Search

SUMMARY: Background: Whether hepatitis E virus (HEV) infection can be transmitted by coagulation factor concentrates remains unclear. Objectives: The HEV seroprevalence in blood donors and recipients of coagulation factor concentrates was compared to obtain evidence of whether a transmission of HEV by coagulation factor concentrates could occur. Methods: Archived samples from whole blood donors and patients who had received coagulation factor concentrates were investigated for the presence of anti‐HEV IgG by ELISA. Western blotting was used to confirm the positive samples that showed reactivity in the ELISA. Results: Of 357 blood donors, 68 (19%) presented IgG antibodies against HEV. Two of 92 patients who had received coagulation factor concentrates (2·2%) and 1 of the 69 patients who had received plasma‐derived products (1·5%) tested positive for anti‐HEV IgG. The seroprevalence of HEV in the patient group was significantly lower (P = 0·038) than that in the donor group. The two positive patients were a 72‐year‐old man treated with plasma‐derived products and a 5‐year‐old girl treated with a recombinant coagulation factor concentrate. Conclusion: HEV seroprevalence was significantly higher in the blood donors than in the patients with a history of coagulation factor concentrate administration. In one of two patients with detectable anti‐HEV IgG antibodies, the coagulation factor concentrate was not the probable source of infection. Our data suggest that HEV is efficiently inactivated during the manufacturing process of coagulation factor concentrates. Thus, testing for the presence of HEV RNA in plasma donated for the preparation of coagulation factor concentrates may not be necessary. [ABSTRACT FROM AUTHOR]

Background and Objectives To assess the relevance of Parvovirus B19 (B19V) DNA at low to intermediate concentrations in blood donors for the recipients of their blood components. Material and Methods We studied recipients of B19V DNA-positive blood components [red blood cell concentrates ( RBCs), pooled platelet concentrates and fresh frozen plasma]. This included archived pretransfusion samples as well as follow-up samples investigated by ELISA or NAT and genome sequence analysis. Results In 132 out of 424 recipients, we could detect no anti-B19V IgG before transfusion. In 67 out of 132 sero-negative recipients, a follow-up sample was available. Sixty-five of these received blood components from donors with <104 IU B19V DNA/ml plasma and had no evidence of transfusion-transmitted ( TT)-B19V infection. Homology in genome sequences in donor and recipient provided evidence for a TT-B19V infection in two recipients. Both patients received RBC containing 3·4 × 106 and 1·8 × 104 IU B19V DNA/ml plasma, respectively. The anti-B19V IgG titres in the donors were 2 and 76 IU/ml plasma, respectively. The antibodies in the second donor were directed against capsid proteins and are thus considered as potential neutralizing antibodies. Conclusions TT-B19V infections through blood components with low (<104 IU/ml plasma) B19V DNA concentrations did not occur in our study. One of the TT-B19V infections occurred from RBC with intermediate B19V DNA concentration despite the presence of potential neutralizing antibodies in the donor, but its clinical significance was low. [ABSTRACT FROM AUTHOR]

Background and Objectives Parvovirus B19 (B19V) DNA seems to persist in the plasma of B19V-infected blood donors. The relevance of this for recipients of single-donor blood components is yet unclear. Material and Methods We studied serial archive and follow-up samples from 75 B19V-infected blood donors to obtain more data about the duration and degree of viraemia and the presence of IgG and IgM anti-B19V. IgG antibodies were further characterized by Western blot analysis in 29 donors. Results In 411 B19V DNA-positive samples collected, we found high concentrations (>106 IU B19V DNA/ml plasma) in five. B19V DNA persisted for a mean of 21·5 months (range: 2·3-52·4; 95% confidence interval, 19·1-23·9 months) in all donors. Only 15 such samples had either no or low-titre IgG anti-B19V. IgG antibodies were predominantly directed against epitopes on the minor capsid protein VP1, thus probably of neutralizing type with high avidity. IgM anti-B19V was detectable in 9/13 samples with high DNA concentrations. Conclusions The vast majority of single-donor blood components with detectable B19V DNA are probably not infectious for their recipients because DNA is at only low levels and the donors also have potentially neutralizing antibodies with high avidity. Anti-B19V IgM testing does not identify every donation with high B19V DNA concentrations, but, in addition to B19V NAT testing, donors with persistent IgG anti-B19V might be considered 'B19V-safe' for single-donor blood components. [ABSTRACT FROM AUTHOR]

SUMMARY Objective and Background To assess the performance characteristics of two fully automated human cytomegalovirus ( HCMV) antibody tests. Materials and Methods Samples from negatively or not pre-screened blood donors were tested by the Biotest anti- HCMV recombinant IgG enzyme-linked immunosorbent assay ( ELISA) in comparison to the Abbott Architect CMV IgG assay [chemiluminescent microparticle immunoassay ( CMIA)]. For clarification, samples with discordant results between both assays were subjected to supplemental testing for anti- HCMV IgG, IgM and HCMV DNA in plasma. Results From 4938 samples tested, 362 delivered positive results in both assays (7·3%). 91 (1·8%) samples were discordant. Of 43 (two not further tested) samples positive only by ELISA, 41 were false positive, one true positive and one indeterminate. Of 45 (one not further tested) samples positive only by CMIA, 20 were false positive, 9 indeterminate and 16 true positive. Anti- HCMV IgM and HCMV DNA testing from the plasma were negative in indeterminate samples. Considering the results of supplemental testing, the CMIA achieved altogether better results concerning resolved sensitivity, resolved specificity as well as negative predictive value. Both assays had an inferior positive predictive value, with a better result for CMIA. Conclusion Overall, the performance characteristics of the CMIA were better than those of the ELISA. Owing to the inferior positive predictive value, positive test results require confirmation if blood products from donors with remote HCMV infection should be administered. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the optimal preanalytical conditions prior to nucleic acid amplification technology (NAT) for human immunodeficiency virus-1 (HIV-1) or Hepatitis C virus (HCV) RNA in pools of 96 plasma specimens with regard to storage temperature, time and plasma separation in a blood donation environment. Changes in viral nucleic acid concentration of HIV-1 and HCV were observed for 5 days according to the Paul-Ehrlich-Institute's (PEI) guidelines that demand 95%-detection limit of at least 10 000 IU mL for HIV-1 RNA and 5000 IU mL for HCV RNA within a single donor blood specimen. Ninety-five per cent detection limits of HIV-1 RNA over 3 days after storage at either 5 or 21 °C were evaluated by using standardised HIV-1 RNA-positive plasma. HCV RNA in whole blood samples proved to be more stable than HIV-1 RNA. Whole blood storage at 21 °C was shown to decrease the detectability of HIV-1 RNA even after only 18 h. Plasma samples once used for NAT at time 18 h did not alter viral stability up to 48 h after donation. Ninety-five per cent detection limits of HIV-1 RNA were securely below 10 000 IU mL for 24 h after whole blood storage at 5 °C. These results may lead to a discussion around the most suitable preanalytical conditions in blood donation environments. Contrary to the current PEI guidelines that allow storage of whole blood specimens up to 18 h at 21 °C, these results suggest that immediate storage in a 5 °C container after blood donation is more suitable and would permit storage of whole blood up to 24 h prior to the separation of plasma from cells. [ABSTRACT FROM AUTHOR]

Background and Objectives As cytomegalovirus (CMV) DNA is frequently detectable in the plasma of recently infected sero-positive blood donors, information concerning primary CMV infection is important for the identification of possibly infectious donors. Materials and Methods Monitoring of 17 982 donors for CMV antibodies and DNA in plasma identified 14 subjects with ongoing primary CMV infection. Thirteen donors were interrogated for possible sources of infection and CMV-related symptoms, and monitored for CMV antigens, CMV DNA in plasma, leucocytes and urine, course of IgG and IgM antibodies as well as markers of systemic infection and parameters of organ function. Results CMV antigens and DNA were detectable in peripheral blood for up to 54 and 269 days respectively. Clearance of CMV DNA from blood correlated with clearance of IgM antibodies, development of IgG antibodies against the membrane glycoprotein gB and development of high avidity IgG antibodies. Eighty-five percent of subjects with primary CMV infection, but even 69% of matched controls reported possibly CMV-related symptoms. Sixty-two and 23%, respectively, had contact with possible sources of infection. One donor developed a febrile illness accompanied by increased levels of CMV DNA in peripheral blood 2 to 3 weeks after seroconversion. In other donors, neither markers of systemic infection nor parameters of organ function correlated with the course of CMV DNA and antigens. Conclusion Potentially infectious donors can be identified by measuring CMV DNA, IgM antibodies or avidity of IgG antibodies. Alternatively, blood products donated during the first year after seroconversion should not be used for immunocompromised patients. [ABSTRACT FROM AUTHOR]

Although structure, biologic activities, and expression of the low-affinity IgE receptor have been investigated, the diagnostic value for allergies of this molecule and its soluble circulating fragment remains unclear. In this study, serum IgE and specific IgE antibodies were measured in 850 blood donors. A careful history of allergy was taken, and physical examination for allergic symptoms was done. Blood donors were defined as atopic subjects by the following criteria: a positive history and physical signs of atopy, as well as a detectable corresponding specific IgE antibody. Increased total IgE protein levels are associated with atopic diseases as well as with neoplasms, immuno-deficiencies, and viral and parasitic infections.