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Research on point-of-care tests in outpatient care in Germany: A scoping review and definition of relevant endpoints in evaluation studies

  • Anni Matthes
    Affiliations
    Jena University Hospital, Institute of General Practice and Family Medicine, Friedrich Schiller University Jena, Germany

    InfectoGnostics Research Campus Jena, Jena, Germany
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  • Jutta Bleidorn
    Affiliations
    Jena University Hospital, Institute of General Practice and Family Medicine, Friedrich Schiller University Jena, Germany
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  • Robby Markwart
    Correspondence
    Corresponding author. Robby Markwart. Jena University Hospital, Institute of General Practice and Family Medicine, Bachstraße 18, 07743 Jena, Germany.
    Affiliations
    Jena University Hospital, Institute of General Practice and Family Medicine, Friedrich Schiller University Jena, Germany

    InfectoGnostics Research Campus Jena, Jena, Germany
    Search for articles by this author
Open AccessPublished:August 30, 2022DOI:https://doi.org/10.1016/j.zefq.2022.06.002

      Abstract

      Background

      The fast turnaround time and user-friendliness of point-of-care tests (POCTs) offer a great potential to improve outpatient health care where clinical decisions have to be made during the physician-patient encounter and time resources are limited. The aim of this scoping review is to describe the extent and nature as well as gaps in German research activities on POCT in outpatient care. In addition, we define research endpoints that should be addressed in the comprehensive evaluation of POCTs targeted for outpatient care.

      Methods

      We performed a scoping review with a systematic literature search in Medline (via PubMed), Scopus, Web of Science, Cochrane library and Google Scholar for German publications on POCT with relevance to German outpatient care published from January 2005 to November 2020.

      Results

      Our literature search identified 2,200 unique records. After literature selection 117 articles were included in this scoping review. Just over half of the articles (67/117, 57.3%) were primary research studies with original data, while one third of all the studies (33.3%) were secondary research articles (e.g., review articles). The remaining articles were clinical recommendations / position papers (7/117, 6.0%) and other types of articles (3.4%). The majority of articles focused on POCT use in infectious diseases (44/117, 37.6%), diabetic syndromes (15.4%), cardiac disease (12.0%) or coagulopathies and thrombosis (10.3%), while the remaining articles did not specify the disease (13.7%) or investigated other diseases (11.1%). Similar to international studies, most primary research studies investigated the diagnostic performance of POCT (e.g., sensitivity, specificity). Evidence beyond diagnostic accuracy remains scarce, such as the impact on therapeutic decisions and practice routines, clinical effectiveness, and user perspectives. In line with this, interventional studies (such as RCTs) on the effectiveness of POCT use in German outpatient care are limited. We define six endpoint domains that should be addressed in the evaluation of POCTs targeted for outpatient care: (i) diagnostic performance, (ii) clinical performance, (iii) time and costs, (iv) impact on clinical routines / processes, (v) perspectives of medical professionals and patients, and (vi) broader aspects.

      Conclusion

      There is considerable research activity on POCTs targeted for use in outpatient care in Germany. Data on their potential benefits beyond diagnostic accuracy is often lacking and should be addressed in future POCT research studies.

      Zusammenfassung

      Hintergrund

      Aufgrund ihrer Schnelligkeit und Anwenderfreundlichkeit besitzen Point-of-Care-Tests (POCT) großes Potenzial, die Patientenversorgung im ambulanten Versorgungsbereich zu verbessern, da dort klinische Entscheidungen direkt während des Arzt-Patient-Kontakts getroffen werden müssen und Zeitressourcen knapp sind. Ziel dieses Scoping-Reviews ist es, den Umfang, die Art sowie potenzielle Lücken der deutschen Forschungsaktivitäten hinsichtlich POCT für die ambulante Versorgung zu beschreiben. Darüber hinaus werden Endpunkte definiert, die bei der Evaluation von POCT adressiert werden sollten.

      Methoden

      Ein Scoping-Review mit systematischer Literaturrecherche in Medline (via PubMed), Scopus, Web of Science, Cochrane Library und Google Scholar nach deutschen wissenschaftlichen Publikationen zu POCT für die ambulante Versorgung wurde durchgeführt (Publikationsdatum: Jan. 2005 bis Nov. 2020).

      Ergebnisse

      In der Literaturrecherche wurden 2200 Artikel identifiziert, von denen nach der Literaturauswahl 117 Artikel in dieses Scoping-Review eingeschlossen wurden. Knapp über die Hälfte der Artikel (67/117; 57,3%) stellten Primärstudien mit Originaldaten dar, während ein Drittel (33,3%) Sekundärstudien (z. B. Literaturreviews) waren. Darüber hinaus wurden sieben (6,0%) klinische Empfehlungen / Positionspapiere und vier sonstige Artikeltypen identifiziert.
      Die überwiegende Anzahl der Artikel untersuchte POCT bei Infektionskrankheiten (44/117; 37,6%), Diabeteserkrankungen (15,4%), Herzerkrankungen (12,0%) sowie Koagulopathien und Thrombosen (10,3%). 16 Artikel (13,7%) fokussierten auf keine spezielle Erkrankung, und 13 Artikel (11,1%) untersuchten POCTs bei sonstigen Erkrankungen.
      Vergleichbar mit internationalen POCT-Studien untersuchten auch deutsche POCT-Primärstudien überwiegend die Testgüte von POCT (z. B. Sensitivität, Spezifität). Selten wurden Outcomes untersucht, die über die Testgüte hinausgehen, wie z. B. Einfluss von POCT auf therapeutische Entscheidungen, patientenrelevante Outcomes und Anwenderperspektiven. Wie in der internationalen POCT-Forschung werden auch in Deutschland nur vereinzelt Interventionsstudien (z. B. RCTs) zum Nutzen des POCT-Einsatzes in der ambulanten Versorgung durchgeführt.
      Wir definieren sechs Endpunktdomänen, die bei der Evaluation von POCT in der ambulanten Versorgung adressiert werden sollten: (i) diagnostische Performance, (ii) klinische Performance, (iii) Zeit und Kosten, (iv) Einfluss auf klinische Routinen / Prozessabläufe, (v) Perspektiven und Einstellungen des medizinischen Personals und von Patient:innen sowie (vi) weitergehende Aspekte.

      Schlussfolgerungen

      In Deutschland gibt es umfangreiche Forschungsaktivitäten im Bereich POCT für den ambulanten Versorgungsbereich. Über die Testgüte hinausgehende Evidenz zum potenziellen Nutzen von POCT fehlt aber überwiegend und sollte in zukünftigen Studien stärker adressiert werden.

      Keywords

      Schlüsselwörter

      Abbreviations:

      CRP (C-reactive protein), POCT (point-of-care tests), RCT (randomized controlled clinical trials)

      Introduction

      Point-of-care-tests (POCTs), also referred to as rapid tests, are in-vitro laboratory procedures that are performed in close proximity to patients and are characterized by their fast turnaround time as they typically yield results within 15 min [
      • Junker R.
      • Schlebusch H.
      • Luppa P.B.
      Point-of-care testing in hospitals and primary care.
      ,
      • Luppa P.B.
      • et al.
      Point-of-care testing (POCT): Current techniques and future perspectives.
      ]. Examples for POCTs typically used in outpatient care include tests for plasma glucose, Troponin and urine dip sticks (pH-value, leucocyte count, protein level, etc.). In contrast to standard laboratory tests carried out in external laboratories, POCT have the potential to directly impact therapeutic and/or diagnostic decision making at the index consultation. This is particularly important in the management of patients in outpatient care where rapid clinical decisions have to be made and time resources are limited. In the last decade, many novel POCT have been developed and the size of the POCT market has steadily increased and is expected to further increase in the future [

      Market Data Forecast, Europe Point of Care (POC) Diagnostics/Testing Market Research Report – Segmented By Product, End-User, Country (UK, France, Spain, Germany, Italy, Russia, Sweden, Denmark, Switzerland, Netherlands, Turkey, Czech Republic and Rest of Europe) - Size, Share, Trends, Growth Opportunities Assessment, Industry Forecast | 2021 to 2026. 2021, Market Data Forecast.

      ]. Although a relatively large number of POCT are now available for diagnostic use in Germany and other countries, many of them are not routinely used in outpatient care [
      • Frese T.
      • et al.
      Use of point-of-care tests among general practitioners: a cross-sectional study in Saxony, Germany.
      ,
      • Howick J.
      • et al.
      Current and future use of point-of-care tests in primary care: an international survey in Australia, Belgium, The Netherlands, the UK and the USA.
      ]. This can be explained by several factors, such as concerns about accuracy, over-reliance on tests and limited usefulness [
      • Jones C.H.
      • et al.
      Primary care clinicians' attitudes towards point-of-care blood testing: a systematic review of qualitative studies.
      ] as well as structural barriers including a lack of reimbursement.
      POCT use in routine outpatient healthcare should be based on the principles of evidence-based medicine. Clinical studies that investigate the effects of POCT diagnostics are therefore necessary. However, while there are often sufficient data on the diagnostic accuracy of POCT (e.g. sensitivity, specificity), the impact of POCT on other relevant outcomes, such as patient health or broader impact, is rarely addressed in clinical studies [
      • Verbakel J.Y.
      • et al.
      Common evidence gaps in point-of-care diagnostic test evaluation: a review of horizon scan reports.
      ]. Since the clinical performance of healthcare interventions might be significantly influenced by the study setting and location [
      • Pocock S.
      • et al.
      International differences in treatment effect: do they really exist and why?†.
      ,
      • Vieta E.
      • et al.
      Impact of geographical and cultural factors on clinical trials in acute mania: lessons from a ziprasidone and haloperidol placebo-controlled study.
      ], study results may not be transferable to settings and regions in other countries. In order to evaluate the diagnostic and clinical value of POCT in outpatient care in Germany, it is therefore necessary that such studies are conducted in the German outpatient healthcare setting.
      The aim of our scoping review [
      • Arksey H.
      • O'Malley L.
      Scoping studies: towards a methodological framework.
      ] is to describe the extent and nature as well as gaps of POCT research in outpatient care in Germany. In particular, we describe the studied endpoints of research articles on POCT use and define endpoints that should be addressed in the comprehensive evaluation of POCT targeted for outpatient care.

      Methods

      This scoping review was conducted according to recognised guidelines on the methodology of scoping reviews [
      • Arksey H.
      • O'Malley L.
      Scoping studies: towards a methodological framework.
      ,
      • Tricco A.C.
      • et al.
      PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation.
      ,
      • von Elm E.
      • Schreiber G.
      • Haupt C.C.
      Methodische Anleitung für Scoping Reviews (JBI-Methodologie).
      ]. The methodology of a scoping review was chosen, because it allows to identify knowledge gaps, scope a body of literature, and to investigate research conduct [
      • Munn Z.
      • et al.
      Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach.
      ].

      Search strategy and study selection criteria

      We systematically searched Medline (via PubMed), Scopus, Web of Science, Cochrane library and Google Scholar for publications published from January 2005 to November 2nd 2020 (date of last search). The detailed search strategy, including search strings and applied filters, is provided in Appendix A. An abstract and title screening of all search results was performed and potentially relevant articles were retrieved for full-text review. The study selection was independently performed by two investigators (AM, RM) using the Rayyan software [
      • Ouzzani M.
      • et al.
      Rayyan—a web and mobile app for systematic reviews.
      ]. Rayyan is a professional software application which helps expediting and organising the literature screening process and was developed by the Qatar Computing Research Institute and Cochrane Bahrain. Discordances were solved by discussion.
      Studies were included if they met all of the following criteria:
      • Publication type: Full research articles (primary or secondary literature), clinical recommendations and guidelines, conference abstracts and academic theses (master’s theses, PhD theses, habilitations). Studies must be published after 2004.
      • Focus on POCTs: The publication’s focus is on POCT or the publication provides substantial information on POC diagnostics. In our study POCT encompass laboratory tests that can be performed in close proximity to patients (i.e. in the physicians’ office) without extensive laboratory equipment or manual procedures. Although most POCTs yield results within 15min, we accepted a maximum of 60min turnaround time.
      • Setting: The clinical setting encompasses outpatient care, including ambulatory emergency care. Studies with clear focus on POCT use in a hospital setting were excluded.
      • Focus on Germany: Studies were included if they were conducted in Germany or involved authors with an affiliation of a German institution (academia or industry). Clinical recommendations and guidelines were included if they were specifically tailored for Germany.

      Data extraction

      Data of all eligible studies were independently extracted by two authors (AM, RM) using standardized forms. All disagreements were resolved through discussion. The following study characteristics and data were extracted: Title, first author, year of publication, study period, publication type, main topics in regard to POCT, setting in outpatient care (e.g. general medicine, emergeny medicine, etc.), study population (e.g. patients, medical professional staff, POCT stakeholder, etc.), disease (e.g. respiratory disease, cardio-vascular disease, etc.), characteristics of POCT, overall conclusion of study authors in regard to POCT use (i.e. favourable or not favourable in the context of the study).

      Results and data synthesis

      In the systematic literature search we identified 2200 unique records. After title and abstract screening, 808 studies were assessed in full-text review. In total, we identified 117 articles [
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      Blankenstein T, et al. Point-of-care (POC) diagnosis of bacterial vaginosis (BV) using VGTest™ ion mobility spectrometry (IMS) in a routine ambulatory care gynecology clinic. Arch Gynecol Obstet 292(2): 355–62.

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      Hays JP, et al. The successful uptake and sustainability of rapid infectious disease and antimicrobial resistance point-of-care testing requires a complex 'mix-and-match' implementation package. Eur J Clin Microbiol Infect Dis. 38(6): 1015–22.

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      Jennings LC, et al. Effect of rapid influenza testing on the clinical management of paediatric influenza. Influenza Other Respir Viruses 3(3): 91–8.

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      Junker R, Schlebusch H, Luppa PB. Point-of-care testing in hospitals and primary care. Dtsch Arztebl Int 107(33): 561–7.

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      Klamp T. Ein schnelles Bead-basiertes und bildgebendes Verfahren zur Quantifizierung von Nukleinsäuren für die Integration in Lab-on-a-Chip-basierten Point-of-Care-Testing-Systemen.

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      • Palacio M.
      • et al.
      Meta-analysis of studies on biochemical marker tests for the diagnosis of premature rupture of membranes: Comparison of performance indexes.
      ,
      • Patzer K.H.
      • et al.
      Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction.
      ,
      • Peetz D.
      • Hafner G.
      • Lackner K.J.
      Near-patient testing of natriuretic peptides.
      ,
      • Pfab T.
      • et al.
      Rapid immunochromatographic strip test for the detection of albuminuria and brief literature review on albuminuria screening.
      ,
      • Pfäfflin A.
      • Schleicher E.
      Inflammation markers in point-of-care testing (POCT).
      ,

      Pleus S, et al. Bewertung der Messgenauigkeit von zwei Point-of-Care-Testing-Blutglukosemesssystemen für den professionellen Gebrauch. 2018, Georg Thieme Verlag KG: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany M4 - Citavi. p. P 194.

      ,
      • Reinert R.R.
      Rapid streptococcal antigen detection tests.
      ,
      • Reis C.
      • Universität S.
      Magneto-hydrodynamische Fokussierung: ein neues Verfahren für die Point of Care Diagnostik.
      ,

      Risch L, Senn O. [Symptom based approaches in point of care laboratory testing]. Ther Umsch. 72(2): 105–12.

      ,

      Ritzi-Lehnert M. Development of chip-compatible sample preparation for diagnosis of infectious diseases. Expert Rev Mol Diagn 12(2): 189–206.

      ,
      • Rizos T.
      • et al.
      Fast point-of-care coagulometer guided reversal of oral anticoagulation at the bedside hastens management of acute subdural hemorrhage.
      ,
      • Rübenhagen R.
      • Dangers M.
      Evaluation of a novel point-of-care test for the rapid semi-quantitative detection of allergen-specific immunoglobulin E.
      ,

      Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.

      ,
      • Schäfer M.
      • et al.
      Diagnostic equivalence of an N-terminal pro-brain natriuretic peptide point-of-care test to the laboratory method in patients with heart failure and in reference populations.
      ,
      • Schito M.
      • et al.
      Opportunities and challenges for cost-efficient implementation of new point-of-care diagnostics for HIV and tuberculosis.
      ,
      • Schmalenberg M.
      • et al.
      Magnetic bead fluorescent immunoassay for the rapid detection of the novel inflammation marker YKL40 at the point-of-care.
      ,
      • Schnell O.
      • Crocker J.B.
      • Weng J.
      Impact of HbA1c Testing at Point of Care on Diabetes Management.
      ,

      Schols AMR, et al. International definition of a point-of-care test in family practice: a modified e-Delphi procedure. Family Practice 35(4): 475–80.

      ,
      • Schweiger B.
      Influenza rapid tests - Advantages and limitations.
      ,
      • Siebenhofer A.
      • et al.
      Self-management of oral anticoagulation. Deutsches Arzteblatt.
      ,
      • Slagman A.
      • et al.
      Diagnostic performance of a high-sensitive troponin T assay and a troponin T point of care assay in the clinical routine of an Emergency Department: A clinical cohort study.
      ,
      • Spitzenberger F.
      Charakteristika der neuen EU-Verordnung über In-vitro-Diagnostika und Auswirkungen auf POCT und medizinische Laboratorien.
      ,

      Stahl LS, et al. Der Quantum Blue® (Bühlmann Laboratories AG) Schnelltest erkennt erhöhte Calprotectin-Werte im Speichel und Serum von Patienten mit Peritonsillar-Abszess. 2019, Georg Thieme Verlag KG: Klinik für HNO, Universitätsklinikum Münster, Münster Institut für Immunologie, Universitätsklinikum Münster, Münster M4 - Citavi. p. 10862.

      ,
      • Strein J.
      Schnelltest zum Nachweis einer Heliobacter pylori-Infektion bei Kindern, in Medizinischen Fakultät, Klinische Medizin.
      ,
      • Stürenburg E.
      • Junker R.
      Point-of-care testing in microbiology - The advantages and disadvantages of immunochromatographic test strips.
      ,
      • Tangermann P.
      • et al.
      Low Sensitivity of Simtomax Point of Care Test in Detection of Celiac Disease in a Prospective Multicenter Study.
      ,
      • Thiery J.
      • et al.
      Anforderungen an die Messqualität und Qualitätssicherung (QS) von Point-of-Care-Testing(POCT)-Blutglukose-Messsystemen, die für das Screening und die Diagnose eines Gestationsdiabetes mellitus (GDM) gemäß der GDM-Leitlinie der Deutschen Diabetes-Gesellschaft (DDG) geeignet sind.
      ,
      • Toepfner N.
      • et al.
      Impact of technical training on rapid antigen detection tests (RADT) in group A streptococcal tonsillopharyngitis.
      ,
      • Topf H.G.
      • et al.
      Closing the gap - Detection of clinically relevant von Willebrand disease in emergency settings through an improved algorithm based on rotational Thromboelastometry 11 Medical and Health Sciences 1103 Clinical Sciences 11 Medical and Health Sciences 1102 Cardiorespiratory Medicine and Haematology.
      ,

      van Oordt TSO, Mark D, Kosse D, Roth G, Achazi K, Patel P, et al. A Functional Blister-Pack LabDisk System for Point of Care Testing, in Deutsche Gesellschaft für Hygiene und Mikrobiologie; 2012.

      ,

      Weber K, et al. Partikel- und chipbasierte Anreicherung von Bakterien für einen Point-of-Care-Nachweis; 2017.

      ,
      • Weitzel T.
      • et al.
      Evaluation of a new point-of-care test for influenza A and B virus in travellers with influenza-like symptoms.
      ,
      • Wiesenreiter J.
      Evaluierung des concile Omega 100 Point-of-Care-Systems zur Bestimmung des totalen und freien prostataspezifischen Antigens im Serum im Hinblick ….
      ,
      • Wratil P.R.
      • et al.
      Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection.
      ,
      • Zugck C.
      • et al.
      Multicentre evaluation of a new point-of-care test for the determination of NT-proBNP in whole blood.
      ,
      • Zumla A.
      • et al.
      Rapid point of care diagnostic tests for viral and bacterial respiratory tract infections-needs, advances, and future prospects.
      ] on POCT use in outpatient care in Germany published between 2004 and 2020 (Figure 1).

      Publication characteristics

      The majority (72.6%, 85/117) of articles were full research articles. Conference abstracts / posters and academic theses accounted for 10.3% and 11.1% of all articles, respectively. Seven clinical recommendations / position papers (6.0%) with primary focus on POCT application in outpatient care were found.
      Just over half of the articles (67/117, 57.3%) were primary studies that collected original data on POCT use or development (Table 1). Among these 67 primary studies, the great majority (62/67, 92.5%) were non-interventional studies, while only five (7.5%) provided results from interventional clinical studies. Out of these, one was a randomized controlled trial (RCT) and four were either non-randomized controlled trials (n = 2) or uncontrolled trials (n = 2).
      Table 1Articles types of articles on POCT use in German outpatient care published between 2005 and 2020.
      Article typeTotal number(%)References
      Primary research studies67(57.3)
       Randomized controlled interventional study (RCTs)1(1.5)
      • Burri E.
      • et al.
      B-type natriuretic peptide in the evaluation and management of dyspnoea in primary care.
       Non-randomized controlled interventional studies2(3.0)
      • Deichmann K.A.
      • Enk C.
      • Hribar I.
      Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
      ,

      Jennings LC, et al. Effect of rapid influenza testing on the clinical management of paediatric influenza. Influenza Other Respir Viruses 3(3): 91–8.

       Uncontrolled interventional studies (i.e. pre-post studies)2(3.0)
      • Patzer K.H.
      • et al.
      Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction.
      ,
      • Toepfner N.
      • et al.
      Impact of technical training on rapid antigen detection tests (RADT) in group A streptococcal tonsillopharyngitis.
       Non-interventional studies62(92.5)
      • Brumberg J.
      ,
      • Busse J.
      Dabigatran, Rivaroxaban, Apixaban, Argatroban und Fondaparinux und ihre Effekte auf Point-of-Care-sowie Plättchenfunktionstests.
      ,
      • Clouth A.
      • et al.
      The point-of-care-diagnostic with C-reactive protein in the routine.
      ,

      Fröde D, Universitätsbibliothek B, Dübel S. Rekombinante Antikörper für die Point‐of‐care‐Diagnostik von CRP; 2012.

      ,
      • Gal M.
      • et al.
      Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
      ,
      • Gilsdorf A.
      • et al.
      Highly variable use of diagnostic methods for sexually transmitted infections-results of a nationwide survey, Germany.
      ,
      • Hasslacher C.
      • Kulozik F.
      Hämatokrit-induzierte Interferenz bei Point-of-Care Geräten zur Blutzuckermessung.
      ,
      • Hermanns N.
      • et al.
      Überprüfung der Messgenauigkeit des „Point of Care“ Blutzuckermesssystems smart LAB®.
      ,
      • Horák J.
      Microfluidic Immunosensor for Point-of-care Diagnostics: Microfluidischer Immunosensor Für Patientennahe Diagnostik.
      ,
      • Kaman W.E.
      • Andrinopoulou E.R.
      • Hays J.P.
      Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
      ,
      • Kampfenkel T.
      Machbarkeit und Nutzen von einem 12-Kanal-EKG und einer “Point-of-care” Bestimmung von Myokardnekroseparametern in der prähospitalen Diagnostik von Patienten mit Verdacht auf ein akutes.
      ,

      Klamp T. Ein schnelles Bead-basiertes und bildgebendes Verfahren zur Quantifizierung von Nukleinsäuren für die Integration in Lab-on-a-Chip-basierten Point-of-Care-Testing-Systemen.

      ,
      • Klein F.K.
      • et al.
      Analytic Issues in the Diagnosis of GDM - Comparison of 6 Analytical Methods for Plasma Glucose.
      ,
      • Maaß S.
      • et al.
      Diagnostics and therapy of sore throat patients presenting in primary care: An observational study.
      ,

      Morbach C, et al. Point-of-care B-type natriuretic peptide and portable echocardiography for assessment of patients with suspected heart failure in primary care: rationale and design of the three-part Handheld-BNP program and results of the training study. Clin Res Cardiol 107(2): 95–107.

      ,
      • Pfab T.
      • et al.
      Rapid immunochromatographic strip test for the detection of albuminuria and brief literature review on albuminuria screening.
      ,

      Pleus S, et al. Bewertung der Messgenauigkeit von zwei Point-of-Care-Testing-Blutglukosemesssystemen für den professionellen Gebrauch. 2018, Georg Thieme Verlag KG: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany M4 - Citavi. p. P 194.

      ,
      • Reis C.
      • Universität S.
      Magneto-hydrodynamische Fokussierung: ein neues Verfahren für die Point of Care Diagnostik.
      ,
      • Schmalenberg M.
      • et al.
      Magnetic bead fluorescent immunoassay for the rapid detection of the novel inflammation marker YKL40 at the point-of-care.
      ,
      • Slagman A.
      • et al.
      Diagnostic performance of a high-sensitive troponin T assay and a troponin T point of care assay in the clinical routine of an Emergency Department: A clinical cohort study.
      ,

      Stahl LS, et al. Der Quantum Blue® (Bühlmann Laboratories AG) Schnelltest erkennt erhöhte Calprotectin-Werte im Speichel und Serum von Patienten mit Peritonsillar-Abszess. 2019, Georg Thieme Verlag KG: Klinik für HNO, Universitätsklinikum Münster, Münster Institut für Immunologie, Universitätsklinikum Münster, Münster M4 - Citavi. p. 10862.

      ,
      • Strein J.
      Schnelltest zum Nachweis einer Heliobacter pylori-Infektion bei Kindern, in Medizinischen Fakultät, Klinische Medizin.
      ,
      • Tangermann P.
      • et al.
      Low Sensitivity of Simtomax Point of Care Test in Detection of Celiac Disease in a Prospective Multicenter Study.
      ,
      • Topf H.G.
      • et al.
      Closing the gap - Detection of clinically relevant von Willebrand disease in emergency settings through an improved algorithm based on rotational Thromboelastometry 11 Medical and Health Sciences 1103 Clinical Sciences 11 Medical and Health Sciences 1102 Cardiorespiratory Medicine and Haematology.
      ,

      van Oordt TSO, Mark D, Kosse D, Roth G, Achazi K, Patel P, et al. A Functional Blister-Pack LabDisk System for Point of Care Testing, in Deutsche Gesellschaft für Hygiene und Mikrobiologie; 2012.

      ,
      • Baumstark A.
      • et al.
      Bewertung der Systemgenauigkeit von Point-of-Care-Geräten für die Blutglukosebestimmung: Ein Vergleich zwischen einem Blutglukose-Messsystem für die Patientenselbstkontrolle mit 6 Geräten für den professionellen Gebrauch.
      ,
      • Baumstark A.
      • et al.
      Measurement accuracy of two professional-use systems for point-of-care testing of blood glucose.
      ,
      • Becker J.
      • Diel R.
      Screening for Methicillin-resistant Staphylococcus aureus in a residence home for elderly in Germany.
      ,
      • Blank W.A.
      • Schmidt R.
      • Schneider A.
      Use of troponin T testing in familiy practice: Use and benefit of troponin T testing based on a census of Bavarian family doctors.
      ,

      Blankenstein T, et al. Point-of-care (POC) diagnosis of bacterial vaginosis (BV) using VGTest™ ion mobility spectrometry (IMS) in a routine ambulatory care gynecology clinic. Arch Gynecol Obstet 292(2): 355–62.

      ,
      • Boldt K.
      Vergleichende Untersuchung der prognostischen Relevanz von BNP, NT-proBNP, hsCRP und TNF-ɑ bei Patienten mit klinisch-anamnestischem Verdacht auf das Vorliegen einer Herzinsuffizienz in der Hausarztpraxis-: Follow-up-Untersuchung zur Grundstudie zur Objektivierung der kardiovaskulären Dysfunktion im ambulanten und hausärztlichen Bereich mittels handgehaltener Echokardiographie und dem BNP-Schnelltest (Handheld-BNP-Studie)Prognostic utility of BNP, NT-proBNP, hsCRP and TNF-ɑ in the assessment of patients with suspected heart failure in primary care.
      ,
      • Borensztajn D.
      • et al.
      Diversity in the emergency care for febrile children in Europe: a questionnaire study.
      ,
      • Dempfle C.E.
      • et al.
      Sensitivity and specificity of a quantitative point of care D-dimer assay using heparinized whole blood, in patients with clinically suspected deep vein thrombosis.
      ,
      • Diel R.
      • Nienhaus A.
      Cost–benefit analysis of real-time influenza testing for patients in german emergency rooms.
      ,
      • Dolscheid-Pommerich R.C.
      • et al.
      Evaluation of the appropriate time period between sampling and analyzing for automated urinalysis.
      ,
      • Eggers M.
      • Enders M.
      • Terletskaia-Ladwig E.
      Evaluation of the becton dickinson rapid influenza diagnostic tests in outpatients in Germany during seven influenza seasons.
      ,
      • Erk A.
      Point-of-Care Bestimmung der Prothrombinzeit mittels CoaguChek® XS bei präklinischen Notfalleinsätzen.
      ,

      Exner V, et al., Prescribing of antibiotics for respiratory tract infections in German outpatient pediatric care Results of a survey of pediatricians and general practitioners. Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz 63(10): 1231–40.

      ,
      • Figueroa M.
      • et al.
      Polyethylene glycol-mediated blocking and monolayer morphology of an electrochemical aptasensor for malaria biomarker detection in human serum.
      ,
      • Freckmann G.
      • et al.
      System accuracy evaluation of systems for pointof- care testing of blood glucose: A comparison of a patient-use system with six professional-use systems.
      ,

      Freiherr Von Recum J, Universitätsbibliothek Der FUB. Akutdiagnostik im notfallmedizinischen Kontext; 2020.

      ,

      Frese T, et al., Use of point-of-care tests among general practitioners: a cross-sectional study in Saxony, Germany. Rural Remote Health 16(1): 3552.

      ,

      Grübl T. Präklinische Point-of-Care-Diagnostik bei Reanimation: Wie relevant sind erste Laborwerte für den Notarzt? 2019.

      ,
      • Hahn B.
      • et al.
      Mobiles Notfall-Labor in der präklinischen Notfallmedizin.
      ,
      • Halimeh S.
      • et al.
      Multiplate® whole blood impedance point of care aggregometry: Preliminary reference values in healthy infants, children and adolescents.
      ,
      • Harenberg J.
      • et al.
      Novel methods for assessing oral direct factor xa and thrombin inhibitors: Use of point-of-care testing and urine samples.
      ,

      Jung E, et al. Combination of channel- and droplet-based microfluidics for complex PoC devices. Fraunhofer IZM, Gustav-Meyer-Allee 25, 13355 Berlin, Germany Technical University of Berlin, FSP-TdM, Gustav-Meyer-Allee 25, 13355 Berlin, Germany CNRS FEMTO Innovation, 32 Avenue Observatoire, F-2500 Besançon, France, 29 May 2012 through 1 June 2012 San Diego, CA.

      ,
      • Jungbauer C.
      • et al.
      Analytical and clinical validation of a point-of-care cardiac troponin T test with an improved detection limit.
      ,
      • Jungbauer C.G.
      • et al.
      Equal performance of novel N-terminal proBNP (Cardiac proBNP®) and established BNP (Triage BNP®) point-of-care tests.
      ,
      • Kunze M.
      • et al.
      Interleukin-6-Schnelltest im Vaginalsekret bei Schwangeren mit vorzeitiger Wehentätigkeit.
      ,
      • Kutz A.
      • et al.
      Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods - A prospective multinational trial.
      ,
      • Lemke C.
      • Matthaei S.
      Präzision und Richtigkeit der neuesten Version des Point of Care (POC) Gerätes A1CNow+.
      ,

      Litwin AH, et al. Perceived barriers related to testing, management and treatment of HCV infection among physicians prescribing opioid agonist therapy: The C-SCOPE Study. J Viral Hepat 26(9): 1094–104.

      ,

      Lorenz K, et al. Evaluation of a novel point-of-care test for active matrix metalloproteinase-8: agreement between qualitative and quantitative measurements and relation to periodontal inflammation. J Periodontal Res 52(2): 277–84.

      ,
      • Rizos T.
      • et al.
      Fast point-of-care coagulometer guided reversal of oral anticoagulation at the bedside hastens management of acute subdural hemorrhage.
      ,
      • Rübenhagen R.
      • Dangers M.
      Evaluation of a novel point-of-care test for the rapid semi-quantitative detection of allergen-specific immunoglobulin E.
      ,

      Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.

      ,
      • Schäfer M.
      • et al.
      Diagnostic equivalence of an N-terminal pro-brain natriuretic peptide point-of-care test to the laboratory method in patients with heart failure and in reference populations.
      ,
      • Weitzel T.
      • et al.
      Evaluation of a new point-of-care test for influenza A and B virus in travellers with influenza-like symptoms.
      ,
      • Wiesenreiter J.
      Evaluierung des concile Omega 100 Point-of-Care-Systems zur Bestimmung des totalen und freien prostataspezifischen Antigens im Serum im Hinblick ….
      ,
      • Wratil P.R.
      • et al.
      Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection.
      ,
      • Zugck C.
      • et al.
      Multicentre evaluation of a new point-of-care test for the determination of NT-proBNP in whole blood.
      Secondary research articles (review articles / experts opinions)39(33.3)
      • Bingisser R.
      • et al.
      Measurement of natriuretic peptides at the point of care in the emergency and ambulatory setting: Current status and future perspectives.
      ,
      • Braun S.
      • Spannagl M.
      • Völler H.
      Patient self-testing and self-management of oral anticoagulation.
      ,
      • Elliott T.
      • et al.
      Challenges of HIV diagnosis and management in the context of pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review.
      ,
      • Erbach M.
      • et al.
      Interferences and limitations in blood glucose self-testing: An overview of the current knowledge.
      ,
      • Freckmann G.
      HbA1c-POC systems for therapy control and diagnostics of diabetes: Is quality and quality control sufficient?.
      ,
      • Fritzenwanker M.
      • et al.
      Modern diagnostic methods for urinary tract infections.
      ,
      • Gauglitz G.
      • Luppa P.B.
      Patientennahe Labordiagnostik. Point-of-Care-Testing.
      ,
      • Gebauer A.
      • Schmidt S.
      • Hoffmann W.
      Status and perspective of lab-on-a-chip systems for common diseases: A systematic review from 2003 to 2013.
      ,
      • Harenberg J.
      • Kraemer R.
      PL-23 measurement of the new anticoagulants.
      ,

      Hays JP, et al. The successful uptake and sustainability of rapid infectious disease and antimicrobial resistance point-of-care testing requires a complex 'mix-and-match' implementation package. Eur J Clin Microbiol Infect Dis. 38(6): 1015–22.

      ,

      Junker R, Schlebusch H, Luppa PB. Point-of-care testing in hospitals and primary care. Dtsch Arztebl Int 107(33): 561–7.

      ,
      • Karl I.
      • Kaduszkiewicz H.
      Labor statt Klinik? Bestimmung des CRP bei Atemwegsinfekten in der Hausarztpraxis.
      ,

      Köchling A, et al. Reduction of antibiotic prescriptions for acute respiratory tract infections in primary care: a systematic review. Implement Sci 13(1): 47.

      ,
      • Koschinsky T.
      Screening and diagnostic procedures for gestational diabetes mellitus. Requirements of blood glucose measurement.
      ,
      • Luppa P.B.
      • et al.
      Clinically relevant analytical techniques, organizational concepts for application and future perspectives of point-of-care testing.
      ,
      • Luppa P.B.
      • Schlebusch H.
      Analytical methods and clinical applications of point-of-care testing - A survey.
      ,
      • MacLean E.
      • et al.
      Advances in molecular diagnosis of tuberculosis.
      ,
      • Meyer T.
      • Buder S.
      The laboratory diagnosis of neisseria gonorrhoeae: Current testing and future demands.
      ,

      Mitsakakis K, et al. Diagnostic tools for tackling febrile illness and enhancing patient management. Microelectron Eng 201: 26–59.

      ,

      Mitsakakis K, et al. Challenges in identifying antibiotic resistance targets for point-of-care diagnostics in general practice. Future Microbiol 13(10): 1157–64.

      ,
      • Peetz D.
      • Hafner G.
      • Lackner K.J.
      Near-patient testing of natriuretic peptides.
      ,
      • Pfäfflin A.
      • Schleicher E.
      Inflammation markers in point-of-care testing (POCT).
      ,
      • Reinert R.R.
      Rapid streptococcal antigen detection tests.
      ,

      Risch L, Senn O. [Symptom based approaches in point of care laboratory testing]. Ther Umsch. 72(2): 105–12.

      ,

      Ritzi-Lehnert M. Development of chip-compatible sample preparation for diagnosis of infectious diseases. Expert Rev Mol Diagn 12(2): 189–206.

      ,
      • Schito M.
      • et al.
      Opportunities and challenges for cost-efficient implementation of new point-of-care diagnostics for HIV and tuberculosis.
      ,
      • Schnell O.
      • Crocker J.B.
      • Weng J.
      Impact of HbA1c Testing at Point of Care on Diabetes Management.
      ,
      • Schweiger B.
      Influenza rapid tests - Advantages and limitations.
      ,
      • Siebenhofer A.
      • et al.
      Self-management of oral anticoagulation. Deutsches Arzteblatt.
      ,
      • Spitzenberger F.
      Charakteristika der neuen EU-Verordnung über In-vitro-Diagnostika und Auswirkungen auf POCT und medizinische Laboratorien.
      ,
      • Stürenburg E.
      • Junker R.
      Point-of-care testing in microbiology - The advantages and disadvantages of immunochromatographic test strips.
      ,

      Weber K, et al. Partikel- und chipbasierte Anreicherung von Bakterien für einen Point-of-Care-Nachweis; 2017.

      ,
      • Zumla A.
      • et al.
      Rapid point of care diagnostic tests for viral and bacterial respiratory tract infections-needs, advances, and future prospects.
      ,
      • Görlinger K.
      • et al.
      Messung der Thrombozytenfunktion mit Point-of-Care-Methoden.
      ,
      • Greaves R.F.
      • et al.
      Key questions about the future of laboratory medicine in the next decade of the 21st century: A report from the IFCC-Emerging Technologies Division.
      ,
      • Greenaway C.
      • et al.
      The effectiveness and cost-effectiveness of hepatitis c screening for migrants in the EU/EEA: A systematic review.
      ,
      • O’Sullivan S.
      • et al.
      Developments in transduction, connectivity and AI/machine learning for point-of-care testing.
      ,
      • Okeke I.N.
      • et al.
      Diagnostics as essential tools for containing antibacterial resistance.
      ,
      • Palacio M.
      • et al.
      Meta-analysis of studies on biochemical marker tests for the diagnosis of premature rupture of membranes: Comparison of performance indexes.
      Clinical guidelines / recommendations and positions papers7(6.0)
      • Betz S.
      • Plöger B.
      • Kill C.
      D - Point of Care – Die präklinische Blutgasanalyse als diagnostisches Tool.
      ,
      • Braun S.
      • et al.
      Update of guidelines for patient self-management of oral anticoagulation.
      ,
      • Koschinsky F.d.A.P.T.
      • et al.
      Verbesserung der Therapiesicherheit durch eine einheitliche Kalibration von POCT-Glukose-Messgeräten auf Plasma Stellungnahme der Arbeitsgruppe POCT der Deutschen Vereinten Gesellschaft für Klinische Chemie und Laboratoriumsmedizin / Improvement of therapeutic safety through standardized plasma calibration of blood glucose test systems at the point-of-care Statement of the POCT Working Group of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL).
      ,
      • Meyer T.
      • et al.
      Schnelltest-Diagnostik sexuell übertragbarer Infektionen in niedrigschwelligen Einrichtungen: Gemeinsame Stellungnahme des RKI, PEI und der DSTIG.
      ,
      • Neumaier M.
      • et al.
      Aktualisierte Anforderungen an die Messqualität und Qualitätssicherung (QS) von Point-of-Care-Testing (POCT)-Blutglukose-Messsystemen mit Unit-use Reagenzien, die für die Erstdiagnostik eines manifesten Diabetes in der Schwangerschaft oder eines Gestationsdiabetes mellitus (GDM) gemäß der GDM-Leitlinie der Deutschen Diabetes-Gesellschaft (DDG) geeignet sind.
      ,
      • Neumaier M.
      • et al.
      Updated Requirements for Measurement Quality and Quality Assurance of Point-Of-Care Testing (POCT) - Blood Glucose Measurement Systems with Unit-Use Reagents Suitable for the Initial Diagnosis of Diabetes Manifested in Pregnancy or Gestational Diabetes Mellitus (GDM) According to the GDM Guideline of the German Diabetes Association (DDG).
      ,
      • Thiery J.
      • et al.
      Anforderungen an die Messqualität und Qualitätssicherung (QS) von Point-of-Care-Testing(POCT)-Blutglukose-Messsystemen, die für das Screening und die Diagnose eines Gestationsdiabetes mellitus (GDM) gemäß der GDM-Leitlinie der Deutschen Diabetes-Gesellschaft (DDG) geeignet sind.
      Others4(3.4)
      • Barabas N.
      • Bietenbeck A.
      Application guide: Training of professional users of devices for near-patient testing.
      ,

      Goncalves A, et al. Innovative and New Approaches to Laboratory Diagnosis of Zika and Dengue: A Meeting Report. J Infect Dis 217(7): 1060–8.

      ,
      • Kachler M.
      • Maschek C.
      Organizational challenges in the management of point-of-care diagnostics in healthcare facilities.
      ,

      Schols AMR, et al. International definition of a point-of-care test in family practice: a modified e-Delphi procedure. Family Practice 35(4): 475–80.

      Total117(100)
      Out of all included studies, one-third (39/117, 33.3%) were secondary research articles, with most of them (87.2%) being narrative reviews / expert opinions and the remaining five articles being systematic reviews and scoping reviews. The majority of articles were published in English (74/117, 63.2%) but over one third (36.7%) of all identified articles were exclusively published in German with English abstract available in most cases. The remaining articles were clinical recommendations/ position papers (7/117, 6.0%) and articles of other types (4/117, 3.4%)
      The majority of articles focused on POCT use in infectious diseases (44/117, 37.6%), diabetic syndromes (15.4%), cardiac diseases (12.0%) or coagulopathies and thrombosis (10.3%) (Table 2). Sixteen out of 117 studies (13.7%) did not specify the disease and 13 studies (11.1%) focused on other diseases, such as cancer or allergic diseases. Among the 44 studies on POCT use in infectious diseases, most studies (61.4%, 27/44) investigated POCT for the detection of pathogens, while seven (15.9%) focused on POCT measurements of inflammatory markers, such as C-reactive protein or procalcitonin. Articles on POCT use in diabetic syndromes (n = 18) predominantly investigated POCT glucose measurement (77.8%, 14/18) while the remaining four studies (22.2%) evaluated POCT for glycosylated hemoglobin (HbA1c). Among the 14 studies on POCT use in cardiac diseases (e.g. cardiac infarction or insufficiency), eight studies (57.1%, 8/14) investigated natriuretic peptides (e.g. BNP, NT-proBNP), while the remaining six studies (42.9%) included POCT measurements of troponin.
      Table 2Disease focus in articles on POCT use in German outpatient care published between 2005 and 2020.
      Total number(%)References
      Total number of studies117
       Infectious diseases44(36.7)
      • Becker J.
      • Diel R.
      Screening for Methicillin-resistant Staphylococcus aureus in a residence home for elderly in Germany.
      ,

      Blankenstein T, et al. Point-of-care (POC) diagnosis of bacterial vaginosis (BV) using VGTest™ ion mobility spectrometry (IMS) in a routine ambulatory care gynecology clinic. Arch Gynecol Obstet 292(2): 355–62.

      ,
      • Clouth A.
      • et al.
      The point-of-care-diagnostic with C-reactive protein in the routine.
      ,
      • Deichmann K.A.
      • Enk C.
      • Hribar I.
      Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
      ,

      Exner V, et al., Prescribing of antibiotics for respiratory tract infections in German outpatient pediatric care Results of a survey of pediatricians and general practitioners. Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz 63(10): 1231–40.

      ,
      • Figueroa M.
      • et al.
      Polyethylene glycol-mediated blocking and monolayer morphology of an electrochemical aptasensor for malaria biomarker detection in human serum.
      ,
      • Gilsdorf A.
      • et al.
      Highly variable use of diagnostic methods for sexually transmitted infections-results of a nationwide survey, Germany.
      ,

      Goncalves A, et al. Innovative and New Approaches to Laboratory Diagnosis of Zika and Dengue: A Meeting Report. J Infect Dis 217(7): 1060–8.

      ,
      • Greenaway C.
      • et al.
      The effectiveness and cost-effectiveness of hepatitis c screening for migrants in the EU/EEA: A systematic review.
      ,

      Hays JP, et al. The successful uptake and sustainability of rapid infectious disease and antimicrobial resistance point-of-care testing requires a complex 'mix-and-match' implementation package. Eur J Clin Microbiol Infect Dis. 38(6): 1015–22.

      ,

      Jennings LC, et al. Effect of rapid influenza testing on the clinical management of paediatric influenza. Influenza Other Respir Viruses 3(3): 91–8.

      ,
      • Kaman W.E.
      • Andrinopoulou E.R.
      • Hays J.P.
      Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
      ,
      • Karl I.
      • Kaduszkiewicz H.
      Labor statt Klinik? Bestimmung des CRP bei Atemwegsinfekten in der Hausarztpraxis.
      ,

      Klamp T. Ein schnelles Bead-basiertes und bildgebendes Verfahren zur Quantifizierung von Nukleinsäuren für die Integration in Lab-on-a-Chip-basierten Point-of-Care-Testing-Systemen.

      ,

      Köchling A, et al. Reduction of antibiotic prescriptions for acute respiratory tract infections in primary care: a systematic review. Implement Sci 13(1): 47.

      ,
      • Kutz A.
      • et al.
      Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods - A prospective multinational trial.
      ,

      Litwin AH, et al. Perceived barriers related to testing, management and treatment of HCV infection among physicians prescribing opioid agonist therapy: The C-SCOPE Study. J Viral Hepat 26(9): 1094–104.

      ,

      Mitsakakis K, et al. Challenges in identifying antibiotic resistance targets for point-of-care diagnostics in general practice. Future Microbiol 13(10): 1157–64.

      ,
      • Okeke I.N.
      • et al.
      Diagnostics as essential tools for containing antibacterial resistance.
      ,
      • Pfäfflin A.
      • Schleicher E.
      Inflammation markers in point-of-care testing (POCT).
      ,
      • Reinert R.R.
      Rapid streptococcal antigen detection tests.
      ,

      Ritzi-Lehnert M. Development of chip-compatible sample preparation for diagnosis of infectious diseases. Expert Rev Mol Diagn 12(2): 189–206.

      ,

      Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.

      ,
      • Schito M.
      • et al.
      Opportunities and challenges for cost-efficient implementation of new point-of-care diagnostics for HIV and tuberculosis.
      ,
      • Schmalenberg M.
      • et al.
      Magnetic bead fluorescent immunoassay for the rapid detection of the novel inflammation marker YKL40 at the point-of-care.
      ,
      • Schweiger B.
      Influenza rapid tests - Advantages and limitations.
      ,
      • Strein J.
      Schnelltest zum Nachweis einer Heliobacter pylori-Infektion bei Kindern, in Medizinischen Fakultät, Klinische Medizin.
      ,
      • Stürenburg E.
      • Junker R.
      Point-of-care testing in microbiology - The advantages and disadvantages of immunochromatographic test strips.
      ,
      • Toepfner N.
      • et al.
      Impact of technical training on rapid antigen detection tests (RADT) in group A streptococcal tonsillopharyngitis.
      ,
      • Wratil P.R.
      • et al.
      Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection.
      ,
      • Zumla A.
      • et al.
      Rapid point of care diagnostic tests for viral and bacterial respiratory tract infections-needs, advances, and future prospects.
      ,
      • Diel R.
      • Nienhaus A.
      Cost–benefit analysis of real-time influenza testing for patients in german emergency rooms.
      ,
      • Dolscheid-Pommerich R.C.
      • et al.
      Evaluation of the appropriate time period between sampling and analyzing for automated urinalysis.
      ,
      • Eggers M.
      • Enders M.
      • Terletskaia-Ladwig E.
      Evaluation of the becton dickinson rapid influenza diagnostic tests in outpatients in Germany during seven influenza seasons.
      ,
      • Elliott T.
      • et al.
      Challenges of HIV diagnosis and management in the context of pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review.
      ,
      • Fritzenwanker M.
      • et al.
      Modern diagnostic methods for urinary tract infections.
      ,

      Fröde D, Universitätsbibliothek B, Dübel S. Rekombinante Antikörper für die Point‐of‐care‐Diagnostik von CRP; 2012.

      ,
      • Gal M.
      • et al.
      Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
      ,
      • MacLean E.
      • et al.
      Advances in molecular diagnosis of tuberculosis.
      ,
      • Meyer T.
      • Buder S.
      The laboratory diagnosis of neisseria gonorrhoeae: Current testing and future demands.
      ,
      • Meyer T.
      • et al.
      Schnelltest-Diagnostik sexuell übertragbarer Infektionen in niedrigschwelligen Einrichtungen: Gemeinsame Stellungnahme des RKI, PEI und der DSTIG.
      ,

      van Oordt TSO, Mark D, Kosse D, Roth G, Achazi K, Patel P, et al. A Functional Blister-Pack LabDisk System for Point of Care Testing, in Deutsche Gesellschaft für Hygiene und Mikrobiologie; 2012.

      ,

      Weber K, et al. Partikel- und chipbasierte Anreicherung von Bakterien für einen Point-of-Care-Nachweis; 2017.

      ,
      • Weitzel T.
      • et al.
      Evaluation of a new point-of-care test for influenza A and B virus in travellers with influenza-like symptoms.
       Diabetic syndromes18(15.4)
      • Baumstark A.
      • et al.
      Bewertung der Systemgenauigkeit von Point-of-Care-Geräten für die Blutglukosebestimmung: Ein Vergleich zwischen einem Blutglukose-Messsystem für die Patientenselbstkontrolle mit 6 Geräten für den professionellen Gebrauch.
      ,
      • Baumstark A.
      • et al.
      Measurement accuracy of two professional-use systems for point-of-care testing of blood glucose.
      ,
      • Brumberg J.
      ,
      • Erbach M.
      • et al.
      Interferences and limitations in blood glucose self-testing: An overview of the current knowledge.
      ,
      • Freckmann G.
      HbA1c-POC systems for therapy control and diagnostics of diabetes: Is quality and quality control sufficient?.
      ,
      • Freckmann G.
      • et al.
      System accuracy evaluation of systems for pointof- care testing of blood glucose: A comparison of a patient-use system with six professional-use systems.
      ,
      • Hasslacher C.
      • Kulozik F.
      Hämatokrit-induzierte Interferenz bei Point-of-Care Geräten zur Blutzuckermessung.
      ,
      • Hermanns N.
      • et al.
      Überprüfung der Messgenauigkeit des „Point of Care“ Blutzuckermesssystems smart LAB®.
      ,
      • Klein F.K.
      • et al.
      Analytic Issues in the Diagnosis of GDM - Comparison of 6 Analytical Methods for Plasma Glucose.
      ,
      • Koschinsky F.d.A.P.T.
      • et al.
      Verbesserung der Therapiesicherheit durch eine einheitliche Kalibration von POCT-Glukose-Messgeräten auf Plasma Stellungnahme der Arbeitsgruppe POCT der Deutschen Vereinten Gesellschaft für Klinische Chemie und Laboratoriumsmedizin / Improvement of therapeutic safety through standardized plasma calibration of blood glucose test systems at the point-of-care Statement of the POCT Working Group of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL).
      ,
      • Koschinsky T.
      Screening and diagnostic procedures for gestational diabetes mellitus. Requirements of blood glucose measurement.
      ,
      • Lemke C.
      • Matthaei S.
      Präzision und Richtigkeit der neuesten Version des Point of Care (POC) Gerätes A1CNow+.
      ,
      • Neumaier M.
      • et al.
      Aktualisierte Anforderungen an die Messqualität und Qualitätssicherung (QS) von Point-of-Care-Testing (POCT)-Blutglukose-Messsystemen mit Unit-use Reagenzien, die für die Erstdiagnostik eines manifesten Diabetes in der Schwangerschaft oder eines Gestationsdiabetes mellitus (GDM) gemäß der GDM-Leitlinie der Deutschen Diabetes-Gesellschaft (DDG) geeignet sind.
      ,
      • Neumaier M.
      • et al.
      Updated Requirements for Measurement Quality and Quality Assurance of Point-Of-Care Testing (POCT) - Blood Glucose Measurement Systems with Unit-Use Reagents Suitable for the Initial Diagnosis of Diabetes Manifested in Pregnancy or Gestational Diabetes Mellitus (GDM) According to the GDM Guideline of the German Diabetes Association (DDG).
      ,
      • Patzer K.H.
      • et al.
      Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction.
      ,

      Pleus S, et al. Bewertung der Messgenauigkeit von zwei Point-of-Care-Testing-Blutglukosemesssystemen für den professionellen Gebrauch. 2018, Georg Thieme Verlag KG: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany M4 - Citavi. p. P 194.

      ,
      • Schnell O.
      • Crocker J.B.
      • Weng J.
      Impact of HbA1c Testing at Point of Care on Diabetes Management.
      ,
      • Thiery J.
      • et al.
      Anforderungen an die Messqualität und Qualitätssicherung (QS) von Point-of-Care-Testing(POCT)-Blutglukose-Messsystemen, die für das Screening und die Diagnose eines Gestationsdiabetes mellitus (GDM) gemäß der GDM-Leitlinie der Deutschen Diabetes-Gesellschaft (DDG) geeignet sind.
       Cardiac syndromes (e.g. cardiac infarction or insufficiency, etc.)14(12.0)
      • Bingisser R.
      • et al.
      Measurement of natriuretic peptides at the point of care in the emergency and ambulatory setting: Current status and future perspectives.
      ,
      • Blank W.A.
      • Schmidt R.
      • Schneider A.
      Use of troponin T testing in familiy practice: Use and benefit of troponin T testing based on a census of Bavarian family doctors.
      ,
      • Boldt K.
      Vergleichende Untersuchung der prognostischen Relevanz von BNP, NT-proBNP, hsCRP und TNF-ɑ bei Patienten mit klinisch-anamnestischem Verdacht auf das Vorliegen einer Herzinsuffizienz in der Hausarztpraxis-: Follow-up-Untersuchung zur Grundstudie zur Objektivierung der kardiovaskulären Dysfunktion im ambulanten und hausärztlichen Bereich mittels handgehaltener Echokardiographie und dem BNP-Schnelltest (Handheld-BNP-Studie)Prognostic utility of BNP, NT-proBNP, hsCRP and TNF-ɑ in the assessment of patients with suspected heart failure in primary care.
      ,
      • Burri E.
      • et al.
      B-type natriuretic peptide in the evaluation and management of dyspnoea in primary care.
      ,

      Freiherr Von Recum J, Universitätsbibliothek Der FUB. Akutdiagnostik im notfallmedizinischen Kontext; 2020.

      ,
      • Jungbauer C.
      • et al.
      Analytical and clinical validation of a point-of-care cardiac troponin T test with an improved detection limit.
      ,
      • Jungbauer C.G.
      • et al.
      Equal performance of novel N-terminal proBNP (Cardiac proBNP®) and established BNP (Triage BNP®) point-of-care tests.
      ,
      • Kampfenkel T.
      Machbarkeit und Nutzen von einem 12-Kanal-EKG und einer “Point-of-care” Bestimmung von Myokardnekroseparametern in der prähospitalen Diagnostik von Patienten mit Verdacht auf ein akutes.
      ,

      Morbach C, et al. Point-of-care B-type natriuretic peptide and portable echocardiography for assessment of patients with suspected heart failure in primary care: rationale and design of the three-part Handheld-BNP program and results of the training study. Clin Res Cardiol 107(2): 95–107.

      ,
      • Peetz D.
      • Hafner G.
      • Lackner K.J.
      Near-patient testing of natriuretic peptides.
      ,
      • Reis C.
      • Universität S.
      Magneto-hydrodynamische Fokussierung: ein neues Verfahren für die Point of Care Diagnostik.
      ,
      • Schäfer M.
      • et al.
      Diagnostic equivalence of an N-terminal pro-brain natriuretic peptide point-of-care test to the laboratory method in patients with heart failure and in reference populations.
      ,
      • Slagman A.
      • et al.
      Diagnostic performance of a high-sensitive troponin T assay and a troponin T point of care assay in the clinical routine of an Emergency Department: A clinical cohort study.
      ,
      • Zugck C.
      • et al.
      Multicentre evaluation of a new point-of-care test for the determination of NT-proBNP in whole blood.
       Coagulopathies and thrombosis12(10.3)
      • Braun S.
      • Spannagl M.
      • Völler H.
      Patient self-testing and self-management of oral anticoagulation.
      ,
      • Braun S.
      • et al.
      Update of guidelines for patient self-management of oral anticoagulation.
      ,
      • Busse J.
      Dabigatran, Rivaroxaban, Apixaban, Argatroban und Fondaparinux und ihre Effekte auf Point-of-Care-sowie Plättchenfunktionstests.
      ,
      • Dempfle C.E.
      • et al.
      Sensitivity and specificity of a quantitative point of care D-dimer assay using heparinized whole blood, in patients with clinically suspected deep vein thrombosis.
      ,
      • Erk A.
      Point-of-Care Bestimmung der Prothrombinzeit mittels CoaguChek® XS bei präklinischen Notfalleinsätzen.
      ,
      • Görlinger K.
      • et al.
      Messung der Thrombozytenfunktion mit Point-of-Care-Methoden.
      ,
      • Rizos T.
      • et al.
      Fast point-of-care coagulometer guided reversal of oral anticoagulation at the bedside hastens management of acute subdural hemorrhage.
      ,
      • Siebenhofer A.
      • et al.
      Self-management of oral anticoagulation. Deutsches Arzteblatt.
      ,
      • Topf H.G.
      • et al.
      Closing the gap - Detection of clinically relevant von Willebrand disease in emergency settings through an improved algorithm based on rotational Thromboelastometry 11 Medical and Health Sciences 1103 Clinical Sciences 11 Medical and Health Sciences 1102 Cardiorespiratory Medicine and Haematology.
      ,
      • Halimeh S.
      • et al.
      Multiplate® whole blood impedance point of care aggregometry: Preliminary reference values in healthy infants, children and adolescents.
      ,
      • Harenberg J.
      • et al.
      Novel methods for assessing oral direct factor xa and thrombin inhibitors: Use of point-of-care testing and urine samples.
      ,
      • Harenberg J.
      • Kraemer R.
      PL-23 measurement of the new anticoagulants.
       Unspecified diseases16(13.7)
      • Barabas N.
      • Bietenbeck A.
      Application guide: Training of professional users of devices for near-patient testing.
      ,
      • Betz S.
      • Plöger B.
      • Kill C.
      D - Point of Care – Die präklinische Blutgasanalyse als diagnostisches Tool.
      ,

      Frese T, et al., Use of point-of-care tests among general practitioners: a cross-sectional study in Saxony, Germany. Rural Remote Health 16(1): 3552.

      ,
      • Gauglitz G.
      • Luppa P.B.
      Patientennahe Labordiagnostik. Point-of-Care-Testing.
      ,
      • Gebauer A.
      • Schmidt S.
      • Hoffmann W.
      Status and perspective of lab-on-a-chip systems for common diseases: A systematic review from 2003 to 2013.
      ,
      • Greaves R.F.
      • et al.
      Key questions about the future of laboratory medicine in the next decade of the 21st century: A report from the IFCC-Emerging Technologies Division.
      ,
      • Horák J.
      Microfluidic Immunosensor for Point-of-care Diagnostics: Microfluidischer Immunosensor Für Patientennahe Diagnostik.
      ,

      Jung E, et al. Combination of channel- and droplet-based microfluidics for complex PoC devices. Fraunhofer IZM, Gustav-Meyer-Allee 25, 13355 Berlin, Germany Technical University of Berlin, FSP-TdM, Gustav-Meyer-Allee 25, 13355 Berlin, Germany CNRS FEMTO Innovation, 32 Avenue Observatoire, F-2500 Besançon, France, 29 May 2012 through 1 June 2012 San Diego, CA.

      ,

      Junker R, Schlebusch H, Luppa PB. Point-of-care testing in hospitals and primary care. Dtsch Arztebl Int 107(33): 561–7.

      ,
      • Kachler M.
      • Maschek C.
      Organizational challenges in the management of point-of-care diagnostics in healthcare facilities.
      ,
      • Luppa P.B.
      • et al.
      Clinically relevant analytical techniques, organizational concepts for application and future perspectives of point-of-care testing.
      ,
      • Luppa P.B.
      • Schlebusch H.
      Analytical methods and clinical applications of point-of-care testing - A survey.
      ,
      • O’Sullivan S.
      • et al.
      Developments in transduction, connectivity and AI/machine learning for point-of-care testing.
      ,

      Risch L, Senn O. [Symptom based approaches in point of care laboratory testing]. Ther Umsch. 72(2): 105–12.

      ,

      Schols AMR, et al. International definition of a point-of-care test in family practice: a modified e-Delphi procedure. Family Practice 35(4): 475–80.

      ,
      • Spitzenberger F.
      Charakteristika der neuen EU-Verordnung über In-vitro-Diagnostika und Auswirkungen auf POCT und medizinische Laboratorien.
       Others13(11.1)
      • Borensztajn D.
      • et al.
      Diversity in the emergency care for febrile children in Europe: a questionnaire study.
      ,

      Grübl T. Präklinische Point-of-Care-Diagnostik bei Reanimation: Wie relevant sind erste Laborwerte für den Notarzt? 2019.

      ,
      • Hahn B.
      • et al.
      Mobiles Notfall-Labor in der präklinischen Notfallmedizin.
      ,
      • Kunze M.
      • et al.
      Interleukin-6-Schnelltest im Vaginalsekret bei Schwangeren mit vorzeitiger Wehentätigkeit.
      ,

      Lorenz K, et al. Evaluation of a novel point-of-care test for active matrix metalloproteinase-8: agreement between qualitative and quantitative measurements and relation to periodontal inflammation. J Periodontal Res 52(2): 277–84.

      ,
      • Maaß S.
      • et al.
      Diagnostics and therapy of sore throat patients presenting in primary care: An observational study.
      ,

      Mitsakakis K, et al. Diagnostic tools for tackling febrile illness and enhancing patient management. Microelectron Eng 201: 26–59.

      ,
      • Palacio M.
      • et al.
      Meta-analysis of studies on biochemical marker tests for the diagnosis of premature rupture of membranes: Comparison of performance indexes.
      ,
      • Pfab T.
      • et al.
      Rapid immunochromatographic strip test for the detection of albuminuria and brief literature review on albuminuria screening.
      ,
      • Rübenhagen R.
      • Dangers M.
      Evaluation of a novel point-of-care test for the rapid semi-quantitative detection of allergen-specific immunoglobulin E.
      ,

      Stahl LS, et al. Der Quantum Blue® (Bühlmann Laboratories AG) Schnelltest erkennt erhöhte Calprotectin-Werte im Speichel und Serum von Patienten mit Peritonsillar-Abszess. 2019, Georg Thieme Verlag KG: Klinik für HNO, Universitätsklinikum Münster, Münster Institut für Immunologie, Universitätsklinikum Münster, Münster M4 - Citavi. p. 10862.

      ,
      • Tangermann P.
      • et al.
      Low Sensitivity of Simtomax Point of Care Test in Detection of Celiac Disease in a Prospective Multicenter Study.
      ,
      • Wiesenreiter J.
      Evaluierung des concile Omega 100 Point-of-Care-Systems zur Bestimmung des totalen und freien prostataspezifischen Antigens im Serum im Hinblick ….
      Total117(100)

      Research focus and studied outcomes in primary studies on the use of POCT in outpatient care in Germany

      Considering the primary studies, we identified nine pre-clinical studies (9/67, 13.4%) which provide data on the technical development of novel POCT (Table 3); among these six studies on POCT targeted for outpatient testing of infectious diseases, such as respiratory tract infections and malaria. However, these studies do not provide any data on the clinical utility of POCTs. Our systematic literature search shows that the majority (40/67, 56.7%) of primary research studies in Germany focus on the analytical and diagnostic performance of POCTs. A typical diagnostic accuracy study includes testing of target patient samples using the POCT and the established reference method (gold standard) which defines the “true” disease status for each patient. By using predefined diagnostic thresholds for the POCT, the diagnostic accuracy can be calculated in comparison to the reference method. Most of these studies found that the diagnostic performance of POCT is sufficient for clinical routine use and is often not significantly inferior to established laboratory tests.
      Table 3Research focus and studied outcomes in primary research studies on POCT use in German outpatient care published between 2005 and 2020.
      Some studies investigated more than one outcome and therefore the numbers of outcomes exceeds the number of studies.
      Total number(%)References
      Total number of primary studies67
      Some studies investigated more than one outcome and therefore the numbers of outcomes exceeds the number of studies.
      (100)
      Preclinical research
       Technical development / preclinical basic research9(13.4)
      • Figueroa M.
      • et al.
      Polyethylene glycol-mediated blocking and monolayer morphology of an electrochemical aptasensor for malaria biomarker detection in human serum.
      ,

      Fröde D, Universitätsbibliothek B, Dübel S. Rekombinante Antikörper für die Point‐of‐care‐Diagnostik von CRP; 2012.

      ,
      • Gal M.
      • et al.
      Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
      ,
      • Horák J.
      Microfluidic Immunosensor for Point-of-care Diagnostics: Microfluidischer Immunosensor Für Patientennahe Diagnostik.
      ,

      Jung E, et al. Combination of channel- and droplet-based microfluidics for complex PoC devices. Fraunhofer IZM, Gustav-Meyer-Allee 25, 13355 Berlin, Germany Technical University of Berlin, FSP-TdM, Gustav-Meyer-Allee 25, 13355 Berlin, Germany CNRS FEMTO Innovation, 32 Avenue Observatoire, F-2500 Besançon, France, 29 May 2012 through 1 June 2012 San Diego, CA.

      ,

      Klamp T. Ein schnelles Bead-basiertes und bildgebendes Verfahren zur Quantifizierung von Nukleinsäuren für die Integration in Lab-on-a-Chip-basierten Point-of-Care-Testing-Systemen.

      ,
      • Reis C.
      • Universität S.
      Magneto-hydrodynamische Fokussierung: ein neues Verfahren für die Point of Care Diagnostik.
      ,
      • Schmalenberg M.
      • et al.
      Magnetic bead fluorescent immunoassay for the rapid detection of the novel inflammation marker YKL40 at the point-of-care.
      ,

      van Oordt TSO, Mark D, Kosse D, Roth G, Achazi K, Patel P, et al. A Functional Blister-Pack LabDisk System for Point of Care Testing, in Deutsche Gesellschaft für Hygiene und Mikrobiologie; 2012.

      Diagnostic performance
       Technical and clinical diagnostic test performance40(59.7)
      • Baumstark A.
      • et al.
      Bewertung der Systemgenauigkeit von Point-of-Care-Geräten für die Blutglukosebestimmung: Ein Vergleich zwischen einem Blutglukose-Messsystem für die Patientenselbstkontrolle mit 6 Geräten für den professionellen Gebrauch.
      ,
      • Baumstark A.
      • et al.
      Measurement accuracy of two professional-use systems for point-of-care testing of blood glucose.
      ,

      Blankenstein T, et al. Point-of-care (POC) diagnosis of bacterial vaginosis (BV) using VGTest™ ion mobility spectrometry (IMS) in a routine ambulatory care gynecology clinic. Arch Gynecol Obstet 292(2): 355–62.

      ,
      • Boldt K.
      Vergleichende Untersuchung der prognostischen Relevanz von BNP, NT-proBNP, hsCRP und TNF-ɑ bei Patienten mit klinisch-anamnestischem Verdacht auf das Vorliegen einer Herzinsuffizienz in der Hausarztpraxis-: Follow-up-Untersuchung zur Grundstudie zur Objektivierung der kardiovaskulären Dysfunktion im ambulanten und hausärztlichen Bereich mittels handgehaltener Echokardiographie und dem BNP-Schnelltest (Handheld-BNP-Studie)Prognostic utility of BNP, NT-proBNP, hsCRP and TNF-ɑ in the assessment of patients with suspected heart failure in primary care.
      ,
      • Dolscheid-Pommerich R.C.
      • et al.
      Evaluation of the appropriate time period between sampling and analyzing for automated urinalysis.
      ,
      • Eggers M.
      • Enders M.
      • Terletskaia-Ladwig E.
      Evaluation of the becton dickinson rapid influenza diagnostic tests in outpatients in Germany during seven influenza seasons.
      ,
      • Erk A.
      Point-of-Care Bestimmung der Prothrombinzeit mittels CoaguChek® XS bei präklinischen Notfalleinsätzen.
      ,
      • Freckmann G.
      • et al.
      System accuracy evaluation of systems for pointof- care testing of blood glucose: A comparison of a patient-use system with six professional-use systems.
      ,

      Freiherr Von Recum J, Universitätsbibliothek Der FUB. Akutdiagnostik im notfallmedizinischen Kontext; 2020.

      ,
      • Harenberg J.
      • et al.
      Novel methods for assessing oral direct factor xa and thrombin inhibitors: Use of point-of-care testing and urine samples.
      ,
      • Hermanns N.
      • et al.
      Überprüfung der Messgenauigkeit des „Point of Care“ Blutzuckermesssystems smart LAB®.
      ,
      • Jungbauer C.
      • et al.
      Analytical and clinical validation of a point-of-care cardiac troponin T test with an improved detection limit.
      ,
      • Jungbauer C.G.
      • et al.
      Equal performance of novel N-terminal proBNP (Cardiac proBNP®) and established BNP (Triage BNP®) point-of-care tests.
      ,
      • Klein F.K.
      • et al.
      Analytic Issues in the Diagnosis of GDM - Comparison of 6 Analytical Methods for Plasma Glucose.
      ,

      Lorenz K, et al. Evaluation of a novel point-of-care test for active matrix metalloproteinase-8: agreement between qualitative and quantitative measurements and relation to periodontal inflammation. J Periodontal Res 52(2): 277–84.

      ,
      • Pfab T.
      • et al.
      Rapid immunochromatographic strip test for the detection of albuminuria and brief literature review on albuminuria screening.
      ,

      Pleus S, et al. Bewertung der Messgenauigkeit von zwei Point-of-Care-Testing-Blutglukosemesssystemen für den professionellen Gebrauch. 2018, Georg Thieme Verlag KG: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany M4 - Citavi. p. P 194.

      ,
      • Slagman A.
      • et al.
      Diagnostic performance of a high-sensitive troponin T assay and a troponin T point of care assay in the clinical routine of an Emergency Department: A clinical cohort study.
      ,

      Stahl LS, et al. Der Quantum Blue® (Bühlmann Laboratories AG) Schnelltest erkennt erhöhte Calprotectin-Werte im Speichel und Serum von Patienten mit Peritonsillar-Abszess. 2019, Georg Thieme Verlag KG: Klinik für HNO, Universitätsklinikum Münster, Münster Institut für Immunologie, Universitätsklinikum Münster, Münster M4 - Citavi. p. 10862.

      ,
      • Strein J.
      Schnelltest zum Nachweis einer Heliobacter pylori-Infektion bei Kindern, in Medizinischen Fakultät, Klinische Medizin.
      ,
      • Tangermann P.
      • et al.
      Low Sensitivity of Simtomax Point of Care Test in Detection of Celiac Disease in a Prospective Multicenter Study.
      ,
      • Toepfner N.
      • et al.
      Impact of technical training on rapid antigen detection tests (RADT) in group A streptococcal tonsillopharyngitis.
      ,
      • Topf H.G.
      • et al.
      Closing the gap - Detection of clinically relevant von Willebrand disease in emergency settings through an improved algorithm based on rotational Thromboelastometry 11 Medical and Health Sciences 1103 Clinical Sciences 11 Medical and Health Sciences 1102 Cardiorespiratory Medicine and Haematology.
      ,
      • Brumberg J.
      ,
      • Burri E.
      • et al.
      B-type natriuretic peptide in the evaluation and management of dyspnoea in primary care.
      ,
      • Busse J.
      Dabigatran, Rivaroxaban, Apixaban, Argatroban und Fondaparinux und ihre Effekte auf Point-of-Care-sowie Plättchenfunktionstests.
      ,
      • Clouth A.
      • et al.
      The point-of-care-diagnostic with C-reactive protein in the routine.
      ,
      • Deichmann K.A.
      • Enk C.
      • Hribar I.
      Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
      ,
      • Dempfle C.E.
      • et al.
      Sensitivity and specificity of a quantitative point of care D-dimer assay using heparinized whole blood, in patients with clinically suspected deep vein thrombosis.
      ,
      • Kunze M.
      • et al.
      Interleukin-6-Schnelltest im Vaginalsekret bei Schwangeren mit vorzeitiger Wehentätigkeit.
      ,
      • Kutz A.
      • et al.
      Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods - A prospective multinational trial.
      ,
      • Lemke C.
      • Matthaei S.
      Präzision und Richtigkeit der neuesten Version des Point of Care (POC) Gerätes A1CNow+.
      ,
      • Rizos T.
      • et al.
      Fast point-of-care coagulometer guided reversal of oral anticoagulation at the bedside hastens management of acute subdural hemorrhage.
      ,
      • Rübenhagen R.
      • Dangers M.
      Evaluation of a novel point-of-care test for the rapid semi-quantitative detection of allergen-specific immunoglobulin E.
      ,

      Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.

      ,
      • Schäfer M.
      • et al.
      Diagnostic equivalence of an N-terminal pro-brain natriuretic peptide point-of-care test to the laboratory method in patients with heart failure and in reference populations.
      ,
      • Weitzel T.
      • et al.
      Evaluation of a new point-of-care test for influenza A and B virus in travellers with influenza-like symptoms.
      ,
      • Wiesenreiter J.
      Evaluierung des concile Omega 100 Point-of-Care-Systems zur Bestimmung des totalen und freien prostataspezifischen Antigens im Serum im Hinblick ….
      ,
      • Wratil P.R.
      • et al.
      Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection.
      ,
      • Zugck C.
      • et al.
      Multicentre evaluation of a new point-of-care test for the determination of NT-proBNP in whole blood.
      Clinical performance
       Impact on therapeutic decisions4(5.9)
      • Deichmann K.A.
      • Enk C.
      • Hribar I.
      Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
      ,

      Grübl T. Präklinische Point-of-Care-Diagnostik bei Reanimation: Wie relevant sind erste Laborwerte für den Notarzt? 2019.

      ,
      • Hahn B.
      • et al.
      Mobiles Notfall-Labor in der präklinischen Notfallmedizin.
      ,

      Jennings LC, et al. Effect of rapid influenza testing on the clinical management of paediatric influenza. Influenza Other Respir Viruses 3(3): 91–8.

       Clinical effectiveness (patient health outcomes)2(3.0)
      • Burri E.
      • et al.
      B-type natriuretic peptide in the evaluation and management of dyspnoea in primary care.
      ,

      Grübl T. Präklinische Point-of-Care-Diagnostik bei Reanimation: Wie relevant sind erste Laborwerte für den Notarzt? 2019.

      Time and costs
       Time-related aspects (e. g. time to result, time saving, etc.)6(9.0)
      • Erk A.
      Point-of-Care Bestimmung der Prothrombinzeit mittels CoaguChek® XS bei präklinischen Notfalleinsätzen.
      ,

      Frese T, et al., Use of point-of-care tests among general practitioners: a cross-sectional study in Saxony, Germany. Rural Remote Health 16(1): 3552.

      ,

      Grübl T. Präklinische Point-of-Care-Diagnostik bei Reanimation: Wie relevant sind erste Laborwerte für den Notarzt? 2019.

      ,
      • Kampfenkel T.
      Machbarkeit und Nutzen von einem 12-Kanal-EKG und einer “Point-of-care” Bestimmung von Myokardnekroseparametern in der prähospitalen Diagnostik von Patienten mit Verdacht auf ein akutes.
      ,
      • Patzer K.H.
      • et al.
      Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction.
      ,
      • Rizos T.
      • et al.
      Fast point-of-care coagulometer guided reversal of oral anticoagulation at the bedside hastens management of acute subdural hemorrhage.
       Costs (e.g. total costs, cost effectiveness, etc.)2(3.0)
      • Burri E.
      • et al.
      B-type natriuretic peptide in the evaluation and management of dyspnoea in primary care.
      ,
      • Diel R.
      • Nienhaus A.
      Cost–benefit analysis of real-time influenza testing for patients in german emergency rooms.
      Impact on clinical routines / processes
       Implementation (e.g. training, quality assurance, etc.)11(16.4)
      • Becker J.
      • Diel R.
      Screening for Methicillin-resistant Staphylococcus aureus in a residence home for elderly in Germany.
      ,
      • Erk A.
      Point-of-Care Bestimmung der Prothrombinzeit mittels CoaguChek® XS bei präklinischen Notfalleinsätzen.
      ,

      Frese T, et al., Use of point-of-care tests among general practitioners: a cross-sectional study in Saxony, Germany. Rural Remote Health 16(1): 3552.

      ,

      Grübl T. Präklinische Point-of-Care-Diagnostik bei Reanimation: Wie relevant sind erste Laborwerte für den Notarzt? 2019.

      ,
      • Kaman W.E.
      • Andrinopoulou E.R.
      • Hays J.P.
      Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
      ,
      • Kampfenkel T.
      Machbarkeit und Nutzen von einem 12-Kanal-EKG und einer “Point-of-care” Bestimmung von Myokardnekroseparametern in der prähospitalen Diagnostik von Patienten mit Verdacht auf ein akutes.
      ,

      Morbach C, et al. Point-of-care B-type natriuretic peptide and portable echocardiography for assessment of patients with suspected heart failure in primary care: rationale and design of the three-part Handheld-BNP program and results of the training study. Clin Res Cardiol 107(2): 95–107.

      ,
      • Patzer K.H.
      • et al.
      Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction.
      ,
      • Rizos T.
      • et al.
      Fast point-of-care coagulometer guided reversal of oral anticoagulation at the bedside hastens management of acute subdural hemorrhage.
      ,

      Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.

      ,
      • Toepfner N.
      • et al.
      Impact of technical training on rapid antigen detection tests (RADT) in group A streptococcal tonsillopharyngitis.
      Perspectives of medical professionals and patients
       Medical professionals4(6.0)

      Frese T, et al., Use of point-of-care tests among general practitioners: a cross-sectional study in Saxony, Germany. Rural Remote Health 16(1): 3552.

      ,
      • Gal M.
      • et al.
      Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
      ,
      • Kaman W.E.
      • Andrinopoulou E.R.
      • Hays J.P.
      Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
      ,
      • Patzer K.H.
      • et al.
      Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction.
       Patients
      Some studies investigated more than one outcome and therefore the numbers of outcomes exceeds the number of studies.
      2(3.0)
      • Kaman W.E.
      • Andrinopoulou E.R.
      • Hays J.P.
      Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
      ,
      • Patzer K.H.
      • et al.
      Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction.
      Broader aspects
       Frequency of use in routine healthcare and/or availability9(13.4)
      • Blank W.A.
      • Schmidt R.
      • Schneider A.
      Use of troponin T testing in familiy practice: Use and benefit of troponin T testing based on a census of Bavarian family doctors.
      ,
      • Borensztajn D.
      • et al.
      Diversity in the emergency care for febrile children in Europe: a questionnaire study.
      ,

      Exner V, et al., Prescribing of antibiotics for respiratory tract infections in German outpatient pediatric care Results of a survey of pediatricians and general practitioners. Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz 63(10): 1231–40.

      ,

      Frese T, et al., Use of point-of-care tests among general practitioners: a cross-sectional study in Saxony, Germany. Rural Remote Health 16(1): 3552.

      ,
      • Gilsdorf A.
      • et al.
      Highly variable use of diagnostic methods for sexually transmitted infections-results of a nationwide survey, Germany.
      ,

      Grübl T. Präklinische Point-of-Care-Diagnostik bei Reanimation: Wie relevant sind erste Laborwerte für den Notarzt? 2019.

      ,

      Jennings LC, et al. Effect of rapid influenza testing on the clinical management of paediatric influenza. Influenza Other Respir Viruses 3(3): 91–8.

      ,

      Litwin AH, et al. Perceived barriers related to testing, management and treatment of HCV infection among physicians prescribing opioid agonist therapy: The C-SCOPE Study. J Viral Hepat 26(9): 1094–104.

      ,
      • Maaß S.
      • et al.
      Diagnostics and therapy of sore throat patients presenting in primary care: An observational study.
       Reimbursement1(1.5)

      Exner V, et al., Prescribing of antibiotics for respiratory tract infections in German outpatient pediatric care Results of a survey of pediatricians and general practitioners. Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz 63(10): 1231–40.

      Others3(4.59)
      • Becker J.
      • Diel R.
      Screening for Methicillin-resistant Staphylococcus aureus in a residence home for elderly in Germany.
      ,
      • Halimeh S.
      • et al.
      Multiplate® whole blood impedance point of care aggregometry: Preliminary reference values in healthy infants, children and adolescents.
      ,
      • Hasslacher C.
      • Kulozik F.
      Hämatokrit-induzierte Interferenz bei Point-of-Care Geräten zur Blutzuckermessung.
      * Some studies investigated more than one outcome and therefore the numbers of outcomes exceeds the number of studies.
      Going beyond test accuracy, eleven studies (16.4%) presented data on implementation aspects of POCT in outpatient care, including quality assurance and user training. Nine studies (13.4%) focused on data on the frequency of use and availability of POCT in German outpatient care.
      Importantly, our results show that only few POCT primary research studies provide data on the therapeutic impact (4/67, 5.9%) and clinical effectiveness (2/67, 3.0%). Among those, Deichmann et al. [
      • Deichmann K.A.
      • Enk C.
      • Hribar I.
      Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
      ] and Jennings et al. [

      Jennings LC, et al. Effect of rapid influenza testing on the clinical management of paediatric influenza. Influenza Other Respir Viruses 3(3): 91–8.

      ] reported results from the same non-randomized interventional study and found that the use of point-of-care influenza testing decreased the number of antibiotic prescriptions and impacts the initiation of antiviral therapy compared to the control group (no influenza POCT) in outpatient pediatric practices. Two observational studies in emergency medical services reported that POCT measurements of vitality markers (such as pH, K+, lactate, glucose) impacts acute therapeutic interventions [

      Grübl T. Präklinische Point-of-Care-Diagnostik bei Reanimation: Wie relevant sind erste Laborwerte für den Notarzt? 2019.

      ,
      • Hahn B.
      • et al.
      Mobiles Notfall-Labor in der präklinischen Notfallmedizin.
      ], but did not result in statistical significant differences in health outcomes between patients with preclinical vs. patients without preclinical POCT measurements [

      Grübl T. Präklinische Point-of-Care-Diagnostik bei Reanimation: Wie relevant sind erste Laborwerte für den Notarzt? 2019.

      ]. One RCT comparing POCT measurement of BNP vs. standard assessment without BNP did not find differences in health outcomes of patients presenting with dyspnea in primary care practices in Switzerland and Germany [
      • Burri E.
      • et al.
      B-type natriuretic peptide in the evaluation and management of dyspnoea in primary care.
      ]. However, BNP-POCT decreased the need for further diagnostic procedures and accelerated the initiation of the appropriate treatment.
      In addition to therapeutic impact and clinical effectiveness, economic aspects (e.g. cost effectiveness and reimbursement) as well as user and patient perspectives are key elements for successful implementation of POCT in routine outpatient healthcare. However, our literature search shows that these endpoints are rarely addressed in German primary research studies (Table 2).

      German clinical recommendations and consensus papers with focus on the use of POCT in outpatient care

      Among the seven clinical recommendations / position papers, three articles summarize requirements for measurement quality and quality assurance of POCT systems in the measurement of blood glucose for diagnosing diabetes manifested in pregnancy [
      • Neumaier M.
      • et al.
      Aktualisierte Anforderungen an die Messqualität und Qualitätssicherung (QS) von Point-of-Care-Testing (POCT)-Blutglukose-Messsystemen mit Unit-use Reagenzien, die für die Erstdiagnostik eines manifesten Diabetes in der Schwangerschaft oder eines Gestationsdiabetes mellitus (GDM) gemäß der GDM-Leitlinie der Deutschen Diabetes-Gesellschaft (DDG) geeignet sind.
      ,
      • Neumaier M.
      • et al.
      Updated Requirements for Measurement Quality and Quality Assurance of Point-Of-Care Testing (POCT) - Blood Glucose Measurement Systems with Unit-Use Reagents Suitable for the Initial Diagnosis of Diabetes Manifested in Pregnancy or Gestational Diabetes Mellitus (GDM) According to the GDM Guideline of the German Diabetes Association (DDG).
      ,
      • Thiery J.
      • et al.
      Anforderungen an die Messqualität und Qualitätssicherung (QS) von Point-of-Care-Testing(POCT)-Blutglukose-Messsystemen, die für das Screening und die Diagnose eines Gestationsdiabetes mellitus (GDM) gemäß der GDM-Leitlinie der Deutschen Diabetes-Gesellschaft (DDG) geeignet sind.
      ]. In 2009, the POCT Working Group of the German Society for Clinical Chemistry and Laboratory Medicine published suggestions on standardized POCT measurements of blood glucose [
      • Koschinsky F.d.A.P.T.
      • et al.
      Verbesserung der Therapiesicherheit durch eine einheitliche Kalibration von POCT-Glukose-Messgeräten auf Plasma Stellungnahme der Arbeitsgruppe POCT der Deutschen Vereinten Gesellschaft für Klinische Chemie und Laboratoriumsmedizin / Improvement of therapeutic safety through standardized plasma calibration of blood glucose test systems at the point-of-care Statement of the POCT Working Group of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL).
      ]. One joint position paper on POCT for sexual transmitted diseases (STI) published in 2017 emphasizes the potential of POC-testing to lower the barrier of testing and improving access to testing [
      • Meyer T.
      • et al.
      Schnelltest-Diagnostik sexuell übertragbarer Infektionen in niedrigschwelligen Einrichtungen: Gemeinsame Stellungnahme des RKI, PEI und der DSTIG.
      ]. This position paper concludes that POCT for HIV, HCV and syphilis are well suited for POC-testing. In contrast, sufficient diagnostic accuracy for detection of C. trachomatis and N. gonorrhoeae can only be achieved by PCR-based POCTs. In a clinical recommendation, Betz et al. [
      • Betz S.
      • Plöger B.
      • Kill C.
      D - Point of Care – Die präklinische Blutgasanalyse als diagnostisches Tool.
      ] describe the diagnostic value and routine use of preclinical POC-testing of blood gas analysis in emergency care. In a clinical guideline on patient self-management of oral anticoagulation from 2009, the authors highlight the diagnostic potential of patient self-testing of oral anticoagulation as it improves therapies and decreases the risk for thromboembolic events and bleedings [
      • Braun S.
      • et al.
      Update of guidelines for patient self-management of oral anticoagulation.
      ]. However, this guideline was not updated and therefore may not reflect the current state of scientific evidence.

      Discussion

      Given their low turnaround time and user-friendliness, POC laboratory tests offer great potential in the management of patients in outpatient care, including primary care practices or outpatient emergency care. In order to ensure an evidence-based use of POCT in German outpatient care, robust scientific evidence is needed, preferably derived from studies conducted in German outpatient healthcare facilities to increase the external validity. Our scoping review identified and analysed 117 articles on POCT use in outpatient care published by German researchers.
      A systemic overview on international POCTs studies concluded that evidence generation tends to focus on accuracy and overlooks other test attributes such as impact, implementation and cost-effectiveness [
      • Verbakel J.Y.
      • et al.
      Common evidence gaps in point-of-care diagnostic test evaluation: a review of horizon scan reports.
      ]. In line with these findings, our results show that also most German primary research studies focused on the diagnostic accuracy of POCTs, while evidence for other critical aspects, such as therapeutic impact, (comparative) clinical and cost effectiveness as well as user and patient perspectives is relatively rare. Even less evidence is available for the feasibility of POCT in routine outpatient healthcare and the organisational consequences of POCT use, such as improved patient flows or optimized practice routines. Importantly, rapid and sufficient diagnostic performance of POCT does not necessarily translate into improved patient outcomes [
      • Gerke O.
      • Høilund-Carlsen P.F.
      • Vach W.
      Analyzing paired diagnostic studies by estimating the expected benefit.
      ] and results from diagnostic accuracy studies provide limited or no evidence on the therapeutic impact or broader implications of POCT use in routine healthcare practice.
      According to Horvath et al. [
      • Horvath A.R.
      • et al.
      From biomarkers to medical tests: the changing landscape of test evaluation.
      ] the evaluation of in-vitro diagnostic tests, including POCTs, encompasses (i) analytical performance (e.g. precision), (ii) diagnostic performance (e.g. sensitivity, specificity), (iii) (comparative) clinical effectiveness (improvement of patient outcomes), (iv) cost-effectiveness and (v) broader impact, such as acceptance and organizational consequences. In addition, Fryback and Thornbury [
      • Fryback D.G.
      • Thornbury J.R.
      The efficacy of diagnostic imaging.
      ] defined the impact of diagnostics on diagnostic thinking and therapy decisions as further relevant endpoints that go beyond analytical and diagnostic performance. Based on these studies, our own research activity and this literature review, we define six domains of endpoints that should be addressed in the evaluation of a given POCT to comprehensively understand its potential benefits in outpatient care: (i) diagnostic performance, (ii) clinical performance, (iii) time and costs, (iv) impact on clinical routines / processes, (v) perspectives of medical professionals and patients, and (vi) broader aspects (see Figure 2). Based on our results from German POCT studies, POCTs for outpatient care are typically well characterized in their diagnostic performance (domain i) but evidence for all other endpoint domains is usually lacking. In accordance with the principles of evidence-based medicine, the effectiveness of POCT use in outpatient care should be assessed in interventional studies, preferably in randomized controlled clinical trials (RCTs), which are the gold standard in clinical research [
      • Hariton E.
      • Locascio J.J.
      Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials.