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  • 1
    Online Resource
    Online Resource
    Kongressbericht: 2. Münchner POCT-Symposium, 15. – 17. September 2014, Klinikum rechts der Isar der TU München
    Walter de Gruyter GmbH ; 2015
    In:  LaboratoriumsMedizin Vol. 39, No. 2 ( 2015-4-1), p. 115-124
    Details
    In: LaboratoriumsMedizin, Walter de Gruyter GmbH, Vol. 39, No. 2 ( 2015-4-1), p. 115-124
    Type of Medium: Online Resource
    ISSN: 1439-0477 , 0342-3026
    URL: Article
    DOI: 10.1515/labmed-2014-0053
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2015
    detail.hit.zdb_id: 2081704-6
    detail.hit.zdb_id: 2909042-8
    SSG: 15,3
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  • 2
    Online Resource
    Online Resource
    Kongressbericht: 3. Münchner POCT-Symposium, 13. – 15. März 2017, Klinikum rechts der Isar der TU München
    Walter de Gruyter GmbH ; 2017
    In:  LaboratoriumsMedizin Vol. 41, No. 5 ( 2017-10-26), p. 205-213
    Details
    In: LaboratoriumsMedizin, Walter de Gruyter GmbH, Vol. 41, No. 5 ( 2017-10-26), p. 205-213
    Abstract: Die Arbeitsgruppe POCT der Deutschen Gesellschaft für Klinische Chemie und Laboratoriumsmedizin (DGKL) hat vom 13. bis 15. März 2017 das dritte Münchner Symposium zum Thema „Weiterentwicklung der patientennahen Sofortdiagnostik in unterschiedlichen klinischen Anwendungsbereichen“ organisiert. Unter der Kongressleitung von Prof. Dr. Peter B. Luppa, TU München wurden die Themenschwerpunkte von 43 Vortragenden behandelt. Dabei wurden insgesamt 9 Sitzungen von den Mitgliedern der Arbeitsgruppe POCT geleitet. Die Kongresssprachen waren Deutsch und Englisch. Eine angeschlossene Industrieausstellung mit 29 IVD-Unternehmen zeigte die neuesten POCT-Analysengeräte. Erstmals fand zudem eine ePosterausstellung mit 24 Postern in zwei eigenen Sessions statt. Dabei lagen die Poster elektronisch vor, der vorstellende Autor konnte es an einem speziellen Monitor allen Teilnehmern wie eine Bilderpräsentation vorführen. Neu war auch die Vergabe von 4 Vortrags- und 2 Posterpreisen.
    Type of Medium: Online Resource
    ISSN: 1439-0477 , 0342-3026
    URL: Article
    DOI: 10.1515/labmed-2017-0086
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2017
    detail.hit.zdb_id: 2081704-6
    detail.hit.zdb_id: 2909042-8
    SSG: 15,3
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  • 3
    Online Resource
    Online Resource
    NPU, LOINC, and SNOMED CT: a comparison of terminologies for laboratory results reveals individual advantages and a lack of possibilities to encode interpretive comments
    Walter de Gruyter GmbH ; 2018
    In:  LaboratoriumsMedizin Vol. 42, No. 6 ( 2018-12-19), p. 267-275
    Details
    In: LaboratoriumsMedizin, Walter de Gruyter GmbH, Vol. 42, No. 6 ( 2018-12-19), p. 267-275
    Abstract: Terminologies facilitate data exchange and enable laboratories to assist in patient care even if complex treatment pathways involve multiple stakeholders. This paper examines the three common terminologies Nomenclature for Properties and Units (NPU), Logical Observation Identifiers Names and Codes (LOINC), and SNOMED Clinical Terms (SNOMED CT). Methods The potential of each terminology to encode five exemplary laboratory results is assessed. The terminologies are evaluated according to scope, correctness, formal representations, and ease of use. Results NPU is based on metrological concepts with strict rules regarding the coding of the measurand and the result value. Clinically equivalent results are regularly mapped to the same code but there is little support to differentiate results from non-standardized measurements. LOINC encodes analyses as offered by the laboratory. Its large number of entries allows different mappings for the same analysis. SNOMED CT contains few analyses natively, but its formal composition mechanism allows representing measurements by post-coordinated expressions that are equivalent to LOINC codes. SNOMED CT’s strength lies in its support of many non-numerical result values. Implicit code hierarchies exist in NPU and LOINC. SNOMED CT has explicit, elaborate axioms that elucidate the meaning of its content. Its complexity and its license conditions, however, impede a more widespread use. Interpretive comments, a crucial part of laboratory results, are still difficult to encode with any of the terminologies. Conclusions All three terminologies have distinct potentials and limitations, but the approximation of SNOMED CT and LOINC suggests using them together. Terminologies need to be expanded to also cover interpretive comments.
    Type of Medium: Online Resource
    ISSN: 1439-0477 , 0342-3026
    URL: Article
    DOI: 10.1515/labmed-2018-0103
    Language: Unknown
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2018
    detail.hit.zdb_id: 2081704-6
    detail.hit.zdb_id: 2909042-8
    SSG: 15,3
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  • 4
    Online Resource
    Online Resource
    Users Regard Operator Training as Critical for Successful POCT Applications
    Clinical Laboratory Publications ; 2020
    In:  Clinical Laboratory Vol. 66, No. 01+02/2020 ( 2020)
    Details
    In: Clinical Laboratory, Clinical Laboratory Publications, Vol. 66, No. 01+02/2020 ( 2020)
    Type of Medium: Online Resource
    ISSN: 1433-6510
    URL: Article
    DOI: 10.7754/Clin.Lab.2019.190619
    Language: English
    Publisher: Clinical Laboratory Publications
    Publication Date: 2020
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  • 5
    Online Resource
    Online Resource
    External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact
    Walter de Gruyter GmbH ; 2018
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 56, No. 8 ( 2018-07-26), p. 1238-1250
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 56, No. 8 ( 2018-07-26), p. 1238-1250
    Abstract: Determination of blood glucose concentration is one of the most important measurements in clinical chemistry worldwide. Analyzers in central laboratories (CL) and point-of-care tests (POCT) are both frequently used. In Germany, regular participation in external quality assessment (EQA) schemes is mandatory for laboratories performing glucose testing. Methods: Glucose testing data from the two German EQAs “Reference Institute for Bioanalytics” (RfB) and “INSTAND – Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien” (Instand) were analyzed from 2012 to 2016. Multivariable odds ratios (OR) for the probability to reach a “good” result were calculated. Imprecision and bias were determined and clinical risk of measurement errors estimated. Results: The device employed was the most important variable required for a “good” performance in all EQAs. Additional participation in an EQA for CL automated analyzers improved performance in POCT EQAs. The reciprocal effect was less pronounced. New participants performed worse than experienced participants especially in CL EQAs. Imprecision was generally smaller for CL, but some POCT devices reached a comparable performance. Large lot-to-lot differences occurred in over 10% of analyzed cases. We propose the “bias budget” as a new metric to express the maximum allowable bias that still carries acceptable medical risk. Bias budgets were smallest and clinical risks of errors greatest in the low range of measurement 60–115 mg/dL (3.3–6.4 mmol/L) for most devices. Conclusions: EQAs help to maintain high analytical performances. They generate important data that serve as the foundation for learning and improvement in the laboratory healthcare system.
    Type of Medium: Online Resource
    ISSN: 1437-4331 , 1434-6621
    URL: Article
    DOI: 10.1515/cclm-2017-1142
    Language: Unknown
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2018
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
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  • 6
    Online Resource
    Online Resource
    Diagnostic value of cardiovascular magnetic resonance in comparison to endomyocardial biopsy in cardiac amyloidosis: a multi-centre study
    Springer Science and Business Media LLC ; 2021
    In:  Clinical Research in Cardiology Vol. 110, No. 4 ( 2021-04), p. 555-568
    Details
    In: Clinical Research in Cardiology, Springer Science and Business Media LLC, Vol. 110, No. 4 ( 2021-04), p. 555-568
    Abstract: Cardiac amyloidosis (CA) is an infiltrative disease characterised by accumulation of amyloid deposits in the extracellular space of the myocardium—comprising transthyretin (ATTR) and light chain (AL) amyloidosis as the most frequent subtypes. Histopathological proof of amyloid deposits by endomyocardial biopsy (EMB) is the gold standard for diagnosis of CA. Cardiovascular magnetic resonance (CMR) allows non-invasive workup of suspected CA. We conducted a multi-centre study to assess the diagnostic value of CMR in comparison to EMB for the diagnosis of CA. Methods We studied N  = 160 patients characterised by symptoms of heart failure and presence of left ventricular (LV) hypertrophy of unknown origin who presented to specialised cardiomyopathy centres in Germany and underwent further diagnostic workup by both CMR and EMB. If CA was diagnosed, additional subtyping based on EMB specimens and monoclonal protein studies in serum was performed. The CMR protocol comprised cine- and late-gadolinium-enhancement (LGE)-imaging as well as native and post-contrast T1-mapping (in a subgroup)—allowing to measure extracellular volume fraction (ECV) of the myocardium. Results An EMB-based diagnosis of CA was made in N  = 120 patients (CA group) whereas N  = 40 patients demonstrated other diagnoses (CONTROL group). In the CA group, N  = 114 (95%) patients showed a characteristic pattern of LGE indicative of CA. In the CONTROL group, only 1/40 (2%) patient showed a “false-positive” LGE pattern suggestive of CA. In the CA group, there was no patient with elevated T1-/ECV-values without a characteristic pattern of LGE indicative of CA. LGE-CMR showed a sensitivity of 95% and a specificity of 98% for the diagnosis of CA. The combination of a characteristic LGE pattern indicating CA with unremarkable monoclonal protein studies resulted in the diagnosis of ATTR-CA (confirmed by EMB) with a specificity of 98% [95%-confidence interval (CI) 92–100%] and a positive predictive value (PPV) of 99% (95%-CI 92–100%), respectively. The EMB-associated risk of complications was 3.13% in this study—without any detrimental or persistent complications. Conclusion Non-invasive CMR shows an excellent diagnostic accuracy and yield regarding CA. When combined with monoclonal protein studies, CMR can differentiate ATTR from AL with high accuracy and predictive value. However, invasive EMB remains a safe invasive gold-standard and allows to differentiate CA from other cardiomyopathies that can also cause LV hypertrophy.
    Type of Medium: Online Resource
    ISSN: 1861-0684 , 1861-0692
    URL: Article
    DOI: 10.1007/s00392-020-01771-1
    RVK:
    XA 37040
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2218331-0
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  • 7
    Online Resource
    Online Resource
    Patient-Based Real Time QC
    Oxford University Press (OUP) ; 2020
    In:  Clinical Chemistry Vol. 66, No. 9 ( 2020-09-01), p. 1140-1145
    Details
    In: Clinical Chemistry, Oxford University Press (OUP), Vol. 66, No. 9 ( 2020-09-01), p. 1140-1145
    Type of Medium: Online Resource
    ISSN: 0009-9147 , 1530-8561
    URL: Article
    DOI: 10.1093/clinchem/hvaa149
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 8
    Online Resource
    Online Resource
    Patient-Based Real-Time Quality Control: Review and Recommendations
    Oxford University Press (OUP) ; 2019
    In:  Clinical Chemistry Vol. 65, No. 8 ( 2019-08-01), p. 962-971
    Details
    In: Clinical Chemistry, Oxford University Press (OUP), Vol. 65, No. 8 ( 2019-08-01), p. 962-971
    Abstract: For many years the concept of patient-based quality control (QC) has been discussed and implemented in hematology laboratories; however, the techniques have not been widely implemented in clinical chemistry. This is mainly because of the complexity of this form of QC, as it needs to be optimized for each population and often for each analyte. However, the clear advantages of this form of QC, together with the ongoing realization of the shortcomings of “conventional” QC, have driven a need to provide guidance to laboratories to assist in deploying patient-based QC. This overview describes the components of a patient-based QC system (calculation algorithm, block size, truncation limits, control limits) and the relationship of these to the analyte being controlled. We also discuss the need for patient-based QC system optimization using patient data from the individual testing laboratory to reliably detect systematic errors while ensuring that there are few false alarms. The term patient-based real-time quality control covers many activities that use data from patient samples to detect analytical errors. These activities include the monitoring of patient population parameters such as the mean or median analyte value or using single within-patient changes such as the delta check. In this report, we will restrict the discussion to population-based parameters. This overview is intended to serve as a guide for the implementation of a patient-based QC system. The report does not cover the clinical evaluation of the population.
    Type of Medium: Online Resource
    ISSN: 0009-9147 , 1530-8561
    URL: Article
    DOI: 10.1373/clinchem.2019.305482
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 9
    Online Resource
    Online Resource
    Clinically relevant analytical techniques, organizational concepts for application and future perspectives of point-of-care testing
    Elsevier BV ; 2016
    In:  Biotechnology Advances Vol. 34, No. 3 ( 2016-05), p. 139-160
    Details
    In: Biotechnology Advances, Elsevier BV, Vol. 34, No. 3 ( 2016-05), p. 139-160
    Type of Medium: Online Resource
    ISSN: 0734-9750
    URL: Article
    DOI: 10.1016/j.biotechadv.2016.01.003
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2016
    detail.hit.zdb_id: 2016279-0
    SSG: 12
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  • 10
    Online Resource
    Online Resource
    Point-of-care testing (POCT) and IT security concepts
    Walter de Gruyter GmbH ; 2020
    In:  Journal of Laboratory Medicine Vol. 44, No. 2 ( 2020-04-28), p. 107-111
    Details
    In: Journal of Laboratory Medicine, Walter de Gruyter GmbH, Vol. 44, No. 2 ( 2020-04-28), p. 107-111
    Abstract: Point-of-care testing (POCT) has been an essential service in hospitals for many years with a main focus on reliability, classical laboratory quality criteria and easy handling. Hospital information technology (IT) security regulations, however, have not yet been adapted to the specificities of POCT. Following the POCT Symposium in Munich, the “1 st Round Table POCT-IT-Security Meeting” held in October 2019 in Cologne addressed these issues and managed to establish first consensus results in the essential fields of user, data and update management, as well as network connections and user-friendliness. First practical steps include optimizing the user management by connection to a directory service and definition of access control (including emergency authorization). Patient data economy on analyzers in combination with data and data transmission encryption as well as technically secure communication protocols are relevant steps in the fields of data management and network connections. An update management needs to be contractually defined for remote services and generally includes testing in a protocol-based scenario. Providing an organizational structure for POCT-IT security is a necessary prerequisite, as are continuous training and awareness for this topic with a strong focus on usability.
    Type of Medium: Online Resource
    ISSN: 2567-9449 , 2567-9430
    URL: Article
    DOI: 10.1515/labmed-2019-0199
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2020
    detail.hit.zdb_id: 2909042-8
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