Prevalence of SENV-H viraemia among healthy subjects and individuals at risk for parenterally transmitted diseases in Germany.

The prevalence of a newly described DNA virus (SENV-H) was examined in a population of 599 individuals by polymerase chain reaction (PCR). All individuals were assigned to a nonrisk or a risk group depending on the presence of historical or serological factors indicating an increased risk for parenterally transmitted diseases. In a group of 226 healthy blood donors, 38 (16.8%) were found to be SENV-H viraemic. The highest prevalence of SENV-H viraemia was observed among patients infected by HIV (28 of 63; 44.4%). Contrarily, of 78 individuals on maintenance haemodialysis, only 10 (12.8%) were found positive in the SENV-H PCR. Our results demonstrate that SENV-H viraemia is widespread in the general population. Therefore, it seems to be questionable if parenteral transmission is the main route for spreading SENV-H. The hepatitis-inducing capacity of SENV-H is unclear. However, taking our clinical and epidemiological data into account it seems unlikely that this virus is responsible for hepatitis.

The HTLV type I sequence from an asymptomatic German blood donor is related to sequences from South America.

In most parts of Europe only a limited number of sporadic cases of HTLV-I infections have been identified. So far, the few cases found in Germany were individuals from endemic areas or with relations to endemic areas. Here we report an HTLV-I infection from an asymptomatic female German blood donor whose only known potential risk was a former partner from South America, where HTLV-I is known to be endemic. The DNA sequence of the LTR region was determined and a phylogenetic analysis indeed suggested homologies with HTLV-I sequences from South America.

Distribution of hepatitis G viremia and antibody response to recombinant proteins with special regard to risk factors in 709 patients.

A new virus named hepatitis G virus (HGV) has been detected recently. Until now, no assays for the detection of antibodies against different HGV proteins have been commercially available. Therefore, a strip immunoblot assay has been established to investigate seroreactivity against recombinant structural (core) and nonstructural proteins (NS3 and NS4) of HGV produced in Escherichia coli. Seropositivity for HGV was evaluated and concordanced with HGV polymerase chain reaction (PCR) results in 709 subjects. These individuals were classified into a nonrisk or a risk group, on the basis of infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or frequent parenteral exposure, including hemophilia, intravenous drug addiction, receipt of blood transfusion, or hemodialysis. The nonrisk group consisted of 257 healthy blood donors with normal alanine transaminase (ALT) levels (ALT < 30 U/L) and 154 patients with suspected non-A-E hepatitis (ALT > 45 U/L). In the group of healthy blood donors, 1.9% (5 of 257) had detectable HGV viremia and 15.9% (41 of 257) showed antibody response to HGV. In the collective of patients with suspected non-A-E hepatitis, results from 1.9% of patients (3 of 154) were positive by HGV PCR, and 15.6% of patients (24 of 154) showed seropositivity against the recombinant HGV proteins. In six groups of patients (n = 298) with different risk factors, the prevalence of both HGV viremia (V) and serological reactivity (SR) was higher compared with that of the nonrisk group: V, 6.80%-35.2%; serological reactivity (SR), 25.4%-52.9%. The following conclusions can be derived from our data. HGV infection is widespread in the general population. The prevalence of antibodies against HGV or detectable HGV viremia is higher in patients with risk factors for parenteral viral transmission than in those without risk factors. The majority of HGV infections (70.2%) is self-limiting and not persistent in our collective of patients. We found no correlation between HGV viremia and clinical or biochemical signs of hepatitis in individuals without risk factors for acquiring parenterally transmitted agents.

Prevalence of hepatitis G viremia among healthy subjects, individuals with liver disease, and persons at risk for parenteral transmission.

The prevalence of hepatitis G virus (HGV) and hepatitis C virus (HCV) infection was determined by reverse transcription-PCR in 777 individuals with and without risk factors for viral transmission via blood. From our results we conclude that transmission of HGV and that of HCV are favored by similar risk factors.

Screening for hereditary hemochromatosis in prospective blood donors.

Prospective blood donors (n = 1,265, mean age 26 years) were screened for elevated serum ferritin and serum iron. Final diagnosis for hereditary hemochromatosis was made by liver iron concentration (noninvasive biomagnetometry), transferrin saturation, and 59Fe absorption in 3 male subjects. This preliminary result confirms for the first time the current frequency estimation of homozygous hemochromatosis (0.2-0.6%) in a group of young North-Germans.

[Hepatitis e antibodies in blood donors, hemodialysis patients and in normal people]. / Hepatitis-E-Antikörper bei Blutspendern, Hämodialysepatienten und in der Normalbevölkerung.

A substantial proportion of cases of enterically transmitted acute viral hepatitis occurring in young to middle-aged adults in Asia and the Indian subcontinent is caused by the hepatitis E virus (HEV). It is transmitted mainly by contaminated drinking water and is associated with a high mortality rate (up to 20%) in pregnant women. Chronic forms of hepatitis E are not known. An enzyme immunoassay (EIA) for the detection of IgG antibodies to hepatitis E (Abbott), based on two recombinant HEV antigens, yielded repeatedly reactive results in 5 of 250 (2%) blood donors, 13 of 543 (2.4%) healthy employees from four firms in Hamburg, and in 5 of 150 (3.3%) hemodialysis patients. Supplemental testing by two synthetic peptide EIAs and by Western Blot confirmed positive results in 22/23 samples. None of the samples was IgM antibody-positive. Since no transfusion-transmitted cases of hepatitis E have been observed so far, HEV assays seem to be more useful for differential diagnosis of viral hepatitis than for the screening of donors in the blood bank setting.

[HIV antigen test of blood donors]. / HIV-Antigen-Test bei Blutspendern.

The importance of an optimal diagnostic standard for the prevention of transfusion-associated AIDS (TAA) was recently enforced by a decision of our Supreme Court. Although only 18 transfusion-associated HIV infections following transfusion of approximately 30 million blood units were officially reported since 1985, HIV-1 p24 antigen testing of blood donors was introduced in Hamburg and by the Bavarian Red Cross in summer 1992. So far, no p24 antigen-positive, HIV antibody-negative blood donor has been found (May 1993).

[Initial experiences with HCV detection and confirmation tests of the 3rd generation]. / Erste Erfahrungen mit Anti-HCV-Such- und Bestätigungstests der 3. Generation.

We compared the reactivity of a new 3rd-generation anti-HCV enzyme immunoassay (EIA) using an additional, nonstructural antigen from the NS5 region, with a currently used 2nd-generation anti-HCV EIA, by investigating 419 serum specimens from healthy blood donors with normal liver function and 256 samples from patients at risk for hepatitis C infection; 2 of 419 blood donors and 1 of 256 patients were reactive to the NS5 region antigens only (later confirmed by Western blot and RP-2 RIBA), whereas 1 patient was reactive with the 2nd-generation EIA only (antibodies against c33c). We further evaluated the recently developed anti-HCV RP-2 RIBA by testing samples, that were indeterminate by the 2nd-generation RIBA. Nine of 15 patients were identified as reactive by RP-2 RIBA, 6 remained indeterminate. Of the 6 blood donor samples tested, 2 were found reactive, 1 remained indeterminate, and 3 were negative. These test results suggest a higher sensitivity and specificity of the RP-2 RIBA, whereas the relevance of an isolated NS5 EIA reactivity remains to be established.

[Prevalence of hepatitis C virus in poly-transfused patients with hematologic and oncologic diseases]. / Prävalenz des Hepatitis-C-Virus bei polytransfundierten Patienten mit hämatologischen und onkologischen Erkrankungen.

Patients with hematological and oncological diseases often require intensive, supportive hematotherapy due to the underlying disease or chemo-/radiotherapy. As a consequence, they had an increased transfusion-associated risk of hepatitis C virus infections (non-A, non-B-posttransfusion hepatitis) until 1989-1990, when specific and sensitive HCV antibody tests became available. This is confirmed by our study of 'first' and 'second' generation (1.0 and 2.0) anti-HCV EIAs against structural and non-structural (NS) antigen-determinants. Ten of 101 patients (10.9%) were anti-HCV positive in 2.0 tests. HCV antibodies were detected more often by 2.0 EIAs and the new HCV-immunoblot (4-RIBA), than by 1.0 EIAs. In this respect, the patients' serological HCV profile differs from that of healthy blood donors, which display a prevalence of NS-antibodies.

[Hepatitis C virus antibodies in patients and the normal population]. / HCV-Antikörper bei Patienten und in der Normalbevölkerung.

With regard to the controversial issue of a reduction of transfusion-associated infections by non-remunerated donations, epidemiological data on the prevalence of HIV-1, HIV-2 and hepatitis C virus (HCV) are of particular interest in our country. We investigated four sample categories: (1) healthy employees and workers from Hamburg; (2) hemodialysis patients; (3) hemato-oncological patients, and (4) blood donors, and tried to differentiate between the three disputed vectors of community-acquired (sexually or pregnancy-transmitted), nosocomial and transfusion/transplantation-associated HCV infections. We conclude from our results that--prior to the implementation of blood screening--our carefully selected 'paid blood donors' conferred no higher HCV risks than the general (working) population (0.66 vs. 0.82% HCV antibody prevalence). Besides transfusions/transplantations, significant nosocomial risks apparently exist in hemodialysis units (21.0 vs. 9.5% HCV seroprevalence in polytransfused patients). Preventive measures, e.g. separate dialysis machines for HCV-positive patients, seem to be advisable.

[Comparative study of 8 combined HIV-1,2-antibody tests]. / Vergleichsuntersuchung von acht kombinierten HIV-1,2-Antikörpertests.

The sensitivity and specificity of eight different' combined' HIV-1,-2 antibody EIA's were compared by investigating serial dilutions of 22 HIV-1 and 11 HIV-2 antibody-positive sera, as well as 520 HIV-negative donor sera. All eight EIA's detected our neat seropositive samples, however with marked differences in diluted samples. For routine purposes six out of seven HIV-EIA's (and possibly also a rapid test pack) proved to be suitable.

[CMV antibody determination with two enzyme immunoassays in each case]. / CMV-Antikörper-Bestimmung in jeweils zwei Enzymimmunoassays.

In each of the two present studies (Frankfurt blood donor center and blood bank of the university of Hamburg) two commercial enzyme immunoassay (EIA) test kits for detecting cytomegalovirus (CMV) antibodies were compared according to their concordance. In the Frankfurt study, 448 sera of blood donors and patients were tested for IgG- and IgM-specific antibodies by CMV-ELA Test (Medac); IgG-specific antibodies were tested in 3 serum dilutions (1:10, 1:100, 1:1000) of each sample, 221 sera were additionally assayed using the EIA of ABBOTT. Both methods showed the same results in 214/221 (96.8%) sera (p less than 0.001). The determination of CMV-IgG-specific antibody levels were as follows: Out of 294 seropositive individuals, titers greater than or equal to 1:1000 were seen in 81% (238). IgM antibodies to CMV were determined in 22/448 serum specimen, which all had IgG antibodies too; there were 18/22 (81.8%) samples with elevated titers for CMV-IgG (greater than or equal to 1:1000). In the second study, 500 sera of blood donors from Hamburg were tested for CMV-IgG antibodies by two enzyme immunoassays, CMV-IgG-ELA (Medac) and Anti-CMV-IgG-ELISA (Biotest). The results were concordant in 418 (83.6%) of the 500 samples (p less than 0.01). All EIA procedures were found to be convenient test methods for CMV antibody screening and the results showed significant correlations. Furthermore, the determination of CMV-IgG-specific antibodies seems to be sufficient for routine CMV screening in blood donor centers.