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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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25. 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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27. 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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30. 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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39. 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

42. 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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