BACKGROUND AND OBJECTIVES: To illustrate that the combination of a single nucleic acid amplification test (NAT) with a single immunoassay for hepatitis C virus (HCV) detection, as proposed internationally, may lead to the omission of anti-HCV reactive sera with non-reactive NAT results. MATERIALS AND METHODS: In total, 822 of 519, 299 serum samples from 11 blood centres in China were retested for anti-HCV by using 10 screening assays to detect HCV antibodies. A recombinant immunoblot assay (RIBA HCV 3·0; Ortho-Clinical Diagnostics) was performed to define confirmed HCV infection status. Samples with positive or indeterminate RIBA-HCV results were tested by quantitative tests for HCV RNA (Roche Diagnostics). RESULTS: We found that 47 of the 822 (5·72%) serum samples were RIBA-positive without detectable HCV RNA. For these samples, the 10 anti-HCV immunoassays gave discordant and unsatisfactory results (detection rate ranging from 10·64 to 34·04%; ratio per 100 000 donations ranging from 5·97 to 8·09). Compared with a single anti-HCV screening assay, the two-assay combination increased the detection of these samples. The five best combinations [Sorin and Lizhu enzyme immunoassays (EIAs), Ortho and Lizhu EIAs, Sorin and Wantai EIAs, Sorin EIA and Roche CIA and Ortho and Wantai EIAs] increased the detection rate from 46·81 to 55·57%, thus reducing the ratio per 100 000 donations of HCV-seropositive samples. CONCLUSION: The combination of two anti-HCV screening immunoassays in parallel with an HCV NAT is a better strategy for HCV detection in blood centres to improve the safety of blood transfusion.
BACKGROUND AND OBJECTIVES: To illustrate that the combination of a single nucleic acid amplification test (NAT) with a single immunoassay for hepatitis C virus (HCV) detection, as proposed internationally, may lead to the omission of anti-HCV reactive sera with non-reactive NAT results. MATERIALS AND METHODS: In total, 822 of 519, 299 serum samples from 11 blood centres in China were retested for anti-HCV by using 10 screening assays to detect HCV antibodies. A recombinant immunoblot assay (RIBA HCV 3·0; Ortho-Clinical Diagnostics) was performed to define confirmed HCV infection status. Samples with positive or indeterminate RIBA-HCV results were tested by quantitative tests for HCV RNA (Roche Diagnostics). RESULTS: We found that 47 of the 822 (5·72%) serum samples were RIBA-positive without detectable HCV RNA. For these samples, the 10 anti-HCV immunoassays gave discordant and unsatisfactory results (detection rate ranging from 10·64 to 34·04%; ratio per 100 000 donations ranging from 5·97 to 8·09). Compared with a single anti-HCV screening assay, the two-assay combination increased the detection of these samples. The five best combinations [Sorin and Lizhu enzyme immunoassays (EIAs), Ortho and Lizhu EIAs, Sorin and Wantai EIAs, Sorin EIA and Roche CIA and Ortho and Wantai EIAs] increased the detection rate from 46·81 to 55·57%, thus reducing the ratio per 100 000 donations of HCV-seropositive samples. CONCLUSION: The combination of two anti-HCV screening immunoassays in parallel with an HCV NAT is a better strategy for HCV detection in blood centres to improve the safety of blood transfusion.