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  1. Article ; Online: Marktversagen in der In-vitro-Diagnostik – kann ein ökonomisches Gedankenspiel dabei helfen, Potentiale und Probleme zu identifizieren?

    Weiss, Nathalie

    GMS Zeitschrift zur Förung der Qualitätssicherung in medizinischen Laboratorien

    2024  Volume 15, Page(s) 1

    Abstract: Der Gesundheitssektor ist ein wichtiger Markt für Deutschland und machte im Jahr 2021 etwa 13,2% des gesamten Bruttoinlandprodukts aus. Auch wenn die Laborleistungen nur sechs Prozent der Ausgaben im Gesundheitssektor stellten, hängen von diesem Bereich ... ...

    Title translation Market failure in in vitro diagnostics – can an economic thought experiment help to identify potentials and problems?
    Abstract Der Gesundheitssektor ist ein wichtiger Markt für Deutschland und machte im Jahr 2021 etwa 13,2% des gesamten Bruttoinlandprodukts aus. Auch wenn die Laborleistungen nur sechs Prozent der Ausgaben im Gesundheitssektor stellten, hängen von diesem Bereich wichtige medizinische Entscheidungen wie Diagnosestellung und Therapieüberwachung ab, die die anderen Sektoren massiv beeinflussen können. Neben qualitätsrelevanten Merkmalen wie Sensitivität und Spezifität eines Tests spielen auch ökonomische Faktoren eine Rolle bei der Entscheidung für die Anschaffung und Verwendung eines Tests oder Verfahrens im Bereich der Laboratoriumsmedizin. Im Rahmen dieser Arbeit soll das ökonomische Modell des Marktversagens, also der Abweichung des realen Markts vom idealen Markt, auf den Spezialbereich In-vitro-Diagnostika angewandt werden. Es wird erläutert, an welcher Stelle geläufige Kennzeichen des Marktversagens, wie beispielsweise Markteintrittsbarrieren und Monopole, wirken und welchen Einfluss sie haben können. Zum Schluss wird ein kurzer Ausblick gegeben, wie diese Faktoren genutzt werden können, um Probleme für den Bereich der Laboratoriumsmedizin zu identifizieren, und Lösungsansätze diskutiert.

    The healthcare sector is an important market for Germany and accounted for around 13.2% of the total gross domestic product in 2021. Even though laboratory services only accounted for six percent of expenditure in the healthcare sector, important medical decisions such as diagnosis and therapy monitoring depend on this area and can have a massive impact on other sectors. In addition to quality-relevant characteristics, such as the sensitivity and specificity of a test, economic factors also play a role in the decision to purchase and use a test or procedure in the field of laboratory medicine. In this paper, the economic model of market failure, i.e. the deviation of the real market from the ideal market, will be applied to the special field of in vitro diagnostics. It is explained at which point common characteristics of market failure, such as market entry barriers and monopolies, have an effect and what influence they can have. Finally, a brief outlook is given on how these factors can be used to identify problems in the field of laboratory medicine and possible solutions are discussed.
    Keywords Medizin, Gesundheit ; market failure ; models ; in vitro diagnostics ; laboratory medicine ; Marktversagen ; Modelle ; In-vitro-Diagnostika ; Laboratoriumsmedizin
    Publishing date 2024-02-05
    Publisher German Medical Science GMS Publishing House; Düsseldorf
    Document type Article ; Online
    ISSN 1869-4241
    ISSN (online) 1869-4241
    DOI 10.3205/lab000048
    Database German Medical Science

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  2. Article ; Online: External quality assurance program for diagnostic complement laboratories: evaluation of the results of the past seven years.

    Kirschfink, Michael / Frazer-Abel, Ashley / Balogh, Emese / Goseberg, Sabine / Weiss, Nathalie / Prohászka, Zoltán

    Frontiers in immunology

    2024  Volume 15, Page(s) 1368399

    Abstract: Introduction: The complement external quality assurance (EQA) program was first organized in 2010 by a group of researchers working in diagnostic complement laboratories. Starting in 2016, INSTAND e.V., a German, non-profit interdisciplinary scientific ... ...

    Abstract Introduction: The complement external quality assurance (EQA) program was first organized in 2010 by a group of researchers working in diagnostic complement laboratories. Starting in 2016, INSTAND e.V., a German, non-profit interdisciplinary scientific medical society dedicated to providing expert EQA programs for medical laboratories, started organizing the EQAs for complement diagnostic laboratories together with the same group of experienced scientists and doctors who also work as EQA experts. The aim of the current work is to provide descriptive analysis of the past seven years' complement EQA results and evaluate timeline changes in proficiency testing.
    Methods: Each year, in March and October, blinded samples (normal, pathological) were sent to the participating diagnostic laboratories, where complement parameters were evaluated exactly as in daily routine samples. Since no reference method/target values exist for these parameters, and participants used different units for measurement, the reported results were compared to the stable mean (Algorithm A) of the participants using the same method/measurement units. A reported result was qualified as "passed" if it fell into the 30-50% evaluation/target range around the mean of reported results (depending on the given parameter).
    Results: While the number of participating laboratories has increased in the past years (from around 120 to 347), the number of complement laboratories providing multiple determinations remained mostly unchanged (around 30 worldwide). C3, C4, C1-inhibitor antigen and activity determinations provided the best proficiency results, with >90% passing quotas in the past years, independent of the applied method. Determination of the functional activity of the three activation pathways was good in general, but results showed large variance, especially with the pathological samples. Complement factor C1q and regulators FH and FI are determined by only a few laboratories, with variable outcomes (in general in the 85-90% pass range). Activation products sC5b-9 and Bb were determined in 30 and 10 laboratories, respectively, with typical passing quotas in the 70-90% range, without a clear tendency over the past years.
    Conclusion: With these accumulated data from the past seven years, it is now possible to assess sample-, method-, and evaluation related aspects to further improve proficiency testing and protocolize diagnostic complement determinations.
    MeSH term(s) Humans ; Laboratories
    Language English
    Publishing date 2024-03-26
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2606827-8
    ISSN 1664-3224 ; 1664-3224
    ISSN (online) 1664-3224
    ISSN 1664-3224
    DOI 10.3389/fimmu.2024.1368399
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Longitudinal analysis of external quality assessment of immunoassay-based steroid hormone measurement indicates potential for improvement in standardization.

    Vierbaum, Laura / Weiss, Nathalie / Kaiser, Patricia / Kremser, Marcel / Wenzel, Folker / Thevis, Mario / Schellenberg, Ingo / Luppa, Peter B

    Frontiers in molecular biosciences

    2024  Volume 11, Page(s) 1345356

    Abstract: As hormonal disorders are linked to several diseases, the accurate quantitation of steroid hormone levels in serum is crucial in order to provide patients with a reliable diagnosis. Mass spectrometry-based methods are regarded as having the highest level ...

    Abstract As hormonal disorders are linked to several diseases, the accurate quantitation of steroid hormone levels in serum is crucial in order to provide patients with a reliable diagnosis. Mass spectrometry-based methods are regarded as having the highest level of specificity and sensitivity. However, immunoassays are more commonly used in routine diagnostics to measure steroid levels as they are more cost effective and straightforward to conduct. This study analyzes the external quality assessment results for the measurement of testosterone, progesterone and 17β-estradiol in serum using immunoassays between early 2020 and May 2022. As reference measurement procedures are available for the three steroid hormones, the manufacturer-specific biases were normalized to the reference measurement values. The manufacturer-specific coefficients of variation were predominantly inconspicuous, below 20% for the three hormones when outliers are disregarded, however there were large differences between the various manufacturer collectives. For some collectives, the median bias to the respective reference measurement value was repeatedly greater than ±35%, which is the acceptance limit defined by the German Medical Association. In the case of testosterone and progesterone determination, some collectives tended to consistently over- or underestimate analyte concentrations compared to the reference measurement value, however, for 17β-estradiol determination, both positive and negative biases were observed. This insufficient level of accuracy suggests that cross-reactivity continues to be a fundamental challenge when antibody detection is used to quantify steroids with a high structural similarity. Distinct improvements in standardization are required to provide accurate analysis and thus, reliable clinical interpretations. The increased accuracy of the AX immunoassay for testosterone measurement, as observed in the INSTAND EQAs between 2020 and 2022, could be the result of a recalibration of the assay and raises hope for further improvement of standardization of immunoassay-based steroid hormone analyses in the coming years.
    Language English
    Publishing date 2024-01-31
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2814330-9
    ISSN 2296-889X
    ISSN 2296-889X
    DOI 10.3389/fmolb.2024.1345356
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany.

    Luppa, Peter B / Zeller, Michael / Pieper, Marija / Kaiser, Patricia / Weiss, Nathalie / Vierbaum, Laura / Freckmann, Guido

    Frontiers in molecular biosciences

    2024  Volume 11, Page(s) 1371426

    Abstract: Background: During the last decade, Germany has seen an increased prevalence and a redistribution from undetected to diagnosed diabetes mellitus. Due to this substantial epidemiological development, the number of people with documented type 2 diabetes ... ...

    Abstract Background: During the last decade, Germany has seen an increased prevalence and a redistribution from undetected to diagnosed diabetes mellitus. Due to this substantial epidemiological development, the number of people with documented type 2 diabetes was 8.7 million in 2022. An estimated two million undiagnosed subjects are to be added. Beyond that, the life expectancy of diabetic subjects is increasing due to more responsive health systems in terms of care. Possible reasons include improved screening of at-risk individuals, the introduction of HbA1c for diagnosis in 2010, and the higher use of risk scores. Additionally, quality aspects of the laboratory methodology should be taken into consideration.
    Methods: Epidemiology and clinical management of diabetes in Germany are presented in the light of publications retrieved by a selective search of the PubMed database. Additionally, the data from German external quality assessment (EQA) surveys for the measurands glucose in plasma and HbA1c in whole blood, reviewed from 2010 until 2022, were evaluated. Above this, data concerning the analytical performance of near-patient glucometer devices, according to the ISO norm 15197:2013, were analyzed.
    Results: Two laboratory aspects are in good accordance with the observation of an increase in the diabetes mellitus prevalence when retrospectively reviewing the period 2010 to 2022: First, the analytical performance according to the ISO norm 15197:2013 of the glucometer devices widely used by patients with diabetes for the glucose self-testing, has improved during this period. Secondly, concerning the EQA program of INSTAND, the number of participating laboratories raised significantly in Germany. The spreads of variations of the specified results for plasma glucose remained unchanged between 2010 and 2022, whereas for HbA1c a significant decrease of the result scattering could be observed.
    Conclusion: These retrospectively established findings testify to an excellent analytical quality of laboratory diagnostics for glucose and HbA1c throughout Germany which may be involved in a better diagnosis and therapy of previously undetected diabetes mellitus.
    Language English
    Publishing date 2024-03-20
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2814330-9
    ISSN 2296-889X
    ISSN 2296-889X
    DOI 10.3389/fmolb.2024.1371426
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Longitudinal analysis of 20 Years of external quality assurance schemes for PCR/NAAT-based bacterial genome detection in diagnostic testing.

    Kremser, Marcel / Weiss, Nathalie / Kaufmann-Stoeck, Anne / Vierbaum, Laura / Kappler, Silke / Schellenberg, Ingo / Hiergeist, Andreas / Fingerle, Volker / Baier, Michael / Reischl, Udo

    Frontiers in molecular biosciences

    2024  Volume 11, Page(s) 1373114

    Abstract: Background: Quality control (QC), quality assurance, and standardization are crucial for modern diagnostic testing in the field of medical microbiology. The need for efficient QC to ensure accurate laboratory results, treatment, and infection prevention ...

    Abstract Background: Quality control (QC), quality assurance, and standardization are crucial for modern diagnostic testing in the field of medical microbiology. The need for efficient QC to ensure accurate laboratory results, treatment, and infection prevention has led to significant efforts in standardizing assay reagents and workflows. External quality assessment (EQA) schemes, like those offered by INSTAND, play a vital role in evaluating in-house and commercial routine diagnostic assays, regarded as mandatory by national and global guidelines. The recent impact of polymerase chain reaction/nucleic acid amplification technology (PCR/NAAT) assays in medical microbiology requires that high-performing assays be distinguished from inadequately performing ones, especially those made by inexperienced suppliers.
    Objectives: The study assesses the evolving diagnostic performance trends over 2 decades for the detection of EHEC/STEC,
    Results: The study highlights the decline in in-house PCR assay usage, the emergence of new diagnostic challenges, and educational aspects within EQA schemes. Specific examples, such as the inclusion, in certain EQA surveys, of EHEC strains carrying
    Conclusion: Achieving excellence in diagnostic molecular microbiology involves a multifaceted approach, including well-evaluated assays, careful instrumentation selection, and structured training programs. EQA schemes contribute significantly to this pursuit by providing insights into the evolving diagnostic landscape and identifying areas for improvement in the diagnostic workflow as well as in PCR/NAAT assay design.
    Language English
    Publishing date 2024-03-27
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2814330-9
    ISSN 2296-889X
    ISSN 2296-889X
    DOI 10.3389/fmolb.2024.1373114
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Improving engagement in mental health treatment for home meal recipients with depression.

    Sirey, Jo Anne / Greenfield, Alexandra / DePasquale, Alyssa / Weiss, Nathalie / Marino, Patricia / Alexopoulos, George S / Bruce, Martha L

    Clinical interventions in aging

    2013  Volume 8, Page(s) 1305–1312

    Abstract: Background: Staff who provide support services to older adults are in a unique position to detect depression and offer a referral for mental health treatment. Yet integrating mental health screening and recommendations into aging services requires staff ...

    Abstract Background: Staff who provide support services to older adults are in a unique position to detect depression and offer a referral for mental health treatment. Yet integrating mental health screening and recommendations into aging services requires staff learn new skills to integrate mental health and overcome client barriers to accepting mental health referrals. This paper describes client rates of depression and a novel engagement intervention (Open Door) for homebound older adults who are eligible for home delivered meals and screened for depression by in-home aging service programs.
    Methods: Homebound older adults receiving meal service who endorsed depressive symptoms were interviewed to assess depression severity and rates of suicidal ideation. Open Door is a brief psychosocial intervention to improve engagement in mental health treatment by collaboratively addressing the individual level barriers to care. The intervention targets stigma, misconceptions about depression, and fears about treatment, and is designed to fit within the roles and responsibilities of aging service staff.
    Results: Among 137 meal recipients who had symptoms when screened for depression as part of routine home meal service assessments, half (51%) had Major Depressive Disorder and 13% met criteria for minor depression on the SCID. Suicidal ideation was reported by 29% of the sample, with the highest rates of suicidal ideation (47%) among the subgroup of individuals with Major Depressive Disorder.
    Conclusion: Individuals who endorse depressive symptoms during screening are likely to have clinically significant depression and need mental health treatment. The Open Door intervention offers a strategy to overcome barriers to mental health treatment engagement and to improve the odds of quality care for depression.
    MeSH term(s) Aged ; Aged, 80 and over ; Depression/diagnosis ; Depression/epidemiology ; Depression/therapy ; Depressive Disorder, Major/diagnosis ; Depressive Disorder, Major/epidemiology ; Depressive Disorder, Major/therapy ; Female ; Food Services ; Health Services Accessibility ; Homebound Persons/psychology ; Humans ; Male ; Middle Aged ; New York/epidemiology ; Qualitative Research ; Severity of Illness Index ; Surveys and Questionnaires
    Language English
    Publishing date 2013-09-27
    Publishing country New Zealand
    Document type Evaluation Study ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2364924-0
    ISSN 1178-1998 ; 1176-9092
    ISSN (online) 1178-1998
    ISSN 1176-9092
    DOI 10.2147/CIA.S49154
    Database MEDical Literature Analysis and Retrieval System OnLINE

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