BACKGROUND: The purpose of this study was to explore strategies to minimize the number of unwarranted consignee notifications resulting from hepatitis C virus (HCV) first-generation (single-antigen) enzyme immunoassay (EIA 1.0) targeted lookback. STUDY DESIGN AND METHOD: The four blood centers participating in this study contributed data on 3753 HCV EIA 1.0-repeatably reactive (RR) donations. The analysis focused on 1) statistical evaluation of HCV EIA 1.0 signal-to-cutoff (S/CO) ratios versus HCV second-generation recombinant immunoblot assay (RIBA 2.0) interpretation from all participating blood centers and 2) RNA testing using transcription-mediated amplification on all HCV EIA 1.0 RR/RIBA 2. 0-positive or -indeterminate specimens and a subset of RIBA 2. 0-negative donations for which specimens were available. RESULTS: Analysis of HCV EIA 1.0 S/CO ratios versus RIBA 2.0 indicated that 1180 (89%) of 1326 RIBA 2.0-positive specimens had an S/CO ratio >2. 5, while 146 (11%) had a ratio </=2.5. In contrast, of 2253 RIBA 2. 0-negative specimens, 299 (13%) had an S/CO ratio >2.5, while 1954 (87%) had a ratio </=2.5. Of 248 HCV EIA 1.0-RR/RIBA 2.0-positive samples with stored specimens available for additional testing, 198 (80%) were HCV RNA positive; 15 (7.5%) of these specimens had an S/CO ratio </=2.5, while 183 (92%) had a ratio >2.5. HCV RNA was detected in only 2 (1.5%) of 137 HCV EIA 1.0-RR/RIBA 2.0-negative specimens: 1 of these 2 specimens had an S/CO >2.5, while the other had an S/CO </=2.5. CONCLUSION: A highly significant (<0.0001) correlation was found between the S/CO ratio on HCV EIA 1.0- and RIBA 2.0-positive or -negative results. An S/CO ratio >2.5 yielded an 89- percent sensitivity for RIBA 2.0-positive specimens, and donations with an S/CO ratio >2.5 had a 75-percent probability of being RIBA 2.0 positive. A policy recommendation to use the S/CO ratio to triage lookback would prevent unwarranted notification of 87 percent of recipients of blood from RIBA 2.0-negative donors and would result in a failure to notify only 5 to 10 percent of recipients potentially exposed to infectious units.
BACKGROUND: The purpose of this study was to explore strategies to minimize the number of unwarranted consignee notifications resulting from hepatitis C virus (HCV) first-generation (single-antigen) enzyme immunoassay (EIA 1.0) targeted lookback. STUDY DESIGN AND METHOD: The four blood centers participating in this study contributed data on 3753 HCV EIA 1.0-repeatably reactive (RR) donations. The analysis focused on 1) statistical evaluation of HCV EIA 1.0 signal-to-cutoff (S/CO) ratios versus HCV second-generation recombinant immunoblot assay (RIBA 2.0) interpretation from all participating blood centers and 2) RNA testing using transcription-mediated amplification on all HCV EIA 1.0 RR/RIBA 2. 0-positive or -indeterminate specimens and a subset of RIBA 2. 0-negative donations for which specimens were available. RESULTS: Analysis of HCV EIA 1.0 S/CO ratios versus RIBA 2.0 indicated that 1180 (89%) of 1326 RIBA 2.0-positive specimens had an S/CO ratio >2. 5, while 146 (11%) had a ratio </=2.5. In contrast, of 2253 RIBA 2. 0-negative specimens, 299 (13%) had an S/CO ratio >2.5, while 1954 (87%) had a ratio </=2.5. Of 248 HCV EIA 1.0-RR/RIBA 2.0-positive samples with stored specimens available for additional testing, 198 (80%) were HCV RNA positive; 15 (7.5%) of these specimens had an S/CO ratio </=2.5, while 183 (92%) had a ratio >2.5. HCV RNA was detected in only 2 (1.5%) of 137 HCV EIA 1.0-RR/RIBA 2.0-negative specimens: 1 of these 2 specimens had an S/CO >2.5, while the other had an S/CO </=2.5. CONCLUSION: A highly significant (<0.0001) correlation was found between the S/CO ratio on HCV EIA 1.0- and RIBA 2.0-positive or -negative results. An S/CO ratio >2.5 yielded an 89- percent sensitivity for RIBA 2.0-positive specimens, and donations with an S/CO ratio >2.5 had a 75-percent probability of being RIBA 2.0 positive. A policy recommendation to use the S/CO ratio to triage lookback would prevent unwarranted notification of 87 percent of recipients of blood from RIBA 2.0-negative donors and would result in a failure to notify only 5 to 10 percent of recipients potentially exposed to infectious units.
Authors: G L Abby Harrison; Jan Pryor; Joji Malani; Mathias Supuri; Andrew Masta; Burentau Teriboriki; Tebuka Toatu; David Penny; Jean-Pierre Allain; Eleanor Barnes; Oliver G Pybus; Paul Klenerman Journal: PLoS One Date: 2013-08-20 Impact factor: 3.240