Direct comparison of clinical diagnostic sensitivity of saliva from buccal swabs versus combined oro-/nasopharyngeal swabs in the detection of SARS-CoV-2 B.1.1.529 Omicron

Background/Purpose: While current guidelines recommend the use of respiratory tract specimens for the direct detection of SARS-CoV-2 infection, saliva has recently been suggested as preferred sample type for the sensitive detection of SARS-CoV-2 B.1.1.529 (Omicron). By comparing saliva collected using buccal swabs and oro-/ nasopharyngeal swabs from patients hospitalized due to COVID-19, we aimed at identifying potential differences in virus detection sensitivity between these sample types. Methods: We compare the clinical diagnostic sensitivity of paired buccal swabs and combined oro-/nasopha- ryngeal swabs from hospitalized, symptomatic COVID-19 patients collected at median six days after symptom onset by real-time polymerase chain reaction (PCR) and antigen test. Results: Of the tested SARS-CoV-2 positive sample pairs, 55.8% were identified as SARS-CoV-2 Omicron BA.1 and 44.2% as Omicron BA.2. Real-time PCR from buccal swabs generated significantly higher quantification cycle (Cq) values compared to those from matched combined oro-/nasopharyngeal swabs and resulted in an increased number of false-negative PCR results. Reduced diagnostic sensitivity of buccal swabs by real-time PCR was observed already at day one after symptom onset. Similarly, antigen test detection rates were reduced in buccal swabs compared to combined oro-/nasopharyngeal swabs. Conclusion: Our results suggest reduced clinical diagnostic sensitivity of saliva collected using buccal swabs when compared to combined oro-/nasopharyngeal swabs in the detection of SARS-CoV-2 Omicron in symptomatic individualsGraphische Zusammenfassung, als Datei angehängt.Peer Reviewe

Spektrum diagnostischer Proben zum Nachweis von SARS-CoV-2

Prinzipiell können zum Nachweis von SARS-CoV-2 bei nicht beatmeten Patientinnen und Patienten Pro¬ben von mehreren Orten entnommen werden. Methode der Wahl ist der vom Fachpersonal entnommene oropharyngeale, nasopharyngeale oder kombinierte Abstrich. Diese Proben können jedoch auch von Patientinnen und Patienten selbst abgenommen werden, was zahlreiche Vorteile birgt (z. B. die Vermeidung einer Virusübertragung auf das Personal). Das Epidemiologische Bulletin 17/2021 gibt anhand einer Literaturübersicht und Studienergebnissen des RKI einen Überblick über die prinzipiell zur Verfügung stehenden Probenahmeorte und -modi. Darüber hinaus werden von Patientinnen und Patienten selbst abgenommene Proben in Hinblick auf Praktikabilität und Akzeptanz mit den vom Fachpersonal abgenommenen Proben vergleichen

Proposed Mobility Assessments with Simultaneous Full-Body Inertial Measurement Units and Optical Motion Capture in Healthy Adults and Neurological Patients for Future Validation Studies: Study Protocol

Healthy adults and neurological patients show unique mobility patterns over the course of their lifespan and disease. Quantifying these mobility patterns could support diagnosing, tracking disease progression and measuring response to treatment. This quantification can be done with wearable technology, such as inertial measurement units (IMUs). Before IMUs can be used to quantify mobility, algorithms need to be developed and validated with age and disease-specific datasets. This study proposes a protocol for a dataset that can be used to develop and validate IMU-based mobility algorithms for healthy adults (18–60 years), healthy older adults (>60 years), and patients with Parkinson’s disease, multiple sclerosis, a symptomatic stroke and chronic low back pain. All participants will be measured simultaneously with IMUs and a 3D optical motion capture system while performing standardized mobility tasks and non-standardized activities of daily living. Specific clinical scales and questionnaires will be collected. This study aims at building the largest dataset for the development and validation of IMU-based mobility algorithms for healthy adults and neurological patients. It is anticipated to provide this dataset for further research use and collaboration, with the ultimate goal to bring IMU-based mobility algorithms as quickly as possible into clinical trials and clinical routine

Seroepidemiological study on the spread of SARS-CoV-2 in Germany:

The SARS-CoV-2 coronavirus has spread rapidly across Germany. Infections are likely to be under-recorded in the notification data from local health authorities on laboratory-confirmed cases since SARS-CoV-2 infections can proceed with few symptoms and then often remain undetected. Seroepidemiological studies allow the estimation of the proportion in the population that has been infected with SARS-CoV-2 (seroprevalence) as well as the extent of undetected infections. The ‘CORONA-MONITORING bundesweit’ study (RKI-SOEP study) collects biospecimens and interview data in a nationwide population sample drawn from the German Socio-Economic Panel (SOEP). Participants are sent materials to self-collect a dry blood sample of capillary blood from their finger and a swab sample from their mouth and nose, as well as a questionnaire. The samples returned are tested for SARS-CoV-2 IgG antibodies and SARS-CoV-2 RNA to identify past or present infections. The methods applied enable the identification of SARS-CoV-2 infections, including those that previously went undetected. In addition, by linking the data collected with available SOEP data, the study has the potential to investigate social and health-related differences in infection status. Thus, the study contributes to an improved understanding of the extent of the epidemic in Germany, as well as identification of target groups for infection protection

SARS-CoV-2 Transmissibility Within Day Care Centers—Study Protocol of a Prospective Analysis of Outbreaks in Germany

Introduction: Until today, the role of children in the transmission dynamics of SARS-CoV-2 and the development of the COVID-19 pandemic seems to be dynamic and is not finally resolved. The primary aim of this study is to investigate the transmission dynamics of SARS-CoV-2 in child day care centers and connected households as well as transmission-related indicators and clinical symptoms among children and adults. Methods and Analysis: COALA (“Corona outbreak-related examinations in day care centers”) is a day care center- and household-based study with a case-ascertained study design. Based on day care centers with at least one reported case of SARS-CoV-2, we include one- to six-year-old children and staff of the affected group in the day care center as well as their respective households. We visit each child's and adult's household. During the home visit we take from each household member a combined mouth and nose swab as well as a saliva sample for analysis of SARS-CoV-2-RNA by real-time reverse transcription polymerase chain reaction (real-time RT-PCR) and a capillary blood sample for a retrospective assessment of an earlier SARS-CoV-2 infection. Furthermore, information on health status, socio-demographics and COVID-19 protective measures are collected via a short telephone interview in the subsequent days. In the following 12 days, household members (or parents for their children) self-collect the same respiratory samples as described above every 3 days and a stool sample for children once. COVID-19 symptoms are documented daily in a symptom diary. Approximately 35 days after testing the index case, every participant who tested positive for SARS-CoV-2 during the study is re-visited at home for another capillary blood sample and a standardized interview. The analysis includes secondary attack rates, by age of primary case, both in the day care center and in households, as well as viral shedding dynamics, including the beginning of shedding relative to symptom onset and viral clearance. Discussion: The results contribute to a better understanding of the epidemiological and virological transmission-related indicators of SARS-CoV-2 among young children, as compared to adults and the interplay between day care and households.Peer Reviewe

Seroepidemiologische Studie zur bundesweiten Verbreitung von SARS-CoV-2 in Deutschland: Studienprotokoll von CORONA-MONITORING bundesweit (RKI-SOEP-Studie)

Das Coronavirus SARS-CoV-2 hat sich in kurzer Zeit bundesweit ausgebreitet. In den Meldedaten der Gesundheitsämter zu laborbestätigten Infektionsfällen ist von einer Untererfassung des Infektionsgeschehens auszugehen, da Infektionen häufig unentdeckt bleiben, zum Beispiel weil sie symptomarm verlaufen. In seroepidemiologischen Studien kann der Bevölkerungsanteil mit durchgemachter SARS-CoV-2-Infektion (Seroprävalenz) wie auch der Umfang unentdeckter Infektionen abgeschätzt werden. In der Studie CORONA-MONITORING bundesweit (RKI-SOEP-Studie) werden Bioproben und Befragungsdaten in einer deutschlandweiten Bevölkerungsstichprobe des Sozio-oekonomischen Panels (SOEP) erhoben. Den Teilnehmenden werden Materialien zur selbstständigen Gewinnung einer Trockenblutprobe aus Kapillarblut des Fingers und einer Abstrichprobe aus Mund und Nase sowie ein Fragebogen postalisch zugesendet. Die zurückgesendeten Proben werden auf SARS-CoV-2-IgG-Antikörper und SARS-CoV-2-RNA zur Identifikation einer durchgemachten oder aktuellen Infektion untersucht. Die eingesetzten Methoden ermöglichen es, auch solche SARS-CoV-2-Infektionen zu erkennen, die bislang unentdeckt blieben. Durch die Verknüpfung mit bereits vorhandenen SOEP-Daten hat die Studie das Potenzial, auch soziale und gesundheitsbezogene Unterschiede im Infektionsstatus zu untersuchen. So kann die Studie zu einem verbesserten Verständnis des Ausmaßes der Epidemie in Deutschland wie auch zur Identifikation von Zielgruppen für den Infektionsschutz beitragen

Measures to cope with the COVID-19 pandemic in Germany: nonpharmaceutical and pharmaceutical interventions

Beim ersten Auftreten des Erregers SARS-CoV‑2 im Dezember 2019 standen weder spezifische therapeutische Möglichkeiten noch ein Impfstoff zur Verfügung. Auch in Deutschland rückten deshalb nichtpharmakologische Maßnahmen zur Kontrolle der COVID-19-Pandemie in den Vordergrund. Am Robert Koch-Institut wurde eine Multikomponentenstrategie aus bevölkerungsbasierten und individuellen infektionshygienischen Maßnahmen entwickelt, die auf bestehenden Influenzapandemieplänen und generischen Planungen aufbaute. Der Beitrag erläutert die empfohlenen nichtpharmakologischen Maßnahmen und stellt die parallel entwickelten pharmakologischen Ansätze dar. Zu den bevölkerungsbasierten Maßnahmen gehören u. a. allgemeine Kontaktbeschränkungen, die Versorgung mit Materialien für den Infektionsschutz, Veranstaltungsverbote, die Schließung von Bildungseinrichtungen und die Beschränkung des Reiseverkehrs. Zusätzlich sind individuelle infektionshygienische Maßnahmen notwendig: z. B. Einhaltung eines Mindestabstands, Reduktion von Kontakten, Tragen einer Mund-Nasen-Bedeckung sowie Einhaltung von Quarantäne und Isolierung. Die Maßnahmen im Gesundheitswesen bauen auf Empfehlungen der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) auf und werden von den Fachgesellschaften spezifiziert und implementiert. Als pharmakologische Maßnahmen stehen mit Stand November 2020 eine antivirale Therapie mit Remdesivir und die Behandlung mit dem Glucocorticoid Dexamethason zur Verfügung. Monoklonale Antikörper sind zu diesem Zeitpunkt noch nicht zugelassen. Die therapeutische Antikoagulation wird empfohlen. Die Empfehlungen werden kontinuierlich an die wachsende Kenntnis der Eigenschaften und Übertragungswege des Erregers angepasst. Eine große Herausforderung besteht darin, das Vertrauen der Bevölkerung in die empfohlenen Maßnahmen zu stärken. Viele Maßnahmen müssen individuell angewandt werden, um gemeinsam zu wirken.When the emerging novel SARS-CoV‑2 virus first appeared in December 2019, neither specific therapeutic options nor vaccinations were available. The role of nonpharmaceutical interventions (NPIs) became of central importance. At the Robert Koch Institute, a multilayer strategy consisting of population-based and individual preventive measures to control the pandemic was developed, which built upon existing influenza pandemic plans as well as generic plans. This paper explains the recommended NPIs and illustrates the pharmaceutical approaches developed in parallel. Among others, general contact bans, providing material for infection prevention and control, ban of events, closing educational institutions, and restricting travel are counted among population-based measures. Additional individual preventive measures are necessary, e.g., keeping a minimum distance, reducing contacts, and wearing a mouth–nose covering as well as quarantine and isolation. Measures within the health system are based on recommendations of the Commission on Hospital Hygiene and Infection Protection (Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO)) and specified and implemented by professional societies. Since November 2020, an antiviral therapy with remdesivir and treatment with the glucocorticoid dexamethasone have been available as pharmaceutical interventions. Monoclonal antibodies are at this time not approved. Therapeutic anticoagulation is recommended. Recommendations are constantly adapted to the increasing knowledge on the pathogen and its means of transmission. A challenge is to strengthen the trust of the population. Many measures have to be applied on an individual basis in order to work together.Peer Reviewe

Das Lagemanagement des Robert Koch-Instituts während der COVID-19-Pandemie und der Austausch zwischen Bund und Ländern

The Robert Koch Institute (RKI) plays a central role in Germany in the management of health hazards of biological origin. The RKI's crisis management aims to contribute to protecting the health of the population in Germany in significant epidemic situations and to maintain the RKI's working ability over a long period of time even under high load. This article illustrates the crisis management of the RKI in general as well as during the COVID-19 pandemic. The generic RKI crisis management structures and the setup of the RKI emergency operations centre (EOC), their operationalisation in the context of the COVID-19 pandemic and the resulting challenges as of 31 October 2020 are described in this paper. The exchange between the federal and state governments during the pandemic is also described.The COVID-19 pandemic has led to extraordinary circumstances. During the epidemic situation, good communication and coordination has been essential, both within the RKI and with other federal or state authorities and expert groups. Under great pressure, the RKI produces and regularly updates recommendations, statements and assessments on various topics. To provide operational support for all COVID-19 related activities, an EOC was activated at the RKI. During the COVID-19 pandemic, there are various challenges regarding personnel and structures. It became apparent that good preparation (e.g. existing task descriptions and premises) has an important positive impact on crisis management