Improving the safety of blood transfusion by using a combination of two screening assays for hepatitis C virus. Issue 5 (29th September 2014)

• Record Type: Journal Article
• Authors: Zhang, K.; Wang, L.; Sun, Y.; Zhang, R.; Lin, G.; Xie, J.; Li, J.
• Is Part Of: Transfusion medicine. Volume 24:Issue 5(2014)
• Page Start: 297
• Page End: 304
• Publication Date: 2014-09-29
• Subjects: Blood -- Transfusion -- Periodicals; 615.39
• DOI: 10.1111/tme.12152
• Languages: English
• ISSNs: 0958-7578

Abstract

<abstract abstract-type="main" id="tme12152-abs-0001"> <title>SUMMARY</title> <sec id="tme12152-sec-0001" sec-type="section"> <title>Background and Objectives</title> <p id="tme12152-para-0001">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.</p> </sec> <sec id="tme12152-sec-0002" sec-type="section"> <title>Materials and Methods</title> <p id="tme12152-para-0002">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).</p> </sec> <sec id="tme12152-sec-0003" sec-type="section"> <title>Results</title> <p id="tme12152-para-0003">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.</p> </sec> <sec id="tme12152-sec-0004" sec-type="section"> <title>Conclusion</title> <p id="tme12152-para-0004">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.</p> </sec> </abstract>