Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome: A multi-center study

Abstract Background The study aim is to compare cTnI values measured with three high-sensitivity (hs) methods in apparently healthy volunteers and patients admitted to emergency department (ED) with acute coronary syndrome enrolled in a large multicentre study. Methods Heparinized plasma samples were collected from 1511 apparently healthy subjects from 8 Italian clinical institutions (mean age: 51.5 years, SD: 14.1 years, range: 18–65 years, F/M ratio:0.95). All volunteers denied chronic or acute diseases and had normal values of routine laboratory tests. Moreover, 1322 heparinized plasma sample were also collected by 9 Italian clinical institutions from patients admitted to ED with clinical symptoms typical of acute coronary syndrome. The reference study laboratory assayed all plasma samples with three hs-methods: Architect hs-cTnI, Access hs-cTnI and ADVIA Centaur XPT methods. Principal Component Analysis (PCA) was also used to analyze the between-method differences among hs-cTnI assays. Results On average, a between-method difference of 31.2% CV was found among the results of hs-cTnI immunoassays. ADVIA Centaur XPT method measured higher cTnI values than Architect and Access methods. Moreover, 99th percentile URL values depended not only on age and sex of reference population, but also on the statistical approach used for calculation (robust non-parametric vs bootstrap). Conclusions Due to differences in concentrations and reference values, clinicians should be advised that plasma samples of the same patient should be measured for cTnI assay in the same laboratory. Specific clinical studies are needed to establish the most appropriate statistical approach to calculate the 99th percentile URL values for hs-cTnI methods

Evaluation of 99th percentile and reference change values of a high-sensitivity cTnI method: A multicenter study

Abstract Background The Italian Society of Clinical Biochemistry (SIBioC) and the Italian Section of the European Ligand Assay Society (ELAS) have recently promoted a multicenter study (Italian hs-cTnI Study) with the aim to accurately evaluate analytical performances and reference values of the most popular cTnI methods commercially available in Italy. The aim of this article is to report the results of the Italian hs-cTnI Study concerning the evaluation of the 99th percentile URL and reference change (RCV) values around the 99th URL of the Access cTnI method. Materials and methods Heparinized plasma samples were collected from 1306 healthy adult volunteers by 8 Italian clinical centers. Every center collected from 50 to 150 plasma samples from healthy adult subjects. All volunteers denied the presence of chronic or acute diseases and had normal values of routine laboratory tests (including creatinine, electrolytes, glucose and blood counts). An older cohort of 457 adult subjects (mean age 63.0 years; SD 8.1 years, minimum 47 years, maximum 86 years) underwent also ECG and cardiac imaging analysis in order to exclude the presence of asymptomatic cardiac disease. Results and conclusions The results of the present study confirm that the Access hsTnI method using the DxI platform satisfies the two criteria required by international guidelines for high-sensitivity methods for cTn assay. Furthermore, the results of this study confirm that the calculation of the 99th percentile URL values are greatly affected not only by age and sex of the reference population, but also by the statistical approach used for calculation of cTnI distribution parameters

Quality performance of laboratory testing in pharmacies: A collaborative evaluation

Background: The quality performance and the comparability between results of pharmacies point-of-care-testing (POCT) and institutional laboratories have been evaluated. Methods: Eight pharmacies participated in the project: a capillary specimen collected by the pharmacist and, simultaneously, a lithium-heparin sample drawn by a physician of laboratory medicine for the pharmacy customers (n = 106) were analyzed in the pharmacy and in the laboratory, respectively. Glucose, cholesterol, HDL-cholesterol, triglycerides, creatinine, uric acid, aspartate aminotransferase, alanine aminotransferase, were measured using: Reflotron, n = 5; Samsung, n = 1; Cardiocheck PA, n = 1; Cholestech LDX, n = 1 and Cobas 8000. The POCT analytical performance only (phase 2) were evaluated testing, in pharmacies and in the laboratory, the lithium heparin samples from a female drawn fasting daily in a week, and a control sample containing high concentrations of glucose, cholesterol and triglycerides. Results: For all parameters, except triglycerides, the slopes showed a satisfactory correlation. For triglycerides, a median value higher in POCT in comparison to the laboratory (1.627 mmol/L vs. 0.950 mmol/L) has been observed. The agreement in the subjects classification, demonstrates that for glucose, 70% of the subjects show concentrations below the POCT recommended level (5.8-6.1 mmol/L), while 56% are according to the laboratory limit (<5.6 mmol/L). Total cholesterol exhibits a similar trend while POCT triglycerides show a greater percentage of increased values (21% vs. 9%). The reduction in triglycerides bias (phase 2) suggests that differences between POCT and central laboratory is attributable to a pre-analytical problem

VALUTAZIONE DELLE ANALISI BIOCHIMICHE IN FARMACIA (POCT): CONFRONTO CON I RISULTATI OTTENUTI SU STRUMENTAZIONI DI LABORATORIO OSPEDALIERE

In uno studio (https://www.degruyter.com/downloadpdf/j/cclm.2016.54.issue-11/cclm-2016-0104/cclm-2016-0104.xml), svolto in collaborazione tra i Dipartimenti di Scienze del Farmaco e di Medicina di Laboratorio dell\u2019Universit\ue0 di Padova, con il patrocinio dell\u2019Ordine dei Farmacisti di Padova, sono stati confrontati i risultati ottenuti attraverso i dispositivi POCT (point-of-care-testing) in alcune farmacie (n. 8) territoriali di Padova con quelli ottenuti presso l\u2019UOC Medicina di Laboratorio dell\u2019 Azienda Ospedaliera di Padova, analizzando campioni biologici dei clienti delle farmacie aderenti al progetto. Il numero di pazienti reclutati \ue8 stato di 106 in totale. In particolare, nello stesso paziente veniva effettuato un prelievo di sangue capillare, analizzato attraverso il sistema POCT in farmacia, e contemporaneamente veniva prelevato un campione di sangue venoso in litio-eparina da un medico dell\u2019UOC Medicina di Laboratorio per la successiva analisi nel laboratorio centralizzato. I parametri biochimici valutati sono stati: colesterolo, colesterolo HDL, trigliceridi, creatinina, acido urico, aspartato aminotransferasi (AST) e alanina aminotransferasi (ALT). Gli strumenti utilizzati nelle farmacie che hanno partecipanto al progetto sono: Reflotron (n = 5, Roche Diagnostics); Samsung (Samsung Electronics, n = 1); CARDIochEcK PA (Polymer Technology, EXXE srl, n = 1); Cholestech LDX (Alere srl, n = 1). Durante lo studio, il corretto funzionamento dello strumento, la manutenzione, la conservazione dei reagenti, e l\u2019identificazione di eventuali guasti sono stati effettuati nelle farmacie in base alle istruzioni dell\u2019azienda produttrice. I campioni nel laboratorio centrale sono stati analizzati su Cobas 8000 (Roche Diagnostics), utilizzando i metodi enzimatici-colorimetrici ampiamente utilizzati negli strumenti automatizzati di routine ed in particolare: Glucosio: metodo dell'esochinasi; Colesterolo: Metodo CHOD-PAP; HDL- colesterolo: CHOD-PAP senza pre-trattamento; Trigliceridi: Metodo GPO-PAP; Creatinina: metodo di Jaffe con calibrazione tracciabile a IDMS; Acido urico: Metodo uricasi-perossidasi; Aspartato e alanina aminotransferasi: secondo la procedura IFCC con piridossal-5-fosfato. Le prestazioni analitiche sono state monitorate seguendo la procedura di controllo interno di qualit\ue0 (CQI, Liquid Unassayed Multiqual, Biorad) e verificate in base al sistema di garanzia di qualit\ue0 esterna dei risultati (VEQ) I risultati ottenuti in questo studio hanno rivelato aspetti interessanti. In particolare, per le analisi pi\uf9 richieste nelle farmacie (glucosio, colesterolo, trigliceridi), le caratteristiche di prestazione analitica si sono state dimostrate soddisfacenti per una vasta gamma di concentrazioni e i risultati paragonabili a quelli ottenuti nel laboratorio centrale. Per gli stessi tests, tuttavia, l'informazione finale data dalle farmacie ai soggetti differiva talvolta in maniera significativa, da quella fornita dal laboratorio centrale. Come indicato nella tabella 1 (metterei la tabella), la disomogeneit\ue0 tra i livelli ottimali adottati nelle farmacie e quelli indicati nel referto del laboratorio centrale (fase post-analitica), ha comportato significative variazioni differenze nella classificazione dei soggetti. Ad esempio, la maggior parte dei soggetti presentava concentrazioni di glucosio e di colesterolo entro il livello ottimale adottato nelle farmacie (70% e 94%, rispettivamente), mentre secondo il referto del laboratorio, tali percentuali erano significativamente inferiori (56,7% e 45%, rispettivamente. Questi risultati suggeriscono un problema nella fase post-analitica, in particolare, una mancanza di uniformit\ue0 tra i livelli ottimali adottati nelle farmacie rispetto a quelli del laboratorio centrale: tale disomogeneit\ue0 determina l'incoerenza delle informazioni che sono state fornite ai soggetti che si sono sottoposti alle indagini biochimiche. Analogamente, sono di importanza fondamentale sia l'adozione di opportune unit\ue0 di misura per l\u2019espressione dei risultati, come pure l'aggiornamento dei valori di riferimento o dei livelli ottimali secondo le linee guida di pi\uf9 recente pubblicazione

Inferior vena cava collapsibility to guide fluid removal in slow continuous ultrafiltration: A pilot study

Objective: To investigate whether ultrasound determination of the inferior vena cava diameter (IVCD) and its collapsibility index (IVCCI) could be used to optimize the fluid removal rate while avoiding hypotension during slow continuous ultrafiltration (SCUF). Methods: Twenty-four consecutive patients [13 men and 11 women, mean age 72 ± 5 years; New York Heart Association (NYHA) functional classes III-IV] with acute decompensated heart failure (ADHF) and diuretic resistance were admitted to our 16-bed medical ICU. Blood pressure (BP), heart rate (HR), respiratory rate (RR), blood samples for hematocrit, creatinine, sodium, potassium, and arterial BGA plus lactate were obtained at baseline and than every 2 h from the beginning of SCUF. IVCD, assessed by M-mode subcostal echocardiography during spontaneous breathing, was evaluated before SCUF, at 12 h, and just after the cessation of the procedure. The IVCCI was calculated as follows: [(IVCDmax - IVCDmin)/IVCD max] × 100. Results: Mean UF time was 20.3 ± 4.6 h with a mean volume of 287.6 ± 96.2 ml h-1 and a total ultrafiltrate production of 5,780.8 ± 1,994.6 ml. No significant difference in MAP, HR, RR, and IVCD before and after UF was found. IVCCI increased significantly after UF (P 30%. In all the other patients, a significant increase in IVCCI was obtained without any hemodynamic instability. Conclusion: IVC ultrasound is a rapid, simple, and non-invasive means for bedside monitoring of intravascular volume during SCUF and may guide fluid removal velocity. © 2010 Copyright jointly hold by Springer and ESICM

Pyrazoloquinazoline tricyclic system as novel scaffold to design new kinase CK2 inhibitors

Casein kinase 2 (CK2) is a ubiquitous, essential, and highly pleiotropic protein kinase whose abnormally high constitutive activity is suspected to underlie its pathogenic potential in neoplasia and infective diseases. Using a combined virtual screening approach, we have identified the pyrazoloquinazoline tricyclic system as a novel scaffold to design new kinase CK2 inhibitors