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Article: Use of Computer Simulation for Calculating Reference Limits for Distribution Overlap.

Vidali, Matteo

The journal of applied laboratory medicine

2023 Volume 8, Issue 1, Page(s) 106–112

Abstract: Background: In laboratory medicine, data collected in different settings or under different conditions are frequently analyzed to obtain meaningful information. Evaluation based only on location or variability measures, although useful, is not enough to ...

Abstract	Background: In laboratory medicine, data collected in different settings or under different conditions are frequently analyzed to obtain meaningful information. Evaluation based only on location or variability measures, although useful, is not enough to extract all the value from data. Other mathematical or statistical approaches are possible, but the specific knowledge required is frequently out of the reach of most laboratorians. Computer simulation may help in solving the problem. The aim of this work was to use computer simulation for calculating reference limits for the overlap of 2 distributions. Methods: Computer simulation was applied to find a reference value, and its confidence limits, from the overlapping area of 2 distributions when population means were allowed to differ by a pre-set amount. The allowable limits were compared with the overlapping area observed between data distributions reported from 3 laboratories. The simulation was run in R language. A description for the experimental setting was added, with the instructions for the simulation reported in structured English. Results: The simulation allowed estimation of a limit to be used as a reference value when comparing two overlapping areas. Based on these limits, one laboratory in the study was found not to be aligned with the others. Conclusions: Computer simulation is a low-cost, powerful, and easy to implement tool which may help in solving simple or complex problems, when assumptions are unrealistic or unmet, or when mathematical algorithms are not known or difficult to calculate.
MeSH term(s)	Humans ; Computer Simulation ; Algorithms ; Monte Carlo Method
Language	English
Publishing date	2023-01-05
Publishing country	England
Document type	Journal Article
ISSN	2576-9456
ISSN	2576-9456
DOI	10.1093/jalm/jfac122
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Article ; Online: Reference Interval Harmonization: Will Big Data Provide a Solution?

Ceriotti, Ferruccio / Vidali, Matteo

Clinical chemistry

2023 Volume 69, Issue 9, Page(s) 945–947

MeSH term(s)	Humans ; Big Data ; Reference Standards
Language	English
Publishing date	2023-07-10
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1093/clinchem/hvad098
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Article ; Online: Customized cutoff limits for the sediMAX-2 automated analyzer reduce the number of urine culture tests.

Ferrari, Davide / Trbos, Mladen / Vidali, Matteo / Locatelli, Massimo

Acta bio-medica : Atenei Parmensis

2023 Volume 94, Issue 5, Page(s) e2023192

Abstract: Background: Urinary tract infections are highly prevalent in nosocomial and community settings. Their diagnosis, although costly and time-consuming, is crucial to avoid inappropriate treatments and/or clinical complications. In this context, automated ... ...

Abstract	Background: Urinary tract infections are highly prevalent in nosocomial and community settings. Their diagnosis, although costly and time-consuming, is crucial to avoid inappropriate treatments and/or clinical complications. In this context, automated analyzers have been developed and commercialized to screen and rule out negative urine samples. Adjustments of the manufacturers' suggested cutoff values might lead to substantial diagnostic and economic advantages. Methods: We retrospectively analyzed 776 urine samples from different individuals. 546 samples (training group) were used to optimize develop new cutoffs values. The remaining 230 samples (validation group) were used to validate the optimized cutoffs. All samples were subjected to urine culture, 17% resulted positive. Escherichia coli and Enterococcus faecalis were the two most frequently identified bacteria, 95 and 9 samples, respectively. Results: Two different cutoffs levels were obtained. Cutoff-A (bacteria>110 and/or white blood cells> 15 cell/µL), showed the same sensitivity of the manufacturers' suggested cutoff, yet leads to a large reduction of the samples to be cultured. Cutoff-B (bacteria>50 and/or white blood cells>20 cell/µL), showed an almost 100% sensitivity by subjecting only ~70% of the samples to urine culture. Conclusion: Cutoff-A is a good compromise between sensitivity and specificity yet allowing economic advantages by reducing the number of urinary cultures. Cutoff-B relegates urinary tract infection misdiagnosis to a rare event without the need of culturing the entire batch of samples. We believe that clinical implementation of the proposed cutoffs will help other laboratories, using similar instrumentation, to reach their most convenient balance between sensitivity and economical needs.
MeSH term(s)	Humans ; Retrospective Studies ; Urinary Tract Infections/diagnosis ; Urinalysis/methods ; Sensitivity and Specificity ; Bacteria
Language	English
Publishing date	2023-10-17
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2114240-3
ISSN	2531-6745 ; 0392-4203
ISSN (online)	2531-6745
ISSN	0392-4203
DOI	10.23750/abm.v94i5.14951
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Article ; Online: Personalized reference intervals: From the statistical significance to the clinical usefulness.

Carobene, Anna / Banfi, Giuseppe / Locatelli, Massimo / Vidali, Matteo

Clinica chimica acta; international journal of clinical chemistry

2021 Volume 524, Page(s) 203–204

MeSH term(s)	Humans ; Reference Values
Language	English
Publishing date	2021-10-29
Publishing country	Netherlands
Document type	Letter ; Comment
ZDB-ID	80228-1
ISSN	1873-3492 ; 0009-8981
ISSN (online)	1873-3492
ISSN	0009-8981
DOI	10.1016/j.cca.2021.10.036
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Article ; Online: Within-person biological variation estimates from the European Biological Variation Study (EuBIVAS) for serum potassium and creatinine used to obtain personalized reference intervals.

Carobene, Anna / Banfi, Giuseppe / Locatelli, Massimo / Vidali, Matteo

Clinica chimica acta; international journal of clinical chemistry

2021 Volume 523, Page(s) 205–207

MeSH term(s)	Creatinine ; Humans ; Potassium ; Reference Values
Chemical Substances	Creatinine (AYI8EX34EU) ; Potassium (RWP5GA015D)
Language	English
Publishing date	2021-09-24
Publishing country	Netherlands
Document type	Letter
ZDB-ID	80228-1
ISSN	1873-3492 ; 0009-8981
ISSN (online)	1873-3492
ISSN	0009-8981
DOI	10.1016/j.cca.2021.09.018
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Article: A machine learning strategy to mitigate the inappropriateness of procalcitonin request in clinical practice.

Agnello, Luisa / Vidali, Matteo / Ciaccio, Anna Maria / Lo Sasso, Bruna / Iacona, Alessandro / Biundo, Giuseppe / Scazzone, Concetta / Gambino, Caterina Maria / Ciaccio, Marcello

Heliyon

2024 Volume 10, Issue 5, Page(s) e26556

Abstract: Aim: The aim of this study was to develop machine learning (ML) models to mitigate the inappropriate request of Procalcitonin (PCT) in clinical wards.: Material and methods: We built six different ML models based on both demographical data, i.e., sex ...

Abstract	Aim: The aim of this study was to develop machine learning (ML) models to mitigate the inappropriate request of Procalcitonin (PCT) in clinical wards. Material and methods: We built six different ML models based on both demographical data, i.e., sex and age, and laboratory parameters, i.e., cell blood count (CBC) parameters, inclusive of monocyte distribution width (MDW), and C-reactive protein (CRP). The dataset included 1667 PCT measurements of different patients. Based on a PCT cut-off of 0.50 ng/mL, we found 1090 negative (65.4%) and 577 positive (34.6%) results. We performed a 70:15:15 train:validation:test splitting based on the outcome. Results: Random Forest, Support Vector Machine and eXtreme Gradient Boosting showed optimal performances for predicting PCT positivity, with an area under the curve ranging from 0.88 to 0.89. Conclusions: The ML models developed could represent a useful tool to predict PCT positivity, avoiding unusefulness PCT requests. ML models are based on laboratory tests commonly ordered together with PCT but have the great advantage to be easy to measure and low-cost.
Language	English
Publishing date	2024-02-17
Publishing country	England
Document type	Journal Article
ZDB-ID	2835763-2
ISSN	2405-8440
ISSN	2405-8440
DOI	10.1016/j.heliyon.2024.e26556
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Article ; Online: Prostate Health Index (PHI) as a triage tool for reducing unnecessary magnetic resonance imaging (MRI) in patients at risk of prostate cancer.

Agnello, Luisa / Vidali, Matteo / Salvaggio, Giuseppe / Agnello, Francesco / Lo Sasso, Bruna / Gambino, Caterina Maria / Ciaccio, Marcello

Clinical biochemistry

2024 Volume 127-128, Page(s) 110759

Abstract: Introduction: The aim of this study is to assess the usefulness of the Prostate Health Index (PHI) as a triage tool for selecting patients at risk of prostate cancer (PCa) who should undergo multiparametric Magnetic Resonance Imaging (mpMRI).: ... ...

Abstract	Introduction: The aim of this study is to assess the usefulness of the Prostate Health Index (PHI) as a triage tool for selecting patients at risk of prostate cancer (PCa) who should undergo multiparametric Magnetic Resonance Imaging (mpMRI). Material and methods: We enrolled 204 patients with suspected PCa. For each patient, a blood sample was collected before mpMRI to measure PHI. Findings on mpMRI were assessed according to the Prostate Imaging Reporting & Data System version 2.0 (PI-RADSv2) category scale. Results: According to PI-RADSv2, patients were classified into two groups: PI-RADS < 3 (48 %) and ≥ 3 (52 %). PHI showed the best performance for predicting PI-RADS ≥ 3 [AUC: 0,747 (0,679-0,815), 0,680(0,607-0,754), and 0,613 (0,535-0,690) for PHI, PSA ratio, and total PSA, respectively]. The best PHI cut-off was 30, with a sensitivity of 90%. At the univariate logistic regression, total PSA (p = 0.007), PSA ratio (p = 0.001), [-2]proPSA (p = 0.019) and PHI (p < 0.001) were associated with PI-RADS ≥ 3; however, at the multivariate analysis, only PHI (p < 0.001) was found to be an independent predictor of PI-RADS ≥ 3. Conclusion: PHI could represent a reliable noninvasive tool for selecting patients to undergo mpMRI.
Language	English
Publishing date	2024-04-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	390372-2
ISSN	1873-2933 ; 0009-9120
ISSN (online)	1873-2933
ISSN	0009-9120
DOI	10.1016/j.clinbiochem.2024.110759
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Article: The Role of TAR DNA Binding Protein 43 (TDP-43) as a CandiDate Biomarker of Amyotrophic Lateral Sclerosis: A Systematic Review and Meta-Analysis.

Gambino, Caterina Maria / Ciaccio, Anna Maria / Lo Sasso, Bruna / Giglio, Rosaria Vincenza / Vidali, Matteo / Agnello, Luisa / Ciaccio, Marcello

Diagnostics (Basel, Switzerland)

2023 Volume 13, Issue 3

Abstract: Background: TAR DNA-binding protein 43 (TDP-43) aggregation in neuronal cells is recognized as a hallmark of amyotrophic lateral sclerosis (ALS). Although the literature strongly supports the pathogenetic role of TDP-43 in ALS pathogenesis, the role of ... ...

Abstract	Background: TAR DNA-binding protein 43 (TDP-43) aggregation in neuronal cells is recognized as a hallmark of amyotrophic lateral sclerosis (ALS). Although the literature strongly supports the pathogenetic role of TDP-43 in ALS pathogenesis, the role of TDP-43 as a biomarker of ALS is controversial. We performed a systematic review and meta-analysis to assess the diagnostic performance of TDP-43 for ALS. Methods: Relevant publications were identified by a systematic literature search on PubMed and Web of Science from their inception to 8 April 2022. Results: Seven studies, including 472 individuals, of whom 254 had ALS according to the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale, met the inclusion criteria for our meta-analysis. According to the random-effects model, CSF TDP-43 levels are higher in ALS patients compared with control groups. Conclusions: CSF TDP-43 could represent a biomarker of ALS, but further studies are mandatory before drawing conclusions.
Language	English
Publishing date	2023-01-23
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2662336-5
ISSN	2075-4418
ISSN	2075-4418
DOI	10.3390/diagnostics13030416
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Article ; Online: Monocyte distribution width (MDW) in sepsis.

Agnello, Luisa / Ciaccio, Anna Maria / Vidali, Matteo / Cortegiani, Andrea / Biundo, Giuseppe / Gambino, Caterina Maria / Scazzone, Concetta / Lo Sasso, Bruna / Ciaccio, Marcello

Clinica chimica acta; international journal of clinical chemistry

2023 Volume 548, Page(s) 117511

Abstract: Sepsis is a life-threatening syndrome due to a dysregulated host response to infection, which can be caused by bacterial, viral, or fungal infection. Thus, it is crucial to know how the different microorganisms influence the levels of a biomarker. In the ...

Abstract	Sepsis is a life-threatening syndrome due to a dysregulated host response to infection, which can be caused by bacterial, viral, or fungal infection. Thus, it is crucial to know how the different microorganisms influence the levels of a biomarker. In the last decade, monocyte distribution width (MDW) has emerged as a promising sepsis biomarker, especially in acute settings, such as the Emergency Department and Intensive Care Unit. In this article, we explore the relationship between MDW and the different pathogens causing infection. Noteworthy, MDW is not a biological molecule, but it is calculated by a mathematical formula based on monocyte characteristics. Monocytes represent the first line defence against microorganisms and undergo activation upon infection, independently from the invading pathogen. According to the knowledge on the biomarker biology and the few literatures evidence, MDW may be considered a biomarker of sepsis, independent of the causative pathogen. However, further investigations are warranted before drawing definite conclusion.
MeSH term(s)	Humans ; Monocytes ; Sepsis ; Biomarkers
Chemical Substances	Biomarkers
Language	English
Publishing date	2023-08-09
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	80228-1
ISSN	1873-3492 ; 0009-8981
ISSN (online)	1873-3492
ISSN	0009-8981
DOI	10.1016/j.cca.2023.117511
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Article: The Role of New Morphological Parameters Provided by the BC 6800 Plus Analyzer in the Early Diagnosis of Sepsis.

Sacchetti, Sara / Vidali, Matteo / Esposito, Teresa / Zorzi, Stefano / Burgener, Alessia / Ciccarello, Lorenzo / Cammarota, Gianmaria / Zanotti, Valentina / Giacomini, Luca / Bellan, Mattia / Pirisi, Mario / Lopez, Ramon Simon / Dianzani, Umberto / Vaschetto, Rosanna / Rolla, Roberta

Diagnostics (Basel, Switzerland)

2024 Volume 14, Issue 3

Abstract: Background: Late diagnosis of sepsis is associated with adverse consequences and high mortality rate. The aim of this study was to evaluate the diagnostic value of hematologic research parameters, that reflect the cell morphology of blood cells, ... ...

Abstract	Background: Late diagnosis of sepsis is associated with adverse consequences and high mortality rate. The aim of this study was to evaluate the diagnostic value of hematologic research parameters, that reflect the cell morphology of blood cells, available on the BC 6800 plus automated analyzer (Mindray) for the early detection of sepsis. Materials and methods: A complete blood count (CBC) was performed by Mindray BC 6800 Plus Analyzer in 327 patients (223 with a confirmed diagnosis of sepsis following sepsis-3 criteria, 104 without sepsis), admitted at the Intensive Care Unit of the Novara's Hospital (Italy) and in 56 patients with localized infection. Results: In univariate logistic regression, age, Hb, RDW, MO#, NMR, NeuX, NeuY, NeuZ, LymX, MonX, MonY, MonZ were associated with sepsis ( Conclusions: In addition to already established biomarkers and basic CBC parameters, new morphological cell parameters can be a valuable aid in the early diagnosis of sepsis at no additional cost.
Language	English
Publishing date	2024-02-04
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662336-5
ISSN	2075-4418
ISSN	2075-4418
DOI	10.3390/diagnostics14030340
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