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SUMMARY Background Implementation of fully automated analysers has become a crucial security step in the blood bank; it reduces human errors, allows standardisation and improves turnaround time ( TAT). Objectives We aimed at evaluating the ease of use and the efficiency of the ORTHO VISION® Analyser ( VISION) in comparison to the ORTHO AutoVue® Innova System ( AutoVue) in six different laboratories. Methods After initial training and system configuration, VISION was used in parallel to AutoVue following the daily workload, both automates being based on ORTHO BioVue® System column agglutination technology. Each participating laboratory provided data and scored the training, system configuration, quality control, maintenance and system efficiency. A total of 1049 individual samples were run: 266 forward and reverse grouping and antibody screens with 10 urgent samples, 473 ABD forward grouping and antibody screens with 22 urgent samples, 160 ABD forward grouping, 42 antibody screens and a series of 108 specific case profiles. Results The VISION instrument was more rapid than the AutoVue with a mean performing test time of 27·9 min compared to 36 min; for various test type comparisons, the TAT data obtained from VISION was shorter than that from AutoVue. Moreover, VISION analysed urgent STAT samples faster. Regarding the ease of use, VISION was intuitive and user friendly. Conclusions VISION is a robust, reproducible system performing the most types of analytical determinations needed for pre-transfusion testing today, thus accommodating a wide range of clinical needs. VISION brings appreciated new features that could further secure blood transfusions. [ABSTRACT FROM AUTHOR]

ABSTRACT- Owing to the low incidence of hepatitis B in Denmark, screening of blood donors for HBsAg has mostly been done by immunoelectroosmophoresis (IEOP). The purpose of the present study was to carry out a cost-effectiveness analysis prior to the introduction of a third-generation test for HBsAg in Danish blood donors. The analysis was performed on data from a subsequent screening of 48 750 blood units by radioimmunoassay (RIA) 3 weeks after donation. The RIA-pos., IEOP-neg. blood donors identified in the study were evaluated by a follow-up examination, and the recipients of RIA-pos., IEOP-neg. blood units were monitored for up to 9 months as to the development of acute hepatitis B. The study shows that the estimated cost for each prevented case of transfusion-associated hepatitis B in Denmark is US$ 1100 when screening donors not previously tested by a third-generation technique, and US$ 240 000 when screening donors tested before by this technique. [ABSTRACT FROM AUTHOR]

Direct immunofluorescence studies were performed on isolated liver cells in order to detect surface localisation of IgG in acute and chronic hepatitis and primary biliary cirrhosis. Membrane-bound IgG was demonstrated in nine patients. Six of eight patients with primary biliary cirrhosis showed granular fluorescence on their liver cell surfaces suggesting that an antibody or immune complex-mediated cytotoxicity might be involved in the pathogenesis of this disease. [ABSTRACT FROM PUBLISHER]

The prevalence of hepatitis B virus (HBV) carriage in Denmark is unknown, but expected to be low (0.1%). This study aimed to evaluate the efficacy of selective antenatal screening for HBV infection and the epidemiology of HBV and hepatitis C virus (HCV) among pregnant women. 4098 women were included in the study. Blood tests were examined for hepatitis B surface antigen (HBsAg), anti-hepatitis B core antigen (HBc) and anti-HCV. Case records were studied to evaluate whether patients at risk for HBV infection had been tested. Among the 4098 women, 18 10.4%, 95% confidence interval (95% CI) 0.3-0.71 were HBsAg positive. All had a risk factor for HBV infection. Only 13 (72%) were identified as HBsAg positive in the selective screening programme. 115 women (2.8%, 95% CI 2.3-3.4) were anti-HBc positive only. 95 (83%) were at risk for HBV. Only 72 of these (63%) were tested for HBsAg. The screening programme in this area of Denmark did not pick up one-third of pregnant women at risk of HBV.

The objective of this study was to examine whether the prevalence of hepatitis C, like hepatitis B, is increased among the mentally retarded in Denmark. The prevalence of serological markers of hepatitis B and C was examined in an institution for the mentally retarded. A total of 126 out of 178 inhabitants (71%) with a median age of 49 years (range 23-78) participated. All subjects were anti-HCV-negative by third generation ELISA antibody test. A total of 45 (35.7%) subjects were anti-HBc-positive and 10 (7.9%) were HBsAg-positive. Among subjects with Down's syndrome (n = 20), 55% were anti-HBc-positive and 30% were HBsAg-positive as compared to 32% and 3.8% respectively among others. In conclusion, hepatitis C infection seems to be uncommon among mentally retarded persons in Denmark and the risk of acquiring infection not significantly increased as compared to that of the general population. The prevalence of serological markers for hepatitis B was high and comparable to previous studies in this population.

Following a survey among all Danish haemophiliac patients 49 HIV-negative patients with chronic hepatitis C were offered enrollment in a randomized controlled open label study comparing two different maintenance regimens following standard interferon-alpha-2b treatment. Dose modifications and treatment discontinuation were based upon changes in transaminase levels. Forty-seven patients enrolled received 3 MU of alpha interferon thrice weekly (TIW) for 3 months. Twenty-six nonresponders had their dose increased to 6 MU TIW for an additional 3 months, while 21 responding patients continued on 3 MU TIW. At 6 months, 25 patients with a complete or a partial biochemical response were randomly allocated to either a fixed dose regimen (13 patients) (3 or 6 MU thrice weekly) or an individualized dose regimen (12 patients) tapering interferon dose from 3 or 6 MU by one-third every 2 months if transaminases were persistently normal. The remaining 22 biochemical nonresponders were followed for an additional 6 months without further treatment. After 12 months of treatment, 18 patients (38%) had a virological response, irrespective of regimen, and seven patients (16%) had a sustained virological and biochemical response after 6 months of follow up. Overall, the individualized treatment regimen did not seem to offer any advantage over the fixed dose regimen. The response to alpha interferon treatment in Danish haemophiliac patients with chronic hepatitis C immediately after treatment is comparable to that obtained in previous studies among nonhaemophiliacs. However, a sustained virological and biochemical response was seen in only 16% of treatment patients.

Antibodies to hepatitis C virus (anti-HCV) were determined in an unselected group of 340 patients with chronic renal failure treated with maintenance dialysis. A second generation hepatitis C virus (HCV) enzyme-linked immunosorbent assay (ELISA) was used and confirmation made by a second generation recombinant immunoblot assay (RIBA). Sixteen patients (4.7%) were anti-HCV positive and 8 (2.4%) were anti-HCV indeterminate. All anti-HCV positive and anti-HCV indeterminate patients had received blood transfusions. No statistically significant differences were found between anti-HCV positive and indeterminate patients considering blood transfusions, dialysis and liver disease. The combined group of anti-HCV positive and indeterminate patients had had more blood transfusions (P < 0.005) and had been on dialysis for a longer period (P < 0.01) compared with anti-HCV negative patients. Further, significant correlation with elevation of transaminases and anti-HCV was observed (P < 0.001). Thirty patients (8.8%) had elevated transaminase levels and 13 (43%) of these were anti-HCV positive or indeterminate. In conclusion, HCV infection accounts for a substantial proportion of liver disease in dialysis patients, probably most often transmitted by blood transfusions but other routes of transmission could not be excluded.

In Denmark only 1-3 cases of transfusion-associated hepatitis NANB (TAH-NANB) are registered annually or about 1 case per 100,000 units transfused. Thus, the prevalence of blood donors with hepatitis NANB infection is estimated to be very low and measures to prevent TAH-NANB such as surrogate testing have not been considered to be worth while. The incidence of TAH-NANB, however, may be underestimated if cases are overlooked or not identified as transfusion-associated or if registration fails. The appearance of the anti-HCV test (Ortho) has clearly provided a more sensitive and specific tool for identifying blood donors, who may transmit hepatitis NANB. In the present study, we have determined the prevalence of anti-HCV in random Danish blood donors from 1989 (fresh serum samples) and 1982 (frozen serum samples). All donors were tested for ALT and anti-HBc. A prevalence of 0.3% anti-HCV positive blood donors was found in 1989 (2/600) as well as in 1982 (2/595). Thus, no change in the prevalence of HCV infected donors seems to have occurred in Denmark during these years. The anti-HCV prevalence of 0.3% in random blood donors is low but not negligible, and if the majority of the reactive donors identified are true positives, the epidemiologic pressure as to HCV infection probably equalizes the pressure as to HBV infection (0.1-0.2%) in people attending our blood banks to become donors. In a group of donors positive for surrogate markers (ALT greater than 40 U/l and/or anti-HBc) we found only 0.9% (2/225) anti-HCV positives.(ABSTRACT TRUNCATED AT 250 WORDS)

The prevalence and course of sexual dysfunction was evaluated in 221 alcoholic cirrhotic men participating in a double-blind, placebo-controlled study on the effect of oral testosterone treatment on liver disease. At entry, 67% (95% confidence limits, 61%-74%) complained of sexual dysfunction. Sexual dysfunction was significantly (p less than 0.05) associated with lower serum concentrations of testosterone, non-protein-bound testosterone, and non-sex hormone-binding globulin-bound testosterone. The significant associations between sexual dysfunction and non-protein-bound and non-sex hormone-binding globulin-bound testosterone concentrations disappeared, however, when age, ethanol consumption, and severity of liver disease were included as covariates in the analysis. During follow-up (median 30 mo, range 1-48 mo) sexual dysfunction improved significantly (p less than 0.05) at 6, 12, and 24 mo. Furthermore, the reported libido and erectile and ejaculatory function improved significantly at the end of the follow-up period (p less than 0.01). However, the testosterone-treated patients did not differ significantly from the placebo-treated patients regarding any of the changes in sexual function. In conclusion, oral testosterone treatment does not significantly influence the type or course of sexual dysfunction in alcoholic cirrhotic men. However, sexual function improved after reduction of ethanol consumption in these patients.

Quantitation of the erythropoiesis with radio-iron (59Fe) was applied to 9 patients with untreated myelomatosis. The method included blocking of the 59Fe reutilization by injection of non-radioactive iron. There was no uniform pattern in the Fe-kinetics values. The Plasma Iron Turnover (PIT) and the Red Blood Cell Iron Turnover (RBCIT) varied from subnormal to values markedly increased above upper normal limit. The calculated average Mean Red Cell Life time (MRCL) of erythrocytes was just below normal range. The mean Marrow Transit Time (MTT) was normal in the patients, despite subnormal venous haematocrit, indicating insufficient stimulation of the bone marrow. The renal function, measured as 51Cr-EDTA clearance, was found positively correlated to the RBCIT (r = 0.78, P less than 0.05). The results suggest that the previously demonstrated relationship between anaemia and renal failure in patients with myelomatosis is caused mainly by an inability of the bone marrow to produce sufficient red blood cells under the stress of anaemia related to the degree of renal impairment.