Publications by authors named "Stephanie Dramburg"

19 Publications

  • Page 1 of 1

@IT2020: An innovative algorithm for allergen immunotherapy prescription in seasonal allergic rhinitis.

Clin Exp Allergy 2021 Mar 23. Epub 2021 Mar 23.

Department of Pediatric Pneumology, Immunology and Critical Care Medicine, Charité Universitätsmedizin - Berlin, Berlin, Germany.

Background: Allergen immunotherapy (AIT) is the only disease-modifying treatment in patients with seasonal allergic rhinoconjunctivitis (SAR). Its efficacy depends on the precise identification of the triggering allergen. However, diagnostics based on retrospective clinical history and sensitization to whole extracts (SWE) often leads to equivocal results.

Objectives: To assess the usability and impact of a recently established algorithm for a clinical decision support system (@IT2020-CDSS) for SAR and its diagnostic steps [anamnesis, SWE (skin prick test or serum IgE), component resolved diagnosis, CRD, and real-time digital symptom recording, eDiary] on doctor's AIT prescription decisions.

Methods: After educational training on the @IT2020-CDSS algorithm, 46 doctors (18 allergy specialists, AS, and 28 general practitioners, GP) expressed their hypothetical AIT prescription for 10 clinical index cases. Decisions were recorded repeatedly based on different steps of the algorithm. The usability and perceived impact of the algorithm were evaluated.

Results: The combined use of CRD and an eDiary increased the hypothetical AIT prescriptions, both among AS and GP (p < .01). AIT prescription for pollen and Alternaria allergy based on anamnesis and SWE was heterogeneous but converged towards a consensus by integrating CRD and eDiary information. Doctors considered the algorithm useful and recognized its potential in enhancing traditional diagnostics.

Conclusions And Clinical Implications: The implementation of CRD and eDiary in the @IT2020-CDSS algorithm improved consensus on AIT prescription for SAR among AS and GP. The potential usefulness of a CDSS for aetiological diagnosis of SAR and AIT prescription in real-world clinical practice deserves further investigation.
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http://dx.doi.org/10.1111/cea.13867DOI Listing
March 2021

Telemedicine in allergology: practical aspects: A position paper of the Association of German Allergists (AeDA).

Allergo J Int 2021 Feb 22:1-11. Epub 2021 Feb 22.

Center for Rhinology and Allergology Wiesbaden, Wiesbaden, Germany.

Since spring 2020, the wide-ranging contact restriction measures in the context of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic have also led to a reduction in physician-patient contacts in the ambulatory care setting. Telemedicine applications will increasingly provide a way to efficiently deliver patient care under infection control measures. In allergology, telemedical as well as digital applications can also significantly facilitate everyday clinical practice. However, the technical and legal hurdles associated with the implementation of digital strategies must be overcome for this to happen. The aim of this article is to provide an intuitive overview of the aspects to be considered in the implementation of telemedicine consultations and to highlight the current state of the framework as well as optimization possibilities and perspectives in allergology. If a structured use is guaranteed, digital and telemedical applications can improve patient care-also in allergology. There is potential to be exploited in many areas, from the remote collection of clinical history, and video consultations, to the discussion of diagnostic findings, disease monitoring, and therapy support. The use of telemedical applications, especially video consultations, has experienced a remarkable acceleration in the context of the coronavirus disease 2019 (COVID-19) pandemic. The present overview of the legal, technical and professional framework is intended to support the anchoring of digital and telemedical technologies in everyday allergology. However, in order to consolidate these in the future, an agreement is needed regarding professional standards of action as well as a remuneration structure that is permanently defined beyond the current pandemic.
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http://dx.doi.org/10.1007/s40629-021-00167-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7977487PMC
February 2021

Validation study of a new chemiluminescent singleplex IgE assay in a set of Italian allergic rhinitis patients.

Clin Exp Allergy 2021 Apr 20;51(4):604-613. Epub 2020 Dec 20.

Division of Pneumonology, Immunology and Intensive Medicine, Department of Pediatrics, Charité - Universitätsmedizin, Berlin, Germany.

Background: The measurement of specific IgE to allergenic extracts and molecules in patients with allergic rhinitis (AR) is crucial for a precise diagnosis and further immunotherapy. Companies providing in vitro diagnostic methods in allergology continuously strive for the optimization and modernization of such methods. A new generation of automated allergy tests based on chemiluminescence detection and paramagnetic microparticles is now available, with possible advantages in sample volume, cost-effectiveness and avoidance of sample-related interference.

Objectives: To test whether sIgE antibody levels obtained with a new singleplex chemiluminescent method have a good agreement with the corresponding results obtained with a "gold standard" test.

Methods: We tested sera from 368 AR patients. Specific IgE sera levels (kU/L) to a comprehensive panel of 15 allergen extracts and 6 molecules were tested with ImmunoCAP (Thermo Fisher Scientific Inc, Phadia AB, Uppsala, Sweden) and NOVEOS™ (HYCOR Biomedical, Garden Grove, CA, USA). We evaluated the qualitative and quantitative performance of the new NOVEOS system in matching the outcome of ImmunoCAP to each of the examined allergens.

Results: In relation to ImmunoCAP, the overall diagnostic sensitivity and specificity of sIgE tests with NOVEOS were 90.8% (95% CI = 88.6-92.7) and 96.2% (95% CI = 93.9-97.8), respectively. These values were higher when only molecules were considered (sensitivity = 98.7% [95% CI = 96.4%-99.7%]; specificity = 94.2% [95% CI = 88.4%-97.6%]) and lower when only extracts were considered (sensitivity = 87.6% [95% CI = 84.7%-90.2%]; specificity = 97% [95% CI = 94.4%-98.6%]). Spearman's correlation between the data set of both methods for a ≥ 0.1 kU/L cut-off was 0.84 (p < .001).

Conclusions: The new singleplex NOVEOS system presented good results for qualitative and quantitative comparisons when testing specific serum IgE antibodies against a range of 21 allergens. This novel immunoassay system using only 4 µl of sample per test appears to be robust and reliable and can, therefore, be used as an aid in allergy diagnosis.
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http://dx.doi.org/10.1111/cea.13785DOI Listing
April 2021

The Potential of Clinical Decision Support Systems for Prevention, Diagnosis, and Monitoring of Allergic Diseases.

Front Immunol 2020 10;11:2116. Epub 2020 Sep 10.

Department of Pediatric Pulmonology, Immunology and Critical Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.

Clinical decision support systems (CDSS) aid health care professionals (HCP) in evaluating large sets of information and taking informed decisions during their clinical routine. CDSS are becoming particularly important in the perspective of precision medicine, when HCP need to consider growing amounts of data to create precise patient profiles for personalized diagnosis, treatment and outcome monitoring. In allergy care, several CDSS are being developed and investigated, mainly for respiratory allergic diseases. Although the proposed solutions address different stakeholders, the majority aims at facilitating evidence-based and shared decision-making, incorporating guidelines, and real-time clinical data. We offer here an overview on existing tools, new developments and novel concepts and discuss the potential of digital CDSS in improving prevention, diagnosis and monitoring of allergic diseases.
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http://dx.doi.org/10.3389/fimmu.2020.02116DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7511544PMC
September 2020

Jetzt teilnehmen!

Allergo J 2020 10;29(5):66. Epub 2020 Aug 10.

Zentrum für Rhinologie & Allergologie, An den Quellen 10, 65183 Wiesbaden, Germany.

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http://dx.doi.org/10.1007/s15007-020-2574-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7396722PMC
August 2020

Digital technologies for an improved management of respiratory allergic diseases: 10 years of clinical studies using an online platform for patients and physicians.

Ital J Pediatr 2020 Jul 25;46(1):105. Epub 2020 Jul 25.

Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.

Background: Digital health technologies carry the great potential of assisting physicians in making well-informed diagnostic and therapeutic decisions. In allergy care, electronic clinical diaries have been recently used to prospectively collect patient data and improve diagnostic precision.

Objective: This review summarizes the clinical and scientific experience we gathered over 10 years of using a digital platform for patients suffering from seasonal allergic rhinitis.

Methods: The mobile application and back-office of AllergyMonitor (TPS software production, Rome, Italy) enable patients to record their daily allergy symptoms as well as drug and immunotherapy intake plus possible side effects in a customizable way. The results can be accessed by the patient and attending physician as concise reports via a smartphone or computer. This technology has been used in several clinical studies and routine practice since 2009.

Results: Our studies showed that A) the etiological diagnosis of SAR may be supported by matching prospectively registered symptoms with pollen counts; B) it is possible to perform a short-term prediction of SAR-symptoms at individual level; C) the adherence to daily symptom monitoring can remain high (> 80%) throughout several weeks when prescribed and thoroughly explained by the treating doctor; D) the use of mobile technology can improve adherence to symptomatic drugs as well as allergen-specific immunotherapy and E) the choice of the correct symptom-severity-score is critical at patient level, but not at group level.

Conclusion: The studies and clinical practice based on the use of AllergyMonitor have proven the reliability and positive impact of a digital platform including an electronic diary (eDiary) on the diagnostic precision of SAR in poly-sensitized patients as well as patient adherence to both, drug therapy and allergen immunotherapy.
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http://dx.doi.org/10.1186/s13052-020-00870-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7382563PMC
July 2020

COVID-19 pandemic: Practical considerations on the organization of an allergy clinic-An EAACI/ARIA Position Paper.

Allergy 2021 03;76(3):648-676

Institute of Pathophysiology and Allergy Research, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna, Austria.

Background: The coronavirus disease 2019 (COVID-19) has evolved into a pandemic infectious disease transmitted by the severe acute respiratory syndrome coronavirus (SARS-CoV-2). Allergists and other healthcare providers (HCPs) in the field of allergies and associated airway diseases are on the front line, taking care of patients potentially infected with SARS-CoV-2. Hence, strategies and practices to minimize risks of infection for both HCPs and treated patients have to be developed and followed by allergy clinics.

Method: The scientific information on COVID-19 was analysed by a literature search in MEDLINE, PubMed, the National and International Guidelines from the European Academy of Allergy and Clinical Immunology (EAACI), the Cochrane Library, and the internet.

Results: Based on the diagnostic and treatment standards developed by EAACI, on international information regarding COVID-19, on guidelines of the World Health Organization (WHO) and other international organizations, and on previous experience, a panel of experts including clinicians, psychologists, IT experts, and basic scientists along with EAACI and the "Allergic Rhinitis and its Impact on Asthma (ARIA)" initiative have developed recommendations for the optimal management of allergy clinics during the current COVID-19 pandemic. These recommendations are grouped into nine sections on different relevant aspects for the care of patients with allergies.

Conclusions: This international Position Paper provides recommendations on operational plans and procedures to maintain high standards in the daily clinical care of allergic patients while ensuring the necessary safety measures in the current COVID-19 pandemic.
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http://dx.doi.org/10.1111/all.14453DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323448PMC
March 2021

EAACI Allergen Immunotherapy User's Guide.

Pediatr Allergy Immunol 2020 05;31 Suppl 25:1-101

Department of Dermatology and Venerology, Medical University of Graz, Graz, Austria.

Allergen immunotherapy is a cornerstone in the treatment of allergic children. The clinical efficiency relies on a well-defined immunologic mechanism promoting regulatory T cells and downplaying the immune response induced by allergens. Clinical indications have been well documented for respiratory allergy in the presence of rhinitis and/or allergic asthma, to pollens and dust mites. Patients who have had an anaphylactic reaction to hymenoptera venom are also good candidates for allergen immunotherapy. Administration of allergen is currently mostly either by subcutaneous injections or by sublingual administration. Both methods have been extensively studied and have pros and cons. Specifically in children, the choice of the method of administration according to the patient's profile is important. Although allergen immunotherapy is widely used, there is a need for improvement. More particularly, biomarkers for prediction of the success of the treatments are needed. The strength and efficiency of the immune response may also be boosted by the use of better adjuvants. Finally, novel formulations might be more efficient and might improve the patient's adherence to the treatment. This user's guide reviews current knowledge and aims to provide clinical guidance to healthcare professionals taking care of children undergoing allergen immunotherapy.
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http://dx.doi.org/10.1111/pai.13189DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7317851PMC
May 2020

Adherence to Prescribed E-Diary Recording by Patients With Seasonal Allergic Rhinitis: Observational Study.

J Med Internet Res 2020 03 16;22(3):e16642. Epub 2020 Mar 16.

Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité University Medicine, Berlin, Germany.

Background: Complete diagnosis and therapy of seasonal allergic rhinoconjunctivitis require evidence that exposure to the sensitizing pollen triggers allergic symptoms. Electronic clinical diaries, by recording disease severity scores and pollen exposure, can demonstrate this association. However, patients who spontaneously download an e-diary app show very low adherence to their recording.

Objective: The objective of our study was to assess adherence of patients with seasonal allergic rhinitis to symptom recording via e-diary explicitly prescribed by an allergist within a blended care approach.

Methods: The @IT-2020 project is investigating the diagnostic synergy of mobile health and molecular allergology in patients with seasonal allergic rhinitis. In the pilot phase of the study, we recruited Italian children (Rome, Italy) and adults (Pordenone, Italy) with seasonal allergic rhinitis and instructed them to record their symptoms, medication intake, and general conditions daily through a mobile app (Allergy.Monitor) during the relevant pollen season.

Results: Overall, we recruited 101 Italian children (Rome) and 93 adults (Pordenone) with seasonal allergic rhinitis. Adherence to device use slowly declined during monitoring in 3 phases: phase A: first week, ≥1267/1358, 90%; phase B: second to sixth week, 4992/5884, 80% to 90%; and phase C: seventh week onward, 2063/2606, 70% to 80%. At the individual level, the adherence assessed in the second and third weeks of recording predicted with enough confidence (Rome: Spearman ρ=0.75; P<.001; Pordenone: ρ=0.81; P<.001) the overall patient adherence to recording and was inversely related to postponed reporting (ρ=-0.55; P<.001; in both centers). Recording adherence was significantly higher during the peak grass pollen season in Rome, but not in Pordenone.

Conclusions: Adherence to daily recording in an e-diary, prescribed and motivated by an allergist in a blended care setting, was very high. This observation supports the use of e-diaries in addition to face-to-face visits for diagnosis and treatment of seasonal allergic rhinitis and deserves further investigation in real-life contexts.
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http://dx.doi.org/10.2196/16642DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7105930PMC
March 2020

Digital allergology: Towards a clinical decision support system for allergen immunotherapy.

Pediatr Allergy Immunol 2020 02;31 Suppl 24:61-64

Department of Pediatrics, Pediatric Allergy Unit, Sandro Pertini Hospital, Rome, Italy.

Mobile health is the "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices." For example, mobile apps (such as MASK-Air, Allergy.Monitor, Pollen, and others) have proven useful in the management of patients with allergic rhinitis. These apps can be used in the context of broader clinical decision support systems (CDSS) for enhancing allergy-related decisions and actions with pertinent, organized clinical knowledge and patient information to improve allergy care. A CDSS targeted to control rhinitis with drugs and other interventions guiding the patient in his/her self- and doctor-driven management is currently being produced and investigated by the MACVIA network. Another one, called @IT-2020, is targeted to support etiologic diagnostics and allergen immunotherapy (AIT) prescriptions for patients with seasonal allergic rhinitis. Intensive investigation is necessary to better define the advantages and limitations of mobile-health technology in allergology and establish guidelines for their proper use in daily practice in the context of a rapidly evolving European regulatory environment.
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http://dx.doi.org/10.1111/pai.13165DOI Listing
February 2020

"Whole" vs. "fragmented" approach to EAACI pollen season definitions: A multicenter study in six Southern European cities.

Allergy 2020 07 11;75(7):1659-1671. Epub 2020 May 11.

Department of Allergy and Immunology, Koç University Hospital, Istanbul, Turkey.

Background: The adequate definition of pollen seasons is essential to facilitate a correct diagnosis, treatment choice, and outcome assessment in patients with seasonal allergic rhinitis. A position paper by the European Academy of Allergy and Clinical Immunology (EAACI) proposed season definitions for Northern and Middle Europe.

Objective: To test the pollen season definitions proposed by EAACI in six Mediterranean cities for seven pollen taxa.

Methods: As part of the @IT.2020 multi-center study, pollen counts for Poaceae, Oleaceae, Fagales, Cupressaceae, Urticaceae (Parietaria spp.), and Compositae (Ambrosia spp., Artemisia spp.) were collected from January 1 to December 31, 2018. Based on these data, pollen seasons were identified according to EAACI criteria. A unified monitoring period for patients in AIT trials was created and assessed for feasibility.

Results: The analysis revealed a great heterogeneity between the different locations in terms of pattern and length of the examined pollen seasons. Further, we found a fragmentation of pollen seasons in several segments (max. 8) separated by periods of low pollen counts (intercurrent periods). Potential monitoring periods included often many recording days with low pollen exposure (max. 341 days).

Conclusion: The Mediterranean climate leads to challenging pollen exposure times. Monitoring periods for AIT trials based on existing definitions may include many intermittent days with low pollen concentrations. Therefore, it is necessary to find an adapted pollen season definition as individual solution for each pollen and geographical area.
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http://dx.doi.org/10.1111/all.14153DOI Listing
July 2020

IgE antibody repertoire in nasal secretions of children and adults with seasonal allergic rhinitis: A molecular analysis.

Pediatr Allergy Immunol 2020 04 22;31(3):273-280. Epub 2020 Jan 22.

Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.

Background: There is growing interest both in testing IgE in nasal secretions (NS) and in molecular diagnosis of seasonal allergic rhinitis (SAR). Yet, the reliability of nasal IgE detection with the newest molecular assays has never been assessed in a large cohort of pollen allergic patients.

Objective: To investigate with microarray technology and compare the repertoires of specific IgE (sIgE) antibodies in NS and sera of a large population of children and adults with SAR.

Methods: Nasal secretions were collected with an absorbent device (Merocel 2000 , Medtronic) and a minimal dilution procedure from 90 children and 71 adults with SAR. Total IgE (tIgE) (ImmunoCAP, Thermo Fisher Scientific (TFS)) and sIgE antibodies against 112 allergen molecules (ISAC-112, TFS) were measured in NS and serum.

Results: Nasal sIgE was detectable in 68.3% of the patients. The detected nasal sIgE antibodies recognized airborne (88%), vegetable (10%), and animal food or other (<1%) allergen molecules. The prevalence and average levels of sIgE in NS and serum were highly interrelated at population level. A positive nasal sIgE antibody to a given molecule predicted the detection of the same antibody in the patient's serum with a specificity of 99.7% and a sensitivity of 40%.

Conclusions: The concentration of sIgE is much lower in nasal secretions than in the serum. sIgE assays with very high analytical sensitivity and sampling methods with minimal dilution will be therefore needed to validate nasal secretions as alternative to serum in testing the sIgE repertoire.
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http://dx.doi.org/10.1111/pai.13148DOI Listing
April 2020

Molecular Diagnosis of Allergy: The Pediatric Perspective.

Front Pediatr 2019 24;7:369. Epub 2019 Sep 24.

Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité University Medicine Berlin, Berlin, Germany.

In times of "Precision Medicine" it is fundamental to identify the individual disease phenotype in order to provide an individualized therapy for every patient. This concept is also becoming increasingly important for the treatment of allergic diseases. Thanks to the biological engineering of recombinant and native allergens for the assessment of allergen-specific IgE antibodies, it is now possible to easily obtain the individual sensitization profile of a patient. This allows the allergist to precisely identify the primary elicitor of an IgE response and, based on this knowledge, to choose the best treatment option. Several studies have observed the longitudinal evolution of sensitization profiles and identified a phenomenon termed "molecular spreading," which describes a broadening of the recognized allergen spectrum from a source over time. Additionally, the identification of marker proteins, which can trigger an IgE response or correlate with an increased risk for certain clinical symptoms, helps to establish an individual risk profile. This information may not only affect the decision-making concerning immunotherapy, but also opens up avenues for future investigations with regard to prevention strategies. We provide here an overview on the role of individual sensitization patterns and their predictive value.
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http://dx.doi.org/10.3389/fped.2019.00369DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6768979PMC
September 2019

Mobile Technology in Allergic Rhinitis: Evolution in Management or Revolution in Health and Care?

J Allergy Clin Immunol Pract 2019 Nov - Dec;7(8):2511-2523. Epub 2019 Aug 21.

KYomed INNOV, Montpellier, France.

Smart devices and Internet-based applications (apps) are largely used in allergic rhinitis and may help to address some unmet needs. However, these new tools need to first of all be tested for privacy rules, acceptability, usability, and cost-effectiveness. Second, they should be evaluated in the frame of the digital transformation of health, their impact on health care delivery, and health outcomes. This review (1) summarizes some existing mobile health apps for allergic rhinitis and reviews those in which testing has been published, (2) discusses apps that include risk factors of allergic rhinitis, (3) examines the impact of mobile health apps in phenotype discovery, (4) provides real-world evidence for care pathways, and finally (5) discusses mobile health tools enabling the digital transformation of health and care, empowering citizens, and building a healthier society.
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http://dx.doi.org/10.1016/j.jaip.2019.07.044DOI Listing
October 2020

The role of mobile health technologies in allergy care: An EAACI position paper.

Allergy 2020 02 16;75(2):259-272. Epub 2019 Sep 16.

Department of Allergy, Broadgreen Hospital, Liverpool, UK.

Mobile health (mHealth) uses mobile communication devices such as smartphones and tablet computers to support and improve health-related services, data and information flow, patient self-management, surveillance, and disease management from the moment of first diagnosis to an optimized treatment. The European Academy of Allergy and Clinical Immunology created a task force to assess the state of the art and future potential of mHealth in allergology. The task force endorsed the "Be He@lthy, Be Mobile" WHO initiative and debated the quality, usability, efficiency, advantages, limitations, and risks of mobile solutions for allergic diseases. The results are summarized in this position paper, analyzing also the regulatory background with regard to the "General Data Protection Regulation" and Medical Directives of the European Community. The task force assessed the design, user engagement, content, potential of inducing behavioral change, credibility/accountability, and privacy policies of mHealth products. The perspectives of healthcare professionals and allergic patients are discussed, underlining the need of thorough investigation for an effective design of mHealth technologies as auxiliary tools to improve quality of care. Within the context of precision medicine, these could facilitate the change in perspective from clinician- to patient-centered care. The current and future potential of mHealth is then examined for specific areas of allergology, including allergic rhinitis, aerobiology, allergen immunotherapy, asthma, dermatological diseases, food allergies, anaphylaxis, insect venom, and drug allergy. The impact of mobile technologies and associated big data sets are outlined. Facts and recommendations for future mHealth initiatives within EAACI are listed.
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http://dx.doi.org/10.1111/all.13953DOI Listing
February 2020

Molecular diagnosis for allergen immunotherapy.

J Allergy Clin Immunol 2019 03;143(3):831-843

Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Philipps University Marburg, German Center for Lung Research (DZL) Marburg, Marburg, Germany.

The extensive use of allergen molecules in birth cohort studies revealed that atopic sensitization is a sequential IgE response to distinct non-cross-reacting molecules from the same allergenic source (ie, molecular spreading), starting with an initiator molecule. This phenomenon reaches different degrees of progression (monomolecular, oligomolecular, and polymolecular) according to the individual atopic propensity and allergen exposure, thus producing an extreme heterogeneity of IgE sensitization profiles in patient populations. In patients with allergic rhinitis, the broader the IgE molecular sensitization profile, the greater is the risk of asthma and other allergic comorbidities, such as oral allergy syndrome. Hence it has been proposed to anticipate immunologic intervention at disease onset (early allergen immunotherapy) or even earlier during the preclinical sensitization stage (allergen immunoprophylaxis). Diagnostic algorithms based on singleplex or multiplex molecular IgE tests allow the discrimination of genuine from cross-reacting sensitization and the selection of the right extracts for allergen immunotherapy composition. Patients with extreme molecular poly-sensitization and greater risk of asthma or other IgE-mediated comorbidities, can be easily identified by means of allergen microarray or macroarray procedures and might benefit from anti-IgE treatment. IgE molecular tests have opened the era of precision allergology, and their routine use should aim at cost-effectiveness, according to the principles of the Choosing Wisely initiative.
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http://dx.doi.org/10.1016/j.jaci.2018.12.1021DOI Listing
March 2019

"Molecular extracts" for allergy diagnostics and therapy.

Pediatr Allergy Immunol 2019 02;30(1):55-58

Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Philipps University Marburg, German Center for Lung Research (DZL), Marburg, Germany.

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http://dx.doi.org/10.1111/pai.13001DOI Listing
February 2019

A new molecular multiplex IgE assay for the diagnosis of pollen allergy in Mediterranean countries: A validation study.

Clin Exp Allergy 2019 03 9;49(3):341-349. Epub 2018 Oct 9.

Department of Pediatric Pneumology and Immunology, Charité Medical University, Berlin, Germany.

Background: The identification of the primary sensitizing pollen is difficult in Southern European patients with Seasonal Allergic Rhinitis (SAR) if sensitized to various pollen sources with overlapping seasonality. A more precise diagnosis is obtained by IgE assays to allergen molecules, currently available as singleplex or microarrays.

Objectives: To test the analytical performance of a multi-parameter immunoblot molecular "Pollen Test" specifically designed to test IgE antibodies to pollen extracts and molecules clinically relevant in Southern Europe.

Methods: Sera were obtained from 101 children and 98 adults with SAR and tested with a customized multiplex immunoblot assay (EUROLINE Southern European Pollen Profile [ESEP]; EUROIMMUN AG, Luebeck, Germany) containing a comprehensive panel of allergen extracts and molecules. ESEP's outcomes were then compared in selected sera (ESEP positive to negative = 2:1) with those of singleplex IgE assays (ImmunoCAP; ThermoFisher Scientific, Uppsala, Sweden). For each of the examined reagents, qualitative (sensitivity, specificity, accuracy), semi-quantitative (classes) and quantitative (Spearman's rank correlation, Bland-Altmann plots) comparisons were performed.

Results: Compared to ImmunoCAP, cumulative ESEP's sensitivity and specificity were 87% (95% CI 84%-90%) and 88% (83%-93%) for extracts and 99% (98%-100%) and 87% (83%-91%) for molecules. Cohen's kappa coefficients (κ ) ranged for extracts from 0.18 (Pellitory) to 0.50 (Cypress) and for molecules from 0.21 (Ole e 1) to 0.68 (Phl p 7). The quantitative outcomes of the two diagnostic tests were highly correlated, with Spearman's rank correlation coefficients always exceeding 0.80. Bland-Altmann plots showed a tendency of ESEP to overestimate serum specific IgE levels, when compared to ImmunoCAP.

Conclusions And Clinical Relevance: Sensitivity and specificity of ESEP in testing serum IgE antibodies against pollen allergen extracts and molecules, in Italian patients with SAR, both exceeded 85%. The advantages and limitations of a multiplex customized immunoblot assay, in the routine clinical use of molecular diagnostics in Southern European pollen allergic patients, deserve to be tested.
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http://dx.doi.org/10.1111/cea.13264DOI Listing
March 2019