Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommen... more Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommends evaluation of all troponin immunoassays within the same population to compare their performance. Hence, we planned a multicenter study to compare the four most widespread contemporary sensitive troponin I (TnI) methods. Methods: Seventy-six serum samples were centrifuged, separated and divided in 5 aliquots. The first aliquot was used for clinical measurement, whereas the rest were shipped to participating laboratories, where they were simultaneously thawed. High-sensitivity troponin T (HS-TnT) was measured on a Roche Cobas, whereas TnI was assessed with the Ortho Vitros cTnI, Beckman Coulter DXI 800 AccuTnI, Siemens Vista cTnI and Abbott Architect STAT cTnI. Results: A substantial bias was found between TnI and HS-TnT values. Although the correlation was acceptable and comprised between 0.86-0.89, the agreement of diagnostic values was poor, with the kappa statistic always lower than 0.50. Although the direct comparison between the four contemporary sensitive TnI immunoassays generated more favourable results, with Pearson's correlations greater than 0.970 and the kappa statistic equal to or higher than 0.59, Kratak sadr`aj Uvod: Radna grupa za klini~ku primenu sr~anih biomarkera Me|unarodne federacije za klini~ku hemiju trenutno pre-poru~uje evaluaciju svih imunoeseja za troponin u okviru iste populacije, kako bi se uporedile njihove performanse. Zbog toga smo osmislili ovu multicentri~nu studiju za pore|enjẽ etiri naj~e{}e upotrebljavane savremene metode osetljive na troponin I (TnI). Metode: Sedamdeset {est uzoraka seruma stavljeno je u centrifugu, razdvojeno i podeljeno u pet alikvota. Prvi alikvot je upotrebljen za klini~ko merenje, dok su ostali poslati laboratorijama koje su u~estvovale u istra`ivanju, gde su istovremeno otopljeni. Visokoosetljivi troponin T (HS-TnT) meren je na ure|aju Roche Cobas, dok je TnI odre|en pomo}u testova Ortho Vitros CtnI, Beckman Coulter DXI 800 Accu TnI, Siemens Vista cTnI i Abbott Achitect STAT cTnI. Rezultati: Otkriveno je znatno odstupanje u vrednostima TnI i HSTnT. Iako je korelacija bila prihvatljiva i u rasponu od 0,86 do 0,89, slaganje dijagnosti~kih vrednosti je bilo slabo, sa statisti~kom vredno{}u »kappa« uvek manjom od 0,50. Iako je direktnim pore|enjem ~etiri savremena imunoeseja osetljiva na TnI dobijeno vi{e povoljnih rezultata, sa Pearsonovim korelacijama ve}im od 0,970 i statisti~kom vredno{}u
International Journal of Laboratory Hematology, Aug 2, 2022
IntroductionDespite the important diagnostic role of peripheral blood morphology, cell classifica... more IntroductionDespite the important diagnostic role of peripheral blood morphology, cell classification is subjective. Automated image‐processing systems (AIS) provide more accurate and objective morphological evaluation. The aims of this multicenter study were the evaluation of the intra and inter‐laboratory variation between different AIS in cell pre‐classification and after reclassification, compared with manual optical microscopy, the reference method.MethodsSix peripheral blood samples were included in this study, for each sample, 70 May‐Grunwald and Giemsa stained PB smears were prepared from each specimen and 10 slides were delivered to the seven laboratories involved. Smears were processed by both optical microscopy (OM) and AIS. In addition, the assessment times of both methods were recorded.ResultsWithin‐laboratory Reproducibility ranged between 4.76% and 153.78%; between‐laboratory Precision ranged between 2.10% and 82.2%, while Total Imprecision ranged between 5.21% and 20.60%. The relative Bland Altman bias ranged between −0.01% and 20.60%. The mean of assessment times were 326 ± 110 s and 191 ± 68 s for AIS post reclassification and OM, respectively.ConclusionsAIS can be helpful when the number of cell counted are low and can give advantages in terms of efficiency, objectivity and time saving in the morphological analysis of blood cells. They can also help in the interpretation of some morphological features and can serve as learning and investigation tools.
Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommen... more Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommends evaluation of all troponin immunoassays within the same population to compare their performance. Hence, we planned a multicenter study to compare the four most widespread contemporary sensitive troponin I (TnI) methods. Methods: Seventy-six serum samples were centrifuged, separated and divided in 5 aliquots. The first aliquot was used for clinical measurement, whereas the rest were shipped to participating laboratories, where they were simultaneously thawed. High-sensitivity troponin T (HS-TnT) was measured on a Roche Cobas, whereas TnI was assessed with the Ortho Vitros cTnI, Beckman Coulter DXI 800 AccuTnI, Siemens Vista cTnI and Abbott Architect STAT cTnI. Results: A substantial bias was found between TnI and HS-TnT values. Although the correlation was acceptable and comprised between 0.86-0.89, the agreement of diagnostic values was poor, with the kappa statistic always lower than 0.50. Although the direct comparison between the four contemporary sensitive TnI immunoassays generated more favourable results, with Pearson's correlations greater than 0.970 and the kappa statistic equal to or higher than 0.59, Kratak sadr`aj Uvod: Radna grupa za klini~ku primenu sr~anih biomarkera Me|unarodne federacije za klini~ku hemiju trenutno pre-poru~uje evaluaciju svih imunoeseja za troponin u okviru iste populacije, kako bi se uporedile njihove performanse. Zbog toga smo osmislili ovu multicentri~nu studiju za pore|enjẽ etiri naj~e{}e upotrebljavane savremene metode osetljive na troponin I (TnI). Metode: Sedamdeset {est uzoraka seruma stavljeno je u centrifugu, razdvojeno i podeljeno u pet alikvota. Prvi alikvot je upotrebljen za klini~ko merenje, dok su ostali poslati laboratorijama koje su u~estvovale u istra`ivanju, gde su istovremeno otopljeni. Visokoosetljivi troponin T (HS-TnT) meren je na ure|aju Roche Cobas, dok je TnI odre|en pomo}u testova Ortho Vitros CtnI, Beckman Coulter DXI 800 Accu TnI, Siemens Vista cTnI i Abbott Achitect STAT cTnI. Rezultati: Otkriveno je znatno odstupanje u vrednostima TnI i HSTnT. Iako je korelacija bila prihvatljiva i u rasponu od 0,86 do 0,89, slaganje dijagnosti~kih vrednosti je bilo slabo, sa statisti~kom vredno{}u »kappa« uvek manjom od 0,50. Iako je direktnim pore|enjem ~etiri savremena imunoeseja osetljiva na TnI dobijeno vi{e povoljnih rezultata, sa Pearsonovim korelacijama ve}im od 0,970 i statisti~kom vredno{}u
BackgroundPatients with Multiple Sclerosis (pwMS) treated with anti-CD20 or fingolimod showed a r... more BackgroundPatients with Multiple Sclerosis (pwMS) treated with anti-CD20 or fingolimod showed a reduced humoral response to mRNA-based SARS-CoV-2 vaccines, while the degree of such responses is unimpaired and similar in pwMS treated with other disease modifying therapies (DMTs), or untreated. However, the nature of the SARS-CoV-2 vaccine-induced immune response is based also on cellular immunity and there is emerging evidence that anti-SARS-CoV-2 specific CD4 and CD8 T cell responses can be detected after vaccination also in patients with low antibody levels. In this study we aimed to monitor the risk of breakthrough SARS-CoV-2 infection and to identify correlates of reduced protection in frail vaccinated pwMS on different DMTs.MethodsWe designed a long term clinical follow-up of the CovaXiMS (Covid-19 vaccine in Multiple Sclerosis), a prospective multicenter cohort study enrolling pwMS scheduled for SARS-CoV-2 vaccination with mRNA vaccines and tested for SARS-CoV-2 antibodies befo...
absorption and its deposition in the liver, pancreas, heart, joints and pituitary. Without treatm... more absorption and its deposition in the liver, pancreas, heart, joints and pituitary. Without treatment, death may result from cirrhosis, primary hepatocellular carcinoma, diabetes or cardiomyopathy. Universal screening is not recommended, but should be done in first-degree relatives of patients with HFE-related hemochromatosis in individuals with evidence of active liver disease or with changed results in the iron study. Hanson et al. in a study that analyzed 69 studies on the mutation in the HFE gene C282Y and H63D concluded that in the general population the H63D/Wild mutation represents 62.4% of these mutations, and C282Y/Wild mutation 25.1%. When considered the population with clinical diagnosis the most frequent mutation is C282Y/C282Y (83.2%), followed by C282Y/H63D (5.7%) and H63D/ Wild mutations (5.6%). The treatment of HH is performed through phlebotomies that, if performed before the beginning of the irreversible organic lesions, lead to a life expectancy of these patients similar to those of the general population.
European Journal of Clinical Microbiology & Infectious Diseases, 2016
International-predominantly American-studies undertaken in the ICUs of teaching centres show that... more International-predominantly American-studies undertaken in the ICUs of teaching centres show that inadequate antibiotic therapy increases mortality and stay. We sought to ascertain whether this pertains also for smaller ICUs in the Veneto region of Northeast Italy. To the best of our knowledge, this is the first such survey in the Veneto or in Italy as a whole. Methods. A retrospective, observational study was performed across five general-hospital ICUs to examine appropriateness of microbiological sampling, empirical antibiotic adequacy and outcomes. Results. Among 911 patients (mean age, 65.8 years + 16.2 SD; median ICU stay, 17.0 days [IQR, 8.0-29.0]), 757 (83.1%) were given empirical antibiotics. Treatment adequacy could be fully assessed in only 212 patients (28.0%) who received empirical treatment and who had a relevant clinical sample collected at the initiation of this antibiotic (T0). Many other patients only had delayed microbiological investigation of their infections between Day 1 to Day 10 of therapy. Mortality was significantly higher among the 34.9% of patients receiving inadequate treatment (48.6% vs. 18.80%; p < 0.001). Only 32.5% of combination regimens comprised a broad-spectrum Gram-negative β-lactam plus an anti-MRSA agent, and many combinations were irrational. Conclusions. Inadequate treatment was frequent and was strongly associated with mortality; moreover, there was delayed microbiological investigation of many infections, precluding appropriate treatment modification and de-escalation. Improvements in these aspects and in antibiotic stewardship are being sought.
International Journal of Laboratory Hematology, 2017
BackgroundThe aims of this study were to compare the diagnostic accuracy of blood smear review cr... more BackgroundThe aims of this study were to compare the diagnostic accuracy of blood smear review criteria, by means of three different panel rules, those proposed by: the International Consensus Group for Hematology [41‐ICGH rules], the Italian Survey [IS rules] and the Working Group on Hematology‐SIBioC (WGH) consensus rules (WGH rules).MethodsThis study is based on 2707 peripheral blood (PB) samples referred for routine hematological testing to the WGH‐associated laboratories displaced all over the Italian territory. The PB samples were processed on seven different hematology analyzers (HAs): Advia 2120i, XE‐2100, BC‐6800, ABX Pentra, XN‐1000, Cell‐DYN Sapphire, and DxH800, respectively. All the results provided by the HAs were analyzed through the application of three different blood smear review criteria: that is, the 41‐ICGH, IS, and WGH rules. Finally, data were compared with those obtained by optical microscopy (OM), as the current gold standard.ResultsThe overall the agreement...
Laboratory Medicine and Emergency Medicine: an essential partnership. A better understanding of t... more Laboratory Medicine and Emergency Medicine: an essential partnership. A better understanding of the pathophysiological bases of many pathologies, along with the considerable technological advances occurred over last few years, have allowed to broaden number and complexity of in vitro diagnostic tests. The emergency department is the clinical setting with the highest risk of forensic disputes, and this explains the inclination that many emergency physicians have towards defensive medicine. Disproportionate request of laboratory tests, with poor awareness on the impact of inappropriateness, is one of the leading negative aftermath of this attitude. The predictable consequences are economic, but also encompass the risk of generating direct damage to the patients, especially in the presence of false positive test results. Since diagnostic appropriateness represents an essential element for patient safety and for sustainability of the National Healthcare System, the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and the Academy of Emergency Medicine and Care (AcEMC) have organized a joint meeting entitled "Laboratory Medicine and Emergency Medicine: an essential partnership", of which this document is a summary. The issues that have been discussed represent major diagnostic dilemmas faced by emergency physicians, and for which the contribution of laboratory medicine may be decisive. These include acute systemic infections, acute abdominal pain, acute chest pain, head injury and acute bleeding. Since timely transmission of test results is an additional critical element for the clinical decision making in emergency settings, the document will also include considerations on sample transportation from the emergency room to the laboratory
The etiological cause of bacterial vaginosis (BV) is the change of the vaginal ecosystem characte... more The etiological cause of bacterial vaginosis (BV) is the change of the vaginal ecosystem characterized by a decrease of lactobacilli and an increase of other germs, such as Gardnerella vaginalis and Atopobium vaginae. Molecular tools have revolutionized the diagnosis of these conditions. The aim of this paper was to compare results obtained from 158 vaginal swabs collected from women aged between 18 and 59 years old and subjected to microscopic evaluation (Nugent Score), culture and to the multiparametric molecular assay Vaginitis and Vaginosis Multiplex-Tandem (MT) PCR (AU27117) - Nuclear Laser Medicine. In 50 samples we also used matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) for bacterial microbiome identification. Our results showed a moderate concordance between traditional and molecular methods for diagnosis of candidiasis and a lower concordance for BV and normal flora. MALDI TOF MS allowed us to discriminate more than 10 species o...
AimsOptical microscopic (OM) evaluation of peripheral blood (PB) cells is still a crucial step of... more AimsOptical microscopic (OM) evaluation of peripheral blood (PB) cells is still a crucial step of the laboratory haematological workflow. The morphological cell analysis is time-consuming and expensive and it requires skilled operator. To address these challenges, automated image-processing systems, as digital morphology (DM), were developed in the last few years. The aim of this multicentre study, performed according to international guidelines, is to verify the analytical performance of DM compared with manual OM, the reference method.MethodsFour hundred and ninety PB samples were evaluated. For each sample, two May Grunwald-stained and Giemsa-stained smears were performed and the morphological evaluation of cells was analysed with both DM and OM. In addition, the assessment times of both methods were recorded.ResultsComparison of DM versus OM methods was assessed with Passing-Bablok and Deming fit regression analysis: slopes ranged between 0.17 for atypical, reactive lymphocytes ...
Objective Some conventional laboratory tests are routinely used for the prediction of systemic au... more Objective Some conventional laboratory tests are routinely used for the prediction of systemic autoimmune disease activity, such as the erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); however, they can give false-negative results, pointing out the need to identify more specific markers. Methods We evaluated biomarkers in 21 Italian patients naïve to treatment with a diagnosis of autoimmune rheumatic disease according to the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis during 6 months of therapeutic treatments. Results We found a significant difference in interleukin-6 (IL-6), CRP, ESR, platelet count, and fecal calprotectin in diagnosed patients compared with healthy participants and a significant decrease in these values during follow-up, except for IL-6 and platelet count. Conclusion We found that CRP, ESR, and fecal calprotectin seemed to be related to autoimmune rheumatic disorders an...
Background: The antibody response to coronavirus disease 2019 (COVID-19) vaccination in patients ... more Background: The antibody response to coronavirus disease 2019 (COVID-19) vaccination in patients with inflammatory bowel disease (IBD) on biological drugs is still unclear. Aim: To determine the anti-SARS-CoV-2 spike 1 (anti-S1-IgG) response rate and antibody levels following a complete COVID-19 vaccination cycle in patients with IBD on biological treatment. Methods: We assessed antibody response to COVID-19 in consecutive patients with IBD on biological drugs and without prior exposure to COVID-19. Sera were prospectively collected at baseline and at 21 days (T1), 42 days (T2), and 3 months (T3) after the first vaccine dose. Results: Among the 42 patients included in the study, the overall response rate at T3 was 97.6%, with no difference across the various biological drugs. After the first dose (T1), the response rate was higher in patients receiving anti-tumour necrosis factor (TNF) compared to patients treated with other biologics (p = 0.031). Among the responders, the anti-S1 l...
Overestimation of creatinine measurement using the Jaffé kinetic method in peritoneal dialysis so... more Overestimation of creatinine measurement using the Jaffé kinetic method in peritoneal dialysis solutions, due to glucose interference, has been quantified and corrected through the elaboration of linear formulas obtained from 110 recovery and 301 biological tests. The added pure powdered creatinine and enzymatic method were considered as references after proven accuracy. Considering creatinine as well as glucose concentration interference, we obtained correction formulas from multiple regression application. All the computed formulas gave satisfactory corrections but different accuracy levels. The best model in biological samples was: Corrected CR = K1JafféCr + K2Glucose (all values in mg/dl) where K1 = 0.973 and K2 = -0.00035 (Rsq = 0.987, F ratio = 10,945, p = 0.00001). Applying formulas to biological samples there was a drop in accuracy, possibly explained by the presence of numerous unidentified substances in peritoneal dialysis biological samples that can amplify scatter. Every laboratory can reduce the error of the Jaffé kinetic assay by calculating their own correction formula in relation to the method and instrument used, because Jaffé kinetic assay gives different results with different kinetic windows. So, especially when applied to peritoneal dialysis fluid measurements, if a creatinine assay reference method is not available, the correction formula can be applied directly as given. Otherwise the method we have described can be followed with a well-structured creatinine recovery fest to identify and quantify assay interferences.
Pre-Analytical Workstations as a Tool for Reducing Laboratory ErrorsReducing errors and improving... more Pre-Analytical Workstations as a Tool for Reducing Laboratory ErrorsReducing errors and improving quality are an integral part of Laboratory Medicine. Laboratory testing, a highly complex process commonly called the total testing process (TTP), is usually subdivided into three traditional (pre-, intra-, and post-) analytical phases. A series of papers published from 1989 drew the attention of laboratory professionals to the pre-analytical phase, which currently appears to be more vulnerable to errors than the other phases. Consequently, the preanalytical phase should be the main target for further quality improvement. Therefore, identifying the critical steps in the pre-analytical phase is a prerequisite for continuous quality improvement, further error reduction and thus for improving patient safety. Use of automated systems where feasible, and use of error reduction/improved quality as a factor when selecting instrumentation are the main tools we have to insure high quality and mi...
Bloodborne pathogens represent a major hazard for healthcare workers (HCWs) and exposure preventi... more Bloodborne pathogens represent a major hazard for healthcare workers (HCWs) and exposure prevention still represents the primary strategy to reduce the risk of occupational bloodborne pathogen infections, such as hepatitis B (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Each healthcare organization should have simple and easy-to-apply operating procedures (OPs), quickly accessible to their personnel, including educational programmes, written protocols for prompt reporting and procedures for correct evaluation, counselling, treatment and follow-up of occupational exposure. From a careful review of literature data and international recommendations, in this study we summarize the recommendations to follow in the event of occupational exposure to HIV, HBV and HCV, also providing tables and a flowchart, that are simple to apply and could be a guide, especially in moments of apprehension caused by the occurrence of an occupational accident due to biohazard, in whi...
Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommen... more Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommends evaluation of all troponin immunoassays within the same population to compare their performance. Hence, we planned a multicenter study to compare the four most widespread contemporary sensitive troponin I (TnI) methods. Methods: Seventy-six serum samples were centrifuged, separated and divided in 5 aliquots. The first aliquot was used for clinical measurement, whereas the rest were shipped to participating laboratories, where they were simultaneously thawed. High-sensitivity troponin T (HS-TnT) was measured on a Roche Cobas, whereas TnI was assessed with the Ortho Vitros cTnI, Beckman Coulter DXI 800 AccuTnI, Siemens Vista cTnI and Abbott Architect STAT cTnI. Results: A substantial bias was found between TnI and HS-TnT values. Although the correlation was acceptable and comprised between 0.86-0.89, the agreement of diagnostic values was poor, with the kappa statistic always lower than 0.50. Although the direct comparison between the four contemporary sensitive TnI immunoassays generated more favourable results, with Pearson's correlations greater than 0.970 and the kappa statistic equal to or higher than 0.59, Kratak sadr`aj Uvod: Radna grupa za klini~ku primenu sr~anih biomarkera Me|unarodne federacije za klini~ku hemiju trenutno pre-poru~uje evaluaciju svih imunoeseja za troponin u okviru iste populacije, kako bi se uporedile njihove performanse. Zbog toga smo osmislili ovu multicentri~nu studiju za pore|enjẽ etiri naj~e{}e upotrebljavane savremene metode osetljive na troponin I (TnI). Metode: Sedamdeset {est uzoraka seruma stavljeno je u centrifugu, razdvojeno i podeljeno u pet alikvota. Prvi alikvot je upotrebljen za klini~ko merenje, dok su ostali poslati laboratorijama koje su u~estvovale u istra`ivanju, gde su istovremeno otopljeni. Visokoosetljivi troponin T (HS-TnT) meren je na ure|aju Roche Cobas, dok je TnI odre|en pomo}u testova Ortho Vitros CtnI, Beckman Coulter DXI 800 Accu TnI, Siemens Vista cTnI i Abbott Achitect STAT cTnI. Rezultati: Otkriveno je znatno odstupanje u vrednostima TnI i HSTnT. Iako je korelacija bila prihvatljiva i u rasponu od 0,86 do 0,89, slaganje dijagnosti~kih vrednosti je bilo slabo, sa statisti~kom vredno{}u »kappa« uvek manjom od 0,50. Iako je direktnim pore|enjem ~etiri savremena imunoeseja osetljiva na TnI dobijeno vi{e povoljnih rezultata, sa Pearsonovim korelacijama ve}im od 0,970 i statisti~kom vredno{}u
International Journal of Laboratory Hematology, Aug 2, 2022
IntroductionDespite the important diagnostic role of peripheral blood morphology, cell classifica... more IntroductionDespite the important diagnostic role of peripheral blood morphology, cell classification is subjective. Automated image‐processing systems (AIS) provide more accurate and objective morphological evaluation. The aims of this multicenter study were the evaluation of the intra and inter‐laboratory variation between different AIS in cell pre‐classification and after reclassification, compared with manual optical microscopy, the reference method.MethodsSix peripheral blood samples were included in this study, for each sample, 70 May‐Grunwald and Giemsa stained PB smears were prepared from each specimen and 10 slides were delivered to the seven laboratories involved. Smears were processed by both optical microscopy (OM) and AIS. In addition, the assessment times of both methods were recorded.ResultsWithin‐laboratory Reproducibility ranged between 4.76% and 153.78%; between‐laboratory Precision ranged between 2.10% and 82.2%, while Total Imprecision ranged between 5.21% and 20.60%. The relative Bland Altman bias ranged between −0.01% and 20.60%. The mean of assessment times were 326 ± 110 s and 191 ± 68 s for AIS post reclassification and OM, respectively.ConclusionsAIS can be helpful when the number of cell counted are low and can give advantages in terms of efficiency, objectivity and time saving in the morphological analysis of blood cells. They can also help in the interpretation of some morphological features and can serve as learning and investigation tools.
Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommen... more Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommends evaluation of all troponin immunoassays within the same population to compare their performance. Hence, we planned a multicenter study to compare the four most widespread contemporary sensitive troponin I (TnI) methods. Methods: Seventy-six serum samples were centrifuged, separated and divided in 5 aliquots. The first aliquot was used for clinical measurement, whereas the rest were shipped to participating laboratories, where they were simultaneously thawed. High-sensitivity troponin T (HS-TnT) was measured on a Roche Cobas, whereas TnI was assessed with the Ortho Vitros cTnI, Beckman Coulter DXI 800 AccuTnI, Siemens Vista cTnI and Abbott Architect STAT cTnI. Results: A substantial bias was found between TnI and HS-TnT values. Although the correlation was acceptable and comprised between 0.86-0.89, the agreement of diagnostic values was poor, with the kappa statistic always lower than 0.50. Although the direct comparison between the four contemporary sensitive TnI immunoassays generated more favourable results, with Pearson's correlations greater than 0.970 and the kappa statistic equal to or higher than 0.59, Kratak sadr`aj Uvod: Radna grupa za klini~ku primenu sr~anih biomarkera Me|unarodne federacije za klini~ku hemiju trenutno pre-poru~uje evaluaciju svih imunoeseja za troponin u okviru iste populacije, kako bi se uporedile njihove performanse. Zbog toga smo osmislili ovu multicentri~nu studiju za pore|enjẽ etiri naj~e{}e upotrebljavane savremene metode osetljive na troponin I (TnI). Metode: Sedamdeset {est uzoraka seruma stavljeno je u centrifugu, razdvojeno i podeljeno u pet alikvota. Prvi alikvot je upotrebljen za klini~ko merenje, dok su ostali poslati laboratorijama koje su u~estvovale u istra`ivanju, gde su istovremeno otopljeni. Visokoosetljivi troponin T (HS-TnT) meren je na ure|aju Roche Cobas, dok je TnI odre|en pomo}u testova Ortho Vitros CtnI, Beckman Coulter DXI 800 Accu TnI, Siemens Vista cTnI i Abbott Achitect STAT cTnI. Rezultati: Otkriveno je znatno odstupanje u vrednostima TnI i HSTnT. Iako je korelacija bila prihvatljiva i u rasponu od 0,86 do 0,89, slaganje dijagnosti~kih vrednosti je bilo slabo, sa statisti~kom vredno{}u »kappa« uvek manjom od 0,50. Iako je direktnim pore|enjem ~etiri savremena imunoeseja osetljiva na TnI dobijeno vi{e povoljnih rezultata, sa Pearsonovim korelacijama ve}im od 0,970 i statisti~kom vredno{}u
BackgroundPatients with Multiple Sclerosis (pwMS) treated with anti-CD20 or fingolimod showed a r... more BackgroundPatients with Multiple Sclerosis (pwMS) treated with anti-CD20 or fingolimod showed a reduced humoral response to mRNA-based SARS-CoV-2 vaccines, while the degree of such responses is unimpaired and similar in pwMS treated with other disease modifying therapies (DMTs), or untreated. However, the nature of the SARS-CoV-2 vaccine-induced immune response is based also on cellular immunity and there is emerging evidence that anti-SARS-CoV-2 specific CD4 and CD8 T cell responses can be detected after vaccination also in patients with low antibody levels. In this study we aimed to monitor the risk of breakthrough SARS-CoV-2 infection and to identify correlates of reduced protection in frail vaccinated pwMS on different DMTs.MethodsWe designed a long term clinical follow-up of the CovaXiMS (Covid-19 vaccine in Multiple Sclerosis), a prospective multicenter cohort study enrolling pwMS scheduled for SARS-CoV-2 vaccination with mRNA vaccines and tested for SARS-CoV-2 antibodies befo...
absorption and its deposition in the liver, pancreas, heart, joints and pituitary. Without treatm... more absorption and its deposition in the liver, pancreas, heart, joints and pituitary. Without treatment, death may result from cirrhosis, primary hepatocellular carcinoma, diabetes or cardiomyopathy. Universal screening is not recommended, but should be done in first-degree relatives of patients with HFE-related hemochromatosis in individuals with evidence of active liver disease or with changed results in the iron study. Hanson et al. in a study that analyzed 69 studies on the mutation in the HFE gene C282Y and H63D concluded that in the general population the H63D/Wild mutation represents 62.4% of these mutations, and C282Y/Wild mutation 25.1%. When considered the population with clinical diagnosis the most frequent mutation is C282Y/C282Y (83.2%), followed by C282Y/H63D (5.7%) and H63D/ Wild mutations (5.6%). The treatment of HH is performed through phlebotomies that, if performed before the beginning of the irreversible organic lesions, lead to a life expectancy of these patients similar to those of the general population.
European Journal of Clinical Microbiology & Infectious Diseases, 2016
International-predominantly American-studies undertaken in the ICUs of teaching centres show that... more International-predominantly American-studies undertaken in the ICUs of teaching centres show that inadequate antibiotic therapy increases mortality and stay. We sought to ascertain whether this pertains also for smaller ICUs in the Veneto region of Northeast Italy. To the best of our knowledge, this is the first such survey in the Veneto or in Italy as a whole. Methods. A retrospective, observational study was performed across five general-hospital ICUs to examine appropriateness of microbiological sampling, empirical antibiotic adequacy and outcomes. Results. Among 911 patients (mean age, 65.8 years + 16.2 SD; median ICU stay, 17.0 days [IQR, 8.0-29.0]), 757 (83.1%) were given empirical antibiotics. Treatment adequacy could be fully assessed in only 212 patients (28.0%) who received empirical treatment and who had a relevant clinical sample collected at the initiation of this antibiotic (T0). Many other patients only had delayed microbiological investigation of their infections between Day 1 to Day 10 of therapy. Mortality was significantly higher among the 34.9% of patients receiving inadequate treatment (48.6% vs. 18.80%; p < 0.001). Only 32.5% of combination regimens comprised a broad-spectrum Gram-negative β-lactam plus an anti-MRSA agent, and many combinations were irrational. Conclusions. Inadequate treatment was frequent and was strongly associated with mortality; moreover, there was delayed microbiological investigation of many infections, precluding appropriate treatment modification and de-escalation. Improvements in these aspects and in antibiotic stewardship are being sought.
International Journal of Laboratory Hematology, 2017
BackgroundThe aims of this study were to compare the diagnostic accuracy of blood smear review cr... more BackgroundThe aims of this study were to compare the diagnostic accuracy of blood smear review criteria, by means of three different panel rules, those proposed by: the International Consensus Group for Hematology [41‐ICGH rules], the Italian Survey [IS rules] and the Working Group on Hematology‐SIBioC (WGH) consensus rules (WGH rules).MethodsThis study is based on 2707 peripheral blood (PB) samples referred for routine hematological testing to the WGH‐associated laboratories displaced all over the Italian territory. The PB samples were processed on seven different hematology analyzers (HAs): Advia 2120i, XE‐2100, BC‐6800, ABX Pentra, XN‐1000, Cell‐DYN Sapphire, and DxH800, respectively. All the results provided by the HAs were analyzed through the application of three different blood smear review criteria: that is, the 41‐ICGH, IS, and WGH rules. Finally, data were compared with those obtained by optical microscopy (OM), as the current gold standard.ResultsThe overall the agreement...
Laboratory Medicine and Emergency Medicine: an essential partnership. A better understanding of t... more Laboratory Medicine and Emergency Medicine: an essential partnership. A better understanding of the pathophysiological bases of many pathologies, along with the considerable technological advances occurred over last few years, have allowed to broaden number and complexity of in vitro diagnostic tests. The emergency department is the clinical setting with the highest risk of forensic disputes, and this explains the inclination that many emergency physicians have towards defensive medicine. Disproportionate request of laboratory tests, with poor awareness on the impact of inappropriateness, is one of the leading negative aftermath of this attitude. The predictable consequences are economic, but also encompass the risk of generating direct damage to the patients, especially in the presence of false positive test results. Since diagnostic appropriateness represents an essential element for patient safety and for sustainability of the National Healthcare System, the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and the Academy of Emergency Medicine and Care (AcEMC) have organized a joint meeting entitled "Laboratory Medicine and Emergency Medicine: an essential partnership", of which this document is a summary. The issues that have been discussed represent major diagnostic dilemmas faced by emergency physicians, and for which the contribution of laboratory medicine may be decisive. These include acute systemic infections, acute abdominal pain, acute chest pain, head injury and acute bleeding. Since timely transmission of test results is an additional critical element for the clinical decision making in emergency settings, the document will also include considerations on sample transportation from the emergency room to the laboratory
The etiological cause of bacterial vaginosis (BV) is the change of the vaginal ecosystem characte... more The etiological cause of bacterial vaginosis (BV) is the change of the vaginal ecosystem characterized by a decrease of lactobacilli and an increase of other germs, such as Gardnerella vaginalis and Atopobium vaginae. Molecular tools have revolutionized the diagnosis of these conditions. The aim of this paper was to compare results obtained from 158 vaginal swabs collected from women aged between 18 and 59 years old and subjected to microscopic evaluation (Nugent Score), culture and to the multiparametric molecular assay Vaginitis and Vaginosis Multiplex-Tandem (MT) PCR (AU27117) - Nuclear Laser Medicine. In 50 samples we also used matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) for bacterial microbiome identification. Our results showed a moderate concordance between traditional and molecular methods for diagnosis of candidiasis and a lower concordance for BV and normal flora. MALDI TOF MS allowed us to discriminate more than 10 species o...
AimsOptical microscopic (OM) evaluation of peripheral blood (PB) cells is still a crucial step of... more AimsOptical microscopic (OM) evaluation of peripheral blood (PB) cells is still a crucial step of the laboratory haematological workflow. The morphological cell analysis is time-consuming and expensive and it requires skilled operator. To address these challenges, automated image-processing systems, as digital morphology (DM), were developed in the last few years. The aim of this multicentre study, performed according to international guidelines, is to verify the analytical performance of DM compared with manual OM, the reference method.MethodsFour hundred and ninety PB samples were evaluated. For each sample, two May Grunwald-stained and Giemsa-stained smears were performed and the morphological evaluation of cells was analysed with both DM and OM. In addition, the assessment times of both methods were recorded.ResultsComparison of DM versus OM methods was assessed with Passing-Bablok and Deming fit regression analysis: slopes ranged between 0.17 for atypical, reactive lymphocytes ...
Objective Some conventional laboratory tests are routinely used for the prediction of systemic au... more Objective Some conventional laboratory tests are routinely used for the prediction of systemic autoimmune disease activity, such as the erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); however, they can give false-negative results, pointing out the need to identify more specific markers. Methods We evaluated biomarkers in 21 Italian patients naïve to treatment with a diagnosis of autoimmune rheumatic disease according to the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis during 6 months of therapeutic treatments. Results We found a significant difference in interleukin-6 (IL-6), CRP, ESR, platelet count, and fecal calprotectin in diagnosed patients compared with healthy participants and a significant decrease in these values during follow-up, except for IL-6 and platelet count. Conclusion We found that CRP, ESR, and fecal calprotectin seemed to be related to autoimmune rheumatic disorders an...
Background: The antibody response to coronavirus disease 2019 (COVID-19) vaccination in patients ... more Background: The antibody response to coronavirus disease 2019 (COVID-19) vaccination in patients with inflammatory bowel disease (IBD) on biological drugs is still unclear. Aim: To determine the anti-SARS-CoV-2 spike 1 (anti-S1-IgG) response rate and antibody levels following a complete COVID-19 vaccination cycle in patients with IBD on biological treatment. Methods: We assessed antibody response to COVID-19 in consecutive patients with IBD on biological drugs and without prior exposure to COVID-19. Sera were prospectively collected at baseline and at 21 days (T1), 42 days (T2), and 3 months (T3) after the first vaccine dose. Results: Among the 42 patients included in the study, the overall response rate at T3 was 97.6%, with no difference across the various biological drugs. After the first dose (T1), the response rate was higher in patients receiving anti-tumour necrosis factor (TNF) compared to patients treated with other biologics (p = 0.031). Among the responders, the anti-S1 l...
Overestimation of creatinine measurement using the Jaffé kinetic method in peritoneal dialysis so... more Overestimation of creatinine measurement using the Jaffé kinetic method in peritoneal dialysis solutions, due to glucose interference, has been quantified and corrected through the elaboration of linear formulas obtained from 110 recovery and 301 biological tests. The added pure powdered creatinine and enzymatic method were considered as references after proven accuracy. Considering creatinine as well as glucose concentration interference, we obtained correction formulas from multiple regression application. All the computed formulas gave satisfactory corrections but different accuracy levels. The best model in biological samples was: Corrected CR = K1JafféCr + K2Glucose (all values in mg/dl) where K1 = 0.973 and K2 = -0.00035 (Rsq = 0.987, F ratio = 10,945, p = 0.00001). Applying formulas to biological samples there was a drop in accuracy, possibly explained by the presence of numerous unidentified substances in peritoneal dialysis biological samples that can amplify scatter. Every laboratory can reduce the error of the Jaffé kinetic assay by calculating their own correction formula in relation to the method and instrument used, because Jaffé kinetic assay gives different results with different kinetic windows. So, especially when applied to peritoneal dialysis fluid measurements, if a creatinine assay reference method is not available, the correction formula can be applied directly as given. Otherwise the method we have described can be followed with a well-structured creatinine recovery fest to identify and quantify assay interferences.
Pre-Analytical Workstations as a Tool for Reducing Laboratory ErrorsReducing errors and improving... more Pre-Analytical Workstations as a Tool for Reducing Laboratory ErrorsReducing errors and improving quality are an integral part of Laboratory Medicine. Laboratory testing, a highly complex process commonly called the total testing process (TTP), is usually subdivided into three traditional (pre-, intra-, and post-) analytical phases. A series of papers published from 1989 drew the attention of laboratory professionals to the pre-analytical phase, which currently appears to be more vulnerable to errors than the other phases. Consequently, the preanalytical phase should be the main target for further quality improvement. Therefore, identifying the critical steps in the pre-analytical phase is a prerequisite for continuous quality improvement, further error reduction and thus for improving patient safety. Use of automated systems where feasible, and use of error reduction/improved quality as a factor when selecting instrumentation are the main tools we have to insure high quality and mi...
Bloodborne pathogens represent a major hazard for healthcare workers (HCWs) and exposure preventi... more Bloodborne pathogens represent a major hazard for healthcare workers (HCWs) and exposure prevention still represents the primary strategy to reduce the risk of occupational bloodborne pathogen infections, such as hepatitis B (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Each healthcare organization should have simple and easy-to-apply operating procedures (OPs), quickly accessible to their personnel, including educational programmes, written protocols for prompt reporting and procedures for correct evaluation, counselling, treatment and follow-up of occupational exposure. From a careful review of literature data and international recommendations, in this study we summarize the recommendations to follow in the event of occupational exposure to HIV, HBV and HCV, also providing tables and a flowchart, that are simple to apply and could be a guide, especially in moments of apprehension caused by the occurrence of an occupational accident due to biohazard, in whi...
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Papers by Giorgio Da Rin