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While treating sensorimotor impairments, a therapist may provide physical assistance by guiding their patient's limb to teach a desired movement. In this scenario, a key aspect is the compliance of the interaction, as the therapist can provide subtle cues or impose a movement as demonstration. One approach to studying these interactions involves haptically connecting two individuals through robotic interfaces. Upper-limb studies have shown that pairs of connected individuals estimate one another's goals during tracking tasks by exchanging haptic information, resulting in improved performance dependent on the ability of one's partner and the stiffness of the virtual connection. In this study, our goal was to investigate whether these findings generalize to the lower limb during an ankle tracking task. Pairs of healthy participants (i.e., dyads) independently tracked target trajectories with and without connections rendered between two ankle robots. We tested the effects of connection stiffness as well as visual noise to manipulate the correlation of tracking errors between partners. In our analysis, we compared changes in task performance across conditions while tracking with and without the connection. We found that tracking improvements while connected increased with connection stiffness, favoring the worse partner in the dyad during hard connections. We modeled the interaction as three springs in series, considering the stiffness of the connection and each partners' ankle, to show that improvements were likely due to a cancellation of random tracking errors between partners. These results suggest a simplified mechanism of improvements compared to what has been reported during upper-limb dyadic tracking.

The current pandemic caused by severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) has encouraged the evaluation of novel instruments for disinfection and lowering infectious pressure. Ultraviolet subtype C (UVC) excimer lamps with 222 nm wavelength have been tested on airborne pathogens on surfaces and the exposure to this wavelength has been considered safer than conventional UVC. To test the efficacy of UVC excimer lamps on coronaviruses, an animal model mimicking the infection dynamics was implemented. An attenuated vaccine based on infectious bronchitis virus (IBV) was nebulized and irradiated by 222 nm UVC rays before the exposure of a group of day-old chicks to evaluate the virus inactivation. A control group of chicks was exposed to the nebulized vaccine produced in the same conditions but not irradiated by the lamps. The animals of both groups were sampled daily and individually by choanal cleft swabs and tested usign a strain specific real time RT-PCR to evaluate the vaccine replication. Only the birds in the control group were positive, showing an active replication of the vaccine, revealing the efficacy of the lamps in inactivating the vaccine below the infectious dose in the other group.

Improving the ergonomy of working environments is essential to reducing work-related musculo-skeletal disorders. We consider real-time ergonomic feedback a key technology for achieving such improvements. To this end, we present supportive tools for online evaluation and visualization of strenuous efforts and postures of a worker, also when physically interacting with a robot. A digital human model is used to estimate human kinematics and dynamics and visualize non-ergonomic joint angles, based on the on-line data acquired from a wearable motion tracking device.

Objectives: To describe a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.617.2 (Delta) variant outbreak among residents (n = 69) and health workers (n = 69) of a small nursing home in northeastern Italy, with full vaccination coverage of 91% and 82%, respectively. Evaluation of the anti-Spike IgG titres 28 weeks after the mRNA vaccine booster dose against SARS-CoV-2 infection and severe coronavirus disease 2019 (COVID-19)., Materials and Methods: Sera were collected within 48 hours from the index case; anti-Spike IgG was determined (expressed as WHO binding antibody units (BAU)/mL) through a commercial quantitative assay; SARS-CoV-2 was diagnosed using RT-PCR, and full-genome sequencing was performed for lineage characterization. Residents were grouped according to anti-Spike IgG titres (≤50, 51-1000 and > 1000 BAU/mL) and the resulting protection against infection and severe disease was measured., Results: None of the health workers and 14 of the 59 (24%) residents fully vaccinated and without a previous SARS-CoV-2 infection showed anti-Spike IgG ≤50 BAU/mL (one-sided Fisher exact test, p 0.011). Among these residents, a level of anti-Spike IgG ≤50 BAU/mL resulted in a higher risk of SARS-CoV-2 infection (relative risk 1.55, 95% CI 1.17-2.05) and severe COVID-19 (relative risk 5.33, 95% CI 1.83-15.57)., Conclusion: Low levels of SARS-CoV-2 neutralizing anti-Spike IgG in serum 28 weeks after the administration of the second dose parallel the waning of vaccine protection., (Copyright © 2021 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Respirable Crystalline Silica (RCS) is a hazardous substance with known effects that can be well correlated with exposure levels that still persist in many traditional sectors, such as construction or stone processing. In the past decade, exposure scenarios for RCS have been found in the sector of artificial stone processing. The aim of this study is to evaluate the levels of RCS in facilities specialized in the production of artificial stone countertops and other accessories for the furnishing of kitchens, bathrooms, and offices after the introduction of some preventive technical measures such as wet processing or local exhaust ventilation systems. The study involved 51 subjects in four facilities. Personal silica exposure assessment was carried out using GS3 cyclones positioned in the breathing zone during the work shift. Quantitative determination of silica was carried out by X-ray diffraction analysis. Respirable dust levels were in the range 0.046-1.154 mg/m 3 with RCS levels within the range <0.003-0.098 mg/m 3 . The highest exposure was found in dry finishing operations. Although there was a remarkable reduction in RCS exposure levels compared to what was observed in the past before the introduction of preventive measures, the data still showed hazardous exposure levels for some of the monitored activities.

Background: Despite recommendations, the uptake of dTap maternal vaccination is still low in many countries. The reasons for this must be investigated both on the patient's and the healthcare professionals' sides., Methods: A record linkage study was performed linking Birth Assitance Certificates and dTap mothers' vaccination records (5183 deliveries) to describe the influence of socioeconomical and obstetrical-gynecological factors after the recommendations concerning dTap vaccination in pregnancy issued by the Italian Ministry of Health (August 2018). An interview was also administered to a subgroup of 656 new mothers on the occasion of the first vaccination of their newborns, in order to assess the dTap vaccination advice received from maternal care providers during pregnancy. A generalized linear model (binomial family, log link) was implemented to give a correct estimate of the mother's relative risk of being vaccinated., Results: Several pregnant women-focused factors are evident, but the most important ones are related to maternal care providers' practices: after mutual adjustment, the explicit advice towards dTap maternal vaccination given by the Obstetrician-Gynecologist or the Midwife is associated with a 12-fold increase in the dTap coverage., Conclusions: Multiprofessional training is essential to make Obstetricians-Gynecologists and Midwives more confident in recommending dTaP maternal immunization., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021. Published by Elsevier Ltd.)

A group of 142 bakers was studied in order to investigate the relationship between higher/lower respiratory signs/symptoms and inflammation biomarkers and occupational exposure to flour dust. A complete upper and lower respiratory tract evaluation was performed. Seven percent of bakers complained of lower respiratory symptoms, while 22% of them complained of upper respiratory symptoms. Fifty five percent of the bakers were allergic, and 37.1% showed sensitization to occupational allergens. Abnormal spirometries were found in 15% of bakers, while fractional exhaled nitric oxide (FeNO) was above the normal reference in 24.5% of them. Moreover, 23.8% of bakers were found to be hyposmic. Population mean peak nasal inspiratory flow (PNIF) was in the normal range even if almost all the workers suffered from neutrophilic rhinitis at nasal cytology with the number of nasal neutrophils increasing with the increase of the duration of exposure to flour dust ( p = 0.03). PNIF and FEV1 (forced expiratory volume in the 1st second) showed a positive correlation ( p = 0.03; r = 0.19). The Tiffeneau index decreased with the increase of dust ( p = 0.017). A similar result was obtained once we divided our population into smokers and non-smokers ( p = 0.021). Long-term exposure to bakery dusts can lead to a status of minimal nasal inflammation and allergy.

The adverse effects associated with exposure to flour dust have been known since the 1700s. The aim of the study was to assess the occupational exposure to flour dust in Italian facilities, identify the activities characterized by the highest exposure, and provide information to reduce workers' exposure. The study was performed in different facilities such as flourmills ( n = 2), confectioneries ( n = 2), bakeries ( n = 24), and pizzerias ( n = 2). Inhalable flour dust was assessed by personal and area samplings ( n = 250) using IOM (Institute of Occupational Medicine) samplers. The results showed personal occupational exposure to flour dust over the American Conference of Governmental Industrial Hygiene (ACGIH) and the Scientific Committee on Occupational Exposure Limit (SCOEL) occupational limits (mean 1.987 mg/m 3 ; range 0.093-14.055 mg/m 3 ). The levels were significantly higher for dough makers in comparison to the dough formers and packaging area subjects. In four bakeries the industrial hygiene surveys were re-performed after some control measures, such as installation of a sleeve to the end of pipeline, a lid on the mixer tub or local exhaust ventilation system, were installed. The exposure levels were significantly lower than those measured before the introduction of control measures. The exposure level reduction was observed not only in the dough making area but also in all bakeries locals.

Background: The present work is part of a greater research project, aimed to examine Safety Representatives' (SRs) role, twenty years after the appointment of this figure., Objectives: The study aims to investigate the role of some personal and organizational dimensions in the promotion of SRs' well-being, in terms of reducing burnout and improving performance., Methods: The study involved 455 SRs operating in North East Italy. They completed a self-report questionnaire, regarding conflicts with co-workers, ethical conflict, training satisfaction, work engagement, performance, and burnout., Results: Structural equation models show that work engagement partially mediates (γ=-0.52, p<0.001; β=0.23, p<0.01) the relationship between conflict with co-workers and performance (γ=-0.26; p<0.01), as well as partially mediating (γ=0.14, p<0.05; β=0.23; p<0.01) the relationship between training satisfaction and performance (γ=0.21, p<0.001). Moreover, it totally mediates the relationship between conflict with co-workers and burnout (γ=-0.52, p<0.001; β=-0.40, p<0.001), as well as totally mediating the relationship between training satisfaction and burnout (γ=0.14, p<0.05; β=-0.40, p<0.001). Finally, ethical conflict is positively associated with burnout (γ=0.047, p<0.001)., Conclusions: This study provides useful information about the improvement of SRs' well-being, highlighting the importance of their involvement in this role.

Background: No data is available on the molecular background of the extra-nodal extension (ENE) of lymph node metastasis (LN) in colorectal cancer (CRC)., Methods: A series of 22 ENE-positive CRCs was considered and three samples per case were selected (the primary CRC, an ENE-negative and an ENE-positive metastatic LN). Samples (n = 66) were analysed by immunohistochemistry for PD-L1, CD4, CD8, CD68 and CD80. Fifteen out of twenty-two cases were further profiled through a hotspot multigene mutational custom panel, including 164 hotspot regions of AKT1 , APC , BRAF , CTNNB1 , KIT , KRAS , NRAS , PDGFRA , PIK3CA , PTEN and TP53 genes., Results: A significantly higher percentage of CD4-, CD8- and CD68-positive cells was observed at the invasive front of both CRCs and in ENE in contrast with what observed at the core of both CRCs and their matched nodal metastases. ENE was also characterized by a significantly higher number of CD80-positive cells. No significant difference was observed in PD-L1 distribution among the different specimens. Fourteen out of 15 CRCs (93%) showed at least a driver mutation. The most frequently mutated gene was TP53 (n = 8 tumors), followed by APC (n = 6), BRAF (n = 4), KRAS , NRAS and PIK3CA (n = 2). In 11 out of 15 CRCs (73%) the mutational profiling of the primary tumor was consistent with what obtained from the two matched LNs., Conclusions: A heterogeneous intratumor immune-microenvironment has been observed in ENE-positive CRCs, which are characterized by an increased leukocytic infiltration at the ENE invasive front.

Squamous Cell Carcinoma Antigen (SCCA) is consistently overexpressed in many different solid tumors, and has been associated with both tumor aggressiveness and chemoresistance. No data, however, is currently available on SCCA expression during esophageal Barrett's carcinogenesis, nor on SCCA expression's role on esophageal adenocarcinoma chemoresistance. The SCCA immunohistochemical expression was assessed in a series of 100 biopsy samples covering the whole histological spectrum of Barrett's oncogenesis. Squamous native mucosa was characterized by a moderate to strong cytoplasmic and nuclear SCCA expression in suprabasal, medium, and superficial layers. On the other hand, almost half of the considered lesions did not express SCCA; the other half featured weak to moderate SCCA expression. The relationship between SCCA protein expression and tumor response to neoadjuvant chemotherapy was assessed in 90 esophageal adenocarcinoma specimens (40 biopsy and 50 surgery specimens), stratified according to Mandard tumor regression grade. As observed in other settings, the presence of SCCA expression clustered in the group of tumors characterized by a lower responsiveness to neoadjuvant treatments. The present results suggest an involvement of SCCA in a subset of Barrett-related tumors, and prompt to consider the SCCA-protein expression as response-predictive marker of neoadjuvant therapy in esophageal adenocarcinomas.

Objectives: to evaluate whether living near motorway A57 (Mestre motorway, Veneto Region, Northern Italy) might have affected the residents' health status., Design: longitudinal cohort study., Setting and Participants: 148,673 residents on the mainland in the Municipality of Venice (Mestre) who never changed their residence during the follow- up period (2002-2009)., Main Outcomes Measures: the 2001 Italian census data were linked with the data sources of the epidemiological integrated system which includes: population registry, death certificates, hospital discharges, drug prescriptions, and tax exemption. Mortality and incidence for several subgroups of causes, incidence of acute myocardial infarction and stroke, and prevalence of asthma, chronic obstructive pulmonary disease, ischemic cardiopathy and diabetes were estimated. The ADMS-Urban model was adopted to define three different exposure areas based on PM10 emissions from the motorway: A (highly exposed), B (moderately exposed) used as a comparison for the analysis, C (unexposed). Hazard ratios (HR) for incidence and mortality were estimated from Cox proportional hazard models adjusted for calendar period, age, gender, and instruction level. The relationship between the exposure area and prevalence was investigated by multiple logistic regression analysis adjusted for the same covariates., Results: compared with B area (23.25%of the population under study), people living in A area (3.16% of the population under study) had an increased incidence of acute myocardial infarction (HR: 1.43; 95%CI 1.03-1.97) in females, and prevalence of ischemic cardiopathy (odds ratio - OR: 1.12; 95%CI 1.01-1.26) in both genders. Results were borderline for COPD in males (OR: 1.17; 95%CI 0.97-1.41). Positive but nonsignificant associations were found with pneumonia and respiratory recoveries., Conclusions: this study showed that residents who live near Mestre motorway had an increased prevalence of some cardiorespiratory diseases, particularly ischemic cardiopathy.

Objective: construction of environmental indicators of air pollution suitable for epidemiological surveillance in 25 Italian cities for EpiAir2 project (2006-2010) and presentation of the results from a 10 years of surveillance system (2001-2010) in 10 Italian cities., Design: data on particulate matter (PM10 and its fine fraction PM2.5), nitrogen dioxide (NO2), and ozone (O3), measured in the 2006-2010 calendar period, were collected. Meteorological data needed to estimate unbiased measures of the effect of pollutants are: temperature, relative humidity (estimated "apparent temperature"), and barometric pressure. In continuity with the previous EpiAir project, the same criteria for the selection of monitoring stations were applied and standard methods to estimate daily environmental indicators were used. Furthermore, it was checked the adequacy of the selected data to represent the population exposure., Setting and Participants: EpiAir2 project, relative to the period 2006-2010, involves the cities of Milano, Mestre-Venezia, Torino, Bologna, Firenze, Pisa, Roma, Taranto, Cagliari, and Palermo, already included in the previous study. The city of Treviso, Trieste, Padova, Rovigo, Piacenza, Parma, Ferrara, Reggio Emilia, Modena, Genova, Rimini, Ancona, Bari, Brindisi, and Napoli are added to the previous group., Results: particulate matter concentrations have decreased in most cities during the study period, while concentrations of NO2 and ozone do not show a similar clear trend. The analysis of the trend showed annual mean values of PM10 higher than 40 µg/m(3) in some areas of the Po Valley, and annual mean values of NO2 higher than 40 µg/m(3) in the cities of Trieste, Milano, Padova, Torino, Modena, Bologna, Roma, and Napoli., Conclusion: the enlargement of the EpiAir project to 13 other cities has highlighted critical issues related to the different geographical areas under study. Results of EpiAir2 project point out the need of a monitoring system of air pollution concentrations in both urban and industrial sites, in order to obtain reliable estimates of exposure for resident populations and to evaluate the related time trend.

Background: This study fits into a perspective of integrated work-related stress assessment, in response to the need to limit the common method variance and the role played by individual variables in subjective measures., Objectives: The goal of this study was to check the metric properties of a new scale of mental and physical strain developed for the evaluation of stress symptoms by the physician and to detect the antecedents of psycho-physical symptoms, in terms of both individual and work characteristics, through an integrated approach., Method: The study was conducted on 409 workers involved in health surveillance activities, to whom the new scale and a subjective assessment tool were administered., Results: Confirmatory factor analysis showed that the scale is a reliable tool for hetero-evaluation of psycho-physical symptoms attributable to stress at work. Moreover, specific individual characteristics, such as the presence of prior health disorders and the female gender, and organizational features, such as the pathological work/life conflict and the workload, were found to be risk factors in relation to psychological and physical strain. Age, consumption of alcoholic beverages between meals, relationships with colleagues, and the characteristics of the workplace were instead found to be important protective factors., Discussion: The adoption of an integrated approach made it possible to improve and study in depth the ways of work-related stress assessment, highlighting the pivotal role of the occupational health physician making the evaluation.

Background: Legislation in Italy concerning health, safety and prevention at the workplace recently established a new data communication standard, Objectives: The findings are reported of a specific survey on 18 Local Health Units (ASL) over the entire Italian territory, aimed at identifying the critical points in data management and analyze the available information., Methods: The occupational health physician for each company must collect and transmit information on the number of workers submitted to health surveillance protocols to the Local Health Unit. Information must be divided by risk factor and gender Local health Units then transmit the data to the Regions and finally to the Italian National Institute for Occupational Safety and Prevention (ISPESL)., Results: A sample of 22.977 companies was studied, providing information on about 410,009 workers undergoing health surveillance protocols. Carrying or moving heavy loads, exposure to noise, VDU and chemical substances were the most frequent risk factors. The difference between genders was significant in risk allocation, with exposures to VDU and biological agents prevalently among females., Conclusions: The information thus collected suffered from a lack of data organization and completeness in the sample under study, but nevertheless provides preliminary evidence of a map of occupational risks on a national basis, confirming the potential for the new law (D.Lgs 81/2008) to investigate health safety and prevention at the workplace.

Background: Serum alanine aminotransferase (ALT) activity, the variable most commonly measured to assess hepatic disease, fails to identify many patients with hepatic injury. Current standards for "normal" ALT level were defined by using populations that included persons with subclinical liver disease., Objective: To update definitions of healthy ranges for serum ALT level., Design: Retrospective cohort study., Setting: A university hospital in Milan, Italy., Participants: 6835 persons who were first-time blood donors from 1995 through 1999, were negative for anti-hepatitis C virus (HCV), and had no contraindications to donation and 209 persons who attempted to donate blood from 1990 through 1999 but were found to have anti-HCV antibodies. Of the latter group, 131 had HCV viremia., Measurements: Univariate and multivariate analyses examined associations between clinical and laboratory factors and ALT levels. Healthy ranges for ALT were computed from the population at lowest risk for liver disease. Sensitivity and specificity of healthy ALT ranges were evaluated in the donors with HCV antibodies, of whom 133 had liver biopsy., Results: Serum ALT activity was independently related to body mass index and to laboratory indicators of abnormal lipid or carbohydrate metabolism. Updated upper limits (for men, 500 nkat/L [30 U/L]; for women, 317 nkat/L [19 U/L]) were lower than current limits (for men, 667 nkat/L [40 U/L]; for women, 500 nkat/L [30 U/L]) and, during 6-month follow-up, showed superior sensitivity in identifying participants with HCV viremia (sensitivity, 76.3% [95 % CI, 69.1% to 83.6%] vs. 55% [CI, 46.4% to 63.5%]). The related tradeoff in specificity was acceptable (88.5% [CI, 79.2% to 94.6%] vs. 97.4% [91% to 99.7%]). The increased sensitivity targeted patients with minimal to mild histologic lesions., Conclusion: In patients with chronic HCV infection or nonalcoholic fatty liver disease, revision of normal limits for ALT level is advisable.

Background and Objectives: We conducted a longitudinal prospective study to assess the eligibility to blood donation of donors with 'minor' risk factors (i.e. minor surgery, professional exposure, cohabitation with 'high risk' people, occasional use of light drugs) or 'medium' risk factors for human immuno-deficiency virus (HIV) infection (i.e. casual sexual relationship, multiple heterosexual exposure, sexual partnership with subjects at risk, regular use of light drugs)., Design and Methods: During a 4-year period we administered a psychosocial questionnaire to all donors attending our Center. In addition we determined anti-HIV, anti-hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) and syphilis serology (TPHA) at entry to the study and at 6-month intervals., Results: Of 25,367 donors, 1,535 (6%) reported medium and 8,761 (34%) minor risk. At enrollment into the study, 4 medium risk donors were anti-HIV positive and there was a significantly higher rate of positivity for TPHA (0.33% vs 0.07%) and anti-HCV (1.17% vs 0.63%) in this group than in donors reporting no risk. No anti-HIV positivity was observed in minor or no risk donors. During a median follow-up of 18 months, none of 24,404 donors undergoing 106,503 visits seroconverted to HIV. The incidences of novel HCV and syphilis infections were almost one log greater in donors at medium risk (3 and 1x10-4/yr, respectively) than in no risk donors (0.4 and 0.1x10-4/yr, respectively). Medium risk donors were more frequently males (Odds Ratio=3.2, 95% confidence interval= 2.8-3.7), aged 26-35 yrs (1.52; 1.3-1.78), single (1.4; 1.2-1.6), divorced (2; 1.4-2.8), freelance workers (1.43; 1.1-1.9) and first-time donors (1.8; 1.6-2.1) than no risk donors., Interpretation and Conclusions: The only 4 HIV positive subjects of the cohort were medium risk donors picked up at enrollment. No HIV seroconversion was observed during the study. On the basis of this study we will continue to defer 'medium' risk donors.

Subjects with minimal-to-mild chronic hepatitis C may suffer long-term consequences of hepatitis C virus (HCV) infection. Nonetheless, they are not candidates for antiviral treatment, mainly because little data are available concerning the efficacy and safety of therapy. Thirty-two HCV RNA positive individuals aged 18-45 years, who had a histological activity index score < or = 8 and alanine aminotransferase (ALT) levels < or = 1.5 times lower than the normal limit for at least 1 year, were prospectively enrolled among a cohort of 35358 candidate blood donors, and treated with 4.5 mega units (MU) of recombinant interferon-alpha2a (IFN-alpha2a) thrice weekly for 6 months, and for an additional 6 months if a virological response was observed. Twelve months after the completion of treatment, 13 of 31 evaluable patients were HCV RNA negative, accounting for a sustained response rate of 42%. Patients without fibrosis had a lower response rate than those with mild fibrosis (two of 14 vs 11 of 17; P=0.012). In responders, median aminotransferase levels were significantly lower after therapy than before (11.04 +/- 3.98 vs 27.3 +/- 12.32 U l-1, respectively; P < 0. 005). When the analysis was limited to the six responders whose pretreatment aminotransferase levels were consistently normal, this difference was still significant (9.33 +/- 4.12 vs 20.58 +/- 6.73 U l-1; P=0.002). In conclusion, a durable suppression of viraemia can be obtained by IFN monotherapy in a relatively high proportion of young subjects with minimal-to-mild chronic hepatitis C, especially when portal fibrosis is found on liver biopsy. The disappearance of viraemia always leads to a reduction in the degree of hepatocellular necrosis.

Objective: Percent free prostate-specific antigen (PSA) is a promising tool for prostate cancer (CaP) diagnosis. However, its diagnostic performances have not yet been established. The present study was carried out with the aim of evaluating percent free PSA in the most favourable analytical conditions., Materials and Methods: Eighty-eight patients affected by newly diagnosed, untreated, primary CaP, and 169 cases with biopsy-confirmed, untreated, benign prostatic hypertrophy (BPH) were prospectively enrolled. Abbott AxSYM total and free PSA were measured by the same technician using the same instrument and the same reagent batch., Results: Percent free PSA was more effective than total PSA in differential diagnosis between CaP and BPH in every evaluated dose range of total PSA. In cases with total PSA >4 microg/l, percent free PSA could have reduced by about 50% the rate of unnecessary biopsies with a probably still acceptable 93% cancer detection rate. The likelihood of CaP after the determination of percent free PSA was in fact higher than 50% using cut-off points which provide low sensitivity values (i.e. 58% in men aged 50-59 years)., Conclusions: Percent free PSA is superior to total PSA in distinguishing primary CaP from BPH in patients with total PSA between 2 and 30 microg/l and in reducing the rate of unnecessary biopsies in men with total PSA higher than 4 microg/l. However, percent free PSA should be cautiously interpreted in decision making in individual patients since post-test probability is relatively low in men aged 50-70 years.

Although general consensus exists that percent free prostate-specific antigen (PSA) is superior to total immunoreactive PSA for prostate cancer (CaP) detection, its diagnostic performance is not yet well established. Analytical problems may account for difficulties in evaluating percent free PSA because the free PSA concentration is substantially lower than that of total PSA. The aim of the present study was to establish the diagnostic performances of the IMMULITE percent free PSA assay from Diagnostics Products Corp. under experimental conditions optimized to minimize analytical variability. Eighty-five patients with untreated primary CaP and 261 with untreated benign prostate hypertrophy (BPH) were prospectively enrolled. The Diagnostics Products IMMULITE total (Third Generation) and free PSA were measured by the same technician, using the same instrument and the same reagent batch. We calculated the post-test probability to express how the likelihood of the diagnosis of CaP changed after the percent free PSA was determined. Areas under the ROC curves of percent free PSA were better than those of total PSA in every evaluated range of total PSA. The percent free PSA could have reduced the rate of unnecessary biopsies by 47% in patients with total PSA >/=4 microg/L with only 3.8% false-negative results. The post-test probability of percent free PSA was, however, <50% in men 50-70 years of age, using cutoff points providing sensitivity from 99% to 80%. Percent free PSA is superior to total PSA in distinguishing primary CaP from BPH in patients with total PSA between 2 and 30 microg/L. In men with low total PSA, the diagnostic performance of the percent free PSA assay may be optimized by controlling methodological variability. The percent free PSA assay is effective in reducing the rate of unnecessary biopsies in men with total PSA >4 microg/L. However, the post-test probability provided by percent free PSA is relatively low in asymptomatic patients 50-70 years of age.

Unlabelled: The percent free PSA value is a promising diagnostic tool for prostate cancer. However, its actual role has not yet been established because of the widely diverging sensitivity and specificity values. This could depend at least in part on analytical difficulties, since the free PSA concentration is much lower than that of total PSA. The present investigation was designed to evaluate the diagnostic performance of the percent free PSA in the most favorable analytical conditions., Materials and Methods: 81 patients affected by newly diagnosed, untreated primary prostate cancer (CaP) and 239 patients with untreated benign prostatic hyperplasia (BPH) were prospectively enrolled. Hybritech total and free PSA were measured by the same technician using the same reagent batch., Results: The percent free PSA was not significantly associated with age, tumor stage, gland volume, Gleason score, and total PSA, nor was it significantly affected by concomitant prostatic complications either in CaP or BPH. Percent free PSA was more effective than total PSA in the differential diagnosis between CaP and BPH in every evaluated dose range of total PSA. Percent free PSA determination could have reduced the rate of unnecessary biopsies in cases with total PSA > or = 4 ng/mL and > or = 10 ng/mL (avoided biopsies 61% and 63%, respectively). The post-test probability of the disease, which represents the proportion of patients with a positive percent free PSA value who have the disease, was, however, relatively low in younger patients with total PSA within the normal range., Conclusions: The diagnostic performance of the percent free PSA value is enhanced when the methodological variability is reduced, particularly in men with low total PSA. Percent free PSA is superior to total PSA in distinguishing primary CaP from BPH in patients with total PSA between 2 and 30 ng/mL. The percent free PSA value is effective in reducing the rate of unnecessary biopsies in men with total PSA higher than 4 or 10 ng/mL. However, due to its relatively low post-test probability, the percent free PSA value should be interpreted with caution in the decision-making related to individual patients and should be used in association with clinical and instrumental evaluation of the patient.

Background & Aims: The association of liver disease with hepatitis C virus (HCV) genotypes mainly refers to patients with serious liver damage; little information is available on symptomless carriers. The aim of this study was to investigate the correlation of genotypes with clinical course, risk factors for infection, and antibody to HCV reactivity in asymptomatic subjects., Methods: One hundred nine viremic blood donors with at least 1 year of follow-up were studied; 41 underwent liver biopsy. Genotypes were determined by line-probe assay., Results: Genotype 1 was found in 47 (43.1%), genotype 2 in 48 (44%), genotype 3 in 8 (7.3%), genotype 4 in 2 (1.8%), and coinfections in 4 (3.7%). The relative risk (RR) for a raised pattern of alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyltranspeptidase was 2.1 (confidence interval [CI], 1.4-3.2), 1.7 (CI, 1.2-2.4), and 2.8 (CI, 1.6-4.9) in subjects with genotype 1 vs. 0.4 (CI, 0.2-0.7), 0.4 (CI, 0.3-0.7), and 0.4 (CI, 0.2-0.8) in subjects with genotype 2. Chronic hepatitis was found in 68%; the RR of chronic hepatitis was similar for genotypes 1 and 2 (RR, 1.1 [CI, 0.8-1.7] vs. RR, 1.0 [CI, 0.7-1.6]). Reactivity to NS4-derived antigens was infrequent in type 2-infected subjects., Conclusions: Genotype 2 was as frequent as genotype 1 but associated with less liver function impairment. The high prevalence of chronic hepatitis should be considered in counseling viremic asymptomatic donors.

The clinical significance of single band reactivity (indeterminate pattern) at anti-hepatitis C virus (HCV) second-generation recombinant immunoblot assay (RIBA-2) was investigated in symptomless subjects with normal liver function tests to obtain data for their counseling and clinical management. Serum and hepatic HCV RNA were determined by the nested polymerase chain reaction, and liver histology was evaluated in 40 symptomless blood donors with stable indeterminate RIBA-2 pattern, including 38 reactive to c22-3. All but one had normal alanine aminotransferase (ALT) levels. Two new immunoblot tests, RIBA-3 and INNO-LIA HCV Ab III (LIA-III), which incorporate additional HCV antigens, were also done to assess whether they could identify the viremic subjects. Ten cases (25%, confidence interval 12 to 38) were HCV RNA positive. Three of the HCV RNA-positive and none of the HCV RNA-negative subjects had chronic hepatitis. RIBA-2 strong intensity of reaction (score > 2+) was observed in all the HCV RNA-positive and in 12 HCV RNA-negative subjects. RIBA-3 and LIA-III gave positive results in 9 of 10 and 10 of 10 HCV RNA-positive, but also in 8 of 30 and 24 of 30 HCV RNA-negative subjects. A c-22-3 reactivity score of 4+ by RIBA-3 and E2/NS1 reactivity by LIA-III were both strongly associated with HCV RNA (P < .001). Based on relatively high prevalence of chronic hepatitis in our series (30%), apparently healthy subjects with stable indeterminate RIBA-2 pattern and HCV RNA positivity should be considered for liver biopsy independently of ALT profile.(ABSTRACT TRUNCATED AT 250 WORDS)

The role of CA 15-3 in breast cancer has been widely studied by several authors. This study was designed to describe the predictivity of CA 15-3 determinations for the metastasis or second primary tumor in patients subjected to follow-up for breast cancer. All the 1,123 determinations of CA 15-3 carried out during 1991 in a hospital laboratory were analyzed. By cross-matching anagraphic items of patients with clinical data from different hospital databases, it was possible to reconstruct the clinical history. At the cutoff point of 40 U/ml, the positive predictive value of the CA 15-3 was 99.4%. This study shows the very close association between CA 15-3 > or = 40.0 U/ml and disease, suggesting a careful restaging when the marker increases without clinical evidence of metastases. Hormonal treatment should also be considered.

The synthetic vasopressin derivative desmopressin (DDAVP) shortens a prolonged bleeding time (BT) in patients with uremia, congenital platelet dysfunction, and von Willebrand disease. To establish the limits of the clinical usefulness of DDAVP, a controlled randomized study was carried out in 53 patients and ten volunteers with different conditions that have in common a prolonged BT. DDAVP significantly shortened the BT in 21 cirrhotics (P less than .01), in eight patients with unclassified prolonged BT (P less than .05) and in ten volunteers taking the antiplatelet drugs aspirin (P less than .05) and ticlopidine. The BT changes were not statistically significant in 15 patients with severe thrombocytopenia nor in nine with congenital platelet dysfunction, even though a few patients with storage pool deficiency responded with a marked BT shortening. Our findings indicate that DDAVP might be given when biopsies or other surgical procedures must be carried out in patients with prolonged BT. However, the compound is often ineffective in patients with thrombocytopenia or congenital platelet dysfunction.

Type I von Willebrand disease (vWD) is characterized by equally low plasma concentrations of von Willebrand factor antigen (vWF:Ag) and ristocetin cofactor (RiCof) and by the presence of all vWF multimers in sodium dodecyl sulfate (SDS)-agarose gel electrophoresis. For 17 patients (13 kindreds) diagnosed with these criteria, we have studied the platelet contents of vWF:Ag and RiCof and the changes of these in plasma after DDAVP infusion. Platelet vWF:Ag and RiCof were normal in four kindreds (called "platelet normal" subgroup); following 1-deamino-8-D-arginine vasopressin; plasma vWF:Ag, RiCof and the bleeding time (BT) became normal. In six kindreds, platelet vWF:Ag and RiCof were equally low (platelet low); after DDAVP, plasma vWF:Ag and RiCof remained low, and the BT was prolonged. In three additional kindreds, platelets contained normal concentrations of vWF:Ag, but RiCof was very low (platelet discordant); even though a complete set of multimers was found in plasma and platelets, there was a relatively small amount of large multimers. After DDAVP, plasma vWF:Ag became normal, but RiCof remained low and the BT was very prolonged. These findings demonstrated that there can be an abnormal vWF (RiCof less than vWF:Ag) even in type I vWD, coexisting with a complete set of vWF multimers (platelet discordant); that the abnormal vWF can be shown more clearly in platelets than in plasma or else in plasma after DDAVP infusion; and that DDAVP normalizes the BT only in those patients with normal platelet levels of both vWF:Ag and RiCof (platelet normal).