Plasma pooling in combination with amotosalen/UVA pathogen inactivation to increase standardisation and safety of therapeutic plasma units.

OBJECTIVES: Assessment of the impact of pooling five single-donor plasma (SDP) units to obtain six pathogen-reduced therapeutic plasma (PTP) units on standardisation and the retention of labile coagulation factors. BACKGROUND: SDP shows a high inter-donor variability with potential implications for the clinical treatment outcome. Additionally, there is still an existing risk for window-period transmissions of blood borne pathogens including newly emerging pathogens. METHODS/MATERIALS: Five ABO-identical SDP units were pooled, treated with the INTERTCEPT™ Blood System (Cerus Corporation, U.S.A.) and split into six PTP units which were frozen and thawed after 30 days. The variability in volume, labile coagulation factor retention and activity was assessed. RESULTS: The variability of volumes between the PTP units was reduced by 46% compared to SDP units. The variability in coagulation factor content between the PTP units was reduced by 63% compared to SDP units. Moderate, but significant losses of coagulation factors (except for vWF) were observed in PTPs compared to SDPs. CONCLUSION: The pooling of five SDP units to obtain six PTP units significantly increases product standardisation with potential implications for safety, economics as well as transfusion-transmitted pathogen safety, making it an interesting alternative to quarantine SDP (qSDP) and pathogen-reduced SDP.

Assessing quality of blood components derived from whole blood treated with riboflavin and ultraviolet light and separated with a fully automated device.

BACKGROUND: Combining pathogen reduction and automated separation of whole blood (WB), together with the use of improved additive solutions, may increase reproducibility and extend shelf-life of blood components. MATERIALS AND METHODS: Forty WB units were collected from volunteer donors and randomised 1:1 into two groups: 1) pathogen reduction with riboflavin and ultraviolet light (PRT); or 2) no treatment (Control). After two hours (h) at room temperature, all units underwent fully automated separation into red blood cell concentrate (RBCC), plasma and leukopack components. RBCCs were leukoreduced and stored in phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) solution while plasma units were shock frozen within 8 h of collection and stored at ≤ -25°C. RBCCs were sampled on day 1 and weekly thereafter until day 42, while plasma was sampled on days 1 and 30. The main study objective was to assess the in vitro quality of separated RBCCs using biochemical and haematological parameters. Plasma protein content after one cycle of freeze-thaw was also analysed. RESULTS: The quality of RBCCs was largely comparable between the PRT and Control groups, except for a significantly higher degree of haemolysis and extracellular potassium levels in the PRT group after 35 days of storage. While potassium concentration was significantly higher in the PRT group at all timepoints, the degree of haemolysis exceeded the accepted European threshold (i.e., <0.8% of red cell mass in ≥ 90.0% of tested units) after day 35. Most plasma protein levels were significantly lower in the PRT than the Control group at both day 1 and day 30. DISCUSSION: Pathogen reduction with riboflavin and ultraviolet light treatment of WB can be combined with fully automated separation to obtain RBCCs that may be stored for up to 35 days in PAGGSM solution with acceptable quality, comparable to that of RBCCs from untreated blood. The relative differences between factor concentrations in plasma from the PRT and the Control groups were similar during the 30-day storage.

[Prevalence of hepatitis C virus markers in Polish blood donors in 1994-2003]. / Analizaczestosci wykrywania markerów zakazenia wirusem zapalenia watroby typu C (HCV) u polskich dawców krwi w latach 1994-2003.

The results of serological and molecular screening tests for HCV performed by Polish Blood Transfusion Service between 1994 and 2003 are presented. Serological tests were performed in 4,233,119 donors. The average frequency of anti-HCV was 0,48%. The frequency of anti-HCV was higher in first time donors (0,86%) than in repeat donors (0,23%). In both groups a decreasing trend in anti-HCV frequency was observed--4% annually in the group of candidates for donors and 21% annually in repeat donors. Molecular methods for identification of HCV infection in serologic window period were introduced in 2000. RNA HCV was detected in 51 out of 2,915,299 (0,002%) anti-HCV negative plasma samples. The frequency of HCV infection markers is in Poland higher than in most European countries. However, a decreasing tendency of HCV markers detection, especially in repeat donors is observed.

[HCV RNA testing for early diagnosis of hepatitis C in blood donors--new challenge for transfusion medicine and hepatology]. / Rozpoznanie wczesnego etapu zakazenia HCV u dawców krwi poprzez badanie RNA HCV--nowe wyzwanie dla transfuzjologii i hepatologii.

To improve the blood transfusion safety, according to the international recommendations anti-HCV negative blood donors are screened for HCV RNA. For decreasing the costs, the pools of 48 donor samples are tested. Until now 2,500,000 Polish donors were tested and HCV RNA was detected in 40. Anti-HCV was detected in plasma of all donors available for follow up for more than three months. No clinical symptoms were observed but in 20 donors slightly elevated ALT level was found. In the follow up, after detection of anti-HCV in 9/11 donors elevated ALT (167-2043 U/l) was observed. In two donors, out of 4 observed for more than 12 months HCV RNA was not detected in the follow up whereas anti-HCV were still present. In 7 donors probable source of infection was identified. The early detection of HCV infection is a serious challenge not only to transfusion medicine but also to general practitioners and hepatologists due to the necessity of further monitoring and treatment of infected individuals.

Hepatitis C core antigen in Polish blood donors.

BACKGROUND: The goal of this study was to evaluate the feasibility of adopting the HCV core antigen ELISA (HCVcAg) for routine screening of Polish blood donors. STUDY DESIGN AND METHODS: A total of 133,279 donor samples were tested by ORTHO HCVcAg. All repeatedly reactive (RR) samples were tested by neutralization test for confirmation, RIBA HCV for anti-HCV, and by Cobas Amplicore for HCV RNA. All donations were tested for ALT level. RESULTS: The HCVcAg test specificity was 99.94 percent. In total, 1499 donations (1.12%) were initially reactive and 124 (0.09%) were RR. Antibodies to HCV were found in 22 out of 124 donors and HCV RNA was detected in 19 out of 22. In 10 out of the 19 HCV-RNA-positive donors, the HCVcAg neutralization test was positive. Among the 102 HCVcAg RR/anti-HCV-negative donors, there were 6 neutralization-test-positive individuals, and all were HCV RNA positive. Elevated ALT level was observed in one of them. During the follow-up studies of three HCVcAg RR/HCV-RNA-positive donors, seroconvertion was observed 5 to 7 weeks after the initial HCVcAg-positive result. In all, HCVcAg results became negative once antibodies to HCV were detected. CONCLUSION: The HCVcAg test proved to be feasible for routine screening in the Polish Blood Transfusion Service. Six HCVcAg RR/anti-HCV-negative donors were identified. The calculated residual risk in this study of donors in the preseroconversion window was 45 per million. Mandatory testing of every blood and plasma donation for HCVcAg or HCV RNA was recommended as of January 2, 2002.