Multicenter evaluation of a fully automated third-generation anti-HCV antibody screening test with excellent sensitivity and specificity.

Early detection of hepatitis C virus (HCV) is an important step in preventing progression to cirrhosis and hepatocellular carcinoma. Serologic assays for anti-hepatitis C (anti-HCV) antibody are valuable first-line tests in the screening and diagnosis of HCV infection. The aim of this multicenter study was to compare the Elecsys(®) Anti-HCV assay with alternative CE-marked Anti-HCV antibody assays against a range of samples that included 1,138 blood donors, 3,553 unselected routine daily specimens, and 46 pre-selected seroconversion panels. Specificity of the Elecsys Anti-HCV assay was 99.5% with blood donor samples and 99.4% with routine clinical specimens. These were similar to those obtained with the Prism(®) Anti-HCV, Architect(®) Anti-HCV assay, ADVIA(®) Centaur Anti-HCV assay and Vitros(®) Eci aHCV assays. Seroconversion sensitivity for the Elecsys Anti-HCV assay was similar to that of the Architect Anti-HCV, AxSYM HCV version 3.0, ADVIA Centaur Anti-HCV, and Vitros Eci aHCV assays. In fact, seroconversion testing on 46 commercially available panels showed that the difference in first detecting a positive blood sample was less than one day between assays (not statistically significant). The Elecsys Anti-HCV assay as well as the Architect, Prism, and Vitros Anti-HCV immunoassays revealed a seroconversion sensitivity of 100%, whereas the ADVIA Centaur HCV immunoassay showed a sensitivity of only 97.5% (39/40). Overall, the performance of the Elecsys Anti-HCV assay was similar to the performances of the comparator CE-marked Anti-HCV antibody assays.

Multicenter evaluation of a new 4th generation HIV screening assay Elecsys HIV combi.

Fourth-generation screening assays which permit a simultaneous detection of human immunodeficiency virus (HIV) antigen and antibody reduce the diagnostic window on average by four days in comparison to third-generation antibody assays. Recently, the new automated Elecsys HIV combi was compared in a multicenter study to alternative fourth- and third-generation assays, p24 antigen test and HIV-1 RNA RT-PCR. A total of 104 serocon-version panels, samples of the acute phase of infection after seroconversion (n = 33), anti-HIV-1 positive specimens (n = 572) from patients in different stages of the disease, 535 subtyped samples from different geographical locations, including group M (subtypes A-J) and group O, anti-HIV-2 positive sera (n = 364), dilutions of cell culture supernatants (n = 60) infected with different HIV-1 subtypes, selected performance panels, 8406 unselected samples from blood donors originating from different blood transfusion centers, 3810 unselected sera from daily routine and from hospitalized patients, 9927 unselected samples from South Africa and 1943 potentially interfering samples were tested with the Elecsys HIV combi. Elecsys HIV combi showed a comparable sensitivity to HIV-1 Ag stand-alone assays for early detection of HIV infection in seroconversion panels. The mean time delay of Elecsys HIV combi (last negative sample + 1 day) in comparison to HIV-1 RT-PCR for 92 panels tested with both methods was 3.23 days. The diagnostic window was reduced with Elecsys HIV combi between 1.56 and 5.32 days in comparison to third-generation assays. The specificity of Elecsys HIV combi in blood donors was 99.80% after repeated testing. Our results show that a fourth-generation assay with improved specificity and sensitivity like the Elecsys HIV combi is suitable for blood donor screening due to its low number of false positives and since it detects HIV p24 antigen with a comparable sensitivity to single antigen assays.

Plasma-exchange in chronic peripheral neurological disorders.

We investigated 19 patients affected by chronic peripheral neurological disorders treated with therapeutic plasma exchange (TPE) to verify the efficacy of the therapeutic protocol used in these diseases. Every patient was clinically considered after 5 TPE. Those who showed an improvement started chemotherapy and continued TPE at the rate of 2 procedures/week for 2 weeks, then 1 procedure/week for 1 month and finally 1 procedure every 2 weeks for 2 months. Intravenous immunoglobulins (IVIg) were infused at the end of apheretic treatment in one of the patients affected by neurological disorders due to monoclonal gammopathy undetermined significance. HCV-positive patients with cryoglobulins were treated with alpha-interferon (alpha-IFN) for 6 months before TPE. Eleven patients (58%) had a symptomatic improvement, 2 (1.5%) stopped TPE treatment owing to side effects and 6 (31.5%) did not respond to apheretic therapy. In order to improve the advantages of TPE we suggest using IVIg at the end of apheretic therapy, while in HCV-positive patients, at least one year of alpha-IFN therapy is required before initiating TPE.

[Efficacy and tolerance of the bisoprolol/hydrochlorothiazide combination in arterial hypertension]. / Eficácia e tolerabilidade da associação bisoprolol/ hidroclorotiazida na hipertensão arterial.

PURPOSE: Multicenter, open and non-controlled study to evaluated the efficacy and the tolerability of a low-dose combination of two anti-hypertensive agents: a cardioselective beta-blocker, bisoprolol (2.5 and 5.0 mg) with 6.25 mg of hydrochlorothiazide. METHODS: One hundred and six patients in the stage I and stage II of the systemic hypertension (mild to moderate) were given the bisoprolol/hydrochlorothiazide combination once daily and the diastolic and systolic blood pressures were monitored during the 8-week trial. RESULTS: The bisoprolol/hydrochlorothiazide combination reduced the initial mean values of systolic and diastolic blood pressures, respectively, from the 157.4 mmHg and 98.8 mmHg to 137.3 mmHg and 87.4 mmHg. At the end of the treatment period, 61% of the patients normalized blood pressure values (< 90 mmHg) and 22.9% of them had responded to the treatment, resulting in a total response rate (normalized + responsive) of 83.9% of cases. Adverse events were described only in 18.9% of the patients and dizziness and headache were the most common. There were no clinically significant changes on plasma levels of potassium, uric acid, glucose, or in the lipid profile. CONCLUSION: The combination of low dosages of bisoprolol and hydrochlorothiazide may be considered an effective, well tolerated and rational alternative for the initial treatment of the patients with mild to moderate hypertension.

Tratamento medicamentoso da doença arterial coronária estável em centros de atendimento primário e terciário / Clinical therapheutics for stable coronary artery disease. Differences between primary and tertiary medical care centers

OBJETIVO - Observar a distribuição das drogas em pacientes com doença arterial coronária (DAC) estável, em centros de atendimento (CA) primário e terciário. MÉTODOS - Foram analisados, 300 pacientes, consecutivos, no ambulatório do Grupo de Coronariopatias do INCOR com diagnóstico de DAC, idades entre 31 a 80 (58,5ñ8,0) anos, sendo 205 (68 por cento) do sexo masculino e 95 (32 por cento) do feminino e estudadas as características clínicas e hemodinâmicas. Avaliaram-se as drogas utilizadas, inicialmente, nos CA primários (comunitários) e, posteriormente, no CA terciário. RESULTADOS - As drogas mais utilizadas nos CA primários foram os ß-bloqueadores (50 por cento dos pacientes), nitratos (48 por cento), bloqueadores dos canais de cálcio (46 por cento), ácido acetil-salicílico (44 por cento), diuréticos (30 por cento) e os inibidores da enzima de conversão de angiotensina (ECA), em 11 'por cento' dos pacientes. No CA terciário as drogas mais utilizadas foram o ácido acetil-salicílico (76 por cento dos casos), nitratos (55 por cento), diuréticos (49 por cento), inibidores da ECA (42 por cento), os antagonistas dos canais de cálcio (37 por cento ) e os betabloqueadores (35 por cento dos pacientes). Os ß-bloqueadores foram mais prescritos em CA primário, p=0,02, já os inibidores da ECA, p<0,0001, o ácido acetil-salicílico, p<0,0001 e os diuréticos, p=0,002, foram mais prescritos no CA terciário. CONCLUSÄO - O tratamento farmacológico preconizado para a DAC estável deve ser otimizado em ambos os CA, dando prioridade às drogas que modificam a história natural da doença, como os betabloqueadores, antiagregantes plaquetários, e os inibidores da ECA nos pacientes com disfunção ventricular esquerda.

[Drug treatment for stable coronary artery disease at primary and tertiary medical centers]. / Tratamento medicamentoso da doença arterial coronária estável em centros de atendimento primário e terciário.

PURPOSE: To observe the distribution of the main drugs used in patients with stable coronary heart disease, in primary and tertiary medical care centers (MCC). METHODS: We studied 300 consecutive out patients at the Hetat Institute with the diagnosis of stable coronary artery disease, 205 (68%) males and 95 (32%) female, aged from 31 to 80 (mean 58 +/- 8.0) years old. Drug intake was evaluated. RESULTS: We observed that the use of nitrates (48% vs 55%; p = NS) and calcium antagonists (46% vs 37%; p = NS), respectively in both primary and tertiary MCC was similar. The beta blockers were used more often in the primary MCC (50% vs 35%; p = 0.02). Angiotensin converting enzyme inhibitors (11% vs 42%; p < 0.001), diuretics (30% vs 49%; p = 0.002) and aspirin (44% vs 76%; p = 0.0001) were more frequently used in the tertiary MCC. CONCLUSION: We observed similar frequency of use of nitrates and calcium antagonists in both centers. There was a higher use of beta blockers in primary MCC. The angiotensin converting enzyme inhibitors and antiplatelet agents were more used in the tertiary MCC. In relation to the updated literature, the best pharmacotherapy to coronary artery disease should be optimized in both centers.

[Anterior ST segment depression in acute inferior myocardial infarct: significance of its reproducibility during early ergometric test]. / Sottoslivellamento eterosede del tratto ST nell'infarto miocardico acuto inferiore: significato della sua riproducibilità al test ergometrico precoce.

The significance of anterior ST segment depression (V1-V4) at the time of acute inferior myocardial infarction and exercise-induced anterior ST segment depression were studied in 30 patients. All patients carried out: two-dimensional echocardiography in the acute phase of myocardial infarction (Echo 1) and at predischarge (Echo 2); symptom-limited exercise test; coronary arteriography. According to ST segment changes, patients were divided into Group A (n = 15) with exercise-induced anterior ST segment depression and Group B (n = 15) with no ST segment depression during exercise. Group A showed a lower work physical capacity than Group B (6.8 +/- 3 METS and 9 +/- 2 METS, respectively). The wall motion index in Group A was 0.26 +/- 0.14 in the Echo 1 and 0.22 +/- 0.18 in the Echo 2 showing an improvement in wall motion abnormality; in Group B the same index was 0.35 +/- 0.19 in the Echo 1 and 0.34 +/- 0.18 in the Echo 2. Group A patients had a higher prevalence of multivessel disease compared with Group B patients and the right coronary artery was always involved. In conclusion, in inferior myocardial infarction the anterior ST segment depression, both in the acute phase and during the predischarge exercise test, reflects more extensive coronary disease and jeopardized myocardium.

Primary hyperfibrinogenolysis in a patient with anaphylactic shock.

Although systemic hyperfibrino(geno)lysis during hypotensive crisis is known, there do not seem to be recent reports of episodes of primary acute fibrinogenolysis during anaphylactic shock. We report the case of a 61-year-old male admitted to the hospital for anaphylactic shock due to an insect bite who presented a clinical and laboratory picture of severe acute generalized hyperfibrinogenolysis not secondary to disseminated intravascular coagulation (DIC). Without specific therapy, the clinical picture resolved itself spontaneously within 40 hours of onset. Careful clinical examination and the execution of simple laboratory tests permitted a rapid diagnosis and therapeutic success.

Presence of anti-Yta antibody in a Yt(a+) patient.

Since 1956 when Cartwright (Yt) was recognized as a new erythrocyte antigenic system, numerous studies about anti-Yta and anti-Ytb antibodies have been published. A number of these studies described the laboratory techniques utilized in antibody identification, while others investigated the clinical importance of anti-Yta, giving variable results. However, most authors agreed upon the homogeneity of expression in this antigenic system. In our study we have described a case regarding 1 Yt(a+) patient with anti-Yta antibody. Family studies indicated inheritance of a variant/variant expression of the Yta antigen from the father.

[A new method for calculating the mass of the left ventricle by angiocardiography]. / Una nuova metodica per il calcolo della massa del ventricolo sinistro mediante angiocardiografia.

The authors describe a simplified method to determine left ventricular volume and mass from the ventricular silhouette, taken from a right oblique anterior angiographic projection at 30 degrees, used to measure the telediastolic surface and major axis, and of measuring the telediastolic thickness of the ventricular wall in the postero-lateral segment of the silhouette taken from a left oblique anterior angiographic projection at 60 degrees. Sixty-four ventricular silhouettes were analysed in patients undergoing left kineventriculography for coronaropathy and ventricular mass was determined using both the new and traditional methods. Using the new method mass values (mean value 87.85 g/sq.mt. and SD 34.04) were obtained which were significantly correlated (r = 0.999) with values obtained using the standard method (mean value 88.02 g/sq mt and SD 34.11). The practical advantages of the new method are discussed (simplicity of calculating equation without determining the minor axis of the ventricular silhouette), together with its limits due to the monoplanar technique used to calculate the volume and the measurement of wall thickness in those cases in which the postero-lateral wall is considered the most representative of the mean thicknesses of the left ventricular wall. Lastly, the paper discusses the possibility of applying this method to non-invasive procedures, such as the two dimensional echocardiogram, where more reliable mass values could be obtained even in the event of non-uniform wall thickness.

Left ventricular filling rate at rest and during exercise in patients with previous myocardial infarction.

The purpose of this investigation was to define, with radionuclide technique, the variation on left ventricular filling rate in patients with coronary artery disease, and to determine the effects of dynamic exercise on this variation. The study was carried out on 91 subjects, 46 patients with anterior and 30 with inferior previous transmural myocardial infarction; 15 healthy subjects were studied as control group. All the patients underwent coronary angiography and left ventriculography. From the left ventricular time activity curve we considered the diastolic parameters of the peak filling rate (PFR). We considered also the relative end-diastolic volume (rEDV) and the relative end-systolic volume (rESV). These parameters were determined at rest and at the fifth minute of a symptom limited dynamic exercise taken in the supine position, on an ergometric bicycle. In normal subjects rest mean PFR values is 3.08 +/- 0.51 edv/s, during exercise occurs a physiological increase and mean PFR values becomes 5.48 +/- 1 edv/s. The patients with previous myocardial infarction show a PFR significantly smaller than in normal subjects. Abnormal PFR indices during exercise are present in a large number of these patients and the higher anomalies of PFR during exercise were found among patients with anterior myocardial infarction. In these patients we found an increase of rESV during exercise. In conclusion myocardial infarction induces significant alterations of the PFR; physical exercise reveals PFR alterations not exhibited at rest and rESV increase during exercise could be responsible for the PFR alteration observed.

Prognostic significance of the evolution of left ventricular ejection fraction in patients with acute myocardial infarction not treated with thrombolytic therapy.

Several controlled trials on the thrombolytic treatment of acute myocardial infarction (AMI) have failed to demonstrate that thrombolysis has a simultaneous positive effect on left ventricular function and survival. One explanation may be that spontaneous changes in left ventricular function occurred during the progression of AMI in control patients. The aim of this study was to evaluate the spontaneous evolution of left ventricular ejection fraction (LVEF) and its prognostic influence on early (1 month) and late (1 year) mortality in patients with AMI. We studied 216 patients admitted to our CCU within 24 h of the onset of symptoms. LVEF was determined by radionuclide ventriculography on admission (RNV1) and at the end of the necrotic phase (RNV2). Fourteen patients died before RNV2. On the basis of LVEF values at RNV1, the remaining 202 patients were divided into two groups: those with a normal LVEF (> or = 55%), and those with an abnormal LVEF (< 55%). Among patients with a normal LVEF at RNV1 (64 patients), a significant increase (> 12%) in LVEF at RNV2 was observed in 12.5%, a significant decrease (> 12%) in 12.5% and no change at all in 75%. All of these patients survived, regardless of the evolution of LVEF. In patients with an abnormal LVEF at RNV1 (138) a significant increase (> 5%) in LVEF at RNV2 was observed in 72.5%, a significant decrease (> 5%) in 6.5% and no change at all in 21%.(ABSTRACT TRUNCATED AT 250 WORDS)

[The development of a computer model in the quantitative assessment of thallium-201 myocardial scintigraphy]. / Sviluppo di un modello informatico nella valutazione quantitativa della scintigrafia miocardica al tallio-201.

Thallium-201 scintigraphy is a widely used noninvasive procedure for the detection and prognostic assessment of patients with suspected or proven coronary artery disease. Thallium uptake can be evaluated by a visual analysis or by a quantitative interpretation. Quantitative scintigraphy enhances disease detection in individual coronary arteries, provides a more precise estimate of the amount of ischemic myocardium, distinguishing scar from hypoperfused tissue. Due to the great deal of data, analysis, interpretation and comparison of thallium uptake can be very complex. We designed a computer-based system for the interpretation of quantitative thallium-201 scintigraphy data uptake. We used a database (DataEase 4.2-DataEase Italia). Our software has the following functions: data storage; calculation; conversion of numerical data into different definitions classifying myocardial perfusion; uptake data comparison; automatic conclusion; comparison of different scintigrams for the same patient. Our software is made up by 4 sections: numeric analysis, descriptive analysis, automatic conclusion, clinical remarks. We introduced in the computer system appropriate information, "logical paths", that use the "IF ... THEN" rules. The software executes these rules in order to analyze the myocardial regions in the 3 phases of scintigraphic analysis (stress, redistribution, re-injection), in the 3 projections (LAO 45 degrees, LAT,ANT), considering our uptake cutoff, obtaining, finally, the automatic conclusions. For these reasons, our computer-based system could be considered a real "expert system".

[Effect of ticlopidine and dipyridamole on platelet aggregation and count in patients with chronic stable angina pectoris]. / Efeito da ticlopidina e do dipiridamol sobre a agregação e contagem das plaquetas de pacientes com angina crônica estável.

PURPOSE: To compare the ticlopidine and dipyridamole effects on platelets count and aggregation in patients with stable coronary artery disease. PATIENTS AND METHODS: Eighty patients with stable coronary artery disease and mean of 58.3 +/- 5.8 years were studied. They were divided into two equal groups of 40 patients and each one treated with ticlopidine or dipyridamole. Platelets count and aggregation were examined before treatment and at first and fourth weeks of treatment. RESULTS: At the end of fourth week of treatment, spontaneous, induced by ADP or by adrenalin platelet aggregation inhibition was observed, respectively, in 82.5%, 72.5% e 67.5% of the patients in ticlopidine group. The spontaneous, induced by ADP or by adrenalin, platelet aggregation inhibition in the patients of dipyridamole group was, respectively, 40%, 30% e 27.5% (p less than 0.001). The platelets count did not change in both groups. CONCLUSION: The ticlopidine effect is much more evident in platelet aggregation inhibition than dipyridamole, and maybe a choice in the prevention of cardiovascular events.

Subjective probability and delay.

Human subjects indicated their preference between a hypothetical $1,000 reward available with various probabilities or delays and a certain reward of variable amount available immediately. The function relating the amount of the certain-immediate reward subjectively equivalent to the delayed $1,000 reward had the same general shape (hyperbolic) as the function found by Mazur (1987) to describe pigeons' delay discounting. The function relating the certain-immediate amount of money subjectively equivalent to the probabilistic $1,000 reward was also hyperbolic, provided that the stated probability was transformed to odds against winning. In a second experiment, when human subjects chose between a delayed $1,000 reward and a probabilistic $1,000 reward, delay was proportional to the same odds-against transformation of the probability to which it was subjectively equivalent.

Quantitative analysis of ventricular late potentials in healthy subjects.

Signal averaging is a technique that improves the signal-to-noise ratio. Obscuring random noise, it allows the detection of low-amplitude wave forms in the terminal portion of the QRS complex, also known as ventricular late potentials. A higher incidence of arrhythmic events has been found in patients with abnormal ventricular late potentials after an acute myocardial infarction. Few studies have been conducted in healthy subjects to assess normal values. Sixty-one healthy subjects were enrolled in our study (33 men and 28 women). The results (mean +/- standard deviation) are as follows: duration of the filtered QRS (QRS duration) was 95 +/- 10 ms; duration of the low-amplitude signals in the terminal portion of QRS less than 40 microV (LAS less than 40) was 32 +/- 8 ms; and root-mean-square voltage in the last 40 ms (RMS - 40) was 33 +/- 16 microV. A significant difference was noted in QRS duration between men and women (98 +/- 11 vs 92 +/- 6 ms, p = 0.006); no difference was found in LAS less than 40 (31 +/- 8 vs 34 +/- 8 ms) and in RMS-40 (36 +/- 17 vs 30 +/- 13 microV). QRS duration confidence limits of 95% were less than or equal to 114 ms for the total group, less than or equal to 120 ms for men and less than or equal to 104 ms for women. Normalization of QRS duration for height (normal value less than 66 ms/m) eliminated any difference between men and women.(ABSTRACT TRUNCATED AT 250 WORDS)

[Electrocardiographic indices of reperfusion and limitation of the necrotic area in acute myocardial infarct]. / Indici elettrocardiografici di riperfusione e di limitazione dell'area di necrosi nell'infarto miocardico acuto.

The aim of this study was to assess the evolution of ST segment displacement and the formation of new Q waves in relation to the late angiographic demonstration of recanalization of the infarct-related vessel in 36 patients with acute myocardial infarction admitted in our Institution within 8 hours from the onset of symptoms. Eighteen patients were treated with intravenous urokinase (200,000 + 1,200,000 UI) followed by sodium-heparin 1,000 U/ev/hour for 48 hours and calcium-heparin 3,000 UI/10 Kg/12 hours from the third day to discharge. Eighteen patients were treated from admission only with calcium-heparin as seen before. All the patients have been followed with serial electrocardiograms; we evaluated the sum of ST displacements (ST12) and Q waves score (Q12) in the 12 standard leads on admission, and on the twelfth, twenty-fourth, forty-eighth hour, and on discharge. On the basis of the late angiographic findings and apart from the treatment, we divided the patients into 2 groups: patients with recanalization of infarct-related vessel (20 patients, 55.5%) and patients with occlusion of the infarct-related vessel (16 patients, 44.6%). We did not observe statistically significant differences between the 2 groups for decrease of ST segment displacement of formation of new Q waves, even if reperfused patients showed a more rapid and complete decrease of ST segment displacement and a more rapid formation of new Q waves with respect to occluded patients. Our data indicate that from a clinical point of view electrocardiographic indices are not a sensitive marker of recanalization of infarct-related vessel.(ABSTRACT TRUNCATED AT 250 WORDS)

[Cardiac arrhythmias in hypertensive subjects with and without left ventricular hypertrophy compared to the circadian profile of the blood pressure]. / Aritmie cardiache in soggetti ipertesi con e senza ipertrofia ventricolare sinistra in rapporto al profilo circadiano della pressione arteriosa.

To evaluate possible correlations between cardiac arrhythmias and circadian pattern of blood pressure (BP) and of heart rate (HR), we studied 2 groups of 20 males with stable arterial hypertension of mild to moderate entity, with (Group I) or without (Group II) left ventricular hypertrophy (LVH). In patients with LVH the mean age (56 vs 46 years), the duration of the hypertensive state (48.1 vs 15.7 months), the thickening of interventricular septum (IVS; 13.7 vs 9.6 mm) and of the posterior wall of the left ventricle (13.2 vs 9.2 mm) and the mass of LV (149.8 vs 99.7 g/m2) were significantly greater (p less than 0.01). On the contrary, the 2 groups did not show significant differences concerning casual BP determined in the morning (178.3/108.4 vs 171.5/106.2 mmHg). After a pharmacological washout of 2 weeks, patients underwent a noninvasive, intermittent, monitoring of BP (every 15 min during daytime and every 30 min from 11 pm to 7 am), using a pressure meter II Del Mar Avionics, and a continuous monitoring of ECG for 24 hours, employing an instrument 445/B Del Mar Avionics. Mean 24-hour BP was not different in the 2 groups of patients (161.7/99.0 vs 158.2/98.3 mmHg); however, patients with LVH showed a significantly greater variability of BP in the morning (7 am-3 pm), while mean 24-hour HR was significantly less (71.6 vs 78.2 b/min).(ABSTRACT TRUNCATED AT 250 WORDS)