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1. Ten rapid antigen tests for SARS-CoV-2 widely differ in their ability to detect Omicron-BA.4 and -BA.5

Author

Krenn, Franziska, Dächert, Christopher, Badell, Irina, Lupoli, Gaia, Öztan, Gamze Naz, Feng, Tianle, Schneider, Nikolas, Huber, Melanie, Both, Hanna, Späth, Patricia M., Muenchhoff, Maximilian, Graf, Alexander, Krebs, Stefan, Blum, Helmut, Durner, Jürgen, Czibere, Ludwig, Kaderali, Lars, Keppler, Oliver T., Baldauf, Hanna-Mari, and Osterman, Andreas

Published
2023
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2. Automated antigen assays display a high heterogeneity for the detection of SARS-CoV-2 variants of concern, including several Omicron sublineages

Author

Osterman, Andreas, Krenn, Franziska, Iglhaut, Maximilian, Badell, Irina, Lehner, Andreas, Späth, Patricia M., Stern, Marcel, Both, Hanna, Bender, Sabine, Muenchhoff, Maximilian, Graf, Alexander, Krebs, Stefan, Blum, Helmut, Grimmer, Timo, Durner, Jürgen, Czibere, Ludwig, Dächert, Christopher, Grzimek-Koschewa, Natascha, Protzer, Ulrike, Kaderali, Lars, Baldauf, Hanna-Mari, and Keppler, Oliver T.

Published
2023
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4. Variable detection of Omicron-BA.1 and -BA.2 by SARS-CoV-2 rapid antigen tests

Author

Osterman, Andreas, Badell, Irina, Dächert, Christopher, Schneider, Nikolas, Kaufmann, Anna-Yasemin, Öztan, Gamze Naz, Huber, Melanie, Späth, Patricia M., Stern, Marcel, Autenrieth, Hanna, Muenchhoff, Maximilian, Graf, Alexander, Krebs, Stefan, Blum, Helmut, Czibere, Ludwig, Durner, Jürgen, Kaderali, Lars, Baldauf, Hanna‑Mari, and Keppler, Oliver T.

Published
2023
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6. Impaired detection of omicron by SARS-CoV-2 rapid antigen tests

Author

Osterman, Andreas, Badell, Irina, Basara, Elif, Stern, Marcel, Kriesel, Fabian, Eletreby, Marwa, Öztan, Gamze Naz, Huber, Melanie, Autenrieth, Hanna, Knabe, Ricarda, Späth, Patricia M., Muenchhoff, Maximilian, Graf, Alexander, Krebs, Stefan, Blum, Helmut, Durner, Jürgen, Czibere, Ludwig, Dächert, Christopher, Kaderali, Lars, Baldauf, Hanna-Mari, and Keppler, Oliver T.

Published
2022
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8. Time as a significant factor in the release of potassium from lithium heparin plasma and serum.

Author

Reuter, Tom, Müller, Michael, Stelter, Felix, Durner, Jürgen, and Kramer, Jan

Subjects
BLOOD collection, HOSPITAL patients, OUTPATIENT medical care, POTASSIUM, HEPARIN
Abstract

Objectives: In most countries the majority of patients are in outpatient care. In difference to hospitalized patients, their blood samples often take hours after collection to centrifugation. The study investigates the release of potassium and the development of pseudohyperkalemia in lithium heparin (Li-Hep) and serum blood collection tubes over time. Methods: From 201 donors 4 serum and 4 Li-Hep blood collection tubes were taken each. After 0.5, 4, 6 and 8h whole blood was centrifuged, and potassium levels were determined. To simulate the preanalytic conditions, the samples with a storage time >0.5h were shaken on a standard shaker for 1h and stored at 4–8°C for the remaining time. Results: Over time, significant more potassium was released before centrifugation from the Li-Hep plasma than from serum (1.21 vs 0.94 mmol/L). After 6h, the two groups were no longer highly statistically significantly different (potassium mean: 5.01 mmol/L in serum group, 4.92 mmol/L in Li-Hep group). In the Li-Hep group 164 donors developed a pseudohyperkalemia after 8h, compared to 76 in the serum group. Significance: The decision as to which material is best suited should not only be based on which value comes closest to the physiological situation immediately after blood collection. The subsequent preanalytic circumstances must also be considered. Serum tubes appear to be at least as suitable for potassium determination as Li-Hep tubes. In terms of patient blood management, serum provides the possibility of performing a wider range of analyses in the outpatient setting. [ABSTRACT FROM AUTHOR]

Published
2024
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13. A Modular Genetic Approach to Newborn Screening from Spinal Muscular Atrophy to Sickle Cell Disease—Results from Six Years of Genetic Newborn Screening.

Author

Bzdok, Jessica, Czibere, Ludwig, Burggraf, Siegfried, Pauly, Natalie, Maier, Esther M., Röschinger, Wulf, Becker, Marc, and Durner, Jürgen

Subjects
SPINAL muscular atrophy, SEVERE combined immunodeficiency, SICKLE cell anemia, GENETIC testing, NEWBORN screening
Abstract

Background/Objectives: Genetic newborn screening (NBS) has already entered the phase of common practice in many countries. In Germany, spinal muscular atrophy (SMA), severe combined immunodeficiency (SCID) and sickle cell disease (SCD) are currently a mandatory part of NBS. Here, we describe the experience of six years of genetic NBS including the prevalence of those three diseases in Germany. Methods: Samples and nucleic acids were extracted from dried blood spot cards, commonly used for NBS. A qPCR assay was used to detect disease-causing variants for SMA and SCD, and the detection of T-cell receptor excision circles (TRECs) was performed for SCID screening. Results: The results of the NBS of over 1 million newborns for SMA, approximately 770,000 for SCID and over 410,000 for SCD are discussed in detail. In these newborns, we have identified 121 cases of SMA, 15 cases of SCID and syndrome-based immunodeficiencies and 77 cases of SCD or β-thalassemia. Conclusions: The flexibility of multiplex qPCR is assessed as an effective tool for incorporating different molecular genetic markers for screening. The processing of dried blood spot (DBS) filter cards for molecular genetic assays and the assays are described in detail; turn-around times and cost estimations are included to give an insight into the processes and discuss further options for optimization. The identified cases are in the range expected for the total number of screened newborns, but present a more exact view on the actual prevalences for Germany. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Quality considerations and major pitfalls for high throughput DNA-based newborn screening for severe combined immunodeficiency and spinal muscular atrophy.

Author

Bzdok, Jessica, Czibere, Ludwig, Burggraf, Siegfried, Landt, Olfert, Maier, Esther M., Röschinger, Wulf, Albert, Michael H., Hegert, Sebastian, Janzen, Nils, Becker, Marc, and Durner, Jürgen

Subjects
SEVERE combined immunodeficiency, SPINAL muscular atrophy, NEWBORN screening, T cell receptors, AUDIOMETRY, SICKLE cell anemia, T cells
Abstract

Background: Many newborn screening programs worldwide have introduced screening for diseases using DNA extracted from dried blood spots (DBS). In Germany, DNA-based assays are currently used to screen for severe combined immunodeficiency (SCID), spinal muscular atrophy (SMA), and sickle cell disease (SCD). Methods: This study analysed the impact of pre-analytic DNA carry-over in sample preparation on the outcome of DNA-based newborn screening for SCID and SMA and compared the efficacy of rapid extraction versus automated protocols. Additionally, the distribution of T cell receptor excision circles (TREC) on DBS cards, commonly used for routine newborn screening, was determined. Results: Contaminations from the punching procedure were detected in the SCID and SMA assays in all experimental setups tested. However, a careful evaluation of a cut-off allowed for a clear separation of true positive polymerase chain reaction (PCR) amplifications. Our rapid in-house extraction protocol produced similar amounts compared to automated commercial systems. Therefore, it can be used for reliable DNA-based screening. Additionally, the amount of extracted DNA significantly differs depending on the location of punching within a DBS. Conclusions: Newborn screening for SMA and SCID can be performed reliably. It is crucial to ensure that affected newborns are not overlooked. Therefore a carefully consideration of potential contaminating factors and the definition of appropriate cut-offs to minimise the risk of false results are of special concern. It is also important to note that the location of punching plays a pivotal role, and therefore an exact quantification of TREC numbers per μl may not be reliable and should therefore be avoided. [ABSTRACT FROM AUTHOR]

Published
2024
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22. High Throughput Newborn Screening for Sickle Cell Disease – Application of Two-Tiered Testing with a qPCR-Based Primary screen

Author

Janda, Joachim, primary, Hegert, Sebastian, primary, Bzdok, Jessica, additional, Tesorero, Rafael, additional, Holtkamp, Ute, additional, Burggraf, Siegfried, additional, Schuhmann, Elfriede, additional, Hörster, Friedrike, additional, Hoffmann, Georg F., additional, Janzen, Nils, additional, Okun, Jürgen G, additional, Becker, Marc, additional, and Durner, Jürgen, additional

Published
2023
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24. The representative COVID-19 cohort Munich (KoCo19): from the beginning of the pandemic to the Delta virus variant

Author

Le Gleut, Ronan, Plank, Michael, Pütz, Peter, Radon, Katja, Bakuli, Abhishek, Rubio-Acero, Raquel, Paunovic, Ivana, Rieß, Friedrich, Winter, Simon, Reinkemeyer, Christina, Schälte, Yannik, Olbrich, Laura, Hannes, Marlene, Kroidl, Inge, Noreña, Ivan, Janke, Christian, Wieser, Andreas, Hoelscher, Michael, Fuchs, Christiane, Castelletti, Noemi, Ahmed, Mohamed Ibraheem Mohamed, Alamoudi, Emad, Anderson, Jared, Baldassarre, Valeria, Baumann, Maximilian, Becker, Marc, Bednarski, Franziska, Behlen, Marieke, Bemirayev, Olimbek, Beyerl, Jessica, Bitzer, Patrick, Böhnlein, Rebecca, Brand, Isabel, Brauer, Anna, Britz, Vera, Bruger, Jan, Bünz, Franziska, Caroli, Friedrich, Coleman, Josephine, Contento, Lorenzo, Czwienzek, Alina, Deák, Flora, Diefenbach, Maximilian N., Diepers, Paulina, Do, Anna, Dobler, Gerhard, Durner, Jürgen, Eser, Tabea, Eberle, Ute, Eckstein, Judith, Falk, Philine, Feyereisen, Manuela, Fingerle, Volker, Fischer, Stefanie, Frese, Jonathan, Forster, Felix, Fröschl, Günter, Geisenberger, Otto, Garí, Mercè, Gasser, Marius, Gauder, Sonja, Geier, Raffaela, Gillig, Kristina, Geldmacher, Christof, Gezgin, Keisha, Gilberg, Leonard, Girl, Philipp, Golschan, Elias, Grauvogl, Vitus, Noller, Jessica Michelle Guggenbuehl, Guglielmini, Elena Maria, Gutierrez, Pablo, Haderer, Anselm, Halfmann, Celina, Hartinger, Lena, Haselwarter, Timm, Hasenauer, Jan, Hernandez, Alejandra, Heller, Luca, Heiber, Arlett, Herrmann, Matthias, Hillari, Leah, Hillmann, Stefan, Hinske, Christian, Hoefflin, Janna, Hofberger, Tim, Höfinger, Michael, Hofmann, Larissa, Horn, Sacha, Huber, Kristina, Karger, Lilian, Kappl, Ursula, Keßler, Antonia, Khan, Zohaib, Kiani, Charlotte, Klugherz, Isabel, Kreider, Norah, Kresin, Johanna, Kroidl, Arne, Kunder, Pratik, Lang, Magdalena, Lang, Clemens, Lange, Silvan, Lapteva, Ekaterina, Laxy, Michael, Leidl, Reiner, Liedl, Leopold, Lindner, Felix, Lucaj, Xhovana, Lucke, Elisabeth, Luppa, Fabian, Nafziger, Alexandra Sophie, Maczka, Alexander, Mang, Petra, Markgraf, Alisa, Matcau, Paula, Mayrhofer, Rebecca, Mekota, Anna-Maria, Metaxa, Dafni, Mohr, Emily, Müller, Hannah, Müller, Katharina, Nascimento, Nathalia, Niermeyer, Kasimir, Nikolaides, Sophia, Pattard, Leonie, Pleimelding, Claire, Pletschette, Michel, Poll, Viona, Prückner, Stephan, Puchinger, Kerstin, Pusl, Konstantin, Raimúndez, Elba, Raschka, Julius, Reich, Jakob, Rothe, Camilla, Ruci, Viktoria, Saathoff, Elmar, Schäfer, Nicole, Schandelmaier, Paul, Schluse, Benedikt, Schneider, Annika, Schneider, Lara, Schultz, Sophie, Schunk, Mirjam, Schwettmann, Lars, Sedlmeier, Josefin, Sintu-Sempta, Linda, Soler, Alba, Sothmann, Peter, Strobl, Katharina, Strüber, Aida, Strüber, Laura, Tang, Jeni, Theis, Fabian, Thiel, Verena, Thumser, Eva, Thur, Niklas, Ullrich, Julian, Vollmayr, Vincent, Von Lovenberg, Emilia, Von Lovenberg, Jonathan, Vos, Carsten, Waibel, Julia, Wallrauch, Claudia, Weigl, Nikolas, Wölfl, Roman, Wolff, Julia, Wullinger, Pia, Würfel, Tobias, Wustrow, Patrick, Zange, Sabine, Zeggini, Eleftheria, Zielke, Anna, Zimmer, Thorbjörn, Zimmermann, Thomas, and Zuche, Lea

Abstract

**Background** Population-based serological studies allow to estimate prevalence of SARS-CoV-2 infections despite a substantial number of mild or asymptomatic disease courses. This became even more relevant for decision making after vaccination started. The KoCo19 cohort tracks the pandemic progress in the Munich general population for over two years, setting it apart in Europe. **Methods** Recruitment occurred during the initial pandemic wave, including 5313 participants above 13 years from private households in Munich. Four follow-ups were held at crucial times of the pandemic, with response rates of at least 70%. Participants filled questionnaires on socio-demographics and potential risk factors of infection. From Follow-up 2, information on SARS-CoV-2 vaccination was added. SARS-CoV-2 antibody status was measured using the Roche Elecsys® Anti-SARS-CoV-2 anti-N assay (indicating previous infection) and the Roche Elecsys® Anti-SARS-CoV-2 anti-S assay (indicating previous infection and/or vaccination). This allowed us to distinguish between sources of acquired antibodies. **Results** The SARS-CoV-2 estimated cumulative sero-prevalence increased from 1.6% (1.1-2.1%) in May 2020 to 14.5% (12.7-16.2%) in November 2021. Underreporting with respect to official numbers fluctuated with testing policies and capacities, becoming a factor of more than two during the second half of 2021. Simultaneously, the vaccination campaign against the SARS-CoV-2 virus increased the percentage of the Munich population having antibodies, with 86.8% (85.5-87.9%) having developed anti-S and/or anti-N in November 2021. Incidence rates for infections after (BTI) and without previous vaccination (INS) differed (ratio INS/BTI of 2.1, 0.7-3.6). However, the prevalence of infections was higher in the non-vaccinated population than in the vaccinated one. Considering the whole follow-up time, being born outside Germany, working in a high-risk job and living area per inhabitant were identified as risk factors for infection, while other socio-demographic and health-related variables were not. Although we obtained significant within-household clustering of SARS-CoV-2 cases, no further geospatial clustering was found. **Conclusions** Vaccination increased the coverage of the Munich population presenting SARS-CoV-2 antibodies, but breakthrough infections contribute to community spread. As underreporting stays relevant over time, infections can go undetected, so non-pharmaceutical measures are crucial, particularly for highly contagious strains like Omicron.

Published
2023
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25. Newbornscreening SMA – From Pilot Project to Nationwide Screening in Germany

Author

Müller-Felber, Wolfgang, primary, Blaschek, Astrid, additional, Schwartz, Oliver, additional, Gläser, Dieter, additional, Nennstiel, Uta, additional, Brockow, Inken, additional, Wirth, Brunhilde, additional, Burggraf, Siegfried, additional, Röschinger, Wulf, additional, Becker, Marc, additional, Durner, Jürgen, additional, Eggermann, Katja, additional, Kölbel, Heike, additional, Müller, Christine, additional, Hannibal, Iris, additional, Olgemöller, Bernd, additional, Schara, Ulrike, additional, von Moers, Arpad, additional, Trollmann, Regina, additional, Johannssen, Jessika, additional, Ziegler, Andreas, additional, Cirak, Sebahattin, additional, Hahn, Andreas, additional, von der Hagen, Maja, additional, Weiss, Claudia, additional, Schreiber, Gudrun, additional, Flotats-Bastardas, Marina, additional, Hartmann, Hans, additional, Illsinger, Sabine, additional, Pechmann, Astrid, additional, Horber, Veronka, additional, Kirschner, Jan, additional, Köhler, Cornelia, additional, Winter, Benedikt, additional, Friese, Johannes, additional, and Vill, Katharina, additional

Published
2023
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26. Variable detection of Omicron-BA.1 and -BA.2 by SARS-CoV-2 rapid antigen tests

Author

Osterman, Andreas, primary, Badell, Irina, additional, Dächert, Christopher, additional, Schneider, Nikolas, additional, Kaufmann, Anna-Yasemin, additional, Öztan, Gamze Naz, additional, Huber, Melanie, additional, Späth, Patricia M., additional, Stern, Marcel, additional, Autenrieth, Hanna, additional, Muenchhoff, Maximilian, additional, Graf, Alexander, additional, Krebs, Stefan, additional, Blum, Helmut, additional, Czibere, Ludwig, additional, Durner, Jürgen, additional, Kaderali, Lars, additional, Baldauf, Hanna‑Mari, additional, and Keppler, Oliver T., additional

Published
2022
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29. Infants Diagnosed with Spinal Muscular Atrophy and 4 SMN2 Copies through Newborn Screening – Opportunity or Burden?

Author

Müller-Felber, Wolfgang, Vill, Katharina, Schwartz, Oliver, Gläser, Dieter, Nennstiel, Uta, Wirth, Brunhilde, Burggraf, Siegfried, Röschinger, Wulf, Becker, Marc, Durner, Jürgen, Eggermann, Katja, Müller, Christine, Hannibal, Iris, Olgemöller, Bernd, Schara, Ulrike, Blaschek, Astrid, and Kölbel, Heike

Subjects
Male, Research Report, newborn screening, Medizin, Infant, Newborn, Infant, Pilot Projects, Spinal muscular atrophy, Survival of Motor Neuron 1 Protein, Pedigree, nervous system diseases, Muscular Atrophy, Spinal, Survival of Motor Neuron 2 Protein, Neonatal Screening, survival motor neuron gene, Germany, Humans, Female, Erratum, Follow-Up Studies, SMN2
Abstract

Although the value of newborn screening (NBS) for early detection and treatment opportunity in SMA patients is generally accepted, there is still an ongoing discussion about the best strategy in children with 4 and more copies of the SMN2 gene. This gene is known to be the most important but not the only disease modifier. In our SMA-NBS pilot project in Germany comprising 278,970 infants screened between January 2018 and November 2019 were 38 positive cases with a homozygous SMN1 deletion. 40% of them had 4 or more SMN2 copies. The incidence for homozygous SMN1 deletion was 1 : 7350, which is within the known range of SMA incidence in Germany. Of the 15 SMA children with 4 SMN2 copies, one child developed physical signs of SMA by the age of 8 months. Reanalysis of the SMN2 copy number by a different test method revealed 3 copies. Two children had affected siblings with SMA Type III, who were diagnosed only after detection of the index patient in the NBS. One had a positive family history with an affected aunt (onset of disease at the age of 3 years). Three families were lost to medical follow up; two because of socioeconomic reasons and one to avoid the psychological stress associated with the appointments. Decisions on how to handle patients with 4 SMN2 copies are discussed in the light of the experience gathered from our NBS pilot SMA program.

Published
2020

30. The interplay of viral loads, clinical presentation, and serological responses in SARS-CoV-2 – Results from a prospective cohort of outpatient COVID-19 cases

Author

Puchinger, Kerstin, primary, Castelletti, Noemi, additional, Rubio-Acero, Raquel, additional, Geldmacher, Christof, additional, Eser, Tabea M., additional, Deák, Flora, additional, Paunovic, Ivana, additional, Bakuli, Abhishek, additional, Saathoff, Elmar, additional, von Meyer, Alexander, additional, Markgraf, Alisa, additional, Falk, Philine, additional, Reich, Jakob, additional, Riess, Friedrich, additional, Girl, Philipp, additional, Müller, Katharina, additional, Radon, Katja, additional, Guggenbuehl Noller, Jessica Michelle, additional, Wölfel, Roman, additional, Hoelscher, Michael, additional, Kroidl, Inge, additional, Wieser, Andreas, additional, Olbrich, Laura, additional, Alamoudi, Emad, additional, Anderson, Jared, additional, Baumann, Maximilian, additional, Behlen, Marieke, additional, Beyerl, Jessica, additional, Böhnlein, Rebecca, additional, Brauer, Anna, additional, Britz, Vera, additional, Bruger, Jan, additional, Caroli, Friedrich, additional, Contento, Lorenzo, additional, Diekmannshemke, Jana, additional, Do, Anna, additional, Dobler, Gerhard, additional, Eberle, Ute, additional, Eckstein, Judith, additional, Frese, Jonathan, additional, Forster, Felix, additional, Frahnow, Turid, additional, Fröschl, Günter, additional, Geisenberger, Otto, additional, Gillig, Kristina, additional, Heiber, Arlett, additional, Hinske, Christian, additional, Hoefflin, Janna, additional, Hofberger, Tim, additional, Höfinger, Michael, additional, Hofmann, Larissa, additional, Horn, Sacha, additional, Huber, Kristina, additional, Janke, Christian, additional, Kappl, Ursula, additional, Kiani, Charlotte, additional, Kroidl, Arne, additional, Laxy, Michael, additional, Leidl, Reiner, additional, Lindner, Felix, additional, Mayrhofer, Rebecca, additional, Mekota, Anna-Maria, additional, Müller, Hannah, additional, Metaxa, Dafni, additional, Pattard, Leonie, additional, Pletschette, Michel, additional, Prückner, Stephan, additional, Pusl, Konstantin, additional, Raimúndez, Elba, additional, Rothe, Camila, additional, Schäfer, Nicole, additional, Schandelmaier, Paul, additional, Schneider, Lara, additional, Schultz, Sophie, additional, Schunk, Mirjam, additional, Schwettmann, Lars, additional, Seibold, Heidi, additional, Sothmann, Peter, additional, Stapor, Paul, additional, Theis, Fabian, additional, Thiel, Verena, additional, Thiesbrummel, Sophie, additional, Thur, Niklas, additional, Waibel, Julia, additional, Wallrauch, Claudia, additional, Winter, Simon, additional, Wolff, Julia, additional, Wullinger, Pia, additional, Yaqine, Houda, additional, Zange, Sabine, additional, Zeggini, Eleftheria, additional, Zimmermann, Thomas, additional, Zielke, Anna, additional, Ibraheem, Mohamed, additional, Ahmed, Mohamed, additional, Becker, Marc, additional, Diepers, Paulina, additional, Schälte, Yannik, additional, Garí, Mercè, additional, Pütz, Peter, additional, Pritsch, Michael, additional, Fingerle, Volker, additional, Le Gleut, Ronan, additional, Gilberg, Leonard, additional, Brand, Isabel, additional, Diefenbach, Max, additional, Eser, Tabea, additional, Weinauer, Franz, additional, Martin, Silke, additional, Quenzel, Ernst-Markus, additional, Durner, Jürgen, additional, Fuchs, Christiane, additional, and Hasenauer, Jan, additional

Published
2022
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32. Additional file 1 of Newborn screening for spinal muscular atrophy in Germany: clinical results after 2 years

Author

Vill, Katharina, Schwartz, Oliver, Blaschek, Astrid, Gläser, Dieter, Nennstiel, Uta, Wirth, Brunhilde, Burggraf, Siegfried, Röschinger, Wulf, Becker, Marc, Czibere, Ludwig, Durner, Jürgen, Eggermann, Katja, Olgemöller, Bernhard, Harms, Erik, Schara, Ulrike, Kölbel, Heike, and Müller-Felber, Wolfgang

Abstract

Additional file 1. Table S1: Age at first consultation at the treatment center or at collection of thesecond blood sample, discrepancy in SMN2 estimation, early-onset symptoms, and initial resultsfrom electrophysiology and CHOP INTEND. Y = years, mo = months, d = days, neg = negative,pos = positive.

Published
2021
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33. Spatially resolved qualified sewage spot sampling to track SARS-CoV-2 dynamics in Munich - One year of experience

Author

Raquel Rubio-Acero, Jessica Beyerl, Maximilian Muenchhoff, Marc Sancho Roth, Noemi Castelletti, Ivana Paunovic, Katja Radon, Bernd Springer, Christian Nagel, Bernhard Boehm, Merle M. Böhmer, Alexander Graf, Helmut Blum, Stefan Krebs, Oliver T. Keppler, Andreas Osterman, Zohaib Nisar Khan, Michael Hoelscher, Andreas Wieser, Alamoudi Emad, Anderson Jared, Bakuli Abhishek, Baumann Maxilmilian, Becker Marc, Bednarzki Franziska, Bemirayev Olimbek, Beyerl Jessica, Bitzer Patrick, Böhnlein Rebecca, Brand Isabel, Bruger Jan, Caroli Friedrich, Castelletti Noemi, Coleman Josephine, Contento Lorenzo, Czwienzek Alina, Deák Flora, N. Diefenbach Maximilian, Diekmannshemke Jana, Dobler Gerhard, Durner Jürgen, Eberle Ute, Eckstein Judith, Eser Tabea, Falk Philine, Feyereisen Manuela, Fingerle Volker, Forster Felix, Frahnow Turid, Frese Jonathan, Fröschl Günter, Fuchs Christiane, Garí Mercè, Geisenberger Otto, Geldmacher Christof, Gilberg Leonard, Gillig Kristina, Girl Philipp, Golschan Elias, Guggenbuehl Noller Jessica Michelle, Guglielmini Elena Maria, Gutierrez Pablo, Haderer Anslem, Hannes Marlene, Hartinger Lena, Hasenauer Jan, Hernandez Alejandra, Hillari Leah, Hinske Christian, Hofberger Tim, Hölscher Michael, Horn Sacha, Huber Kristina, Janke Christian, Kappl Ursula, Keßler Antonia, Khan Zohaib, Kresin Johanna, Kroidl Inge, Kroidl Arne, Lang Magdalena, Lang Clemens, Lange Silvan, Laxy Michael, Le Gleut Ronan, Leidl Reiner, Liedl Leopold, Lucaj Xhovana, Luppa Fabian, Nafziger Alexandra Sophie, Mang Petra, Markgraf Alisa, Mayrhofer Rebecca, Metaxa Dafni, Müller Hannah, Müller Katharina, Olbrich Laura, Paunovic Ivana, Plank Michael, Pleimelding Claire, Pletschette Michel, Pritsch Michael, Prückner Stephan, Puchinger Kerstin, Pütz Peter, Radon Katja, Raimundéz Elba, Reich Jakob, Riess Friedrich, Rothe Camilla, Rubio-Acero Raquel, Ruci Viktoria, Saathoff Elmar, Schäfer Nicole, Schälte Yannik, Schluse Benedikt, Schneider Lara, Schunk Mirjam, Schwettmann Lars, Soler Alba, Sothmann Peter, Strobl Kathrin, Tang Jeni, Theis Fabian, Thiel Verena, Thiesbrummel Sophie, Vollmayr Vincent, Von Lovenberg Emilia, Von Lovenberg Jonathan, Waibel Julia, Wallrauch Claudia, Wieser Andreas, Winter Simon, Wölfel Roman, Wolff Julia, Würfel Tobias, Zange Sabine, Zeggini Eleftheria, Zielke Anna, and Zimmer Thorbjörn

Subjects
Environmental Engineering, Population, Sewage, Wastewater, Track (rail transport), Article, Pandemic, Environmental Chemistry, Humans, Sequencing, education, B.1.1.7, Waste Management and Disposal, education.field_of_study, Surveillance, business.industry, SARS-CoV-2, Incidence (epidemiology), Sampling (statistics), COVID-19, Pollution, Metropolitan area, Geography, PCR, RNA, Viral, business, Cartography, Viral load
Abstract

Wastewater-based epidemiology (WBE) is a tool now increasingly proposed to monitor the SARS-CoV-2 burden in populations without the need for individual mass testing. It is especially interesting in metropolitan areas where spread can be very fast, and proper sewage systems are available for sampling with short flow times and thus little decay of the virus. We started in March 2020 to set up a once-a-week qualified spot sampling protocol in six different locations in Munich carefully chosen to contain primarily wastewater of permanent residential areas, rather than industry or hospitals. We used RT-PCR and sequencing to track the spread of SARS-CoV-2 in the Munich population with temporo-spatial resolution. The study became fully operational in mid-April 2020 and has been tracking SARS-CoV-2 RNA load weekly for one year. Sequencing of the isolated viral RNA was performed to obtain information about the presence and abundance of variants of concern in the Munich area over time. We demonstrate that the evolution of SARS-CoV-2 RNA loads (between, Graphical abstract Unlabelled Image

Published
2021

34. Additional file 2 of Newborn screening for spinal muscular atrophy in Germany: clinical results after 2 years

Author

Vill, Katharina, Schwartz, Oliver, Blaschek, Astrid, Gläser, Dieter, Nennstiel, Uta, Wirth, Brunhilde, Burggraf, Siegfried, Röschinger, Wulf, Becker, Marc, Czibere, Ludwig, Durner, Jürgen, Eggermann, Katja, Olgemöller, Bernhard, Harms, Erik, Schara, Ulrike, Kölbel, Heike, and Müller-Felber, Wolfgang

Abstract

Additional file 2. Table S2: Patient’s family history, ethnical background, and outcome details. = years, mo = months, d = days, neg = negative, pos = positive.

Published
2021
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35. From first to second wave: follow-up of the prospective COVID-19 cohort (KoCo19) in Munich (Germany)

Author

Radon, Katja, Bakuli, Abhishek, Pütz, Peter, Le Gleut, Ronan, Guggenbuehl Noller, Jessica Michelle, Olbrich, Laura, Saathoff, Elmar, Garí, Mercè, Schälte, Yannik, Frahnow, Turid, Wölfel, Roman, Pritsch, Michael, Rothe, Camilla, Pletschette, Michel, Rubio-Acero, Raquel, Beyerl, Jessica, Metaxa, Dafni, Forster, Felix, Thiel, Verena, Castelletti, Noemi, Rieß, Friedrich, Diefenbach, Maximilian N., Fröschl, Günter, Bruger, Jan, Winter, Simon, Frese, Jonathan, Puchinger, Kerstin, Brand, Isabel, Kroidl, Inge, Wieser, Andreas, Hoelscher, Michael, Hasenauer, Jan, Fuchs, Christiane, Ackermann, Nikolaus, Alamoudi, Emad, Anderson, Jared, Baumann, Maxilmilian, Becker, Marc, Bednarzki, Franziska, Bemirayev, Olimbek, Bitzer, Patrick, Böhnlein, Rebecca, Caroli, Friedrich, Coleman, Josephine, Contento, Lorenzo, Czwienzek, Alina, Deák, Flora, Diekmannshemke, Jana, Dobler, Gerhard, Durner, Jürgen, Eberle, Ute, Eckstein, Judith, Eser, Tabea, Falk, Philine, Feyereisen, Manuela, Fingerle, Volker, Geisenberger, Otto, Geldmacher, Christof, Gilberg, Leonard, Gillig, Kristina, Girl, Philipp, Golschan, Elias, Guglielmini, Elena Maria, Gutierrez, Pablo, Haderer, Anslem, Hannes, Marlene, Hartinger, Lena, Hernandez, Alejandra, Hillari, Leah, Hinske, Christian, Hofberger, Tim, Horn, Sacha, Huber, Kristina, Janke, Christian, Kappl, Ursula, Keßler, Antonia, Khan, Zohaib, Kresin, Johanna, Kroidl, Arne, Lang, Magdalena, Lang, Clemens, Lange, Silvan, Laxy, Michael, Leidl, Reiner, Liedl, Leopold, Lucaj, Xhovana, Luppa, Fabian, Nafziger, Alexandra Sophie, Mang, Petra, Markgraf, Alisa, Mayrhofer, Rebecca, Müller, Hannah, Müller, Katharina, Paunovic, Ivana, Plank, Michael, Pleimelding, Claire, Prückner, Stephan, Raimúndez, Elba, Reich, Jakob, Ruci, Viktoria, Schäfer, Nicole, Schluse, Benedikt, Schneider, Lara, Schunk, Mirjam, Schwettmann, Lars, Sing, Andreas, Soler, Alba, Sothmann, Peter, Strobl, Kathrin, Tang, Jeni, Theis, Fabian, Thiesbrummel, Sophie, Vollmayr, Vincent, von Lovenberg, Emilia, von Lovenberg, Jonathan, Waibel, Julia, Wallrauch, Claudia, Wolff, Julia, Würfel, Tobias, Yaqine, Houda, Zange, Sabine, Zeggini, Eleftheria, Zielke, Anna, and Zimmer, Thorbjörn

Subjects
Research Article, Viral diseases, COVID-19, SARS-CoV-2, Population-based cohort study, Sero-prevalence, Sero-incidence, ORCHESTRA, ddc
Published
2020

36. A Serology Strategy for Epidemiological Studies Based on the Comparison of the Performance of Seven Different Test Systems - The Representative COVID-19 Cohort Munich

Author

Olbrich, Laura, primary, Castelletti, Noemi, additional, Schälte, Yannik, additional, Garí, Mercè, additional, Pütz, Peter, additional, Bakuli, Abhishek, additional, Pritsch, Michael, additional, Kroidl, Inge, additional, Saathoff, Elmar, additional, Noller, Jessica Michelle Guggenbuehl, additional, Fingerle, Volker, additional, Le Gleut, Ronan, additional, Gilberg, Leonard, additional, Brand, Isabel, additional, Falk, Philine, additional, Markgraf, Alisa, additional, Deák, Flora, additional, Riess, Friedrich, additional, Diefenbach, Max, additional, Eser, Tabea, additional, Weinauer, Franz, additional, Martin, Silke, additional, Quenzel, Ernst-Markus, additional, Becker, Marc, additional, Durner, Jürgen, additional, Girl, Philipp, additional, Müller, Katharina, additional, Radon, Katja, additional, Fuchs, Christiane, additional, Wölfel, Roman, additional, Hasenauer, Jan, additional, Hoelscher, Michael, additional, and Wieser, Andreas, additional

Published
2021
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37. Newborn Screening for SMA - Results After Two Years of a Large Pilot Project 

Author

Vill, Katharina, primary, Schwartz, Oliver, additional, Blaschek, Astrid, additional, Gläser, Dieter, additional, Nennstiel, Uta, additional, Wirth, Brunhilde, additional, Burggraf, Siegfried, additional, Röschinger, Wulf, additional, Becker, Marc, additional, Czibere, Ludwig, additional, Durner, Jürgen, additional, Eggermann, Katja, additional, Olgemöller, Bernhard, additional, Harms, Erik, additional, Schara, Ulrike, additional, Kölbel, Heike, additional, and Müller-Felber, Wolfgang, additional

Published
2020
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39. Fast and simple high-throughput testing of COVID 19

Author

Durner, Jürgen, primary, Burggraf, Siegfried, additional, Czibere, Ludwig, additional, Fleige, Tobias, additional, Madejska, Arleta, additional, Watts, David C., additional, Krieg-Schneider, Frank, additional, and Becker, Marc, additional

Published
2020
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40. Newborn Screening for SMA - Results after Two Years of a German Pilot Project

Author

Vill, Katharina, primary, Schwartz, Oliver, additional, Blaschek, Astrid, additional, Gläser, Dieter, additional, Nennstie, Uta, additional, Wirth, Brunhilde, additional, Burggraf, Siegfried, additional, Röschinger, Wulf, additional, Becker, Marc, additional, Czibere, Ludwig, additional, Durner, Jürgen, additional, Eggermann, Katja, additional, Olgemöller, Bernhard, additional, Harms, Erik, additional, Schara, Ulrike, additional, Kölbe, Heike, additional, and Müller-Felber, Wolfgang, additional

Published
2020
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41. One Year of Newborn Screening for SMA – Results of a German Pilot Project

Author

Vill, Katharina, primary, Kölbel, Heike, additional, Schwartz, Oliver, additional, Blaschek, Astrid, additional, Olgemöller, Bernhard, additional, Harms, Erik, additional, Burggraf, Siegfried, additional, Röschinger, Wulf, additional, Durner, Jürgen, additional, Gläser, Dieter, additional, Nennstiel, Uta, additional, Wirth, Brunhilde, additional, Schara, Ulrike, additional, Jensen, Beate, additional, Becker, Marc, additional, Hohenfellner, Katharina, additional, and Müller-Felber, Wolfgang, additional

Published
2019
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42. Next generation sequencing as second-tier test in high-throughput newborn screening for nephropathic cystinosis

Author

Fleige, Tobias, primary, Burggraf, Siegfried, additional, Czibere, Ludwig, additional, Häring, Julia, additional, Glück, Birgit, additional, Keitel, Lisa Marie, additional, Landt, Olfert, additional, Harms, Erik, additional, Hohenfellner, Katharina, additional, Durner, Jürgen, additional, Röschinger, Wulf, additional, and Becker, Marc, additional

Published
2019
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43. High-throughput genetic newborn screening for spinal muscular atrophy by rapid nucleic acid extraction from dried blood spots and 384-well qPCR

Author

Czibere, Ludwig, primary, Burggraf, Siegfried, additional, Fleige, Tobias, additional, Glück, Birgit, additional, Keitel, Lisa Marie, additional, Landt, Olfert, additional, Durner, Jürgen, additional, Röschinger, Wulf, additional, Hohenfellner, Katharina, additional, Wirth, Brunhilde, additional, Müller-Felber, Wolfgang, additional, Vill, Katharina, additional, and Becker, Marc, additional

Published
2019
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45. Infants Diagnosed with Spinal Muscular Atrophy and 4 SMN2Copies through Newborn Screening – Opportunity or Burden?

Author

Müller-Felber, Wolfgang, Vill, Katharina, Schwartz, Oliver, Gläser, Dieter, Nennstiel, Uta, Wirth, Brunhilde, Burggraf, Siegfried, Röschinger, Wulf, Becker, Marc, Durner, Jürgen, Eggermann, Katja, Müller, Christine, Hannibal, Iris, Olgemöller, Bernd, Schara, Ulrike, Blaschek, Astrid, and Kölbel, Heike

Abstract

Although the value of newborn screening (NBS) for early detection and treatment opportunity in SMA patients is generally accepted, there is still an ongoing discussion about the best strategy in children with 4 and more copies of the SMN2gene. This gene is known to be the most important but not the only disease modifier. In our SMA-NBS pilot project in Germany comprising 278,970 infants screened between January 2018 and November 2019 were 38 positive cases with a homozygous SMN1deletion. 40% of them had 4 or more SMN2copies. The incidence for homozygous SMN1deletion was 1 : 7350, which is within the known range of SMA incidence in Germany. Of the 15 SMA children with 4 SMN2copies, one child developed physical signs of SMA by the age of 8 months. Reanalysis of the SMN2 copy number by a different test method revealed 3 copies. Two children had affected siblings with SMA Type III, who were diagnosed only after detection of the index patient in the NBS. One had a positive family history with an affected aunt (onset of disease at the age of 3 years). Three families were lost to medical follow up; two because of socioeconomic reasons and one to avoid the psychological stress associated with the appointments. Decisions on how to handle patients with 4 SMN2copies are discussed in the light of the experience gathered from our NBS pilot SMA program.

Published
2020
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47. Laboratory information system and necessary improvements in function and programming.

Author

Kammergruber, Roland and Durner, Jürgen

Subjects
DATABASE management, ELECTRONIC data interchange, GRAPHICAL user interfaces, INFORMATION storage & retrieval systems, MEDICAL databases, MEDICAL laboratories, QUALITY assurance, DATA mining, ORGANIZATIONAL structure, SOFTWARE architecture, LABORATORY equipment & supplies, DATA security, ACQUISITION of data, LOGICAL Observation Identifiers, Names & Codes (Database)
Abstract

Since the 1970s, computer supported data processing has been implemented in the laboratory and laboratory information systems (LIS) are being developed. In the following years, the programs were expanded and new laboratory requirements were inserted to the LIS. In the last few years, the requirements have grown more and more. The current tasks of the LIS are not only the management of laboratory requirements but also management of processes, data security and data transfer and they have become very important. Therefore, the current monolithic architecture of LIS has reached its limits. New methodologies like service oriented architecture, e.g. microservices, should be implemented. Thereby different specialized manufacturers provide software for one or a few tasks. These tasks can be more easily actualized like in the new field of agile software development. This new concept has been designed to provide updates and customer requirements according to its new organization structure in program development in a short time. For efficient data transfer, new interfaces and a standardization of master data like logical observation identifier names and codes (LOINC®) are advisable. With the growing data transfer, data security plays an increasingly important role. New concepts like blockchain programming (e.g. Medrec) are currently tested in (laboratory) medicine. To get an overview of the requirements of the own LIS, an Ishikawa diagram should be created. The main points of an Ishikawa diagram are shown and discussed. Based on the today-collected data, expert systems will be developed. For this kind of data mining, a structured data exchange is necessary. [ABSTRACT FROM AUTHOR]

Published
2018
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48. Head-to-head evaluation of seven different seroassays including direct viral neutralisation in a representative cohort for SARS-CoV-2.

Author

Olbrich L, Castelletti N, Schälte Y, Garí M, Pütz P, Bakuli A, Pritsch M, Kroidl I, Saathoff E, Guggenbuehl Noller JM, Fingerle V, Le Gleut R, Gilberg L, Brand I, Falk P, Markgraf A, Deák F, Riess F, Diefenbach M, Eser T, Weinauer F, Martin S, Quenzel EM, Becker M, Durner J, Girl P, Müller K, Radon K, Fuchs C, Wölfel R, Hasenauer J, Hoelscher M, Wieser A, and On Behalf Of The KoCo-Study Group

Subjects
COVID-19 Nucleic Acid Testing, Cohort Studies, Humans, COVID-19 diagnosis, COVID-19 Serological Testing methods, Neutralization Tests methods, SARS-CoV-2 immunology
Abstract

A number of seroassays are available for SARS-CoV-2 testing; yet, head-to-head evaluations of different testing principles are limited, especially using raw values rather than categorical data. In addition, identifying correlates of protection is of utmost importance, and comparisons of available testing systems with functional assays, such as direct viral neutralisation, are needed.We analysed 6658 samples consisting of true-positives ( n =193), true-negatives ( n =1091), and specimens of unknown status ( n =5374). For primary testing, we used Euroimmun-Anti-SARS-CoV-2-ELISA-IgA/IgG and Roche-Elecsys-Anti-SARS-CoV-2. Subsequently virus-neutralisation, GeneScriptcPass, VIRAMED-SARS-CoV-2-ViraChip, and Mikrogen- recom Line-SARS-CoV-2-IgG were applied for confirmatory testing. Statistical modelling generated optimised assay cut-off thresholds. Sensitivity of Euroimmun-anti-S1-IgA was 64.8%, specificity 93.3% (manufacturer's cut-off); for Euroimmun-anti-S1-IgG, sensitivity was 77.2/79.8% (manufacturer's/optimised cut-offs), specificity 98.0/97.8%; Roche-anti-N sensitivity was 85.5/88.6%, specificity 99.8/99.7%. In true-positives, mean and median Euroimmun-anti-S1-IgA and -IgG titres decreased 30/90 days after RT-PCR-positivity, Roche-anti-N titres decreased significantly later. Virus-neutralisation was 80.6% sensitive, 100.0% specific (≥1:5 dilution). Neutralisation surrogate tests (GeneScriptcPass, Mikrogen- recom Line-RBD) were >94.9% sensitive and >98.1% specific. Optimised cut-offs improved test performances of several tests. Confirmatory testing with virus-neutralisation might be complemented with GeneScriptcPass TM or recom Line-RBD for certain applications. Head-to-head comparisons given here aim to contribute to the refinement of testing strategies for individual and public health use.

Published
2021
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