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Special Issue "Highlights in Swiss Laboratory Medicine 2023"

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A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Clinical Laboratory Medicine".

Deadline for manuscript submissions: 31 December 2023 | Viewed by 4880

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Special Issue Editors

Dr. Michael Nagler

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Guest Editor

Department of Clinical Chemistry, Inselspital, Bern University Hospital, Freiburgerstrasse 10, 3010 Bern, Switzerland
Interests: diagnosis; prediction; monitoring; diagnostic accuracy; sensitivity and specificity; effectiveness of diagnostic procedures; predictive value of tests; clinical decision making; health services research; risk factors; diagnostic techniques and procedures; epidemiology; cohort studies; anticoagulants; venous thromboembolism; heparin-induced thrombocytopenia

Prof. Dr. Gilbert Greub

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Guest Editor

Institute of Microbiology, Lausanne University Hospital, University of Lausanne, 1011 Lausanne, Switzerland
Interests: antibiotics; bacteremia; Gram's stain; Enterobacteriaceae; Gram-negative bacteria; lasers; spectrometry; mass; matrix-assisted laser desorption-ionization; mass spectrometry; pathogenic organism; gram-negative bacteremia; ionization; empirical antibiotic therapy; blood culture; extended-spectrum beta lactamases; bloodstream infections; early diagnosis; time-of-flight mass spectrometry; time-of-flight; marseilleviruses
Special Issues, Collections and Topics in MDPI journals

Prof. Dr. Vera Ulrike Bacher

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Guest Editor

Department of Hematology, University Hospital Bern, 3010 Bern, Switzerland
Interests: hematologic diagnostics; flow cytometry; cytomorphology; molecular genetics; measurable disease diagnostics; acute leukemias; chronic leukemias; lymphomas; myeloma; personalized therapies; interaction of diagnostics and therapies in hematology; prognosis; predictive markers
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The development of new laboratory analytics techniques, such as proteomics, genomics, metabolomics, and immunoprofiling, has enabled extremely sensitive analyses of biomarkers, sometimes down to the level of individual cells. Additionally, the use of multiplexed techniques allows researchers to determine hundreds of biomarkers simultaneously without causing any interference. Despite this, most of these techniques are used only for research purposes, and very few of them have been successfully translated into clinical practice. This implementation gap can be attributed to two main reasons. First, new tests are often not evaluated in adequately designed studies and are not integrated into existing diagnostic pathways. Furthermore, laboratory medicine experts are dispersed across a variety of topic-specific scientific societies, making a unified and concerted effort difficult.

This Special Issue wishes to contribute to addressing these problems. We invite laboratory experts from all specialties and scientific societies to contribute to the evaluation of laboratory tests. Even if we start our call in the Swiss setting, it should not be limited to that. If experts from all scientific societies contribute here, this will help to increase attention to the problems mentioned. In addition, the research methods will be harmonized, and the research field will be strengthened.

We hope that we can arouse your interest with our Special Issue, and we look forward to your contribution to support laboratory medicine progress.

Dr. Michael Nagler
Prof. Dr. Gilbert Greub
Prof. Dr. Vera Ulrike Bacher
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Diagnostics is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

laboratory medicine
analytical techniques
diagnostic techniques and procedures
diagnosis
prediction
monitoring
diagnostic accuracy
sensitivity and specificity
effectiveness of diagnostic procedures
predictive value of tests

Published Papers (6 papers)

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Research

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Open AccessArticle

The Association of suPAR with Cardiovascular Risk Factors in Young and Healthy Adults

Niklas Fabio Wohlwend

and

Diagnostics 2023, 13(18), 2938; https://doi.org/10.3390/diagnostics13182938 - 13 Sep 2023

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Abstract

The soluble urokinase plasminogen activator receptor (suPAR), as a correlate of chronic low-grade inflammation, may be used to predict individual cardiovascular risk. Since chronic low-grade inflammation is thought to be associated with the development of cardiovascular disease, this study aimed to evaluate if suPAR plasma levels are correlated with cardiovascular risk factors in young and healthy adults (aged 25–41 years). Consequently, data from the GAPP (genetic and phenotypic determinants of blood pressure and other cardiovascular risk factors) study were used to investigate suPAR plasma levels in relation to the following cardiovascular risk factors and laboratory parameters: BMI, physical activity, alcohol consumption, smoking status, blood pressure parameters, glucose status, and lipid levels. Additionally, suPAR was compared to the healthy lifestyle score and the Framingham score representing the overall cardiovascular risk profile. These associations were assessed using two different statistical approaches. Firstly, all cardiovascular risk factors and scores were compared amongst sex-specific suPAR plasma levels with ANOVA analysis. Secondly, sex-specific multivariable linear regressions were performed. Female participants had higher plasma suPAR levels than male participants (1.73 ng/mL versus 1.50 ng/mL; p < 0.001). A significant inverse correlation between suPAR plasma levels and HDL cholesterol was found in men (p = 0.001) and women (p < 0.001). Furthermore, male (p < 0.001) and female participants (p < 0.001) who smoked showed significantly higher plasma levels of suPAR (p < 0.001). For male participants, an inverse correlation of the healthy lifestyle score with suPAR plasma levels (p = 0.001) and a positive correlation of the Framingham score with suPAR plasma levels (p < 0.001) were detected. In women, no such correlation was found. The cholesterol levels (p = 0.001) and HbA1c (p = 0.008) correlated significantly with plasma suPAR levels in female participants. suPAR plasma levels were found to be strongly associated with certain cardiovascular risk factors; however, sex-specific differences were found. These sex-specific differences might be explained by the higher prevalence of cardiovascular risk factors in men resulting in a stronger correlation of suPAR as a marker of low-grade inflammation, since the existence of the risk factors already led to subclinical damage in men. Further research on suPAR levels in an older study population is needed. Full article

(This article belongs to the Special Issue Highlights in Swiss Laboratory Medicine 2023)

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Open AccessArticle

Machine Learning in Antibody Diagnostics for Inflammatory Bowel Disease Subtype Classification

Christiane Sokollik

Aurélie Pahud de Mortanges

Alexander B. Leichtle

Pascal Juillerat

and

Michael P. Horn

Diagnostics 2023, 13(15), 2491; https://doi.org/10.3390/diagnostics13152491 - 26 Jul 2023

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Abstract

Antibody testing in inflammatory bowel disease (IBD) can add to diagnostic accuracy of the main subtypes Crohn’s disease (CD) and ulcerative colitis (UC). Whether modern modeling techniques such as supervised and unsupervised machine learning are of value for finer distinction of subtypes such as IBD-unclassified (IBD-U) is not known. We determined the antibody profile of 100 adult IBD patients from the Swiss IBD cohort study with known subtype (50 CD, 50 UC) as well as of 76 IBD-U patients. We included ASCA IgG and IgA, p-ANCA, MPO- and PR3-ANCA, and xANCA measurements for computing different antibody panels as well as machine learning models. The AUC of an optimized antibody panel was 85% (95%CI, 78–92%) to distinguish CD from UC patients. The antibody profile of IBD-U patients was closely related to UC. No specific antibody profile was predictive for IBD-U nor for re-classification. The panel diagnostic was in favor of UC reclassification prediction with a correct assignment rate of 69.2–73.1% depending on the cut-off applied. Supervised machine learning could not distinguish between CD, UC, and IBD-U. More so, unsupervised machine learning suggested only two distinct clusters as a likely number of IBD subtypes. Antibodies in IBD are supportive in confirming clinical determined subtypes CD and UC but have limited capacity to predict IBD-U and reclassification during follow-up. In terms of antibody profiles, IBD-U is not a distinct subtype of IBD. Full article

(This article belongs to the Special Issue Highlights in Swiss Laboratory Medicine 2023)

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Open AccessArticle

Concentrations of Serum Brain Injury Biomarkers Following SARS-CoV-2 Infection in Individuals with and without Long-COVID—Results from the Prospective Population-Based COVI-GAPP Study

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Diagnostics 2023, 13(13), 2167; https://doi.org/10.3390/diagnostics13132167 - 26 Jun 2023

Viewed by 2037

Abstract

It is unknown whether neurological symptoms are associated with brain injury after SARS-CoV-2 infections and whether brain injury and related symptoms also emerge in Long-COVID patients. Biomarkers such as serum neurofilament light chain (sNfL) and glial fibrillary acidic protein (sGFAP) can be used to elucidate neuro-axonal and astroglial injuries. We investigated whether these biomarkers are associated with COVID-19 infection status, associated symptoms and Long-COVID. From 146 individuals of the general population with a post-acute, mild-to-moderate SARS-CoV-2 infection, sNfL and sGFAP were measured before, during and after (five and ten months) the infection. Individual symptoms and Long-COVID status were assessed using questionnaires. Neurological associated symptoms were described for individuals after a mild and moderate COVID-19 infection; however, sNfL (p = 0.74) and sGFAP (p = 0.24) did not change and were not associated with headache (p = 0.51), fatigue (p = 0.93), anosmia (p = 0.77) or ageusia (p = 0.47). In Long-COVID patients, sGFAP (p = 0.038), but not sNfL (p = 0.58), significantly increased but was not associated with neurological associated symptoms. Long-COVID status, but not post-acute SARS-CoV-2 infections, may be associated with astroglial injury/activation, even if neurological associated symptoms were not correlated. Full article

(This article belongs to the Special Issue Highlights in Swiss Laboratory Medicine 2023)

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Open AccessArticle

Determination of Anti-Xa Inhibitor Plasma Concentrations Using a Universal Edoxaban Calibrator

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Diagnostics 2023, 13(12), 2128; https://doi.org/10.3390/diagnostics13122128 - 20 Jun 2023

Cited by 1 | Viewed by 624

Abstract

A universal calibrator for the determination of all anti-Xa inhibitors would support laboratory processes. We aimed to test the clinical performance of an anti-Xa assay utilizing a universal edoxaban calibrator to determine clinically relevant concentrations of all anti-Xa inhibitors. Following a pilot study, we enrolled 553 consecutive patients taking rivaroxaban, edoxaban, or apixaban from nine study centers in a prospective cross-sectional study. The Technochrom^® anti-Xa assay was conducted using the Technoview^® edoxaban calibrator. Using ultra-high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS), anti-Xa inhibitor drug concentrations were determined. Sensitivities and specificities to detect three clinically relevant drug concentrations (30 µgL⁻¹, 50 µgL⁻¹, 100 µgL⁻¹) were determined. Overall, 300 patients treated with rivaroxaban, 221 with apixaban, and 32 with edoxaban were included. The overall correlation coefficient (r_s) was 0.95 (95% CI 0.94, 0.96). An area under the receiver operating characteristic curve of 0.96 for 30 µgL⁻¹, 0.98 for 50 µgL⁻¹, and 0.99 for 100 µgL⁻¹ was found. The sensitivities were 92.3% (95% CI 89.2, 94.6), 92.7% (89.4, 95.1), and 94.8% (91.1, 97.0), respectively (specificities 82.2%, 93.7%, and 94.4%). In conclusion, the clinical performance of a universal, edoxaban-calibrated anti-Xa assay was solid and most drug concentrations were predicted correctly. Full article

(This article belongs to the Special Issue Highlights in Swiss Laboratory Medicine 2023)

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Open AccessOpinion

IVDR: Analysis of the Social, Economic, and Practical Consequences of the Application of an Ordinance of the In Vitro Diagnostic Ordinance in Switzerland

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Diagnostics 2023, 13(18), 2910; https://doi.org/10.3390/diagnostics13182910 - 11 Sep 2023

Viewed by 292

Abstract

IVDR regulation represents a major challenge for diagnostic microbiology laboratories. IVDR complicates a broad range of aspects and poses a risk given the high diversity of pathogens (including rare but highly virulent microbes) and the large variety of samples submitted for analysis. The regular emergence of new pathogens (including Echovirus E-11, Adenovirus 41, Monkeypox virus, Alongshan virus, and Enterovirus D68, as recent examples in Europe in the post SARS-CoV-2 era) is another factor that makes IVDR regulation risky, because its detrimental effect on production of in-house tests will negatively impact knowledge and expertise in the development of new diagnostic tests. Moreover, such regulations negatively impact the availability of diagnostic tests, especially for neglected pathogens, and has a detrimental effect on the overall costs of the tests. The increased regulatory burden of IVDR may thereby pose an important risk for public health. Taken together, it will have a negative impact on the financial balance of diagnostic microbiology laboratories (especially small ones). The already-high standards of quality management of all ISO-accredited and Swissmedic-authorized laboratories render IVDR law of little value, at least in Switzerland, while tremendously increasing the regulatory burden and associated costs. Eventually, patients will need to pay for diagnostic assays outside of the framework of their insurance in order to obtain a proper diagnostic assessment, which may result in social inequity. Thus, based on the risk assessment outlined above, the coordinated commission for clinical microbiology proposes adjusting the IvDO ordinance by (i) introducing an obligation to be ISO 15189 accredited and (ii) not implementing the IvDO 2028 milestone. Full article

(This article belongs to the Special Issue Highlights in Swiss Laboratory Medicine 2023)

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Open AccessBrief Report

Determination of the Diagnostic Performance of Laboratory Tests in the Absence of a Perfect Reference Standard: The Case of SARS-CoV-2 Tests

Sonja Hartnack

Henning Nilius

Sabrina Jegerlehner

Franziska Suter-Riniker

Pascal Bittel

Philipp Jent

and

Michael Nagler

Diagnostics 2023, 13(18), 2892; https://doi.org/10.3390/diagnostics13182892 - 09 Sep 2023

Viewed by 226

Abstract

Background: Currently, assessing the diagnostic performance of new laboratory tests assumes a perfect reference standard, which is rarely the case. Wrong classifications of the true disease status will inevitably lead to biased estimates of sensitivity and specificity. Objectives: Using Bayesian’ latent class models (BLCMs), an approach that does not assume a perfect reference standard, we re-analyzed data of a large prospective observational study assessing the diagnostic accuracy of an antigen test for the diagnosis of SARS-CoV-2 infection in clinical practice. Methods: A cohort of consecutive patients presenting to a COVID-19 testing facility affiliated with a Swiss University Hospital were recruited (n = 1465). Two real-time PCR tests were conducted in parallel with the Roche/SD Biosensor rapid antigen test on nasopharyngeal swabs. A two-test (PCR and antigen test), three-population BLCM was fitted to the frequencies of paired test results. Results: Based on the BLCM, the sensitivities of the RT-PCR and the Roche/SD Biosensor rapid antigen test were 98.5% [95% CRI 94.8;100] and 82.7% [95% CRI 66.8;100]. The specificities were 97.7% [96.1;99.7] and 99.9% [95% CRI 99.6;100]. Conclusions: Applying the BLCM, the diagnostic accuracy of RT-PCR was high but not perfect. In contrast to previous results, the sensitivity of the antigen test was higher. Our results suggest that BLCMs are valuable tools for investigating the diagnostic performance of laboratory tests in the absence of perfect reference standard. Full article

(This article belongs to the Special Issue Highlights in Swiss Laboratory Medicine 2023)

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