No abstract

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.

Recent studies indicate that potentially infectious blood collected during a donor's anti-HCV-negative window period may be detected by testing for HCV RNA 1 or HCV core antigen. 2,3 HCV RNA mini-pool screening of blood donations for HCV by PCR was started in Poland at the beginning of 2000. All donations were screened for anti-HCV to eliminate anti-HCV reactive samples before the preparation of mini-pools. Testing for HCV RNA was accomplished in mini-pools of 48 prepared using a robotic sample processor (Genesis 200, Tecan, Hombrechtikon, Switzerland). Isolation of RNA and detection of HCV RNA was performed with PCR (COBAS Amplicor version 2.0, Roche Diagnostic, Mannheim, Germany) in the presence of the internal control and the positive control containing 100 IU of HCV (WHO Standard). Identification of positive donations was performed by using a pool management system ( Tecan Software GmbH, Hannover, Germany). The HCV RNA-positive samples were further tested for HCV core antigen (Ortho-Clinical Diagnostics, Raritan, NJ), anti-HCV (Ortho HCV 3.0; Abbott HCV 3.0, Abbott Laboratories, Wiesbaden-Delkenheim, Germany; and Organon UBI, Organon Teknika, Boxtel, the Netherlands), HCV genotype (InnoLipa HCV, Innogenetics, Zwifnaarde, Belgium), and quantitative HCV RNA (COBAS Amplicor HCV Monitor 2.0). The total number of donations tested was 144,000. Two donations (0.0014%) of 144,000 tested were identified as HCV RNApositive and anti-HCV-negative. Both donations also reacted for HCV core antigen. The HCV serologic test and PCR results for these two specimens are shown in Table 1.The identification of two RNA-positive specimens among the 144,000 tested represents a somewhat greater yield of specimens (1/72,000) identified by NAT than has been observed elsewhere in Europe and the United States. 4,5 It should be noted that the average rate of anti-HCV reactivity among Polish blood donors between 1996 and 1998 was 0.53 percent. Notably, both HCV RNA-positive specimens identified by PCR testing of mini-pools reacted strongly in an HCV core antigen ELISA (Ortho). These results support previous studies 2,3 suggesting that the HCV core antigen ELISA may be an acceptable alternative technology for identifying viremic preseroconversion donations containing hepatitis C virus. Moreover, the HCV core antigen ELISA offers operational advantages over PCR testing of pooled donations, 1 because of the shorter time to results and the ability to screen individual blood donations.

Treatment of blood components with the Mirasol PRT System has proven to be safe for patients and is not associated with increased rates and grades of adverse events in patients of hospitals in the Warsaw Region.

Background. The quality of platelet concentrates (PCs) is affected by preparation, storage, the type of container, and pathogen reduction technology (PRT). The Mirasol® Pathogen Reduction Technology (PRT) system (Terumo BCT Inc., Lakewood, USA), which uses riboflavin and ultraviolet (UV) light, has recently been proven effective against bacteria, viruses, parasites, and leukocytes.