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In recent years there has been an increase in the number of new graduate nurses hired on the cardiovascular surgery unit at the Halifax Infirmary. This increase has led to limited available support, decline in morale, and a high percentage of inexperienced nurses in the overall staff mix. To assist in the transition to working independently and helping maintain a high standard of care on the unit, the role of unit resource nurse (URN) was implemented. The URN was selected through a request of expression of interest from current registered nurses employed on the unit. Expectations of the role were developed through consultation with a nurse manager, clinical nurse educator (CNE), and the URN. The URN role was customized to the needs of the unit and scheduling was based on the schedules of the new staff members. Responsibilities of the URN include, but are not limited to: arranging for preceptors, mentoring new and IMCU staff, exposing new staff to clinical skills, auditing documentation, enforcing best practice and developing tools to aid in daily practice on the unit. While the evaluation of the role is currently ongoing, feedback has been mostly positive with reports of high levels of support. The role has also supported the CNE by providing feedback on individual nursing needs and educational needs of the unit, with a resultant decrease in the demand for the presence of the CNE on the unit. As the demand for new nurses continues to grow, the URN provides the much-needed support for all nurses in the health care team during this ongoing phase of transition. [ABSTRACT FROM AUTHOR]

Background: The diagnostic accuracy of serum creatinine and cystatin C (Cys) as early predictors of contrast-induced nephropathy (CIN) has been debated. We investigated the diagnostic sensitivities, diagnostic specificities, and variations from baseline for serum creatinine and Cys in CIN., Methods: We prospectively evaluated 166 patients at risk for CIN at baseline, and at 12, 24, and 48 h after exposure to contrast media. CIN occurred in 30 patients (18%). Changes (Δ) compared to baseline in serum creatinine and Cys were evaluated at the predefined time points. ROC curve analysis was performed for the Δ 12-h basal serum creatinine and Cys., Results: The Δ serum creatinine at 12 h from baseline was the earliest predictor of CIN [area under the ROC curve (AUC) = 0.80; P < 0.001]. The Δ serum creatinine 15% variation [0.15 mg/dL (13.2 μmol/L)] yielded 43% diagnostic sensitivity and 93% diagnostic specificity. The ΔCys at 12 h from baseline performed significantly worse than serum creatinine (AUC = 0.48; P = 0.74)., Conclusions: Variations from the serum creatinine baseline offer better diagnostic accuracy for predicting CIN at an earlier stage than similar variations in Cys. An additional diagnostic value of Cys over the determination of serum creatinine in the setting of CIN was not observed.

Background and Objectives: Sufficiently powered studies to investigate the CKD prevalence are few and do not cover southern Europe., Design, Setting, Participants, & Measurements: For the INCIPE study, 6200 Caucasian patients ≥40 years old were randomly selected in northeastern Italy in 2006. Laboratory determinations were centralized. The albumin to creatinine ratio in urine and estimated GFR from calibrated creatinine (SCr) were determined. A comparison with 2001 through 2006 NHANES surveys was performed., Results: Prevalence of CKD was 13.2% in northeastern (NE) Italy (age and gender standardized to the U.S. 2007 Caucasian population). Prevalence of CKD in U.S. Caucasians is higher (20.3%), the major difference being in CKD 3. Risk factors for CKD are more prevalent in the United States than in Italy. With use of CKD 3a and 3b stages, CKD prevalence decreased in NE Italy (8.5%) and in the United States (12.8%)., Conclusions: The prevalence of CKD is high in NE Italy, but lower than that in the United States. A large part of the difference in CKD prevalence in NE Italy versus that in the United States is due to the different prevalence of CKD 3. The higher prevalence of a number of renal risk factors in persons from the United States explains in part the different dimensions of the CKD problem in the two populations.

Purpose: The purpose of this study was to evaluate incidence and predictors of contrast-induced nephropathy after coronary angiography and interventions, and to assess renal function at 30 days. The prognostic value of any early shift of serum creatinine compared with baseline was investigated; such measurement, being a delta, is largely independent of creatinine variations., Methods: There were 216 patients at risk for contrast-induced nephropathy prospectively evaluated at baseline and at 12, 24, and 48 hours after exposure to contrast media, and 190 (88%) evaluated 1 month after discharge., Results: Contrast-induced nephropathy occurred in 39 patients (18%), and 30-day renal damage was detected in 15 (7%). Contrast media/kg volume predicted contrast-induced nephropathy (P=.002), and percentage change of creatinine 12 hours from baseline was significantly higher in patients with nephropathy (P <.001). At multivariate analysis, percentage change of creatinine 12 hour-basal was the best predictor of nephropathy (P <.001). A 5% increase of its value yielded 75% sensitivity and 72% specificity (area under the curve 0.80; odds ratio 7.37; 95% confidence interval, 3.34-16.23) for early contrast-induced nephropathy detection. Furthermore, it strongly correlated with the development of renal impairment at 30 days (P=.002; sensitivity 87%, specificity 70%; area under the curve 0.85; odds ratio 13.29; 95% confidence interval, 2.91-60.64)., Conclusion: Minimal elevations of serum creatinine at 12 hours are highly predictive of contrast-induced nephropathy and 30-day renal damage after exposure to contrast media., (Copyright 2010 Elsevier Inc. All rights reserved.)

Context: A downward trend in cystic fibrosis (CF) birth incidence has been reported in some areas., Objective: To evaluate the association between carrier screening and CF birth incidence., Design, Setting, and Participants: In northeastern Italy, CF birth incidence is monitored by means of a long-standing neonatal screening program. In the same area, 2 sections using different carrier detection approaches were identified--the western region, in which CF carrier tests are offered only to relatives of patients or to couples planning in vitro fertilization; and the eastern region, in which carrier testing is offered to relatives and carrier screening to infertile couples and to couples of reproductive age. A total of 779,631 newborns underwent CF neonatal screening between January 1993 and December 2007, of whom 195 had CF detected., Main Outcome Measure: Cystic fibrosis birth incidence in the 2 regions., Results: A time-related decrease in birth incidence was found, with a mean annual percentage decrease of 0.16 per 10,000 neonates (P < .001). In the western region, 2559 carrier tests were performed, 314 carriers were identified, and 9 carrier couples were detected. In the eastern region, 87,025 carrier tests were performed, 3650 carriers were identified, and 82 carrier couples were detected. The birth rate decrease was greater in the eastern region (decrease rate, 0.24; 95% confidence interval [CI], 0.12-0.36) than in the western region (decrease rate, 0.04; 95% CI, -0.16 to 0.08; P = .01). The increase in the number of screened carriers over time was significantly correlated with the decrease in CF birth incidence (correlation coefficient = -0.53; 95% CI, -0.20 to -0.74; P = .003)., Conclusion: In northeastern Italy, carrier screening was associated with a decrease in the incidence of CF.

Aim: Cystic Fibrosis (CF) Newborn Screening occasionally identifies neonates where a CF diagnosis can neither be confirmed nor excluded. To assess how parents of these infants cope with this ambiguous situation., Methods: Parents of 11 children with Ambiguous Diagnosis (group AD) were compared with parents of 11 children diagnosed with CF through neonatal screening [group Cystic Fibrosis Diagnosis (CFD)] and with parents of 11 Healthy Control children (group HC) matched for gender and age., Results: The emotional reaction to the inconclusive result was less pronounced in AD than in CFD (p = 0.003), and AD parents considered their infants as healthy as controls. Parents' anxiety about their child's health is stronger in CFD than in AD (p < 0.05) and HC (p < 0.001). Long-term emotional distress was rated similarly in AD and CFD, and greater than in HC (p = 0.0003). The parent/child relationship was less influenced in AD than in the CF group (p = 0.03). Seven AD and CFD parents changed their family planning projects., Conclusion: Inconclusive neonatal screening results appear to be understood and associated with lower anxiety levels than CF diagnosis. Concern about the child's health is similar to healthy controls and lower than in parents of CF children.

Persistent recruitment of neutrophils in the bronchi of cystic fibrosis patients contributes to airway tissue damage, suggesting the importance of intervening on the expression of the neutrophil chemokine IL-8. Extracts from plants have been investigated to select components able to reduce IL-8 expression in bronchial epithelial cells challenged with Pseudomonas aeruginosa. Extracts and purified components have been added to cells 24 h before pro-inflammatory challenge with P. aeruginosa and IL-8 transcription was quantified in the IB3-1 CF cells in vitro. P. aeruginosa-dependent IL-8 mRNA induction was increased by Argemone mexicana and Vernonia anthelmintica whereas no significant modification of transcription was observed with Aphanamixis polystachya, Lagerstroemia speciosa and Hemidesmus indicus. Finally, inhibition of IL-8 was observed with Polyalthia longifolia (IC50=200 microg/ml) and Aegle marmelos (IC50=20 microg/ml). Compounds from A. marmelos were isolated and identified by GC-MS. No significant effect was observed with butyl-p-tolyl sulphate, whereas the inhibition obtained with 6-methyl-4-chromanone concentration was accompanied by an anti-proliferative effect. On the contrary, 5-methoxypsoralen resulted in IL-8 inhibition at 10 microM concentration, without effects on cell proliferation. In synthesis, 5-methoxypsoralen can be taken into consideration to investigate mechanisms of neutrophil chemotactic signalling and for its potential application in modulating the excessive CF lung inflammation.

Lentiviruses (LVs) are considered one of the most promising tools for gene transfer, however, their potential to induce pro-inflammatory cytokines on delivery into the respiratory tissue remains to be established. Here we tested a third-generation vesicular stomatitis virus (VSV)-G pseudotyped LV vector in the two respiratory epithelial cell lines A549 and CFT1-C2. We observed that the VSV-G LV vector does not induce (a) activation of the nuclear factor (NF)-kappaB, which intervenes in transcription of pro-inflammatory genes; (b) expression of ICAM-1; and (c) transcription of a panel of cytokines, with the exception of a mild and transient (24h) increase of IFN-gamma mRNA. In contrast, an adenovirus-derived vector strongly activated NF-kappaB and different transcripts such as those of ICAM-1, IL-8, RANTES, IP-10, TNF-alpha, IL-6, IL-1 beta. In conclusion, this third-generation VSV-G pseudotyped LV vector does not elicit major pro-inflammatory signals in human airway epithelial cells and appears to be better suited for gene delivery strategies.

Background: Albuminuria is a sensitive marker of renal derangement and has been included in a number of studies investigating chronic kidney diseases (CKDs). This study is aimed to evaluate the diagnostic performances of a strip for measuring the albumin/creatinine ratio (ACR) in the general population and to compare it with those found in a diabetic population., Methods: Urine samples were obtained from 201 consecutive subjects enrolled in an epidemiological study and from 259 type 2 diabetic patients. Urine was tested for albumin and creatinine using the strip (Clinitek Microalbumin) and laboratory methods. A hundred samples were stored under various conditions to assess analyte stability., Results: In the general population, the strip test reached a 90% sensitivity and 91% specificity, considering the laboratory method as the 'gold standard', sparing >80% of subjects the laboratory tests at the expense of a 1% false negative rate and an 8% false positive rate. Regarding sensitivity and specificity, the ACR test performs very similarly in the general population and in the diabetics. The stability study showed that storage at -20 degrees C induced a significant decrease in the albumin concentration with both methods, such that 5% of the samples were re-classified in the lower ACR class. Storage at -80 degrees C for up to 12 months did not affect the measurement with both methods., Conclusion: Clinitek Microalbumin strips can be used for screening purposes in the general population since they correctly classify a significant percentage of subjects, particularly those with a normal albuminuria. Storage at -80 degrees C does not affect strip results. Screening with the strip and confirming positive results with a wet chemistry method are an efficient strategy for detecting albuminuria in the general population.

There is wide agreement on the benefits of NBS for CF in terms of lowered disease severity, decreased burden of care, and reduced costs. Risks are mainly associated with disclosure of carrier status and diagnostic uncertainty. When starting a NBS programme for CF it is important to take precautions in order to minimise avoidable risks and maximise benefits. In Europe more than 25 screening programmes have been developed, with quite marked variation in protocol design. However, given the wide geographic, ethnic, and economic variations, complete harmonisation of protocols is not appropriate. There is little evidence to support the use of IRT alone as a second tier, without involving DNA mutation analysis. However, if IRT/DNA testing does not lead to the desired specificity/sensitivity ratio in a population, a screening programme based on IRT/IRT may be used. Sweat chloride concentration remains the gold standard for discriminating between NBS false and true positives, but age-related changes in sweat chloride should be taken into account. CF phenotypes associated with less severe disease often have intermediate or normal sweat chloride concentrations. Programmes should include arrangements for counselling and management of infants where the diagnosis is not clear-cut. All newborns identified by NBS should be managed according to internationally accepted guidelines. CF centre care and the availability of necessary medication are essential prerequisites before the introduction of NBS programmes. Clear explanation to families of the process of screening and of implications of normal and abnormal results is central to the success of CF NBS programmes. Effective communication is especially important when parents are told that their child is affected or is a carrier. When establishing a NBS programme for CF, attention should be given to ensuring timely and appropriate processing of results, to minimise potential stress for families.

Background: Splanchnic vein thrombosis (SVT) is a severe complication of essential thrombocythemia (ET). No clear explanation has been given for the occurrence of thrombosis in this unusual site in patients with ET, but the existence of a specific association between unexplained SVT and the JAK2 mutation has been reported., Methods and Results: The present study describes SVT (portal and splenic vein thrombosis) in a young woman as the first presenting symptom of latent ET. Extensive screening for thrombophilia was negative. Our patient in fact did not fulfill the WHO diagnostic criteria for myeloproliferative disease (MPD), while she had splenomegaly and developed features suggestive of latent ET during follow-up., Conclusions: In these patients with SVT, the detection of JAK2(V617F) mutation is diagnostic for masked MPD as could be documented by bone marrow histopathology. The presence of JAK2(V617F) mutation should be considered per se a prothrombotic state for cerebral, coronary and peripheral microvascular disturbances and for SVT but not for deep vein thrombosis. Anticoagulation is the treatment of choice for all SVT and proper treatment of the MPD is recommended in patients with SVT associated with the JAK2(V617F) mutation., (Copyright (c) 2009 S. Karger AG, Basel.)

The most relevant cause of morbidity and mortality in cystic fibrosis (CF) patients is the lung pathology characterized by chronic infection and inflammation sustained mainly by Pseudomonas aeruginosa (P. aeruginosa). Innovative pharmacological approaches to control the excessive inflammatory process in the lung of CF patients are thought to be beneficial to reduce the extensive airway tissue damage. Medicinal plants from the so-called traditional Asian medicine are attracting a growing interest because of their potential efficacy and safety. Due to the presence of different active compounds in each plant extract, understanding the effect of each component is important to pursue selective and reproducible applications. Extracts from Emblica officinalis (EO) were tested in IB3-1 CF bronchial epithelial cells exposed to the P. aeruginosa laboratory strain PAO1. EO strongly inhibited the PAO1-dependent expression of the neutrophil chemokines IL-8, GRO-alpha, GRO-gamma, of the adhesion molecule ICAM-1 and of the pro-inflammatory cytokine IL-6. Pyrogallol, one of the compounds extracted from EO, inhibited the P. aeruginosa-dependent expression of these pro-inflammatory genes similarly to the whole EO extract, whereas a second compound purified from EO, namely 5-hydroxy-isoquinoline, had no effect. These results identify Pyrogallol as an active compound responsible for the anti-inflammatory effect of EO and suggest to extend the investigation in pre-clinical studies in airway animal models in vivo, to test the efficacy and safety of this molecule in CF chronic lung inflammatory disease.

The role of CFTR deficiency in promoting inflammation remains unclear. Perez et al. [A. Perez, A.C. Issler, C.U. Cotton, T.J. Kelley, A.S. Verkman and P.B. Davis, CFTR inhibition mimics the cystic fibrosis inflammatory profile. Am J Physiol Lung Cell Mol Physiol 2007; 292:L383-L395.] recently demonstrated that the inhibition of function of w/t CFTR produces an inflammatory profile that resembles that observed in CF patients, whereas we found that correction of F508del-CFTR function with MPB-07 down-modulates the inflammatory response to P. aeruginosa in CF bronchial cells [M.C. Dechecchi, E. Nicolis, V. Bezzerri, A. Vella, M. Colombatti, B.M. Assael, et al., MPB-07 reduces the inflammatory response to Pseudomonas aeruginosa in cystic fibrosis bronchial cells. Am J Respir Cell Mol Biol 2007; 36, 615-624.]. Since both evidence support a link between CFTR function and inflammation, we extended our investigation to other F508del-CFTR correctors, such as miglustat (Norez, 2006), an approved drug for Gaucher disease, in comparison with the galactose analogue NB-DGJ. We report here that miglustat but not NB-DGJ restores F508del-CFTR function in CF bronchial epithelial IB3-1 and CuFi-1 cells. Miglustat and NB-DGJ reduce the inflammatory response to P. aeruginosa in both CF and non-CF bronchial cells, indicating that the anti-inflammatory effect is independent of the correction of F508del-CFTR function. Miglustat also inhibits the inflammatory response induced by the supernatant of mucopurulent material obtained from the lower airway tract of cystic fibrosis patients with chronic bacterial colonization (Ribeiro, 2005). Both compounds do not interfere with the adherence of P. aeruginosa to the cells and reduce the expression of IL-8 not only after challenge with P. aeruginosa but also after exposure to TNF alpha or IL-1 beta, suggesting an effect on transduction proteins downstream and in common with different receptors for pathogens. Finally, miglustat has no major effects on overall binding activity of transcription factors NF-kappaBNF-kB and AP-1. Since miglustat is an approved drug, it could be investigated as a novel anti-inflammatory molecule to ameliorate lung inflammation in CF patients.

The most common mutation of the cystic fibrosis (CF) gene, the deletion of Phe508, encodes a protein (DeltaF508-CFTR) that fails to fold properly, thus mutated DeltaF508-cystic fibrosis transmembrane conductance regulator (CFTR) is recognized and degraded via the ubiquitin-proteasome endoplasmic reticulum-associated degradation pathway. Chemical and pharmacological chaperones and ligand-induced transport open options for designing specific drugs to control protein (mis)folding or transport. A class of compounds that has been proposed as having potential utility in DeltaF508-CFTR is that which targets the molecular chaperone and proteasome systems. In this study, we have selected deoxyspergualin (DSG) as a reference molecule for this class of compounds and for ease of cross-linking to human serum albumin (HSA) as a protein transporter. Chemical cross-linking of DSG to HSA via a disulfide-based cross-linker and its administration to cells carrying DeltaF508-CFTR resulted in a greater enhancement of DeltaF508-CFTR function than when free DSG was used. Function of the selenium-dependent oxidoreductase system was required to allow intracellular activation of HSA-DSG conjugates. The principle that carrier proteins can deliver pharmacological chaperones to cells leading to correction of defective CFTR functions is therefore proven and warrants further investigations.

Chronic pulmonary inflammation in patients affected by cystic fibrosis (CF) is characterized by massive bronchial infiltrates of neutrophils, which is sustained by the interaction of pathogens (e.g., Pseudomonas aeruginosa) with surface bronchial cells. To explore new treatment options focused on the reduction of neutrophil chemotaxis, we applied the transcription factor (TF) decoy approach, based on the intracellular delivery of double-stranded oligodeoxynucleotides (ODNs) causing inhibition of the binding of TF-related proteins to the different consensus sequences in the promoter of specific genes. In CF bronchial IB3-1 cells, P. aeruginosa induced transcription of the neutrophil chemokines IL-8 and GRO-gamma, of the adhesion molecule intercellular adhesion molecule (ICAM)-1, and of the cytokines IL-1beta and IL-6. Since consensus sequences for the TF, NF-kappaB, are contained in the promoters of all these genes, IB3-1, CuFi-1, Beas-2B, and CaLu-3 cells were transfected with double-stranded TF "decoy" ODNs mimicking different NF-kappaB consensus sequences. IL-8 NF-kappaB decoy ODN partially inhibited the P. aeruginosa-dependent transcription of IL-8, GRO-gamma, and IL-6, whereas decoy ODNs to both HIV-1 long terminal repeat and Igk produced a strong, 80 to 85% inhibition of transcription of IL-8, without reducing that of GRO-gamma, ICAM-1, IL-1beta, and IL-6. In conclusion, intracellular delivery of "decoy" molecules aimed to compete with the TF, NF-kappaB, is a promising strategy to obtain inhibition of IL-8 gene transcription.

Background: To investigate the potential use of Artificial Neural Network (ANN) in the evaluation of serum protein electrophoresis, we set up a multicenter study involving six Italian laboratories. For this purpose, we developed an algorithm named CASPER (Computer Assisted Serum Protein Electrophoresis Recognizer)., Methods: A total of 59,516 samples from the six centers were divided into three groups. Training and validation sets were used to develop the neural network, whereas evaluation set was used to test the performance of CASPER in recognizing abnormal electrophoretic profiles., Results: CASPER showed 93.0% sensitivity and 47.4% specificity. CASPER sensitivity and specificity ranged in the six sites from 88% (site 3) to 97% (site 5) and from 36% (site 6) to 53% (site 3), respectively. Sensitivity for gamma zone was 94.6%, for beta zone 89.7% and for oligoclonal patterns 92.0%., Conclusions: The sensitivity of the CASPER algorithm does not allow us to recommend its use as a replacement for the visual inspection, but it could be helpful in avoiding accidental misclassifications by the operator. Moreover, the CASPER algorithm may be a useful tool for training operators and students. This study evidenced a high inter-observer variability, which should be addressed in a dedicated study. Data set to train and validate ANNs should contain a huge range and an adequate number of different abnormalities.

Cystic fibrosis (CF) is a genetic disease characterized by chronic bacterial lung infection, most commonly sustained by Pseudomonas aeruginosa. Upon infection, elevated concentrations of pro-inflammatory cytokines (i.e. IL-6 and IL1beta) and chemokines (i.e. IL-8 and GROgamma) are found in the bronchoalveolar fluid of CF patients. We report in this paper that: (a) IL-8, IL-6, IL-1beta, ICAM-1, and GRO-gamma genes are upregulated following infection of CF bronchial epithelial IB3-1 cells with P. aeruginosa; (b) Sp1 transcription factor activity is induced following infection of the cystic fibrosis IB3-1 and CuFi-1 cell lines; (c) inhibition of Sp1 activity using transcription factor decoy molecules leads to inhibition of the expression of IL-6 gene. From the theoretical point of view, our results demonstrate that Sp1 transcription factor activity is induced following infection of CF cells with P. aeruginosa, and that this effect is important in the activation of IL-6 gene transcription. From the practical point of view, our data sustain the potential use of decoy molecules targeting the transcription factor Sp1 to control a relevant molecule involved in the inflammatory process associated with the cystic fibrosis airway pathology.

Objectives: To assess the effectiveness of different procalcitonin cutoff values to distinguish non-infected (negative+SIRS) from infected (sepsis+severe sepsis+septic shock) medical and surgical patients., Design and Methods: PCT plasma concentration was measured using an automated chemiluminescence analyzer in 1013 samples collected in 103 patients within 24 h of admission in ICU and daily during the ICU stay. We compared PCT levels in medical and surgical patients. We also compared PCT plasma levels in non-infected versus infected patients and in SIRS versus infected patients both in medical and in surgical groups., Results: Median values of PCT plasma concentrations were significantly higher in infected than in non-infected groups, both in medical (3.18 vs. 0.45 microg/L) (p<0.0001) and in surgical (10.45 vs. 3.89 microg/L; p<0.0001) patients. At the cutoff of 1 microg/L, the LR+ was 4.78, at the cutoff of 6 microg/L was 12.53, and at the cutoff of 10 microg/L was 18.4., Conclusions: This study highlights the need of different PCT cutoff values in medical and surgical critically ill patients, not only at the ICU admission but also in the entire ICU stay.

Self-monitoring of blood glucose (SMBG) is a cornerstone of diabetes care. However, the effectiveness of any glucose-monitoring programme depends on the ability to integrate SMBG into a program of self-care and therapeutic decision-making. Because the accuracy of SMBG is instrument dependent, we analysed 45 heparinized whole blood specimens using four marketed portable glucose meters to evaluate whether their precision and accuracy would be efficient and safe for clinical use. All measurements were standardized and performed by a single expert health-care professional at the same clinical chemistry laboratory. Results were compared with those obtained on the same plasma samples by the hexokinase method on a secondary reference analyser and further analysed according to the error tolerance criteria and the current American Diabetes Association (ADA), Clinical Laboratory Improvement Amendments (CLIA), and National Committee for Clinical Laboratory Standards (NCCLS) guidelines. The within-run imprecision ranged from 2.2% to 3.2%. Passing and Bablok regression analysis yielded slope values from 0.93 to 1.07 and correlation coefficients between 0.994 and 0.998. When compared with the secondary reference analyser, mean variations were between -4.9% and 14.1%, fulfilling in three out of four cases the 5.5% current desirable analytical quality specifications for total error. Nevertheless, when considering the two standard deviations level of this bias, several results exceeded this limit. Although three out of four devices tested achieved or came closer to the NCCLS C30-A2, CLIA and error tolerance targets, none of them met the current analytical ADA thresholds. Despite the acceptable analytical performances, we demonstrated that standardization and harmonization of results in SMBG have not been fully achieved.

Background: At present test tube allergy diagnosis is becoming increasingly more comparable to skin prick tests and is therefore increasingly more reliable, not only from an analytical point of view but also from a clinical one. The cost of test tube allergens has decreased over the years and the specific IgE dosage can quickly give a good diagnostic indication., Objective: To study the percentage of positive subjects for each individual allergen in cases of suspected allergy, the laboratory can easily identify, also by age bracket, the positivity for those well known allergens that are more commonly responsible for allergic pathologies by using the skin prick test. Our laboratory has studied the test tube diagnostic activity of 2002 and 2003. The inhaled allergens used to identify the positivity percentage were selected from those in our Allergy Unit and which literature identifies as those more commonly positive at skin prick tests., Methods: The positivity rate of specific IgEs (UniCAP100- Phamarcia) were analyses for two age brackets before and after the age of 12. The younger than 12 group was then subdivided further into pre-school age (3-5 years) and school age (6-12)., Results: It can be stated that in the grass group, the seasonal allergens, the most commonly positive were cereals and pellitory, the latter increasing in adult age (above 12 years). In the tree group of seasonal allergens, positivity was found to increase in adult age for olive and cypress trees. The more commonly positive perennial allergens in the adult age (above 12) are dermathophagoides and cat. Below 12, there is a strong positivity to alternaria., Conclusions: Such test tube studies on IgE positivity are not only useful for better defining diagnostic patterns to give an initial idea of suspected allergy, but also to highlight any changes in the IgE antibody count within different age brackets, with the possibility of documenting the progress of the pathology which is characteristic of the allergy in question.

Background: It has been known for some time now that reactions to allergens, not only those inhaled but also those in food, varies with age in atopical patients., Objective: To evaluate the specific IgE positivity percentage in order to improve laboratory diagnosis in subjects with suspected food allergy., Methods: The positivity percentages of specific IgE were analysed (UniCAP100-Pharmacia) taking into consideration the two age brackets of below and above 12 years. The below 12 years age bracket was then further divided into pre-school age (3-5 years) and school age (6-12 years)., Results: By measuring the simple positivity percentage for specific IgE to food allergens, there is a clear decrease as the child matures in reactions to milk and eggs and an increase towards food IgEs that cross-react with grass and tree pollens or other inhaled allergens like moulds and mites., Conclusion: It will be necessary in the future to have the diagnostic means to identify this cross-reaction problem by using recombinant allergens that can demonstrate the combined reaction between inhaled and food allergens.

Background: The ability of immunometric methods to identify anti-topoisomerase I (Scl70) antibodies is controversial. We wished to quantify the performance of the currently available commercial systems for the assay of anti-topoisomerase I antibodies in a large multicenter study., Methods: Fifty Italian clinical laboratories analyzed 36 serum samples: 27 from individuals with scleroderma/systemic sclerosis, and 9 from a control group. The scleroderma/systemic sclerosis samples were positive in our laboratories by both ELISA and immunoblot (IB), and the control samples were negative. The laboratories used 42 immunoenzymatic (ELISA), 21 IB, 3 counterimmunoelectrophoresis, and 2 dot-blot methods, produced by 23 different manufacturers., Results: We obtained 2389 results. The ELISA methods showed 99.2% specificity and 97.2% sensitivity for detection of anti-Scl70 antibodies. For IB methods, specificity was 97.6% and sensitivity was 96.1%. The Western-blot method had poor analytical specificity (27% false positives for anti-extractable nuclear antigen antibodies other than anti-Scl70)., Conclusions: Excluding Western blots, commercial ELISA and IB reagents as used in clinical laboratories have a sensitivity and a specificity >95% for determination of anti-Scl70 antibodies.

The therapeutic approach to cancer is generally limited to the advanced phases of disease. The preventive strategies aim at eliminating or reducing the exposition to known carcinogenes. We act with pharmacological and/or with an accurate dietary education to induce cellular differentiation phenomena, cytostasis and apoptosis. Chemoprevention acts both on the inductive phase (metabolic activation, DNA adducts), as well as on the promotion/proliferation of the long pre-clinical period of latency (antioxidants, anti-inflammatory, retinoids, carotenoids, vitamins and micronutrients, hormones and hormonal inhibitors, polyamine inhibitors, ditholetions, isothiocyanates, telomerase inhibitors, etc). Unanimous agreement has been reached on the preventive role of retinoids in head and neck tumors and of the cervical uterus, of hormonal inhibitors in breast and prostate cancer, and of anti-inflammatory in colorectal cancer. New and more accurate parameters for the evaluation of results and individual applications of chemopreventive strategies are linked to the biological research of high-risk subjects (genetic damage) or increased individual susceptibility. Caution, instead, should be applied in the clinical trial planning. An increased risk in developing and dying of lung tumor in smokers has been shown for the use vitamin A. Many clinical studies have been started in order to establish an efficient chemoprevention in oncology, and with the early diagnostic programs, and the evaluation of genotypic and phenotypic alterations, encouraging results will be reached for the next millennium.

This study was designed to assess the analytical sensitivity and rate of agreement between commercial methods and reagents, among the most used in Italy for the detection of autoantibodies to extractable nuclear antigens (ENA). Sixty-eight serum samples from patients with clinically diagnosed systemic rheumatic diseases were aliquoted and distributed to 4 hospital laboratories; three ELISA (Elias, Shield, Inova) and 1 immunoblot method (Euroimmun) were used. Overall agreement between the test reagents, for each anti-ENA specificity, was 69.1% for Ro/SSA, 83.3% for La/SSB, 70.6% for RNP, 73.5% for Sm, 91.1% for Jo1, and 82.3% for Scl70. Lack of specificity (i.e., false positive reactions) was the most important cause of low concordance. When the data were analysed according to the clinical diagnosis, total agreement and specificity improved. However, a significant difference in terms of sensitivity was observed in the SLE group (30 sera) for RNP (positivity ranged from 20% to 43%) and for Sm (from 7% to 37%), and in the Sjögren's syndrome group (13 sera) for anti-La/SSB (from 8% to 38%). Comparable data were obtained for anti-Ro/SSA (from 70% to 77%) both in the SLE and the Sjögren's syndrome group. Sensitivity of all 4 reagents was good in detecting anti-Scl70 autoantibodies in the 8 patients with diffuse systemic sclerosis, as well as anti-Jo1 autoantibody in the 5 polymyositis patients, with a 100% and a 95% agreement, respectively. These data suggest the need of a better standardization of commercial reagents and analytical procedures, and the opportunity that every laboratory should perform anti-ENA determination by at least two different methods, since none of the methods tested was completely reliable in detecting all anti-ENA autoantibody specificities.

Several factors, such as disability, malnutrition, weight loss, and the interactive effect of diseases and aging have been associated with morbidity and mortality in the elderly population. Nevertheless, the relationship between disability and biological parameters has not been extensively investigated as a primary focus. In a cross sectional survey, 344 institutionalized elderly subjects were evaluated. Disability was measured according to the Katz index, and patients were divided into three groups: low (0-1 lost ADL), mild (2-4 lost ADL), and severe (5-6 lost ADL). Anthropometric, metabolic, and nutritional parameters were assessed; age, gender, number of pathologies, and number of drugs were also recorded. Data were analyzed by multiple comparison of means according to Scheffé, and by multivariate logistic regression analysis. An impairment in functional status was associated with several modifications in biological parameters. Logistic regression analysis showed that severe disability (5-6 lost ADL) was associated with low waist/hip ratio (< 0.9 vs > 0.9, OR: 1.56, CI 95%: 1.08-2.25), high body resistance (> 625 vs < 575 omega, OR: 1.39, CI 95%: 1.38-1.39), low plasma albumin levels (< 3.5 vs > 4.0 g/dL, OR: 6.02, CI 95%: 5.18-6.85), and low plasma transferrin levels (< 200 vs > 250 mg/dL, OR: 5.47, CI 95%: 4.56-4.58) independently of age, gender, comorbidity, and other confounding factors. Our results indicate that severe disability in ADL is strongly associated with anthropometric and biohumoral parameters suggesting the presence of malnutrition. A careful evaluation of the nutritional state appears to be of primary importance, and efforts to improve nutritional status are needed in approaching disabled elderly patients.

In the present paper the incidence of lymphomatous disease in Messina and its province, with growing urbanization and rural limiting areas, is discussed: by analysing 150 cases of malignant lymphoma observed at our Institute from 1990 to 1995. The method proposed, based on data obtained from the medical files of these patients, took into consideration various parameters such as age, sex, residence, profession, clinical and bioptic diagnosis, LDH and disease presentation. The final results showed an increase of the risk for NHL in the rural province where the main profession is agriculture or handicraft (ceramics, forged iron, glasswork, refinery), in subjects above 60 years of age; for the HL instead, over the years, a minor incidence of risk has been observed. The data obtained were partially similar to those reported in the international literature. The most present form in NHL was the lymphocytic and the centrocytic follicular form, while for HL it was the mixed cells form. The relationship between the two sexes was higher in males with HL and almost equal in NHL. The age range mostly affected by HL was between 25 and 65 years of age.

This study was performed by the Italian Society of Laboratory Medicine (SIMeL) in order to establish the variability between the different analytical systems currently used in clinical laboratories for the detection of autoantibodies diagnostic of systemic autoimmune disease. Sixteen industrial, and two university laboratories participated in this study which entailed the determination of anti-nuclear (ANA), anti-dsDNA and anti-ENA antibodies in 11 sera from patients with clinically diagnosed systemic rheumatic disease, using reagents produced by these companies and different methodologies (indirect immunofluorescence, immunoenzymatic assay, counterimmunolectrophoresis, immuno and western blotting). We found 93.5% agreement between the methods used for the detection of ANA, 85.2% for anti-dsDNA antibodies, and 86.9% for anti-ENA antibodies. Among the anti-ENA antibodies, regardless of the method used, detection percentages were excellent for anti-RNP and anti-SSB/La (100%), good for anti-SSA/Ro (93%), but unacceptable for the anti-Jo-1 (67%), anti-Scl70 and anti-Sm (47%) antibodies. This further stresses the need for rigorous standardisation of commercial reagents and analytical procedures, as well as the introduction of external quality assessment (EQA) programs, and a complete definition of operative protocols adjusted to the sensitivity and specificity of the various methods.

The authors report on case of isolated rectal relapse of non Hodgkin lymphoma after complete remission with chemotherapy. They analyse diagnostic and therapeutic aspects, on the grounds of literature data and personal experience.

We evaluated the performance (ie, imprecision, inaccuracy, and analytic sensitivity) of the Sysmex SE-9000 commercial hematology analyzer (TOA Medical Electronics, Kobe, Japan) on differential leukocyte counts according to the National Committee for Clinical Laboratory Standards H20-A protocol. The results obtained were compared with those from the Bayer H6000 and H3 (Bayer Diagnostic Division, Tarrytown, NY), the Coulter MAXM (Miami, Fla), and the microscopic method. Altogether, samples from 462 subjects were analyzed. The results show a substantial superimposition of reference intervals between the methods. The imprecision of the SE-9000 is low for all the leukocyte subpopulations, with the exception of basophils (coefficient of variation: neutrophils, 3.35%; lymphocytes, 4.25%; monocytes, 7.9%; eosinophils, 9.5%; and basophils, 44.2%) and is consistently lower than that of manual counts. The correlation with other methods is high, with the exception of basophils (r2: neutrophils, 0.94-0.95; lymphocytes, 0.93-0.97; monocytes, 0.76-0.85; eosinophils, 0.96-0.99; and basophils, 0.02-0.56). When compared with the microscopic method, an overestimation of neutrophils is seen mostly at low concentrations (mean difference, 2.63), and an underestimation of lymphocytes is seen at high concentrations (mean difference, -3.1). The clinical sensitivity was good, with an agreement of 75.7% on morphologic and 89.6% on distributional abnormalities. With a new analytical channel for immature cells (IMI), the analyzer shows high sensitivity in detecting immature cells of the granulocytic lineage (from 94.4% for immature granulocytes to 96% for myeloblasts).