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  1. Article ; Online: Blood alcohol concentration in the clinical laboratory: a narrative review of the preanalytical phase in diagnostic and forensic testing.

    Ialongo, Cristiano

    Biochemia medica

    2023  Volume 34, Issue 1, Page(s) 10501

    Abstract: The analysis of blood alcohol concentration (BAC), a pivotal toxicological test, concerns acute alcohol intoxication (AAI) and driving under the influence (DUI). As such, BAC presents an organizational challenge for clinical laboratories, with unique ... ...

    Abstract The analysis of blood alcohol concentration (BAC), a pivotal toxicological test, concerns acute alcohol intoxication (AAI) and driving under the influence (DUI). As such, BAC presents an organizational challenge for clinical laboratories, with unique complexities due to the need for forensic defensibility as part of the diagnostic process. Unfortunately, a significant number of scientific investigations dealing with the subject present discrepancies that make it difficult to identify optimal practices in sample collection, transportation, handling, and preparation. This review provides a systematic analysis of the preanalytical phase of BAC that aims to identify and explain the chemical, physiological, and pharmacological mechanisms underlying controllable operational factors. Nevertheless, it seeks evidence for the necessity to separate preanalytical processes for diagnostic and forensic BAC testing. In this regard, the main finding of this review is that no literature evidence supports the necessity to differentiate preanalytical procedures for AAI and DUI, except for the traceability throughout the chain of custody. In fact, adhering to correct preanalytical procedures provided by official bodies such as European federation of clinical chemistry and laboratory medicine for routine phlebotomy ensures both diagnostic accuracy and forensic defensibility of BAC. This is shown to depend on the capability of modern pre-evacuated sterile collection tubes to control major factors influencing BAC, namely non-enzymatic oxidation and microbial contamination. While certain restrictions become obsolete with such devices, as the use of sodium fluoride (NaF) for specific preservation of forensic BAC, this review reinforces the recommendation to use non-alcoholic disinfectants as a means to achieve "error-proof" procedures in challenging operational environments like the emergency department.
    MeSH term(s) Humans ; Pre-Analytical Phase ; Blood Alcohol Content ; Laboratories, Clinical ; Phlebotomy/methods ; Specimen Handling
    Chemical Substances Blood Alcohol Content
    Language English
    Publishing date 2023-12-15
    Publishing country Croatia
    Document type Journal Article ; Review
    ZDB-ID 1208725-7
    ISSN 1846-7482 ; 1330-0962
    ISSN (online) 1846-7482
    ISSN 1330-0962
    DOI 10.11613/BM.2024.010501
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Biological matrices, reagents and turnaround-time: the full-circle of artificial intelligence in the pre-analytical phase: comment on Turcic A, et al., Machine learning to optimize cerebrospinal fluid dilution for analysis of MRZH reaction. CCLM 2024;62:436-41.

    Ialongo, Cristiano / Pieri, Massimo

    Clinical chemistry and laboratory medicine

    2024  

    Language English
    Publishing date 2024-03-20
    Publishing country Germany
    Document type Letter
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2024-0210
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Confidence interval of percentiles in skewed distribution: The importance of the actual coverage probability in practical quality applications for laboratory medicine.

    Ialongo, Cristiano

    Biochemia medica

    2019  Volume 29, Issue 3, Page(s) 30101

    Abstract: Introduction: Quality indicators (QI) based on percentiles are widely used for managing quality in laboratory medicine nowadays. Due to their statistical nature, their estimation is affected by sampling so they should be always presented together with ... ...

    Abstract Introduction: Quality indicators (QI) based on percentiles are widely used for managing quality in laboratory medicine nowadays. Due to their statistical nature, their estimation is affected by sampling so they should be always presented together with the confidence interval (CI). Since no methodological recommendation has been issued to date, our aim was investigating the suitability of the parametric method (LP-CI), the non-parametric binomial (NP-CI) and bootstrap (BCa-CI) procedures for the CI estimation of 2.5
    Materials and methods: Skewness was reproduced by numeric simulation of a lognormal distribution in order to have samples with different right-tailing (moderate, heavy and very heavy) and size (20, 60 and 120). Performance was assessed with respect to the actual coverage probability (ACP, accuracy) against the confidence level of 1-α with α = 0.5, and the median interval length (MIL, precision).
    Results: The parametric method was accurate for sample size N ≥ 20 whereas both NP-CI and BCa-CI required N ≥ 60. However, for extreme percentiles of heavily right-tailed data, the required sample size increased to 60 and 120 units respectively. A case study also demonstrated the possibility to estimate the ACP from a single sample of real-life laboratory data.
    Conclusions: No method should be applied blindly to the estimation of CI, especially in small-sized and skewed samples. To this end, the accuracy of the method should be investigated through a numeric simulation that reproduces the same conditions of the real-life sample.
    MeSH term(s) Biostatistics ; Confidence Intervals ; Laboratories ; Quality of Health Care
    Language English
    Publishing date 2019-03-19
    Publishing country Croatia
    Document type Journal Article ; Review
    ZDB-ID 1208725-7
    ISSN 1846-7482 ; 1330-0962
    ISSN (online) 1846-7482
    ISSN 1330-0962
    DOI 10.11613/BM.2019.030101
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Confidence interval for quantiles and percentiles.

    Ialongo, Cristiano

    Biochemia medica

    2018  Volume 29, Issue 1, Page(s) 10101

    Abstract: Quantiles and percentiles represent useful statistical tools for describing the distribution of results and deriving reference intervals and performance specification in laboratory medicine. They are commonly intended as the sample estimate of a ... ...

    Abstract Quantiles and percentiles represent useful statistical tools for describing the distribution of results and deriving reference intervals and performance specification in laboratory medicine. They are commonly intended as the sample estimate of a population parameter and therefore they need to be presented with a confidence interval (CI). In this work we discuss three methods to estimate CI on quantiles and percentiles using parametric, nonparametric and resampling (bootstrap) approaches. The result of our numerical simulations is that parametric methods are always more accurate regardless of sample size when the procedure is appropriate for the distribution of results for both extreme (2.5
    MeSH term(s) Humans ; Laboratories/standards ; Models, Statistical ; Reference Values ; Sample Size
    Language English
    Publishing date 2018-12-15
    Publishing country Croatia
    Document type Journal Article ; Review
    ZDB-ID 1208725-7
    ISSN 1846-7482 ; 1330-0962
    ISSN (online) 1846-7482
    ISSN 1330-0962
    DOI 10.11613/BM.2019.010101
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Systems Biology and Inborn Error of Metabolism: Analytical Strategy in Investigating Different Biochemical/Genetic Parameters.

    Piombarolo, Aurora / Ialongo, Cristiano / Bizzarri, Mariano / Angeloni, Antonio

    Methods in molecular biology (Clifton, N.J.)

    2023  Volume 2745, Page(s) 191–210

    Abstract: Inborn errors of metabolism (IEM) are a group of about 500 rare genetic diseases with large diversity and complexity due to number of metabolic pathways involved in. Establishing a correct diagnosis and identifying the specific clinical phenotype is ... ...

    Abstract Inborn errors of metabolism (IEM) are a group of about 500 rare genetic diseases with large diversity and complexity due to number of metabolic pathways involved in. Establishing a correct diagnosis and identifying the specific clinical phenotype is consequently a difficult task. However, an inclusive diagnosis able in capturing the different clinical phenotypes is mandatory for successful treatment. However, in contrast with Garrod's basic assumption "one-gene one-disease," no "simple" correlation between genotype-phenotype can be vindicated in IEMs. An illustrative example of IEM is Phenylketonuria (PKU), an autosomal recessive inborn error of L-phenylalanine (Phe) metabolism, ascribed to variants of the phenylalanine hydroxylase (PAH) gene encoding for the enzyme complex phenylalanine-hydroxylase. Blood values of Phe allow classifying PKU into different clinical phenotypes, albeit the participation of other genetic/biochemical pathways in the pathogenetic mechanisms remains elusive. Indeed, it has been shown that the most serious complications, such as cognitive impairment, are not only related to the gene dysfunction but also to the patient's background and the participation of several nongenetic factors.Therefore, a Systems Biology-based strategy is required in addressing IEM complexity, and in identifying the interplay between different pathways in shaping the clinical phenotype. Such an approach should entail the concerted investigation of genomic, transcriptomics, proteomics, metabolomics profiles altogether with phenylalanine and amino acids metabolism. Noticeably, this "omic" perspective could be instrumental in planning personalized treatment, tailored accordingly to the disease profile and prognosis.
    MeSH term(s) Humans ; Phenylketonurias/diagnosis ; Phenylketonurias/genetics ; Phenylketonurias/metabolism ; Metabolism, Inborn Errors/diagnosis ; Metabolism, Inborn Errors/genetics ; Phenylalanine Hydroxylase/genetics ; Phenotype ; Phenylalanine/genetics ; Phenylalanine/metabolism
    Chemical Substances Phenylalanine Hydroxylase (EC 1.14.16.1) ; Phenylalanine (47E5O17Y3R)
    Language English
    Publishing date 2023-12-07
    Publishing country United States
    Document type Journal Article
    ISSN 1940-6029
    ISSN (online) 1940-6029
    DOI 10.1007/978-1-0716-3577-3_12
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Analytical Performance of the New Siemens Affinity Chrome-Mediated Immunoassay Everolimus Assay and Its Interchangeability With the Thermo Quantitative Microsphere System for Routine Therapeutic Drug Monitoring of Patients After Solid Organ Transplantation.

    Ialongo, Cristiano / Sapio, Maria / Angeloni, Antonio

    Therapeutic drug monitoring

    2023  Volume 45, Issue 2, Page(s) 217–222

    Abstract: Background: A new homogeneous affinity chrome-mediated immunoassay (ACMIA) "EVRO" from Siemens Healthcare was evaluated for therapeutic drug monitoring of everolimus (EVL) with automated sample pretreatment and compared with quantitative microsphere ... ...

    Abstract Background: A new homogeneous affinity chrome-mediated immunoassay (ACMIA) "EVRO" from Siemens Healthcare was evaluated for therapeutic drug monitoring of everolimus (EVL) with automated sample pretreatment and compared with quantitative microsphere system (QMS) "EVER" from Thermo Fisher Scientific.
    Methods: Imprecision, inaccuracy, and limit of quantitation (LoQ) of ACMIA/EVRO were verified using both hemolysate quality control (QC) samples and pooled whole blood specimens. The interchangeability of methods and the agreement of results were analyzed using 72 specimens (from 38, 30, and 4 kidney, liver, and lung transplant recipients, respectively).
    Results: Within-run imprecision ranged within %CV = 2.81-2.53 with pooled whole blood specimens and within %CV = 2.88-2.53 with QCs; total imprecision with QCs was within %CV = 2.14-1.51. Inaccuracy with value assigned QC was %△ = 5.36 at the 5.6 ng/mL level and %△ = 5.56 at the 11.7 ng/mL level. LoQ was 0.93 ng/mL (%CV = 10). Passing-Bablok regression showed a constant bias of 0.679 ng/mL (95% CI: 0.216-1.026) and a proportional bias of 1.326 (95% CI: 1.240-1.425). Bland-Altman analysis showed 5/72 (6.9%) paired differences exceeding the limits of agreement and 1/72 (1.4%) paired differences exceeding 1.96 SD to a combined bias of 39.9% after detrending.
    Conclusions: ACMIA/EVRO shows satisfactory analytical performances that comply with recommendations, but it does not fulfill requirements for interchangeability with QMS/EVER. Particularly, this new assay using sirolimus-specific antibody shows a sizable proportional bias versus the more specific comparator, which may be because of EVL metabolites. This is supported by the lack of agreement for individual differences in most samples collected at the peak concentration (C2). Therefore, further evidence is needed to support the transition of EVL level monitoring from QMS/EVER to ACMIA/EVRO without making extensive changes to both reference interval and patient's baseline.
    MeSH term(s) Humans ; Everolimus ; Immunosuppressive Agents ; Drug Monitoring/methods ; Microspheres ; Chromatography, Liquid/methods ; Tandem Mass Spectrometry/methods ; Organ Transplantation ; Immunoassay/methods
    Chemical Substances Everolimus (9HW64Q8G6G) ; Immunosuppressive Agents
    Language English
    Publishing date 2023-03-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 424443-6
    ISSN 1536-3694 ; 0163-4356
    ISSN (online) 1536-3694
    ISSN 0163-4356
    DOI 10.1097/FTD.0000000000001009
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: The logic of equivalence testing and its use in laboratory medicine.

    Ialongo, Cristiano

    Biochemia medica

    2017  Volume 27, Issue 1, Page(s) 5–13

    Abstract: Hypothesis testing is a methodological paradigm widely popularized outside the field of pure statistics, and nowadays more or less familiar to the largest part of biomedical researchers. Conversely, the equivalence testing is still somehow obscure and ... ...

    Abstract Hypothesis testing is a methodological paradigm widely popularized outside the field of pure statistics, and nowadays more or less familiar to the largest part of biomedical researchers. Conversely, the equivalence testing is still somehow obscure and misunderstood, although it represents a conceptual mainstay for some biomedical fields like pharmacology. In order to appreciate the way it could suit laboratory medicine, it is necessary to understand the philosophy behind it, and in turn how it stemmed and differentiated along the history of classical hypothesis testing. Here we present the framework of equivalence testing, the various tests used to assess equivalence and discuss their applicability to laboratory medicine research and issues.
    Language English
    Publishing date 2017-02-15
    Publishing country Croatia
    Document type Journal Article ; Review
    ZDB-ID 1208725-7
    ISSN 1846-7482 ; 1330-0962
    ISSN (online) 1846-7482
    ISSN 1330-0962
    DOI 10.11613/BM.2017.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Preanalytic of total antioxidant capacity assays performed in serum, plasma, urine and saliva.

    Ialongo, Cristiano

    Clinical biochemistry

    2017  Volume 50, Issue 6, Page(s) 356–363

    Abstract: The investigation of oxidative stress (OS), its mechanisms and connections with human diseases, is a topic of interest with more than 36,000 PubMed citations to date. The OS can be approached either from the perspective of pro-oxidation, either of anti- ... ...

    Abstract The investigation of oxidative stress (OS), its mechanisms and connections with human diseases, is a topic of interest with more than 36,000 PubMed citations to date. The OS can be approached either from the perspective of pro-oxidation, either of anti-oxidation, and both can be investigated considering individual chemical constituents or their pooled effect. Actually, as it is for any laboratory assay, whatever source of variability introduces a bias potentially undermining the test results regardless of its application. In this regard, the effect of sample collection, handling and storage - that collectively constitute the preanalytical phase - on the likeliness of the measured value represent a major challenge for any researcher. In this review, we will deal with methods devised to assess the so-called total antioxidant capacity (TAC), which represents the sinking capability expressed toward a given load of pro-oxidant species. Thus, it will be presented the information available to date on the preanalytical phase of TAS assessment, focusing on the issues that strictly concern the preservation of antioxidants within the specimen. Obviously, preanalytic should represent a first concern in any laboratory research, to which this work could contribute giving practical indications and raising the researchers' awareness about the issue.
    MeSH term(s) Antioxidants/metabolism ; Biological Assay/methods ; Humans ; Oxidation-Reduction ; Oxidative Stress ; Plasma/metabolism ; Saliva/metabolism ; Serum/metabolism ; Specimen Handling/methods ; Urinalysis
    Chemical Substances Antioxidants
    Language English
    Publishing date 2017-04
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 390372-2
    ISSN 1873-2933 ; 0009-9120
    ISSN (online) 1873-2933
    ISSN 0009-9120
    DOI 10.1016/j.clinbiochem.2016.11.037
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Understanding the effect size and its measures.

    Ialongo, Cristiano

    Biochemia medica

    2016  Volume 26, Issue 2, Page(s) 150–163

    Abstract: The evidence based medicine paradigm demands scientific reliability, but modern research seems to overlook it sometimes. The power analysis represents a way to show the meaningfulness of findings, regardless to the emphasized aspect of statistical ... ...

    Abstract The evidence based medicine paradigm demands scientific reliability, but modern research seems to overlook it sometimes. The power analysis represents a way to show the meaningfulness of findings, regardless to the emphasized aspect of statistical significance. Within this statistical framework, the estimation of the effect size represents a means to show the relevance of the evidences produced through research. In this regard, this paper presents and discusses the main procedures to estimate the size of an effect with respect to the specific statistical test used for hypothesis testing. Thus, this work can be seen as an introduction and a guide for the reader interested in the use of effect size estimation for its scientific endeavour.
    MeSH term(s) Biomedical Research/statistics & numerical data ; Biostatistics/methods ; Data Interpretation, Statistical ; Humans ; Sample Size ; Statistics as Topic
    Language English
    Publishing date 2016
    Publishing country Croatia
    Document type Journal Article ; Review
    ZDB-ID 1208725-7
    ISSN 1846-7482 ; 1330-0962
    ISSN (online) 1846-7482
    ISSN 1330-0962
    DOI 10.11613/BM.2016.015
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Six Sigma revisited: We need evidence to include a 1.5 SD shift in the extraanalytical phase of the total testing process.

    Coskun, Abdurrahman / Ialongo, Cristiano

    Biochemia medica

    2020  Volume 30, Issue 1, Page(s) 10901

    Abstract: The Six Sigma methodology has been widely implemented in industry, healthcare, and laboratory medicine since the mid-1980s. The performance of a process is evaluated by the sigma metric (SM), and 6 sigma represents world class performance, which implies ... ...

    Abstract The Six Sigma methodology has been widely implemented in industry, healthcare, and laboratory medicine since the mid-1980s. The performance of a process is evaluated by the sigma metric (SM), and 6 sigma represents world class performance, which implies that only 3.4 or less defects (or errors)
    MeSH term(s) Humans ; Total Quality Management/standards
    Language English
    Publishing date 2020-01-23
    Publishing country Croatia
    Document type Journal Article ; Review
    ZDB-ID 1208725-7
    ISSN 1846-7482 ; 1330-0962
    ISSN (online) 1846-7482
    ISSN 1330-0962
    DOI 10.11613/BM.2020.010901
    Database MEDical Literature Analysis and Retrieval System OnLINE

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