Post-Ureteroscopic Lesion Scale to determine ureteral wall damage, not so easy to employ.

OBJECTIVE: To analyze the level of agreement of the Post-Ureteroscopy Lesion Scale (PULS) and the consequences on its application in clinical practice with more reliable statistical data than the one used in the original work. METHODS: 14 URS and 14 micro-URS were performed in 14 female porcine model. All the procedures were video recorded and an anatomopathological analysis was performed in each ureter. Sixteen urologists (9 endourologists and 7 general urologists) and 4 residents evaluated the ureteral lesions according to the PULS, with degrees 0, 1 and ≥2. The agreement was calculated with percentages, Kendall's W coefficient and the indicators Fleiss' Kappa and Krippendorff's Alpha, while the inter-rater agreement was calculated with Spearman's correlation and Cohen's Kappa. RESULTS: The percent of agreement was 11.1%. The coefficients were likewise classified as low or very low, with the greatest agreement found among the inexperienced. Also, 50% of the raters did not agree with the rest. CONCLUSIONS: The low inter-rater agreement, the specificity of the PULS and the clinical-pathological correlation suggests that this scale is not simple, and probably has a long learning curve.

Placental concentrations of xenoestrogenic organochlorine pesticides and polychlorinated biphenyls and assessment of their xenoestrogenicity in the PA-MAMI mother-child cohort.

BACKGROUND: Organochlorine pesticides (OCPs) and polychlorinated biphenyls (PCB), they have contributed to the exposure of women to persistent organic pollutants (POPs). These compounds can cross the placental barrier and interfere with the hormonal system of newborns. AIM: To determine concentrations of OCPs and PCBs and their xenoestrogenic activity in placentas of women from the PA-MAMI cohort of Panama. METHODS: Thirty-nine placenta samples from women in the Azuero peninsula (Panama) were analyzed. Five OCPs [p-p'-dichlorodiphenyldichloroethylene (p-p'-DDE), beta-hexachlorohexane (ß-HCH), γ-hexachlorohexane (lindane), hexachlorobenzene (HCB) and mirex] and three PCB congeners (PCB-138, PCB-153 and PCB-180) were quantified in placenta extracts. The xenoestrogenic activity of extracts was assessed with the E-Screen bioassay to estimate the total effective xenoestrogen burden (TEXB). RESULTS: All placental samples were positive for at least three POP residues and >70% for at least six. The frequencies of quantified OCPs ranged from 100% for p,p'-DDE and HCB to 30.8% for ß-HCH. The highest median concentration was for lindane (380.0 pg/g placenta), followed by p,p'-DDE (280.0 pg/g placenta), and HCB (90.0 pg/g placenta). Exposure to p,p'-DDE was associated with greater meat consumption, suggesting that animal fat is a major source of exposure to DDT metabolites. The frequency of detected PCBs ranged between 70 and 90%; the highest median concentration was for PCB 138 (17.0 pg/g placenta), followed by PCB 153 (16.0 pg/g placenta). All placentas were positive in the estrogenicity bioassay with a median TEXB-α of 0.91 pM Eeq/g of placenta. Exposure to lindane was positively associated with the xenoestrogenicity of TEXB- α, whereas this association was negative in the case of exposure to PCB 153. CONCLUSIONS: To our best knowledge, this study contributes the first evidence on the presence of POPs and xenoestrogenic burden in placentas from Latin-American women. Given concerns about the consequences of prenatal exposure to these compounds on children's health, preventive measures are highly recommended to eliminate or minimize the risk of OCP exposure during pregnancy.

Determination of bisphenols, parabens, and benzophenones in placenta by dispersive liquid-liquid microextraction and gas chromatography-tandem mass spectrometry.

Human exposure to endocrine disrupting chemicals (EDCs) is of particular concern during development. Bisphenols, parabens, and benzophenones are EDCs widely used in the manufacture of numerous goods, personal care products, and cosmetics. The aim of this study was to develop a new and practical method for determining three bisphenols, four parabens, and five benzophenones in placenta samples. It uses dispersive liquid-liquid microextraction (DLLME) in combination with gas chromatography-tandem mass spectrometry (GC-MS/MS). Several chemometric approaches were employed to optimize the experimental parameters. Limits of detection ranged from 0.04 to 0.08 ng g-1 and inter-day variabilities (evaluated as relative standard deviation) from 4.2% to 13.4%. The method was validated using matrix-matched standard calibration followed by a recovery assay with spiked samples. Recovery percentages ranged from 87.1% to 113.2%. Finally, the method was used to measure target compounds in 20 placental tissue samples from voluntary donors. This analytical procedure can provide information on the exposure of the fetus to non-persistent EDCs.

Cosmetic and personal care product use, urinary levels of parabens and benzophenones, and risk of endometriosis: results from the EndEA study.

AIM: To explore the relationship of urinary concentrations of different congeners of benzophenones and parabens with the utilization of cosmetics and personal care products (PCPs) and their impact on the risk of endometriosis, and to evaluate the influence of oxidative stress on associations found. METHODS: This case-control study comprised a subsample of 124 women (35 cases; 89 controls). Endometriosis was confirmed (cases) or ruled out (controls) by laparoscopy, with visual inspection of the pelvis and biopsy of suspected lesions (histological diagnosis). Urinary concentrations of benzophenone-1 (BP-1), benzophenone-3 (BP-3), 4-hydroxibenzophenone (4-OH-BP), methyl- (MeP), ethyl- (EtP), propyl- (PrP), and butyl-paraben (BuP), and biomarkers of oxidative stress [lipid peroxidation (TBARS) and total antioxidant power (TAP)] were quantified. Information was gathered on the frequency of use of cosmetics and PCPs. Associations between the frequency of cosmetics/PCP use, urinary concentrations of benzophenones and parabens, oxidative stress, and endometriosis risk were explored in logistic and linear multivariable regression analyses. RESULTS: The frequency of utilization of certain cosmetics and PCPs was significantly associated with urinary concentrations of benzophenones and parabens. After adjustment for potential confounders, the risk of endometriosis was increased in women in the second versus first terciles of MeP (OR = 5.63; p-value<0.001), BP-1 (OR = 5.12; p-value = 0.011), BP-3 (OR = 4.98; p-value = 0.008), and Æ©BPs (OR = 3.34; p-value = 0.032). A close-to-significant relationship was observed between TBARS concentrations and increased endometriosis risk (OR = 1.60, p-value = 0.070) and an inverse association between TAP concentrations and this risk (OR = 0.15; p-value = 0.048). Oxidative stress results did not modify associations observed between benzophenone/paraben exposure and endometriosis risk. CONCLUSIONS: Our findings indicate that the frequency of cosmetics and PCP utilization is a strong predictor of exposure to certain benzophenone and paraben congeners. These compounds may increase the risk of endometriosis in an oxidative stress-independent manner. Further studies are warranted to corroborate these findings.

Historical exposure to non-persistent environmental pollutants and risk of type 2 diabetes in a Spanish sub-cohort from the European Prospective Investigation into Cancer and Nutrition study.

BACKGROUND: Environmental factors are believed to account for a substantial burden of type 2 diabetes mellitus (T2DM). Non-persistent environmental pollutants (npEPs) are a group of widely-used chemicals identified as endocrine/metabolic disrupting chemicals and obesogens. The aim of this study was to analyse the potential associations of serum levels of three groups of npEPs with the risk of incident T2DM. METHODS: This is a longitudinal study within a sub-sample of Granada EPIC-Spain cohort (n = 670). We quantified serum concentrations of 7 npEPs: four parabens (Methylparaben (MP) ethylparaben (EP), propylparaben (PP) and butilparaben (BP); two benzophenones: Benzophenone 1 (BP1), Benzophenone 3 (BP3); and Bisphenol A (BPA). Exposure was assessed by means of chemical analyses of serum samples collected at recruitment, and information on potential confounders was gathered by using validated questionnaires at baseline. Follow-up was performed by review of patients' clinical records. Cox Proportional Hazards Models were used for the statistical analyses. RESULTS: Median follow-up time was 23 years. There were 182 (27%) incident T2DM diagnoses in our sub-cohort. MP was the most frequently detected npEP, 88.42% samples above the limit of detection, and BP showed the lowest percentage of detection (19.21%). Those individuals within the fourth PP quartile (0.53-9.24 ng/ml) showed a statistically significant increased risk of T2DM (HR = 1.668 p = 0.012), while BP1 concentrations showed an inverse non-significant trend with the risk. CONCLUSIONS: We evidenced a potential contribution of npEP exposure on T2DM, but no clear trend was observed. However, limitations in relation to exposure estimation might influence our findings and further research is warranted to confirm our results.

Androgen receptor expression is associated with adverse pathological features in ureteral but not in pelvicalyceal urothelial carcinomas of the upper urinary tract.

PURPOSE: This study aims to determine the significance of androgen receptor (AR) expression in urothelial carcinoma of the upper urinary tract (UTUC). METHODS: AR expression was assessed on tissue microarrays containing specimens of 737 patients with UTUC who underwent radical nephroureterectomy with curative intent. AR expression was correlated with clinical and pathological tumor features as well as recurrence-free survival (RFS), cancer-specific survival (CSS) and overall survival (OS). RESULTS: Overall, AR was expressed in 11 % of tumors. AR expression was significantly associated with tumor necrosis as well as sessile and multifocal tumor growth but not with RFS, CSS or OS. AR was detected nearly twice as often in tumors of the ureter than of the pelvicalyceal system (p = 0.005). Subgroup analyses showed that the significant associations of AR with unfavorable pathologic features were exclusively attributable to tumors located in the ureter. However, in both ureteral and pelvicalyceal tumors, AR status was independent of RFS, CSS and OS. CONCLUSIONS: In this cohort of patients treated with RNU, AR expression was found in approximately 10 % of UTUCs, twice as often in ureteral than in pelvicalyceal tumors. While AR expression had no impact on postoperative prognosis, it was significantly associated with unfavorable pathologic features in ureteral tumors. Steroid hormone signaling might be relevant for future investigations of differences between ureteral and pelvicalyceal tumors.

The impact of local treatment of the primary tumor site in node positive and metastatic prostate cancer patients.

BACKGROUND: Surgical treatment of the primary tumor in patients with metastatic prostate cancer (mPCa) is gaining traction. We discuss the biological rational and the existing literature on this approach. METHODS: We reviewed the literature regarding surgical management of advanced and mPCa disease. RESULTS: Surgical removal of the primary tumor despite metastases is becoming a standard in an increasing number of malignancies. Basic science data support the use of surgical removal of the prostate in metastatic PCa. In addition, durable long-term survival has been reported in patients with node-positive PCa treated with radical prostatectomy (RP) as mono or multimodal approach. Based on these data, several groups have demonstrated the feasibility and safety of RP in the metastatic setting. Retrospective series have also reported an improvement in survival for metastatic patients treated with RP in addition to systemic treatment. CONCLUSIONS: Although no level I data exist at this time to support the use of RP in clinically node-positive or mPCa patients, retrospective data together with basic research data and experience from other malignancies suggest that treatment of the primary tumor, in form of a RP, is safe and could improve long-term quality of life and survival. However, prospective evaluations are requested to validate these findings before including in the standard clinical practice.

The surgical management of patients with clinical stage T4 bladder cancer: A single institution experience.

INTRODUCTION: Patients with clinical T4 (cT4) bladder cancer (BCa) infrequently undergo radical cystectomy (RC). We investigated the reliability of preoperative clinical staging, perioperative and survival outcomes in patients treated with RC due to cT4a-b BCa disease at a single tertiary care institution. METHODS: The study relied on 917 BCa patients treated with RC and pelvic lymph node dissection (PLND) at a single institution between January 1995 and December 2012. We compared the accuracy of the clinical assessment with final pathology results. Moreover, we evaluated perioperative outcomes, complication rates and survival after surgery. RESULTS: The median follow-up was 62 months. Overall, 74 (8.1%) patients presented cT4 stage at preoperative evaluation. Conversely, a pathological T4 disease was confirmed only in 68.9% patients staged initially as cT4. No differences were recorded in complications, 30 days readmission or 30 days death rates between cT1-T3 vs. cT4a vs. cT4b (p > 0.1). At multivariable Cox regression analyses predicting cancer specific mortality, clinical T4 stage vs. clinical T1-2, clinical T3 stage vs. clinical T1-2 and age were predictors of worst survival after RC (all p < 0.04). CONCLUSIONS: We recorded poor concordance between preoperative imaging and pathology in cT4 patients. No differences in major perioperative outcomes and acceptable survival expectancies were reported in patients treated for cT4 disease.

[Metallic ureteral stents. Present and future.] / Stents ureterales metálicos. Presente y futuro.

The management of ureteral obstruction of malignant origin or complicated benign obstruction continues to be a challenge for the urological community. In this sense, the use of metallic stents could be considered a useful alternative to the conventional drainage techniques, because it accomplishes the resolution of obstruction in a single procedure, without external diversions and without the adverse effects of current diversions. Another important advantage they offer is that they do not need replacement as frequently as double J catheters or nephrostomy tubes require. From their first applications in the upper urinary tract until now the design of metallic stents has experienced a notable evolution. The main obstacle at the beginning was the use of stents intended for other organic territories, which caused a high rate of failures, since they did not take into consideration in their designs the hostile environment represented by urine for this type of devices, neither the existence of ureteral peristaltism. Thanks to subsequent metallic designs (Memokath, Uventa, Allium Medical URS-stent, Resonance), the current generation of ureteral metallic stents has improved the success rate in comparison to classical designs, accommodating to ureteral dynamics and improving the coating and alloys. Despite these advances, today, their application is limited to very selected patients due to the onset of undesirable effects still associated with theses stents, such as obstructive urothelial hyperplasia, encrustation or migration. The precise knowledge of the physiopathological mechanisms responsible for the cited adverse effects, together with the application of Bioengineering enabling the development of drug eluting metallic stents, biocoated stents, or new biodegradable metallic materials that mitigate or diminish their effects, may be the key to allow the development of the ideal metallic stent.

The importance of psychosexual counselling in the re-establishment of organic and erotic functions after penile prosthesis implantation.

Although many studies about penile prosthesis implantation (PPI) have been published so far, only a small amount of them take into account patients and partners outcome in terms of satisfaction and erotic function. The aim of this study is to explore the value of psycosexual counselling in and the sexual and erotic function of penile prosthesis recipients. Thirty patients and their partners were randomised into two groups. In arm A (case group) patients and their partners underwent a multistep psychosexual counselling before and after surgery. In arm B (control group) surgery was performed without the specific psychosexual counselling scheme. Specific questionnaires (International Index of Erectile Function (IIEF) and the Sexual Daydreaming Scale (SDS)) were administered before surgery and 12 months afterwards. Twenty-four months postoperatively patients were asked to complete the Global Assessment Questions (GAQ) and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), while their partners were asked to answer to the EDITS partner's section. Between January 2009 and October 2011, we enrolled 30 patients undergoing PPI in our institution (15 in each arm). Twenty-four months postoperative follow-up is available for all of them. No significant differences between the two groups in terms of baseline questionnaires scores were observed. Mean IIEF score was significantly higher in case group (arm A 68.3, arm B 53.4, P-value<0.001). At 12 months after PPI the improvement of erotic function according to SDS was significantly higher in the study group for both patients and their partners. Improvement in satisfaction rates were confirmed at 24 months, with statistically significant scores for EDITS in arm A patients and partners as compared with arm B. PPI with a pre- and postoperative psychosexual counselling scheme resulted in better postoperative sexual activity and erotic function for both patients and partners than PPI alone.

A new method for the determination of benzophenone-UV filters in human serum samples by dispersive liquid-liquid microextraction with liquid chromatography-tandem mass spectrometry.

Benzophenone-UV filters (BP-UV filters) are extensively used in cosmetics products to avoid damaging effects of UV radiation. Despite their low toxicity, many research papers indicate that BP-UV filters are weak endocrine disruptors (EDCs). There are clear relationships between BP-UV filters exposure and several health disorders such as carcinogenesis and malformations observed in animals. In the present work, a new sample treatment procedure by dispersive liquid-liquid microextraction (DLLME) is proposed for the extraction of six BPs, namely benzophenone-1 (BP-1), benzophenone-2 (BP-2), benzophenone-3 (BP-3), benzophenone-6 (BP-6), benzophenone-8 (BP-8) and 4-hydroxybenzophenone (4-OH-BP), in human serum samples, followed by ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) analysis. The method involves an enzymatic treatment to quantify the total content (free plus conjugated species) of BP-UV filters in serum. The extraction parameters were accurately optimized using multivariate optimization approach. Benzophenone-d10 (BP-d10) was used as surrogate. Limits of quantification (LOQs) ranged from 0.4 to 0.9 ng mL(-1) and inter-day precision (evaluated as relative standard deviation) ranged from 1.9% to 13.1%. The method was validated using matrix-matched calibration and a recovery assay. Recovery rates for spiked samples ranged from 97% to 106%, and acceptable linearity was obtained up to concentrations of 40 ng mL(-1). The method was applied to the determination of the target compounds in human serum samples from 20 randomly selected anonymous individuals.

A new treatment by dispersive liquid-liquid microextraction for the determination of parabens in human serum samples.

Alkyl esters of p-hydroxybenzoic acid (parabens) are a family of compounds that have been in use since the 1920s as preservatives in cosmetic formulations, with one of the lowest rates of skin problems reported in dermatological patients. However, in the last few years, many scientific publications have demonstrated that parabens are weak endocrine disruptors, meaning that they can interfere with the function of endogenous hormones, increasing the risk of breast cancer. In the present work, a new sample treatment method is introduced based on dispersive liquid-liquid microextraction for the extraction of the most commonly used parabens (methyl-, ethyl-, propyl-, and butylparaben) from human serum samples followed by separation and quantification using ultrahigh performance liquid chromatography-tandem mass spectrometry. The method involves an enzymatic treatment to quantify the total content of parabens. The extraction parameters (solvent and disperser solvent, extractant and dispersant volume, pH of the sample, salt addition, and extraction time) were accurately optimized using multivariate optimization strategies. Ethylparaben ring (13)C6-labeled was used as surrogate. Limits of quantification ranging from 0.2 to 0.7 ng mL(-1) and an interday variability (evaluated as relative standard deviations) from 3.8 to 11.9 % were obtained. The method was validated using matrix-matched calibration standard and a spike recovery assay. Recovery rates for spiked samples ranged from 96 to 106 %, and a good linearity up to concentrations of 100 ng mL(-1) was obtained. The method was satisfactorily applied for the determination of target compounds in human serum samples.

[Airway pressure monitoring by the continuous flow method in paediatric thoracoscopic surgery. A study in an animal model]. / Monitorización de las presiones de la vía aérea con la modalidad de flujo continuo en cirugía toracoscópica pediátrica. Estudio en modelo animal.

OBJECTIVE: To compare the airway pressures obtained before the endotracheal tube with the intratracheal ones in the continuous flow ventilation mode, in thoracoscopic surgery for one lung ventilation, in a paediatric model in animals. MATERIAL AND METHODS: A simple prospective observational study was conducted. Ten Large White pigs weighing 4.6 ± 0.8 kg were used. The animals were ventilated in neonatal mode (continuous flow) with a Temel Supra ventilator. Using tracheotomy, we completely sealed the respiratory system in order to use tubes without special endotracheal cuffs, which would enable tracheal pressures to be registered without interfering with ventilation. Collapse of the right lung was performed by videothoracoscopy and was maintained for 120 min. The variables were measured at 10 time periods: start and 5 min with both lungs, after collapse at 5, 15, 30, 60, 90 and 120 min, and 5 and 15 min after lung re-expansion. We recorded the baseline, peak, plateau and positive end expiratory pressure in the mouth of the animal and intratracheal. RESULTS: The mean peak pressure in the mouth of the animal in one lung ventilation was 23.38 mmHg and tracheal ventilation was 21.24 mmHg, while the mean plateau pressure in the mouth of the animal in one lung ventilation it was 21.88 mmHg and tracheal was 21.39 mmHg, respectively, with significant differences in all of them (P<.05). We found statistically significant differences (P<.05) for peak and plateau pressure on comparing the record in the animal mouth with the tracheal record. The difference in absolute value was higher for the peak pressure record. CONCLUSIONS: The pressure parameters recorded in the animal mouth were acceptable for surgery, with a suitable respiratory and haemodynamic stability being maintained. We can state that the continuous flow mode according to the pressures study may be suitable for this type of surgery, and that the mouth of the animal (patient) record for the peak pressure does not reflect what really happens in the alveoli, but we can give a suitable clinical estimate for the plateau pressure.

[Experimental study with Doppler ultrasound in partial chronic obstructive uropathy]. / Estudio experimental con Ecografía Doppler en uropatía obstructiva parcial crónica.

INTRODUCTION: This study has aimed to assess the hemodynamic parameters, Renal Resistive Index (RI), Peak Systolic Velocity (PSV), End-Diastolic Velocity (EDV) and Blood Flow of the Renal Artery (FR) by Doppler Ultrasound for diagnosis and monitoring postsurgical partial chronic obstructive uropathy. MATERIAL AND METHODS: Fifty pigs were used. The experiment was divided into three phases. Phase I consisted of a duplex-Doppler evaluation of the both kidneys to determine the parameters under study. The ratio of each index is calculated as the difference between the value of study kidney and the contralateral. After, a fluoroscopic examination was performed by compressive cystography, excretory urography and retrograde ureteropyelography. Finally, a model of partial right ureteral obstruction was created. After six weeks of the obstructive model, Phase II was begun with the diagnosis of the uropathy, by means of the aforementioned diagnostic methods and the endourological treatment was completed. Phase III is a follow-up performed at 6 months of treatment using the same methods as in the previous phases. RESULTS: Of the parameters studied, the EDV and its ratio showed greater sensitivity and specificity as a diagnostic marker of obstructive uropathy. In the postoperative monitoring, it was observed that the RI and the EDV returned to baseline levels, with the baseline values. CONCLUSIONS: The ΔEDV and its ratio is the parameter that shows the greater efficacy for the diagnosis of chronic partial obstructive uropathy, however, it is insufficient to avoid conventional diagnostic techniques. All the parameters, mainly the EDV, have proven useful as complementary tests for monitoring after endourologic resolution of obstructive uropathy.

Prevalence and prognostic influence of peripheral arterial disease in patients >or=40 years old admitted into hospital following an acute coronary event.

OBJECTIVE: A significant proportion of patients with ischemic heart disease have associated peripheral arterial disease (PAD), but many are asymptomatic and this condition remains underdiagnosed. We aimed to study the prevalence of PAD in patients with an acute coronary syndrome (ACS) and to evaluate its influence in hospital clinical outcomes. METHODS: The PAMISCA register is a prospective, multicenter study involving patients >or=40 years old with ACS admitted to selected Spanish hospitals. All patients had their ankle-brachial index (ABI) measured between days 3 and 7 after the ischemic event. RESULTS: 1410 ACS patients (71.4% male) were included. PAD determined by ABI was documented in 561 patients (39.8%). Factors independently related to PAD were age (OR: 1.04; 95% CI: 1.03-1.06; p<0.001), smoking (OR: 1.88; 95% CI: 1.41-2.49; p<0.0001), diabetes (OR: 1.30; 95% CI: 1.02-1.65; p<0.05), previous cardiac disease (OR: 1.54; 95% CI: 1.22-1.95; p<0.001) and previous cerebrovascular disease (OR: 1.90; 95% CI: 1.28-2.80; p<0.001). Following the ACS, an ABIor=40 years presenting with ACS is high and it is associated with increased cardiovascular risk.

Double-balloon enteroscopy in two dogs.

It is difficult to insert a flexible endoscope deep into the small intestine. A new method, double-balloon enteroscopy, has been developed to improve access to the small intestine, and the aim of this study was to evaluate its usefulness for examination of the small intestine of dogs. The method uses two balloons, one attached to the tip of the endoscope and another attached to the tip of an overtube. The double-balloon endoscope is advanced through the intestine by being held alternately by the balloon on the endoscope and the balloon on the overtube. The technique was applied in two dogs of medium size, using both oral and anal approaches, and it was possible to examine the whole surface of the mucosa of their small intestines.

New electrochemiluminescent immunoassay for the determination of CYFRA 21-1: analytical evaluation and clinical diagnostic performance in urine samples of patients with bladder cancer.

BACKGROUND: A new electrochemiluminescent immunoassay (ECLIA) has been developed for the determination of cytokeratin 19 (CYFRA 21-1) in the Elecsys 2010 immunoassay system. Urinary CYFRA 21-1 might have a role in the diagnosis of bladder cancer. METHODS: We performed an analytical evaluation of the CYFRA 21-1 ECLIA for serum and urine samples. The clinical value of urinary CYFRA 21-1 for the detection of bladder cancer was evaluated through its measurement in 226 urine samples from symptomatic and asymptomatic controls. RESULTS: At concentrations of 2-30 microg/L, within-assay imprecision (CV) was below 2.1% for sera and 3.3% for urines, with interassay CVs below 3.3% for sera and 4.9% for urines. The day-to-day CV was <20% at concentrations >0.2 microg/L (functional sensitivity). Measurement of diluted samples showed that the assay estimated CYFRA 21-1 between 98% and 103% for sera and 98% and 105% for urines. Recovery of added CYFRA 21-1 was 99-105% for sera and 96-115% for urines. We separately compared serum and urine CYFRA 21-1 ECLIA results with those obtained with an IRMA (CIS bio international). Regression analysis for sera was: CYFRA 21-1 (ECLIA) = 0.520 + 1.018 CYFRA 21-1 (IRMA); [95% confidence interval (CI) (y-intercept), -0.260 to 1.309]; 95% CI (slope), 0.978-1.060; n = 100; S(y|x) = 3.242; r(2) = 0.987. For urine samples it was: CYFRA 21-1 (ECLIA) = 0.716 + 0.966 CYFRA 21-1 (IRMA); 95% CI (y-intercept), 0.009-1.422; 95% CI (slope), 0.956-0.976; n = 100; S(y|x) = 4.136; r(2) = 0.986. In urine samples voided by patients with and without bladder cancer, the best ROC analysis discrimination provided 81.0% (95% CI, 72.7-87.7%) sensitivity and 97.2% (95% CI, 90.2-99.6%) specificity at a threshold value of 5.7 microg/L. CONCLUSIONS: Our initial evaluation showed reliable analytical performance for urinary CYFRA 21-1, which might assist urologists in the detection of bladder cancer as a noninvasive adjunct to cystoscopy.