Increased detection of hepatitis C virus (HCV)‐infected blood donors by a multiple‐antigen HCV enzyme immunoassay

Abstract

A new, multiple-antigen enzyme immunoassay (EIA-2) for hepatitis C virus (HCV) antibodies was evaluated in parallel with the previously available c100-3 HCV EIA (EIA-1) in 14,068 volunteer blood donors as well as in 25 cases of transfusion-associated hepatitis C for which recipient and donor samples were available. When compared to EIA-1, the EIA-2 was more sensitive in detecting HCV-infected blood donors. The EIA-2 detected an additional 1 in 1000 EIA-1-negative, surrogate marker-negative donors who were infected with HCV as demonstrated by polymerase chain reaction (PCR). The specificity of the EIA-2 was comparable to that of the EIA-1, but the two tests appear to detect different populations of false-positive donors. Recombinant immunoblot assay-indeterminate donors were detected five times more frequently by the EIA-2; PCR demonstrated that 21 percent of these donors were infected with HCV. The greater sensitivity of EIA-2 was also found in 25 transfusion recipients with non-A, non-B hepatitis; however, in 16 percent of these cases of posttransfusion HCV infection, the EIA-2 failed to detect an HCV-seropositive donor. These data indicate that EIA-2 testing will significantly reduce, but probably not eliminate, the risk of transfusion-associated HCV infection; we estimate this residual per-unit risk to be 1 in 2000 to 1 in 6000 units transfused. On a national level, it is projected that the replacement of the anti-HCV EIA-1 with the EIA-2 will initially prevent up to 40 additional cases of transfusion-associated hepatitis C per day.

A clinical, epidemological, laboratorial, histological and ultrasonographical evaluation of anti-HCV EIA-2 positive blood donors

“…This proportion is greater than the 36% of RIBA-2 positive cases reported in similar individuals in studies conducted in Italy 16,19 and France 22 and the 39% observed in the USA 13 . In Spain, 33-63% of anti-HCV positive donors were also RIBA-2 positive 17,20 .…”

“…Of the anti-HCV donors tested, 75% were HCV RNA positive. In Italy, in the USA and in Spain the frequency of HCV RNA positivity was 66%, 58% and 63%, respectively, among RIBA-2 positive and indeterminate donors 13,16,20 . In a recent compilation 15 62% of RIBA-2 positive or indeterminate donors were HCV RNA positive, a frequency slightly lower than that observed here among our donors (75%) with an EIA ratio>3 and high positivity for RIBA-2.…”

Transfusion-related bacterial sepsis

“…The frequency of patient sepsis attributable to transfusion of bacterially contaminated blood components appears to be very low but is similar to or less than that of transfusion-associated hepatitis C virus infection, which is transmitted in approximately 1 of 2,000 to 6,000 tested units (79) …”

Hepatitis C Virus Infection

“…13,14 A more sensitive second-generation test became available in 1992. 15 Some transfusion-associated HCV infections continue to occur because assays currently available (secondgeneration) do not detect anti-HCV in ϳ5% of infected persons, and rare donations of blood are made by persons during the period between acquisition of infection and seroconversion. Hemodialysis patients and health care workers also are at risk as a result of exposure to infectious blood.…”