and C Berg and R Goelz and L de Catte and D Wallwiener and S Brucker and S P Adler and G Jahn and K Hamprecht},
doi = {10.1002/uog.19164},
year = {2019},
date = {2019-03-01},
journal = {Ultrasound in obstetrics \& gynecology},
volume = {53},
number = {3},
pages = {383--389},
abstract = {OBJECTIVE
To examine the efficacy of biweekly hyperimmunoglobulin (HIG) administration to women with first trimester CMV infection for preventing maternal-fetal transmission of CMV.
METHODS
Subjects were 40 pregnant women with a primary CMV infection with a median gestational age at diagnosis of 9.6 weeks with a range of 5.1 to 14.3 weeks' gestation. On average, HIG administration started at 11.1 weeks and continued until 16.6 weeks' gestation. Within this interval, HIG was administered between 2 and 6 times. While CMV IgG monitoring showed periodic fluctuations during biweekly HIG administration cycles, high CMV IgG avidity indices remained stable over the whole treatment period. The results were compared with a historic cohort with first trimester CMV infection without treatment that also had an amniocentesis at about 20 weeks RESULTS: Each subject had amniocentesis performed. Maternal-fetal transmission before amniocentesis occurred in only one of the 40 cases (2.5%, [95% CI:0 - 13.2%]). At delivery, two additional subjects had late gestation transmission. Considering all three cases with maternal-fetal transmission, the transmission rate was 7.5% of 40 cases, [95% CI: 1,6 - 20.4%]). All infected neonates were asymptomatic at birth. Matched historical controls were 108 pregnancies with 38 transmissions (35.2%, [95% CI: 26.2 - 45.0%]), which was significantly higher than in the HIG administration group.
CONCLUSION
After a primary maternal CMV infection in the first trimester, HIG administration prevents maternal-fetal transmission up to 20 weeks of gestation. This article is protected by copyright. All rights reserved.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
OBJECTIVE
To examine the efficacy of biweekly hyperimmunoglobulin (HIG) administration to women with first trimester CMV infection for preventing maternal-fetal transmission of CMV.
METHODS
Subjects were 40 pregnant women with a primary CMV infection with a median gestational age at diagnosis of 9.6 weeks with a range of 5.1 to 14.3 weeks' gestation. On average, HIG administration started at 11.1 weeks and continued until 16.6 weeks' gestation. Within this interval, HIG was administered between 2 and 6 times. While CMV IgG monitoring showed periodic fluctuations during biweekly HIG administration cycles, high CMV IgG avidity indices remained stable over the whole treatment period. The results were compared with a historic cohort with first trimester CMV infection without treatment that also had an amniocentesis at about 20 weeks RESULTS: Each subject had amniocentesis performed. Maternal-fetal transmission before amniocentesis occurred in only one of the 40 cases (2.5%, [95% CI:0 - 13.2%]). At delivery, two additional subjects had late gestation transmission. Considering all three cases with maternal-fetal transmission, the transmission rate was 7.5% of 40 cases, [95% CI: 1,6 - 20.4%]). All infected neonates were asymptomatic at birth. Matched historical controls were 108 pregnancies with 38 transmissions (35.2%, [95% CI: 26.2 - 45.0%]), which was significantly higher than in the HIG administration group.
CONCLUSION
After a primary maternal CMV infection in the first trimester, HIG administration prevents maternal-fetal transmission up to 20 weeks of gestation. This article is protected by copyright. All rights reserved.
To examine the efficacy of biweekly hyperimmunoglobulin (HIG) administration to women with first trimester CMV infection for preventing maternal-fetal transmission of CMV.
METHODS
Subjects were 40 pregnant women with a primary CMV infection with a median gestational age at diagnosis of 9.6 weeks with a range of 5.1 to 14.3 weeks' gestation. On average, HIG administration started at 11.1 weeks and continued until 16.6 weeks' gestation. Within this interval, HIG was administered between 2 and 6 times. While CMV IgG monitoring showed periodic fluctuations during biweekly HIG administration cycles, high CMV IgG avidity indices remained stable over the whole treatment period. The results were compared with a historic cohort with first trimester CMV infection without treatment that also had an amniocentesis at about 20 weeks RESULTS: Each subject had amniocentesis performed. Maternal-fetal transmission before amniocentesis occurred in only one of the 40 cases (2.5%, [95% CI:0 - 13.2%]). At delivery, two additional subjects had late gestation transmission. Considering all three cases with maternal-fetal transmission, the transmission rate was 7.5% of 40 cases, [95% CI: 1,6 - 20.4%]). All infected neonates were asymptomatic at birth. Matched historical controls were 108 pregnancies with 38 transmissions (35.2%, [95% CI: 26.2 - 45.0%]), which was significantly higher than in the HIG administration group.
CONCLUSION
After a primary maternal CMV infection in the first trimester, HIG administration prevents maternal-fetal transmission up to 20 weeks of gestation. This article is protected by copyright. All rights reserved.
Gemein, S; Gebel, J; Christiansen, B; Martiny, H; Vossebein, L; Brill, F H H; Decius, M; Eggers, M; Koburger-Janssen, T; Meckel, M; Werner, S; Hunsinger, B; Selhorst, T; Kampf, G; Exner, M
In: The Journal of hospital infection, Bd. 103, Nr. 1, S. 78–84, 2019.
@article{Gemein.2019,
title = {Interlaboratory reproducibility of a test method following 4-field test methodology to evaluate the susceptibility of Clostridium difficile spores},
author = {S Gemein and J Gebel and B Christiansen and H Martiny and L Vossebein and F H H Brill and M Decius and M Eggers and T Koburger-Janssen and M Meckel and S Werner and B Hunsinger and T Selhorst and G Kampf and M Exner},
doi = {10.1016/j.jhin.2019.04.011},
year = {2019},
date = {2019-01-01},
journal = {The Journal of hospital infection},
volume = {103},
number = {1},
pages = {78--84},
abstract = {BACKGROUND
Sporicidal surface disinfection is recommended to control transmission of Clostridium difficile in healthcare facilities. EN 17126 provides a method to determine the sporicidal activity in suspension and has been approved as a European standard. In addition, a sporicidal surface test has been proposed.
AIM
To determine the interlaboratory reproducibility of a test method for evaluating the susceptibility of a C.~difficile spore preparation to a biocidal formulation following the 4-field test (EN 16615 methodology).
METHODS
Nine laboratories participated. C.~difficile NCTC 13366 spores were used. Glutaraldehyde (1% and 6%; 15 min) and peracetic acid (PAA; 0.01% and 0.04%; 15 min) were used to determine the spores' susceptibility in suspension in triplicate.
FINDINGS
One-percent glutaraldehyde revealed a mean decimal log10 reduction of 1.03 with variable results in the nine laboratories (0.37-1.49) and a reproducibility of 0.38. The effect of 6% glutaraldehyde was stronger (mean: 2.05; range: 0.96-4.29; reproducibility: 0.86). PAA revealed similar results. An exemplary biocidal formulation based on 5% PAA was used at 0.5% (non-effective concentration) and 4% (effective concentration) to determine the sporicidal efficacy (4-field test) under clean conditions in triplicate with a contact time of 15 min. When used at 0.5% it demonstrated an overall log10 reduction of 2.68 (range: 2.35-3.57) and at 4% of 4.61 (range: 3.82-5.71). The residual contamination on the three primarily uncontaminated test fields was textless50 cfu/25 cm2 in one out of nine laboratories (0.5%) and in seven out of nine laboratories (4%).
CONCLUSION
The interlaboratory reproducibility seems to be robust.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND
Sporicidal surface disinfection is recommended to control transmission of Clostridium difficile in healthcare facilities. EN 17126 provides a method to determine the sporicidal activity in suspension and has been approved as a European standard. In addition, a sporicidal surface test has been proposed.
AIM
To determine the interlaboratory reproducibility of a test method for evaluating the susceptibility of a C.~difficile spore preparation to a biocidal formulation following the 4-field test (EN 16615 methodology).
METHODS
Nine laboratories participated. C.~difficile NCTC 13366 spores were used. Glutaraldehyde (1% and 6%; 15 min) and peracetic acid (PAA; 0.01% and 0.04%; 15 min) were used to determine the spores' susceptibility in suspension in triplicate.
FINDINGS
One-percent glutaraldehyde revealed a mean decimal log10 reduction of 1.03 with variable results in the nine laboratories (0.37-1.49) and a reproducibility of 0.38. The effect of 6% glutaraldehyde was stronger (mean: 2.05; range: 0.96-4.29; reproducibility: 0.86). PAA revealed similar results. An exemplary biocidal formulation based on 5% PAA was used at 0.5% (non-effective concentration) and 4% (effective concentration) to determine the sporicidal efficacy (4-field test) under clean conditions in triplicate with a contact time of 15 min. When used at 0.5% it demonstrated an overall log10 reduction of 2.68 (range: 2.35-3.57) and at 4% of 4.61 (range: 3.82-5.71). The residual contamination on the three primarily uncontaminated test fields was textless50 cfu/25 cm2 in one out of nine laboratories (0.5%) and in seven out of nine laboratories (4%).
CONCLUSION
The interlaboratory reproducibility seems to be robust.
Sporicidal surface disinfection is recommended to control transmission of Clostridium difficile in healthcare facilities. EN 17126 provides a method to determine the sporicidal activity in suspension and has been approved as a European standard. In addition, a sporicidal surface test has been proposed.
AIM
To determine the interlaboratory reproducibility of a test method for evaluating the susceptibility of a C.~difficile spore preparation to a biocidal formulation following the 4-field test (EN 16615 methodology).
METHODS
Nine laboratories participated. C.~difficile NCTC 13366 spores were used. Glutaraldehyde (1% and 6%; 15 min) and peracetic acid (PAA; 0.01% and 0.04%; 15 min) were used to determine the spores' susceptibility in suspension in triplicate.
FINDINGS
One-percent glutaraldehyde revealed a mean decimal log10 reduction of 1.03 with variable results in the nine laboratories (0.37-1.49) and a reproducibility of 0.38. The effect of 6% glutaraldehyde was stronger (mean: 2.05; range: 0.96-4.29; reproducibility: 0.86). PAA revealed similar results. An exemplary biocidal formulation based on 5% PAA was used at 0.5% (non-effective concentration) and 4% (effective concentration) to determine the sporicidal efficacy (4-field test) under clean conditions in triplicate with a contact time of 15 min. When used at 0.5% it demonstrated an overall log10 reduction of 2.68 (range: 2.35-3.57) and at 4% of 4.61 (range: 3.82-5.71). The residual contamination on the three primarily uncontaminated test fields was textless50 cfu/25 cm2 in one out of nine laboratories (0.5%) and in seven out of nine laboratories (4%).
CONCLUSION
The interlaboratory reproducibility seems to be robust.
Kagan, K O; Maier, V; Sonek, J; Abele, H; Lüthgens, K; Schmid, M; Wagner, P; Hoopmann, M
In: Fetal diagnosis and therapy, Bd. 45, Nr. 5, S. 317–324, 2019.
@article{Kagan.2019,
title = {False-Positive Rate in First-Trimester Screening Based on Ultrasound and Cell-Free DNA versus First-Trimester Combined Screening with Additional Ultrasound Markers},
author = {K O Kagan and V Maier and J Sonek and H Abele and K L\"{u}thgens and M Schmid and P Wagner and M Hoopmann},
doi = {10.1159/000489121},
year = {2019},
date = {2019-01-01},
journal = {Fetal diagnosis and therapy},
volume = {45},
number = {5},
pages = {317--324},
abstract = {OBJECTIVE
To determine whether screening for trisomy 21 based on first-trimester combined screening (FTCS) with assessment of nasal bone (NB), tricuspid flow (TCF), and ductus venosus flow (DVF) results in similar false-positive rates compared to ultrasound and cell-free DNA (cfDNA) screening.
METHODS
This is a subanalysis of a prospective randomized controlled trial which was performed between October 2015 and December 2016. Pregnant women with a normal first-trimester ultrasound examination at 11 to 13 weeks' gestation were randomized into two groups: (1) FTCS with assessment of the NB, TCF, and DVF (extended FTCS [eFTCS]), and (2) ultrasound + cfDNA screening. The false-positive rate in screening for trisomy 21 was defined as the primary outcome parameter.
RESULTS
The study population consisted of 688 women in each study arm. In the eFTCS group, the median delta fetal nuchal translucency thickness (NT) was 0.0 mm, free beta-hCG and PAPP-A were 0.96 and 1.11 MoM, and NB, TCF, and DVF PIV were abnormal in 0.9, 0.6, and 7.0% cases. In the ultrasound + cfDNA group, the median delta NT was 0.0 mm. In 10 pregnancies the cfDNA analysis was uninformative and the risk of trisomy 21 was based on eFTCS. There were no false-positive cases in the ultrasound + cfDNA group, whereas the false-positive rates were between 0.9 and 2.2% with eFTCS.
CONCLUSION
Screening for trisomy 21 based on ultrasound + cfDNA has a lower false-positive rate than screening based on eFTCS.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
OBJECTIVE
To determine whether screening for trisomy 21 based on first-trimester combined screening (FTCS) with assessment of nasal bone (NB), tricuspid flow (TCF), and ductus venosus flow (DVF) results in similar false-positive rates compared to ultrasound and cell-free DNA (cfDNA) screening.
METHODS
This is a subanalysis of a prospective randomized controlled trial which was performed between October 2015 and December 2016. Pregnant women with a normal first-trimester ultrasound examination at 11 to 13 weeks' gestation were randomized into two groups: (1) FTCS with assessment of the NB, TCF, and DVF (extended FTCS [eFTCS]), and (2) ultrasound + cfDNA screening. The false-positive rate in screening for trisomy 21 was defined as the primary outcome parameter.
RESULTS
The study population consisted of 688 women in each study arm. In the eFTCS group, the median delta fetal nuchal translucency thickness (NT) was 0.0 mm, free beta-hCG and PAPP-A were 0.96 and 1.11 MoM, and NB, TCF, and DVF PIV were abnormal in 0.9, 0.6, and 7.0% cases. In the ultrasound + cfDNA group, the median delta NT was 0.0 mm. In 10 pregnancies the cfDNA analysis was uninformative and the risk of trisomy 21 was based on eFTCS. There were no false-positive cases in the ultrasound + cfDNA group, whereas the false-positive rates were between 0.9 and 2.2% with eFTCS.
CONCLUSION
Screening for trisomy 21 based on ultrasound + cfDNA has a lower false-positive rate than screening based on eFTCS.
To determine whether screening for trisomy 21 based on first-trimester combined screening (FTCS) with assessment of nasal bone (NB), tricuspid flow (TCF), and ductus venosus flow (DVF) results in similar false-positive rates compared to ultrasound and cell-free DNA (cfDNA) screening.
METHODS
This is a subanalysis of a prospective randomized controlled trial which was performed between October 2015 and December 2016. Pregnant women with a normal first-trimester ultrasound examination at 11 to 13 weeks' gestation were randomized into two groups: (1) FTCS with assessment of the NB, TCF, and DVF (extended FTCS [eFTCS]), and (2) ultrasound + cfDNA screening. The false-positive rate in screening for trisomy 21 was defined as the primary outcome parameter.
RESULTS
The study population consisted of 688 women in each study arm. In the eFTCS group, the median delta fetal nuchal translucency thickness (NT) was 0.0 mm, free beta-hCG and PAPP-A were 0.96 and 1.11 MoM, and NB, TCF, and DVF PIV were abnormal in 0.9, 0.6, and 7.0% cases. In the ultrasound + cfDNA group, the median delta NT was 0.0 mm. In 10 pregnancies the cfDNA analysis was uninformative and the risk of trisomy 21 was based on eFTCS. There were no false-positive cases in the ultrasound + cfDNA group, whereas the false-positive rates were between 0.9 and 2.2% with eFTCS.
CONCLUSION
Screening for trisomy 21 based on ultrasound + cfDNA has a lower false-positive rate than screening based on eFTCS.
Enders, M
Zytomegalie, Ringelröteln und Co. - Pränatale Virus-Infektionen Artikel
In: Gynäkologie + Geburtshilfe, Bd. 24, Nr. 3, S. 28–34, 2019.
@article{Enders.2019,
title = {Zytomegalie, Ringelr\"{o}teln und Co. - Pr\"{a}natale Virus-Infektionen},
author = {M Enders},
doi = {10.1007/s15013-019-1729-6},
year = {2019},
date = {2019-01-01},
journal = {Gyn\"{a}kologie + Geburtshilfe},
volume = {24},
number = {3},
pages = {28--34},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Böttcher, S; Diedrich, S; Keeren, K
Increased detection of enterovirus A71 infections, Germany, 2019 Artikel
In: Eurosurveillance, Bd. 24, Nr. 39, S. 30005, 2019.
@article{Bottcher.2019,
title = {Increased detection of enterovirus A71 infections, Germany, 2019},
author = {S B\"{o}ttcher and S Diedrich and K Keeren},
doi = {10.2807/1560-7917.ES.2019.24.39.1900556},
year = {2019},
date = {2019-01-01},
journal = {Eurosurveillance},
volume = {24},
number = {39},
pages = {30005},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
2018
Eggers, M; Koburger-Janssen, T; Eickmann, M; Zorn, J
In: Infectious diseases and therapy, Bd. 7, Nr. 2, S. 249–259, 2018, ISSN: 2193-8229.
@article{Eggers.2018,
title = {In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens},
author = {M Eggers and T Koburger-Janssen and M Eickmann and J Zorn},
doi = {10.1007/s40121-018-0200-7},
issn = {2193-8229},
year = {2018},
date = {2018-01-01},
journal = {Infectious diseases and therapy},
volume = {7},
number = {2},
pages = {249--259},
abstract = {INTRODUCTION
Recent virus epidemics and rising antibiotic resistance highlight the importance of hygiene measures to prevent and control outbreaks. We investigated the in vitro bactericidal and virucidal efficacy of povidone-iodine (PVP-I) 7% gargle/mouthwash at defined dilution against oral and respiratory tract pathogens.
METHODS
PVP-I was tested against Klebsiella pneumoniae and Streptococcus pneumoniae according to bactericidal quantitative suspension test EN13727 and against severe acute respiratory syndrome and Middle East respiratory syndrome coronaviruses (SARS-CoV and MERS-CoV), rotavirus strain Wa and influenza virus A subtype H1N1 according to virucidal quantitative suspension test EN14476. PVP-I 7% gargle/mouthwash was diluted 1:30 with water to a concentration of 0.23% (the recommended concentration for textquotedblreal-lifetextquotedbl use in Japan) and tested at room temperature under clean conditions [0.3~g/l bovine serum albumin (BSA), viruses only] and dirty conditions (3.0~g/l BSA + 3.0~ml/l erythrocytes) as an interfering substance for defined contact times (minimum 15~s). Rotavirus was tested without protein load. A $geq$ 5 log10 (99.999%) decrease of bacteria and $geq$ 4 log10 (99.99%) reduction in viral titre represented effective bactericidal and virucidal activity, respectively, per European standards.
RESULTS
PVP-I gargle/mouthwash diluted 1:30 (equivalent to a concentration of 0.23% PVP-I) showed effective bactericidal activity against Klebsiella pneumoniae and Streptococcus pneumoniae and rapidly inactivated SARS-CoV, MERS-CoV, influenza virus A (H1N1) and rotavirus after 15~s of exposure.
CONCLUSION
PVP-I 7% gargle/mouthwash showed rapid bactericidal activity and virucidal efficacy in vitro at a concentration of 0.23% PVP-I and may provide a protective oropharyngeal hygiene measure for individuals at high risk of exposure to oral and respiratory pathogens.
FUNDING
Mundipharma Research GmbH \& Co. KG (MRG).},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
INTRODUCTION
Recent virus epidemics and rising antibiotic resistance highlight the importance of hygiene measures to prevent and control outbreaks. We investigated the in vitro bactericidal and virucidal efficacy of povidone-iodine (PVP-I) 7% gargle/mouthwash at defined dilution against oral and respiratory tract pathogens.
METHODS
PVP-I was tested against Klebsiella pneumoniae and Streptococcus pneumoniae according to bactericidal quantitative suspension test EN13727 and against severe acute respiratory syndrome and Middle East respiratory syndrome coronaviruses (SARS-CoV and MERS-CoV), rotavirus strain Wa and influenza virus A subtype H1N1 according to virucidal quantitative suspension test EN14476. PVP-I 7% gargle/mouthwash was diluted 1:30 with water to a concentration of 0.23% (the recommended concentration for textquotedblreal-lifetextquotedbl use in Japan) and tested at room temperature under clean conditions [0.3~g/l bovine serum albumin (BSA), viruses only] and dirty conditions (3.0~g/l BSA + 3.0~ml/l erythrocytes) as an interfering substance for defined contact times (minimum 15~s). Rotavirus was tested without protein load. A $geq$ 5 log10 (99.999%) decrease of bacteria and $geq$ 4 log10 (99.99%) reduction in viral titre represented effective bactericidal and virucidal activity, respectively, per European standards.
RESULTS
PVP-I gargle/mouthwash diluted 1:30 (equivalent to a concentration of 0.23% PVP-I) showed effective bactericidal activity against Klebsiella pneumoniae and Streptococcus pneumoniae and rapidly inactivated SARS-CoV, MERS-CoV, influenza virus A (H1N1) and rotavirus after 15~s of exposure.
CONCLUSION
PVP-I 7% gargle/mouthwash showed rapid bactericidal activity and virucidal efficacy in vitro at a concentration of 0.23% PVP-I and may provide a protective oropharyngeal hygiene measure for individuals at high risk of exposure to oral and respiratory pathogens.
FUNDING
Mundipharma Research GmbH & Co. KG (MRG).
Recent virus epidemics and rising antibiotic resistance highlight the importance of hygiene measures to prevent and control outbreaks. We investigated the in vitro bactericidal and virucidal efficacy of povidone-iodine (PVP-I) 7% gargle/mouthwash at defined dilution against oral and respiratory tract pathogens.
METHODS
PVP-I was tested against Klebsiella pneumoniae and Streptococcus pneumoniae according to bactericidal quantitative suspension test EN13727 and against severe acute respiratory syndrome and Middle East respiratory syndrome coronaviruses (SARS-CoV and MERS-CoV), rotavirus strain Wa and influenza virus A subtype H1N1 according to virucidal quantitative suspension test EN14476. PVP-I 7% gargle/mouthwash was diluted 1:30 with water to a concentration of 0.23% (the recommended concentration for textquotedblreal-lifetextquotedbl use in Japan) and tested at room temperature under clean conditions [0.3~g/l bovine serum albumin (BSA), viruses only] and dirty conditions (3.0~g/l BSA + 3.0~ml/l erythrocytes) as an interfering substance for defined contact times (minimum 15~s). Rotavirus was tested without protein load. A $geq$ 5 log10 (99.999%) decrease of bacteria and $geq$ 4 log10 (99.99%) reduction in viral titre represented effective bactericidal and virucidal activity, respectively, per European standards.
RESULTS
PVP-I gargle/mouthwash diluted 1:30 (equivalent to a concentration of 0.23% PVP-I) showed effective bactericidal activity against Klebsiella pneumoniae and Streptococcus pneumoniae and rapidly inactivated SARS-CoV, MERS-CoV, influenza virus A (H1N1) and rotavirus after 15~s of exposure.
CONCLUSION
PVP-I 7% gargle/mouthwash showed rapid bactericidal activity and virucidal efficacy in vitro at a concentration of 0.23% PVP-I and may provide a protective oropharyngeal hygiene measure for individuals at high risk of exposure to oral and respiratory pathogens.
FUNDING
Mundipharma Research GmbH & Co. KG (MRG).
Eggers, M; Koburger-Janssen, T; Ward, L S; Newby, C; Müller, S
In: Infectious diseases and therapy, Bd. 7, Nr. 2, S. 235–247, 2018, ISSN: 2193-8229.
@article{Eggers.2018b,
title = {Bactericidal and Virucidal Activity of Povidone-Iodine and Chlorhexidine Gluconate Cleansers in an In Vivo Hand Hygiene Clinical Simulation Study},
author = {M Eggers and T Koburger-Janssen and L S Ward and C Newby and S M\"{u}ller},
doi = {10.1007/s40121-018-0202-5},
issn = {2193-8229},
year = {2018},
date = {2018-01-01},
journal = {Infectious diseases and therapy},
volume = {7},
number = {2},
pages = {235--247},
abstract = {INTRODUCTION
Standard in vitro and in vivo tests help demonstrate efficacy of hand hygiene products; however, there is no standard in vivo test method for viruses. We investigated the bactericidal and virucidal efficacy of povidone-iodine (PVP-I) 7.5% scalp and skin cleanser, chlorhexidine gluconate (CHG) 4% hand cleanser and the reference hand wash (soft soap) in 15 healthy volunteers following European Standard EN1499 (hygienic hand wash test method for bacteria), which was adapted for virucidal testing.
METHODS
Separate test series were performed for bactericidal (Escherichia coli) and virucidal [murine norovirus (MNV)] testing. After pre-washing and artificial contamination of hands with test organisms, volunteers underwent testing with 3 and 5~mL of each product for contact times of 15, 30 and 60~s according to a Latin-square randomization. The number of test organisms released from fingertips into sampling fluids was assessed before and after hand washing and mean log10 reduction factor (RF) was calculated. RFs (test-reference) were compared using a Wilcoxon-Wilcox multiple comparisons test per EN1499; efficacy was concluded if p $\leq$ 0.01.
RESULTS
PVP-I 7.5% and CHG 4% cleansers both passed EN1499 requirements against E. coli, with statistically significantly greater (p $\leq$ 0.01) mean log10 RFs compared with reference soft soap across all tests (PVP-I: 4.09-5.27; CHG: 4.12-5.22; soap: 2.75-3.11). The experimental design using EN1499 was applicable to testing with MNV as discriminatory and reproducible results were generated. Mean log10 RFs of MNV were statistically significantly greater for PVP-I (1.57-2.57) compared with soft soap (1.24-1.62), while mean log10 RFs with CHG (0.90-1.34) were lower than for soft soap across all tests.
CONCLUSION
PVP-I 7.5% cleanser showed superior efficacy against MNV compared to soft soap and CHG 4% cleanser, while both PVP-I and CHG were superior to soft soap against E. coli. The experimental set-up may be applicable to future testing for antiviral hand washes.
FUNDING
Mundipharma Manufacturing Pte Ltd. Plain language summary available for this article.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
INTRODUCTION
Standard in vitro and in vivo tests help demonstrate efficacy of hand hygiene products; however, there is no standard in vivo test method for viruses. We investigated the bactericidal and virucidal efficacy of povidone-iodine (PVP-I) 7.5% scalp and skin cleanser, chlorhexidine gluconate (CHG) 4% hand cleanser and the reference hand wash (soft soap) in 15 healthy volunteers following European Standard EN1499 (hygienic hand wash test method for bacteria), which was adapted for virucidal testing.
METHODS
Separate test series were performed for bactericidal (Escherichia coli) and virucidal [murine norovirus (MNV)] testing. After pre-washing and artificial contamination of hands with test organisms, volunteers underwent testing with 3 and 5~mL of each product for contact times of 15, 30 and 60~s according to a Latin-square randomization. The number of test organisms released from fingertips into sampling fluids was assessed before and after hand washing and mean log10 reduction factor (RF) was calculated. RFs (test-reference) were compared using a Wilcoxon-Wilcox multiple comparisons test per EN1499; efficacy was concluded if p $łeq$ 0.01.
RESULTS
PVP-I 7.5% and CHG 4% cleansers both passed EN1499 requirements against E. coli, with statistically significantly greater (p $łeq$ 0.01) mean log10 RFs compared with reference soft soap across all tests (PVP-I: 4.09-5.27; CHG: 4.12-5.22; soap: 2.75-3.11). The experimental design using EN1499 was applicable to testing with MNV as discriminatory and reproducible results were generated. Mean log10 RFs of MNV were statistically significantly greater for PVP-I (1.57-2.57) compared with soft soap (1.24-1.62), while mean log10 RFs with CHG (0.90-1.34) were lower than for soft soap across all tests.
CONCLUSION
PVP-I 7.5% cleanser showed superior efficacy against MNV compared to soft soap and CHG 4% cleanser, while both PVP-I and CHG were superior to soft soap against E. coli. The experimental set-up may be applicable to future testing for antiviral hand washes.
FUNDING
Mundipharma Manufacturing Pte Ltd. Plain language summary available for this article.
Standard in vitro and in vivo tests help demonstrate efficacy of hand hygiene products; however, there is no standard in vivo test method for viruses. We investigated the bactericidal and virucidal efficacy of povidone-iodine (PVP-I) 7.5% scalp and skin cleanser, chlorhexidine gluconate (CHG) 4% hand cleanser and the reference hand wash (soft soap) in 15 healthy volunteers following European Standard EN1499 (hygienic hand wash test method for bacteria), which was adapted for virucidal testing.
METHODS
Separate test series were performed for bactericidal (Escherichia coli) and virucidal [murine norovirus (MNV)] testing. After pre-washing and artificial contamination of hands with test organisms, volunteers underwent testing with 3 and 5~mL of each product for contact times of 15, 30 and 60~s according to a Latin-square randomization. The number of test organisms released from fingertips into sampling fluids was assessed before and after hand washing and mean log10 reduction factor (RF) was calculated. RFs (test-reference) were compared using a Wilcoxon-Wilcox multiple comparisons test per EN1499; efficacy was concluded if p $łeq$ 0.01.
RESULTS
PVP-I 7.5% and CHG 4% cleansers both passed EN1499 requirements against E. coli, with statistically significantly greater (p $łeq$ 0.01) mean log10 RFs compared with reference soft soap across all tests (PVP-I: 4.09-5.27; CHG: 4.12-5.22; soap: 2.75-3.11). The experimental design using EN1499 was applicable to testing with MNV as discriminatory and reproducible results were generated. Mean log10 RFs of MNV were statistically significantly greater for PVP-I (1.57-2.57) compared with soft soap (1.24-1.62), while mean log10 RFs with CHG (0.90-1.34) were lower than for soft soap across all tests.
CONCLUSION
PVP-I 7.5% cleanser showed superior efficacy against MNV compared to soft soap and CHG 4% cleanser, while both PVP-I and CHG were superior to soft soap against E. coli. The experimental set-up may be applicable to future testing for antiviral hand washes.
FUNDING
Mundipharma Manufacturing Pte Ltd. Plain language summary available for this article.
Kagan, K O; Sroka, F; Sonek, J; Abele, H; Lüthgens, K; Schmid, M; Wagner, P; Brucker, S; Wallwiener, D; Hoopmann, M
In: Ultrasound in obstetrics & gynecology, Bd. 51, Nr. 4, S. 437–444, 2018, ISSN: 0960-7692.
@article{Kagan.2018,
title = {First-trimester risk assessment based on ultrasound and cell-free DNA vs combined screening: a randomized controlled trial},
author = {K O Kagan and F Sroka and J Sonek and H Abele and K L\"{u}thgens and M Schmid and P Wagner and S Brucker and D Wallwiener and M Hoopmann},
doi = {10.1002/uog.18905},
issn = {0960-7692},
year = {2018},
date = {2018-01-01},
journal = {Ultrasound in obstetrics \& gynecology},
volume = {51},
number = {4},
pages = {437--444},
abstract = {OBJECTIVE
This was a randomized controlled trial to compare risk assessment by first-trimester combined screening (FTCS) with an approach that combines a detailed ultrasound examination at 11-13 weeks' gestation and cell-free DNA (cfDNA) analysis.
METHODS
Pregnant women with a normal first-trimester ultrasound examination at 11-13 weeks' gestation (fetal nuchal translucency (NT)~$\leq$ 3.5 mm and no fetal defects) were randomized into one of two groups. In the first group, risk of aneuploidy was assessed using FTCS based on the most recent UK Fetal Medicine Foundation algorithm. In the second group, risk assessment was based on ultrasound findings and cfDNA analysis. An additional tube of blood was collected for FTCS in case the cfDNA analysis was uninformative. Primary outcome was false-positive rate in screening for trisomy 21. A case was considered false positive if the karyotype was not trisomy 21 and if the risk for trisomy 21 was textgreater1:100, irrespective of the method of risk calculation. Results were compared using 95% CIs using the Clopper-Pearson method.
RESULTS
Between October 2015 and December 2016, 1518 women with singleton pregnancy underwent first-trimester screening. Thirty-one (2.0%) pregnancies were not eligible for randomization due to increased NT (textgreater 3.5 mm) and/or fetal defect. After exclusion of women who declined randomization (n~= 87) and cases of fetal death and loss to follow-up (n~= 24), 688 pregnancies were randomized into the FTCS arm and 688 into the ultrasound + cfDNA analysis arm. There were no differences in maternal and gestational age, maternal weight and BMI, ethnicity, use of assisted reproduction and cigarette smoking between the two arms. In the ultrasound + cfDNA analysis arm, median risk for trisomy 21 was 1 in 10 000. None of the cases had a risk above 1: 100 (95% CI, 0.0-0.5%). In the FTCS arm, the median risk for trisomy 21 was 1 in 3787 and in 17 cases, the risk was higher than 1:100, which corresponds to 2.5% (95% CI, 1.5-3.9%) of the FTCS study-arm population.
CONCLUSION
Our study has shown that first-trimester risk assessment for trisomy 21 that includes a detailed ultrasound examination as well as NT measurement and is followed by cfDNA testing is associated with a significant reduction in the false-positive rate compared with FTCS. This approach obviates the need for maternal serum free textgreekb-human chorionic gonadotropin and pregnancy-associated plasma protein-A in screening for fetal aneuploidy. Copyright copyright 2017 ISUOG. Published by John Wiley \& Sons Ltd.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
OBJECTIVE
This was a randomized controlled trial to compare risk assessment by first-trimester combined screening (FTCS) with an approach that combines a detailed ultrasound examination at 11-13 weeks' gestation and cell-free DNA (cfDNA) analysis.
METHODS
Pregnant women with a normal first-trimester ultrasound examination at 11-13 weeks' gestation (fetal nuchal translucency (NT)~$łeq$ 3.5 mm and no fetal defects) were randomized into one of two groups. In the first group, risk of aneuploidy was assessed using FTCS based on the most recent UK Fetal Medicine Foundation algorithm. In the second group, risk assessment was based on ultrasound findings and cfDNA analysis. An additional tube of blood was collected for FTCS in case the cfDNA analysis was uninformative. Primary outcome was false-positive rate in screening for trisomy 21. A case was considered false positive if the karyotype was not trisomy 21 and if the risk for trisomy 21 was textgreater1:100, irrespective of the method of risk calculation. Results were compared using 95% CIs using the Clopper-Pearson method.
RESULTS
Between October 2015 and December 2016, 1518 women with singleton pregnancy underwent first-trimester screening. Thirty-one (2.0%) pregnancies were not eligible for randomization due to increased NT (textgreater 3.5 mm) and/or fetal defect. After exclusion of women who declined randomization (n~= 87) and cases of fetal death and loss to follow-up (n~= 24), 688 pregnancies were randomized into the FTCS arm and 688 into the ultrasound + cfDNA analysis arm. There were no differences in maternal and gestational age, maternal weight and BMI, ethnicity, use of assisted reproduction and cigarette smoking between the two arms. In the ultrasound + cfDNA analysis arm, median risk for trisomy 21 was 1 in 10 000. None of the cases had a risk above 1: 100 (95% CI, 0.0-0.5%). In the FTCS arm, the median risk for trisomy 21 was 1 in 3787 and in 17 cases, the risk was higher than 1:100, which corresponds to 2.5% (95% CI, 1.5-3.9%) of the FTCS study-arm population.
CONCLUSION
Our study has shown that first-trimester risk assessment for trisomy 21 that includes a detailed ultrasound examination as well as NT measurement and is followed by cfDNA testing is associated with a significant reduction in the false-positive rate compared with FTCS. This approach obviates the need for maternal serum free textgreekb-human chorionic gonadotropin and pregnancy-associated plasma protein-A in screening for fetal aneuploidy. Copyright copyright 2017 ISUOG. Published by John Wiley & Sons Ltd.
This was a randomized controlled trial to compare risk assessment by first-trimester combined screening (FTCS) with an approach that combines a detailed ultrasound examination at 11-13 weeks' gestation and cell-free DNA (cfDNA) analysis.
METHODS
Pregnant women with a normal first-trimester ultrasound examination at 11-13 weeks' gestation (fetal nuchal translucency (NT)~$łeq$ 3.5 mm and no fetal defects) were randomized into one of two groups. In the first group, risk of aneuploidy was assessed using FTCS based on the most recent UK Fetal Medicine Foundation algorithm. In the second group, risk assessment was based on ultrasound findings and cfDNA analysis. An additional tube of blood was collected for FTCS in case the cfDNA analysis was uninformative. Primary outcome was false-positive rate in screening for trisomy 21. A case was considered false positive if the karyotype was not trisomy 21 and if the risk for trisomy 21 was textgreater1:100, irrespective of the method of risk calculation. Results were compared using 95% CIs using the Clopper-Pearson method.
RESULTS
Between October 2015 and December 2016, 1518 women with singleton pregnancy underwent first-trimester screening. Thirty-one (2.0%) pregnancies were not eligible for randomization due to increased NT (textgreater 3.5 mm) and/or fetal defect. After exclusion of women who declined randomization (n~= 87) and cases of fetal death and loss to follow-up (n~= 24), 688 pregnancies were randomized into the FTCS arm and 688 into the ultrasound + cfDNA analysis arm. There were no differences in maternal and gestational age, maternal weight and BMI, ethnicity, use of assisted reproduction and cigarette smoking between the two arms. In the ultrasound + cfDNA analysis arm, median risk for trisomy 21 was 1 in 10 000. None of the cases had a risk above 1: 100 (95% CI, 0.0-0.5%). In the FTCS arm, the median risk for trisomy 21 was 1 in 3787 and in 17 cases, the risk was higher than 1:100, which corresponds to 2.5% (95% CI, 1.5-3.9%) of the FTCS study-arm population.
CONCLUSION
Our study has shown that first-trimester risk assessment for trisomy 21 that includes a detailed ultrasound examination as well as NT measurement and is followed by cfDNA testing is associated with a significant reduction in the false-positive rate compared with FTCS. This approach obviates the need for maternal serum free textgreekb-human chorionic gonadotropin and pregnancy-associated plasma protein-A in screening for fetal aneuploidy. Copyright copyright 2017 ISUOG. Published by John Wiley & Sons Ltd.
Rauch, S; Doescher, A; Bald, R
D blocking phenomenon overcome Artikel
In: Transfusion, Bd. 58, Nr. 6, S. 1338–1339, 2018.
@article{Rauch.2018,
title = {D blocking phenomenon overcome},
author = {S Rauch and A Doescher and R Bald},
doi = {10.1111/trf.14496},
year = {2018},
date = {2018-01-01},
journal = {Transfusion},
volume = {58},
number = {6},
pages = {1338--1339},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Wiesmann, F; Ehret, R; Naeth, G; Däumer, M; Fuhrmann, J; Kaiser, R; Noah, C; Obermeier, M; Schalasta, G; Tiemann, C; Wolf, E; Knechten, H; Braun, P
In: Journal of clinical microbiology, Bd. 56, Nr. 10, 2018, ISSN: 0095-1137.
@article{Wiesmann.2018,
title = {Multicenter Evaluation of Two Next-Generation HIV-1 Quantitation Assays, Aptima Quant Dx and Cobas 6800, in Comparison to the RealTime HIV-1 Reference Assay},
author = {F Wiesmann and R Ehret and G Naeth and M D\"{a}umer and J Fuhrmann and R Kaiser and C Noah and M Obermeier and G Schalasta and C Tiemann and E Wolf and H Knechten and P Braun},
doi = {10.1128/JCM.00292-18},
issn = {0095-1137},
year = {2018},
date = {2018-01-01},
journal = {Journal of clinical microbiology},
volume = {56},
number = {10},
abstract = {High accuracy and precision at the lower end of quantification are crucial requirements of a modern HIV viral load (VL) assay, since some clinically relevant thresholds are located at 50 and 200 copies/ml. In this study, we compared the performance of two new fully automated HIV-1 VL assays, Aptima HIV-1 Quant Dx and Cobas HIV-1 (Cobas 6800), with the established RealTime m2000 assay. Assay precision and accuracy were evaluated in a retrospective evaluation out of excess plasma material from four HIV-1+ individuals (subtypes B, C, CRF01_AE, and CRF02_AG). Native plasma samples were diluted to nominal concentrations at 50 and 200 copies/ml (according to the RealTime m2000 assay). All dilutions were tested in triplicate in five independent runs over 5 days and in three labs per system. Assay concordance was determined using 1,011 surplus clinical routine samples, as well as selected retrospective longitudinal samples from 7 patients on treatment. The three assays yielded highly concordant results for individual clinical samples (R2 textgreater 0.98; average difference, $\leq$0.2 log copies/ml) and retrospective longitudinal samples from patients on treatment. The Aptima and RealTime assays showed similar high precision, meeting the 5textgreeks criterion for the majority of samples across all labs and subtypes. The Cobas assay was less precise, missing the 5textgreeks criterion for the majority of samples at low concentrations. In this analysis, results from the Cobas assay appeared less reliable near the clinically relevant cutoff and should be interpreted with more caution in this context. Due to high precision, full automation, and high concordance with the RealTime assay, the Aptima assay represents a good alternative in routine VL monitoring.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
High accuracy and precision at the lower end of quantification are crucial requirements of a modern HIV viral load (VL) assay, since some clinically relevant thresholds are located at 50 and 200 copies/ml. In this study, we compared the performance of two new fully automated HIV-1 VL assays, Aptima HIV-1 Quant Dx and Cobas HIV-1 (Cobas 6800), with the established RealTime m2000 assay. Assay precision and accuracy were evaluated in a retrospective evaluation out of excess plasma material from four HIV-1+ individuals (subtypes B, C, CRF01_AE, and CRF02_AG). Native plasma samples were diluted to nominal concentrations at 50 and 200 copies/ml (according to the RealTime m2000 assay). All dilutions were tested in triplicate in five independent runs over 5 days and in three labs per system. Assay concordance was determined using 1,011 surplus clinical routine samples, as well as selected retrospective longitudinal samples from 7 patients on treatment. The three assays yielded highly concordant results for individual clinical samples (R2 textgreater 0.98; average difference, $łeq$0.2 log copies/ml) and retrospective longitudinal samples from patients on treatment. The Aptima and RealTime assays showed similar high precision, meeting the 5textgreeks criterion for the majority of samples across all labs and subtypes. The Cobas assay was less precise, missing the 5textgreeks criterion for the majority of samples at low concentrations. In this analysis, results from the Cobas assay appeared less reliable near the clinically relevant cutoff and should be interpreted with more caution in this context. Due to high precision, full automation, and high concordance with the RealTime assay, the Aptima assay represents a good alternative in routine VL monitoring.
