Pilot study on the probability of drug-drug interactions among direct oral anticoagulants (DOACs) and antiseizure medications (ASMs): a clinical perspective.

BACKGROUND: There is little and controversial information about changes in plasma concentrations (PCs) or clinical events during coadministration of antiseizure medications (ASMs) and direct oral anticoagulants (DOACs). We aimed to explore possible determinants of dosage class among DOACs trough PCs when ASMs are co-administered and the relative risks. We also provided some clinical examples of patients' management. METHODS: Data on adult patients concomitantly treated with ASMs (grouped in enzyme-inducing [I-ASMs], non-inducing [nI-ASMs], and levetiracetam [LEV]) and DOACs with at least one measurement of DOACs' PC were retrospectively collected. The role of DOAC-ASM combinations in predicting PC class (ranging from I at ischemic/thromboembolic risk to IV at increased bleeding risk) was investigated by an ordered logit model, and the marginal probabilities of belonging to the four dosage classes were calculated. RESULTS: We collected 46 DOACs' PCs out of 31 patients. There were 5 (10.9%) determinations in class I (4 out of 5 with concomitant I-ASMs) and 5 (10.9%) in class IV. The rivaroxaban/I-ASM combination was associated with lower DOAC dosages than rivaroxaban/LEV (OR: 0.00; 95% CI: 0.00-0.62). Furthermore, patient's probability of being in class I was approximately 50% with the rivaroxaban/I-ASM combination, while apixaban, dabigatran, and edoxaban had the highest cumulative probability of being in class II or III despite the ASM used. CONCLUSION: These preliminary results confirm the reduction of DOAC's PC by I-ASMs and suggest a better manageability of apixaban, dabigatran, and edoxaban independently from the concomitant ASM, whereas rivaroxaban seems the most liable to PC alterations with I-ASMs.

Neutrophil Gelatinase-Associated Lipocalin in Peritoneal Dialysis-Related Peritonitis: Correlation with White Blood Cells over Time and a Possible Role as the Outcome Predictor.

INTRODUCTION: The present study aimed to monitor peritoneal neutrophil gelatinase-associated lipocalin (pNGAL) during peritonitis episodes and to enhance its diagnostic value by evaluating pNGAL at scheduled times in parallel with white blood cell (WBC) count. In addition, we investigated possible correlations between pNGAL and the etiology of peritonitis, evaluating it as a possible marker of the clinical outcome. METHODS: Twenty-two patients with peritoneal dialysis (PD)-related peritonitis were enrolled. Peritonitis was divided into Gram-positive, Gram-negative, polymicrobial, and sterile. WBC count and neutrophil gelatinase-associated lipocalin (NGAL) in PD effluent were measured at different times (days 0, 1, 5, 10, 15, and/or 20 and 10 days after antibiotic therapy discontinuation). NGAL was measured by standard quantitative laboratory-based immunoassay and by colorimetric NGAL dipstick (NGALds) (dipstick test). RESULTS: We found strong correlations between peritoneal WBC, laboratory-based NGAL, and NGALds values, both overall and separated at each time point. On day 1, we observed no significant difference in WBC, both NGALds (p = 0.3, 0.9, and 0.2) between Gram-positive, Gram-negative, polymicrobial, and sterile peritonitis. No significant difference has been found between de novo versus relapsing peritonitis for all markers (p > 0.05). We observed a parallel decrease of WBC and both NGAL in patients with favorable outcomes. WBC count and both pNGAL resulted higher in patients with negative outcomes (defined as relapsing peritonitis, peritonitis-associated catheter removal, peritonitis-associated hemodialysis transfer, peritonitis-associated death) at day 10 (p = 0.04, p = 0.03, and p = 0.05, respectively) and day 15 (p = 0.01, p = 0.04, and tendency for p = 0.005). There was a tendency toward higher levels of WBC and NGAL in patients with a negative outcome at day 5. No significant difference in all parameters was proven at day 1 (p = 0.3, p = 0.9, p = 0.2) between groups. CONCLUSION: This study confirms pNGAL as a valid and reliable biomarker for the diagnosis of PD-peritonitis and its monitoring. Its trend is parallel to WBC count during peritonitis episodes, in particular, patients with unfavorable outcomes.

Influence of patients' clinical features at intensive care unit admission on performance of cell cycle arrest biomarkers in predicting acute kidney injury.

Objectives: Identification of acute kidney injury (AKI) can be challenging in patients with a variety of clinical features at intensive care unit (ICU) admission, and the capacity of biomarkers in this subpopulation has been poorly studied. In our study we examined the influence that patients' clinical features at ICU admission have over the predicting ability of the combination of urinary tissue inhibitor of metalloproteinase-2 (TIMP2) and insulin-like growth factor binding protein 7 (IGFBP7). Methods: Urinary [TIMP2]•[IGFBP7] were measured for all patients upon admission to ICU. We calculated the receiver operating characteristics (ROC) curves for AKI prediction in the overall cohort and for subgroups of patients according to etiology of ICU admission, which included: sepsis, trauma, neurological conditions, cardiovascular diseases, respiratory diseases, and non-classifiable causes. Results: In the overall cohort of 719 patients, 239 (33.2%) developed AKI in the first seven days. [TIMP2]•[IGFBP7] at ICU admission were significantly higher in AKI patients than in non-AKI patients. This is true not only for the overall cohort but also in the other subgroups. The area under the ROC curve (AUC) for [TIMP2]•[IGFBP7] in predicting AKI in the first seven days was 0.633 (95% CI 0.588-0.678), for the overall cohort, with sensitivity and specificity of 66.1 and 51.9% respectively. When we considered patients with combined sepsis, trauma, and respiratory disease we found a higher AUC than patients without these conditions (0.711 vs. 0.575; p=0.002). Conclusions: The accuracy of [TIMP2]•[IGFBP7] in predicting the risk of AKI in the first seven days after ICU admission has significant variability when the reason for ICU admission is considered.

Presepsin and Procalcitonin Levels as Markers of Adverse Postoperative Complications and Mortality in Cardiac Surgery Patients.

Backgound: This study was aimed at evaluating the presepsin and procalcitonin levels to predict adverse postoperative complications and mortality in cardiac surgery patients. METHODS: A total of 122 cardiac surgery patients were enrolled for the study. Presepsin and procalcitonin levels were measured 48 h after the procedure. The primary endpoints were adverse renal, respiratory, and cardiovascular outcomes and mortality. RESULTS: Presepsin and procalcitonin levels were significantly higher in patients with adverse renal and respiratory outcome (p < 0.001 and 0.0081). The presepsin levels were significantly higher in patients with adverse cardiovascular outcome (p = 0.023) and the procalcitonin values in patients with sepsis (p = 0.0013). Presepsin levels were significantly higher in patients who died during hospitalization (382 pg/mL, interquartile range [IQR] 243-717.5 vs. 1,848 pg/mL, IQR 998-5,451.5, p = 0.049). In addition, the predictive value for in-hospital, 30-days, and 6-months mortality was higher for presepsin, with a significant difference between the 2 biomarkers (p = 0.025, p = 0.035, p = 0.003; respectively). Presepsin and procalcitonin seem to have comparable predictive value for adverse renal, cardiovascular, and respiratory outcome in cardiac surgery patients. Although a positive trend was notable for presepsin and adverse renal outcome (area under the ROC [receiver operating characteristic] curves [AUC] of 0.760, 95% CI 0.673-0.833 versus procalcitonin: AUC 0.692; 95% CI 0.601-0.773): no statistically significant difference was evident between the AUC of the 2 biomarkers (p = 0.25). CONCLUSIONS: Presepsin and -procalcitonin seem to have comparable predictive value for -adverse renal, cardiovascular, and respiratory outcome in cardiac surgery patients. Also, presepsin possesses a better predictive value for in-hospital, 30-days, and 6-months mortality.

Predicting Acute Kidney Injury in Intensive Care Unit Patients: The Role of Tissue Inhibitor of Metalloproteinases-2 and Insulin-Like Growth Factor-Binding Protein-7 Biomarkers.

BACKGROUND: Acute kidney injury (AKI) diagnosis is based on a rise in serum creatinine and/or fall in urine output. It has been shown that there are patients that fulfill AKI definition but do not have AKI, and there are also patients with evidence of renal injury who do not meet any criteria for AKI. Recently the innovative and emerging proteomic technology has enabled the identification of novel biomarkers that allow improved risk stratification. METHODS: Tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor-binding protein 7 (IGFBP7) were measured to a cohort of 719 consecutive patients admitted to Intensive Care Unit (ICU). The primary endpoint was the evaluation of clinical performances of the biomarkers focusing on the probability do develop AKI in the first 7 days. RESULTS: The Kaplan-Meier analysis considering the first 7 days of ICU stay suggested a lower risk of developing AKI (p < 0.0001) for patients with a negative (<0.3; TIMP-2*IGFBP7) test. CONCLUSION: (TIMP-2*IGFBP7) at ICU admission has a good performance in predicting AKI, especially in the first 4 days in ICU.

Procalcitonin and Interleukin-6 Levels: Are They Useful Biomarkers in Cardiac Surgery Patients?

BACKGROUND/AIM: Cardiac surgery-associated acute kidney injury is an independent predictor of chronic renal disease and mortality. The scope of this study was to determine the utility of procalcitonin (PCT) and plasma interleukin-6 (IL-6) levels in predicting renal outcome and mortality in these patients. METHODS: PCT and plasma IL-6 levels of 122 cardiac surgery patients were measured at 48 h after the surgical procedure. Primary endpoints were adverse renal outcome and mortality. Secondary endpoints were length of stay, bleeding, and number of transfusions. RESULTS: PCT was found to be a better predictor of adverse renal outcome than IL-6. IL-6 seemed to be a better predictor of both 30-day and overall mortality than PCT. Neither PCT nor IL-6 levels were found to be good predictors of intensive care unit stay and bleeding. CONCLUSION: PCT may be considered a good predictor of adverse renal outcome in cardiac surgery patients, whereas IL-6 seems to possess a good predictive value for mortality in this population of patients.

Stage 5 Chronic Kidney Disease: Epidemiological Analysis in a NorthEastern District of Italy Focusing on Access to Nephrological Care.

BACKGROUND: We conducted a retrospective epidemiological study about the prevalence of stage 5 chronic kidney disease (CKD) in a high-income district, comparing some demographic characteristics and outcomes of those patients who had nephrological consultations and those who had not. RESULTS: In a district of 400,000 adult subjects in 2020, 925 patients had an estimated glomerular filtration rate (eGFR) under 15 mL/min and CKD. In the same period, 747 (80.4%) patients were assessed by nephrologists, while 178 (19.6%) were not. Age (88 vs. 75, p < 0.0001), female gender (66.3% vs. 47%, p < 0.001), and eGFR (12 vs. 9 mL/min, p < 0.001) were significantly different in the patients assessed by a nephrologist as compared those who did not have nephrological care. Furthermore, unfollowed CKD patients had a significantly higher death rate, 83.1% versus 14.3% (p < 0.0001). CONCLUSIONS: About 20% of ESKD patients did not receive a nephrologist consultation. Older people and women were more likely not to be referred to nephrology clinics. Unfollowed patients with stage 5 CKD had a significantly higher death rate.

Analysis of annual distributions of hemoglobin A2 values as a method to test for HbA2 standardization.

BACKGROUND AND AIMS: The monitoring of yearly distributions of HbA2 measured has been indicated as a reliable indicator of worldwide standardization. MATERIALS AND METHODS: Measurements/year of HbA2 have been collected over three consecutive years in 15 Italian laboratories each using the same analytical method over three years period. HbA2 distributions, cleaned of replicated measurements, were compared by the overlapping area of the raw probability density functions expressed by coefficient eta (η), and by comparing the reference intervals for the central part of each distribution estimated by the indirect method refineR using the R package "refineR". RESULTS: According to the overlapping areas analysis the distributions/year of the data provided by 4 centers able to perform at least 1000 measurements/year were similar in 2 consecutive years. Moreover, the reference intervals provided by 2 centers using the same analytical methods in two separate locations over the three consecutive years, were very similar. The highest overlap (99.7 %) was observed in one center over two consecutive years. The overlapping areas were very high (93.6-95.7%) in 8 out of 9 inter-comparisons. CONCLUSION: Despite the limitations of this study the yearly distribution of the HbA2 measured in various centers appears a reliable tool to test HbA2 standardization over different centers using different analytical methods.

Evaluating the role of a fully automated SARS-CoV-2 antigen ECLIA immunoassay in the management of the SARS COV 2 pandemic on general population.

OBJECTIVES: Chemiluminescence immunoassay (CLIA) automated assays (fourth-generation antigen test) for SARS-CoV-2 detection are promising because of their analytical productivity, but have lower sensitivity and specificity than rt-PCR assays. The authors of this paper evaluated a recent immunoassay implemented on Siemens Atellica IM, investigating how much this could affect the actual feasibility of this diagnostic during the pandemic. METHODS: From the three-day routine 134 positive and 241 negative swab samples by rt-PCR test were evaluated, selected as 1/3 positive - 2/3 negative. RESULTS: Using rt-PCR as gold standard, the specificity of immunoassay was 96.7%, while sensitivity was 68.0%. Sensitivity is inversely proportional to the viral load: 100% for cycles threshold (CT) values from 14 to 29, 95% until 30 CT, then 85, 74, 72, 68%, for 31-35 CT respectively. CONCLUSIONS: Our study confirms the reliability of the fourth-generation antigen assay in recognizing negative samples. Conversely, sensitivity appears to be less reliable (68.0%) than reported in the literature. This could be due to a non-randomized study group: many swab samples were taken from patients with expected low viral load (hospitalized for COVID for more than 10-12 days or asymptomatic patients for epidemiological surveillance). The strong correlation of sensitivity and viral load could prove significant to track the infectiousness of infected people, as previous studies reported that a viral load of at least 10E6 copies of RNA/mL, corresponding to 25 CT, is the threshold of transmission of the disease.

Comparison of Anti-SARS-CoV-2 S1 Receptor-Binding Domain Antibody Immunoassays in Health Care Workers Before and After the BNT162b2 mRNA Vaccine.

OBJECTIVES: The Pfizer-BioNTech BNT162b2 vaccine against SARS-CoV-2 infection is now available. This vaccine induces antibody production against the receptor-binding domain (RBD) of the spike glycoprotein S1 (S1-RBD). This study evaluated the performance of new immunoassays to measure this type of antibody. METHODS: Blood samples were collected at t0 (prime dose), after 21 days (t1, booster dose), and then after another 15 days (t2) from 70 health care professionals who had tested negative for previous SARS-CoV-2 infection and underwent vaccination with BNT162b2. RESULTS: Antibodies against S1-RBD were measured using 4 commercial assays. At t0, t1, and t2, the median antibody concentrations (interquartile range) were, respectively, 0.2 (0.1-0.4), 49.5 (19.1-95.7), and 888.0 (603.6-1,345.8) U/mL by Maglumi SARS-CoV-2 S-RBD immunoglobulin G (IgG) (Shenzen New Industries Biomedical Engineering, Snibe Diagnostics); 0.0 (0.0-0.0), 7.9 (4.2-15.6), and 112.3 (76.4-205.6) U/mL by Atellica IM SARS-CoV-2 IgG assay (Siemens Healthineers); 0.0 (0.0-0.0), 59.9 (18.3-122.0), and 2,646.0 (1,351.2-4,124.0) U/mL by Elecsys Anti-SARS-CoV-2 S assay (Roche Diagnostics); and 1.8 (1.8-1.8), 184 (94-294), and 1,841.0 (1,080.0-2,900.0) AU/mL by LIAISON SARS-CoV-2 TrimericS IgG assay (DiaSorin). The differences between medians at t0, t1, and t2 were all statistically significant (P < .001). CONCLUSIONS: Antibodies against nucleocapsid proteins (N) were also measured using Maglumi 2019-nCoV IgG assay, which showed all negative results. All the considered anti-RBD methods detected response to the vaccine, while the method directed against anti-N failed to show response.

Copeptin and high sensitive troponin for a rapid rule out of acute myocardial infarction?

BACKGROUND: Rapid and reliable exclusion of acute myocardial infarction during emergency department triage is an important clinical need. The purpose of this study was to evaluate the potential role of copeptin, a marker of acute endogenous stress, together with high sensitive troponin-I for a rapid and early rule-out of acute myocardial infarction. METHODS: Copeptin and myoglobin were measured in 80 subjects presenting to the emergency department with chest pain and symptoms suggestive of acute myocardial infarction, 46 patients had a negative high sensitive troponin-I concentration at presentation, 3, 6 and 12 hours; whereas 34 patients had negative or very low high sensitive troponin-I at presentation, but rising troponin values at 3, 6 and 12 hours. RESULTS: Copeptin was significantly higher in patients with evidence of myocardial damage (median 92.2 pmol/L vs 8.5 pmol/L, p < 0.0001). The area under the receiver-operating characteristic curve (AUC) for copeptin at initial presentation was 0.86 (95 % confidence interval, CI: 0.76 to 0.93), which was significantly higher than 0.68 (95% CI: 0.57 to 0.78, p < 0.05) for myoglobin but not significantly different from 0.88 (95% CI: 0.79 to 0.93) for high sensitive troponin-I. The combination of high sensitive troponin-I and copeptin resulted in an AUC of 0.94 (95% CI: 0.86 to 0.98), while the combination of high sensitive troponin-I and myoglobin results in an AUC of 0.89 (95% CI: 0.81 to 0.95). CONCLUSIONS: Copeptin concentrations are more sensitive than myoglobin as an early marker of myocardial damage. Although copeptin provides significant incremental value on top of high sensitivity troponin-I, myoglobin does not.

Improvements and limits of anti SARS-CoV-2 antibodies assays by WHO (NIBSC 20/136) standardization.

OBJECTIVES: A few CLIA automated immunoassays for the recognition of anti S1-RBD SARS-CoV-2 antibodies have recently been placed on the market. Preliminary data demonstrate a high correlation between methods but wide differences in absolute concentrations. A new WHO international standard for anti-SARS-CoV-2 immunoglobulin, NIBSC code 20/136, has been recently introduced to reduce the differences. The aim of this study is thus to verify the harmonization made by NIBSC 20/136 on Ab anti S1-RBD measurement on real samples. METHODS: The following assays were studied: LIAISON® SARS-CoV-2 TrimericS IgG (DiaSorin); Elecsys® anti-SARS-CoV-2 S (ROCHE); Atellica IM SARS-CoV-2 IgG (sCOVG) (Siemens); MAGLUMI® SARS-CoV-2 S-RBD IgG (Snibe), measuring 210 samples from 70 health workers with no previous SARS-CoV2 infection, during their Pfizer-BioNTech's BNT162b2 vaccination period. RESULTS: The recalculation of concentrations based on the NIBSC 20/136 standardization improve the analytical and diagnostic comparability but do not cancel this variability between methods: recalibrated results remain different across methods, both in terms of tendency and single data. CONCLUSIONS: The recalculation of concentrations based on the NIBSC 20/136 standardization improves the analytical and diagnostic comparability but does not cancel the differences between methods: recalibrated results remain different across methods, both in terms of tendency and single data.

Evaluation of STA-NeoPTimal, an extraction thromboplastin reagent with ISI close to 1.

INTRODUCTION: The prothrombin time (PT) is the most requested test to investigate patients with congenital or acquired coagulopathies or to monitor oral anticoagulant therapy. However, thromboplastins can show markedly different responsiveness to the defects induced by vitamin K antagonist (VKA) therapy and are thus characterized by their ISI (International Sensitivity Index). INR results are optimal for patients under VKA but for patients screened for other reasons expressing PT results as ratio can be more appropriate. As it is very difficult to define the PT results reporting unit from the PT testing request, it would be ideal to use a thromboplastin with ISI = 1. The study aims to compare our reference PT reagent with two candidate thromboplastins with ISI close to 1. METHODS: We compared 3 different thromplastins: two rabbit brain extracted based reagents (STA-Neoplastine CI Plus, with ISI = 1.26, routinely used in our laboratory and STA-NeoPTimal with ISI = 1.01) and a recombinant thromboplastin (STA-Neoplastine R with ISI = 0.97). The comparison was done on 175 samples: 75 from individuals without coagulation defects and 100 from patients under VKA. RESULTS: STA-NeoPTimal and STA-Neoplastine R well correlate to our reference, STA-Neoplastine CI Plus: regression equations are y = 1.186x-0.1351, r2  = .9454 and y = 1.1432x-0.1554, r2  = .9951, respectively. The lowest bias on INR results was obtained with STA-NeoPTimal reagent (interval: -0.7/+0.4). CONCLUSION: We conclude that STA-NeoPTimal can be used in the laboratory as it gives results comparable to those obtained with STA-Neoplastine CI Plus. Besides, thanks to its ISI = 1, it guarantees reporting a PT ratio equal to INR which avoids errors.

Gadolinium-based contrast media exposure and the possible risk of subclinical kidney damage: a pilot study.

PURPOSE: We performed a pilot study to evaluate the feasibility of future research about the presence of subclinical kidney damage after Gadolinium-based contrast media exposure. The future study aims to understand which are the behaviors of two markers of kidney damage, such as urinary NephroCheck (NC) and/or neutrophil gelatinase-associated lipocalin (NGAL). Specifically, after GBCM exposure, NC urinary detection should identify proximal tubule damage while NGAL urinary detection should be related to distal tubule damage. METHODS: We performed a pilot study in patients who had Gadolinium exposure. The feasibility of future study is reached when at least 90% of candidates completed the pilot study. In each patient, we tested urinary NC and NGAL levels 24 h before magnetic resonance imaging (MRI) and 12-24 h after the exposure. Furthermore, we evaluated the administration of other nephrotoxic agents, the presence of comorbidity, and kidney function by S-creatinine and urine protein before the MRI. RESULTS: We enrolled 35 candidates of whom 33 patients completed all study procedures. Our population had a mean age of 60.7 ± 14.8 years with normal kidney function with a median S-creatinine equal to 0.7 mg/dl (Interquartile range [IQR] 0.6-0.91). Urinary NC levels increased from 0.21 ng2/ml2 (IQR 0.11-0.4) before MRI to 0.34 ng2/ml2 (IQR 0.16-0.86) (p = 0.005). Conversely, we did not appreciate any significant modification in urinary NGAL (p = 0.53). CONCLUSION: Our pilot study seems adequate in terms of feasibility and encourages us to focus our future research on renal proximal tubule, as the principal site of subclinical kidney damage after Gadolinium exposure.

Hemoglobin A2 and Heterogeneous Diagnostic Relevance Observed in Eight New Variants of the Delta Globin Gene.

BACKGROUND: Hemoglobin A (Hb A) (α2ß2) in the normal adult subject constitutes 96-98% of hemoglobin, and Hb F is normally less than 1%, while for hemoglobin A2 (Hb A2) (α2δ2), the normal reference values are between 2.0 and 3.3%. It is important to evaluate the presence of possible delta gene mutations in a population at high risk for globin gene defects in order to correctly diagnose the ß-thalassemia carrier. METHODS: The most used methods for the quantification of Hb A2 are based on automated high performance liquid chromatography (HPLC) or capillary electrophoresis (CE). In particular Hb analyses were performed by HPLC on three dedicated devices. DNA analyses were performed according to local standard protocols. RESULTS: Here, we described eight new δ-globin gene variants discovered and characterized in some laboratories in Northern Italy in recent years. These new variants were added to the many already known Hb A2 variants that were found with an estimated frequency of about 1-2% during the screening tests in our laboratories. CONCLUSIONS: The knowledge recognition of the delta variant on Hb analysis and accurate molecular characterization is crucial to provide an accurate definitive thalassemia diagnosis, particularly in young subjects who would like to ask for a prenatal diagnosis or preimplantation genetic diagnosis.

Recommendations for the implementation of international standardization of glycated hemoglobin in Italy.

This document is issued by the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and a number of other National Scientific Societies and Associations in order to promote a coordinated plan for implementing the standardization of glycated hemoglobin (HbA(1c)) measurement in Italy according to the recommendations by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Changes in reporting HbA(1c) results, new units, how to relate old and new units, a timeline for changes and definition of the analytical goals are the main issues discussed.

Glucose meters: What's the laboratory reference glucose?

BACKGROUND: The accuracy of glucose meters is evaluated by comparing their results with those from a reference laboratory glucose analyser. The main scientific societies recommend the use of a prompt glycolysis inhibitor such as citrate for an accurate glucose determination. In the present preliminary study, we discuss the bias between capillary and plasma glucose measured concentrations, determined in two Italian clinical laboratories, using tubes containing an NaF and citrate mixture in liquid and granular form. METHODS: 139 volunteers in whom 75 g OGTT was requested were recruited. Basal capillary glucose was determined using Abbott FreeStyle Precision Neo in Brescia (n=63), while clinical laboratory reference P-glucose was determined using tubes containing NaF/K3EDTA and liquid NaF/Na2EDTA/citrate. Basal capillary glucose was determined using a Roche Cobas Accu-Chek Inform II in Vicenza (n=76), while P-glucose was determined using tubes containing NaF/K2Ox and NaF/Na2EDTA/citrate in granulated form. Reference P-glucose was determined with a hexokinase method on Dimension Vista systems. Differences between capillary and reference P-glucose were evaluated according to ADA/ISO 15197:2013 specifications. RESULTS: 96.82% and 97.37% of capillary determinations were within specifications when liquid and granular citrate mixture tubes were used, respectively. Conversely, only 73.02% and 80.26% of determinations were within criteria using NaF. CONCLUSIONS: It's important to know what is the laboratory reference glucose in evaluating glucose meters' accuracy. The evaluation of glucometers' accuracy with respect to a reference laboratory may be wrong if tubes containing only NaF are used due to in vitro glycolysis. Only tubes containing citrate mixture permit the correct evaluation of glucose meters' accuracy.

Anti SARS-CoV-2 antibodies monitoring in a group of residents in a long term care facility during COVID-19 pandemic peak.

Objectives Clinical laboratories plays a key role in screening, diagnosis and containment of the Coronavirus 2019 infection epidemic. The etiological diagnosis presupposes the isolation of virus genetic material in the patient's biological sample but laboratory diagnostics also make use of searching possibility for immunoglobulin (Ig)G, IgM classes antibodies. The characteristics of the antibody response are not yet completely clear. Methods This study describes a serological monitoring of subjects, elderly nursing care residence guests, interested by a very large infection outbreak. After first nasopharyngeal swab, all the positive subjects (43) were monitored for the persistence of the virus infection through nasopharyngeal swab after 20 days (16-24), 32 days (28-36) and after 49 days (47-50). At the same time, during the second (day 32) and third (day 49) follow up, all the guests were investigated for IgM and IgG anti SARS-CoV-2 antibodies, by using a quantitative chemiluminescence method. Results Thirty two days after performing the first diagnostic swab, 39 of 43 patients (90%) had IgG higher than the cut off value. After 49 days the four patients with negative IgG were still negative. The comparison of the levels of IgG-Ab between the controls shows a significant decrease in concentrations (-10%). Conclusions Our study confirms that in most patients affected by COVID-19 there is a typical antibody response with IgG-Ab present in 90% of nursing care COVID-19 positive residence guests. For IgM-Ab only 23% of tested subjects were positive on the 32nd and 49th day of illness, always in parallel with the IgG-Ab positivity.

Subclinical Contrast-Induced Acute Kidney Injury in Patients Undergoing Cerebral Computed Tomography.

INTRODUCTION: The nephrotoxicity of modern contrast media remains controversial. Novel biomarkers of kidney damage may help in identifying a subclinical structural renal injury not revealed by widely used markers of kidney function. OBJECTIVE: The aim of this study was to investigate clinical (contrast-induced acute kidney injury [CI-AKI]) and subclinical CI-AKI (SCI-AKI) after intra-arterial administration of Iodixanol and Iopamidol in patients with an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2. METHODS: This is a prospective observational monocentric study. Urinary sample was collected at 4-8 h after contrast medium exposure to measure neutrophil gelatinase associated lipocalin (NGAL) and the product tissue inhibitor of metalloproteinase-2 and insulin-like growth factor-binding protein 7 ([TIMP-2] × [IGFBP7]), while blood samples were collected at 24 and 48 h after exposure to measure serum creatinine. RESULTS: One hundred patients were enrolled, of whom 53 were exposed to Iodixanol and 47 to Iopamidol. Patients in Iodixanol and Iopamidol groups were comparable in terms of demographics, pre-procedural and procedural data. No patient developed CI-AKI according KDIGO criteria, while 13 patients reported SCI-AKI after exposure to iodine-based medium contrast (3 patients in Iodixanol group and 10 patients in Iopamidol group), defined by positive results of NGAL and/or [TIMP-2] × [IGFBP7]. A positive correlation was found between NGAL and [TIMP-2] × [IGFBP7] in the analysed population (Spearman's rho 0.49, p < 0.001). In logistic regression analysis, Iopamidol exposure showed higher risk for SCI-AKI compared to Iodixanol (OR 4.5 [95% CI 1.16-17.52], p = 0.030), even after controlling for eGFR and volume of contrast medium used. CONCLUSIONS: This study showed that intra-arterial modern contrast media administration may have a nephrotoxic effect in a population without pre-existing chronic kidney disease. Further investigations on larger scale are warranted to confirm if Iopamidol exposed patients to increased risk of SCI-AKI compared to Iodixanol.