Detection of HCV core antigen in HCV RNA positive, anti‐HCV negative blood donations from Polish blood donors

Abstract

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.

Characterization of HBV DNA+/HBsAg− blood donors in Poland identified by triplex NAT

“…Such yield is considerably higher than that obtained in antibody-negative samples tested for HCV antigen or RNA or HIV RNA, which also have been implemented. [15][16][17] Anti-HBc screening, the alternative approach to HBV blood safety used in countries such as France, Germany, the United States, and Canada, could not be considered in Poland because the deferral of over 5% of anti-HBc-reactive donations would compromise the national blood supply.…”

“…This pattern of fluctuating detectability of viral genome and neutralizing antibody was seen in samples from donors 7 through 13 (Table 3). A second large group of donors (15)(16)(17)(18)(19)(20)(21)(22) was characterized by the repeated detection of HBV DNA at low concentration (Ͻ1,000 IU/ mL; in most cases, Ͻ200 IU/mL) without detectable antiHBs. Anti-HBc, often associated with anti-HBe, was consistently detected.…”

Total HCV core antigen assay: A new marker of hepatitis C viremia for monitoring the progress of therapy

“…It has been demonstrated that the potential risk of transfusion-associated infection may be reduced significantly by screening for circulating HCV core antigen (HCVcAg) [Couroucé et al, 2000;Peterson et al, 2000;Brojer et al, 2001;Icardi et al, 2001;Lee et al, 2001;Piccoli et al, 2001], before the appearance of anti-HCV antibody. The diagnostic value of this assay has been limited by the relative lack of sensitivity observed in anti-HCV-positive specimens.…”

APASL consensus statements and recommendations for hepatitis C prevention, epidemiology, and laboratory testing

“…A few studies have shown that they can shorten the window period. Therefore, this was applied in blood testing to enhance the overall effectiveness of serological HCV screening in some countries [101][102][103]. However, the Global Database on Blood Safety shows that testing with anti-HCV ELISA is insufficient, particularly in countries with a low human development index-only 51.3 % of units of blood are tested for HCV [104].…”