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Jena University Hospital, Institute of General Practice and Family Medicine, Friedrich Schiller University Jena, GermanyInfectoGnostics Research Campus Jena, Jena, Germany
Jena University Hospital, Institute of General Practice and Family Medicine, Friedrich Schiller University Jena, GermanyInfectoGnostics Research Campus Jena, Jena, Germany
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.
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 [
]. 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 [
] 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 [
], 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.
] 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 [
]. 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 [
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 [
]. 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 [
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.
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.
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.
Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
Sensitivity and specificity of a quantitative point of care D-dimer assay using heparinized whole blood, in patients with clinically suspected deep vein thrombosis.
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.
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.
System accuracy evaluation of systems for pointof- care testing of blood glucose: A comparison of a patient-use system with six professional-use systems.
Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
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.
Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
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.
Köchling A, et al. Reduction of antibiotic prescriptions for acute respiratory tract infections in primary care: a systematic review. Implement Sci 13(1): 47.
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).
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.
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.
Mitsakakis K, et al. Challenges in identifying antibiotic resistance targets for point-of-care diagnostics in general practice. Future Microbiol 13(10): 1157–64.
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.
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.
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).
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.
Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.
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.
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.
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.
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.
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.
Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
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.
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.
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.
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.
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.
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.
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.
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.
Sensitivity and specificity of a quantitative point of care D-dimer assay using heparinized whole blood, in patients with clinically suspected deep vein thrombosis.
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.
System accuracy evaluation of systems for pointof- care testing of blood glucose: A comparison of a patient-use system with six professional-use systems.
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.
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.
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.
Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.
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.
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.
Köchling A, et al. Reduction of antibiotic prescriptions for acute respiratory tract infections in primary care: a systematic review. Implement Sci 13(1): 47.
Mitsakakis K, et al. Challenges in identifying antibiotic resistance targets for point-of-care diagnostics in general practice. Future Microbiol 13(10): 1157–64.
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).
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.
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).
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.
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.
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.
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.
Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
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.
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.
Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.
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.
Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
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.
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.
System accuracy evaluation of systems for pointof- care testing of blood glucose: A comparison of a patient-use system with six professional-use systems.
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).
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.
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).
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.
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.
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.
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.
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.
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.
Sensitivity and specificity of a quantitative point of care D-dimer assay using heparinized whole blood, in patients with clinically suspected deep vein thrombosis.
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.
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.
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.
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.
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.
Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
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.
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.
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.
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.
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.
System accuracy evaluation of systems for pointof- care testing of blood glucose: A comparison of a patient-use system with six professional-use systems.
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.
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.
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.
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.
Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
Sensitivity and specificity of a quantitative point of care D-dimer assay using heparinized whole blood, in patients with clinically suspected deep vein thrombosis.
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.
Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.
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.
Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
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.
Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
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.
Schafberger ASK, Sporleder U, Taubert S. DeutscheAIDS-Hilfe, Externe Qualitätssicherung für den Syphilis-Schnelltest: A 78, in Deutscher STI-Kongress. 2014: Berlin, Germany.
Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.
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.
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.
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.
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. [
Impact of rapid influenza testing on physician prescribing behaviour. Results from a prospective study in German pediatric centers during the influenza season 2006/2007.
] 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 [
], but did not result in statistical significant differences in health outcomes between patients with preclinical vs. patients without preclinical POCT measurements [
]. 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 [
]. 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 [
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.
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).
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 [
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 [
]. 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. [
] 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 [
]. 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 [
]. 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 [
] 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.
] 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 [
] 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 [
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