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Lookback on donors who are repeatedly reactiveon first‐generation hepatitis C virus assays:justification and rational implementation
Author(s) -
Tobler L.H.,
Tegtmeier G.,
Stramer S.L.,
Quan S.,
Dockter J.,
Giachetti C.,
Busch M.P.
Publication year - 2000
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1046/j.1537-2995.2000.40010015.x
Subject(s) - hepatitis c virus , medicine , hepatitis c , virology , hepacivirus , flaviviridae , recombinant dna , immunoassay , antibody , virus , immunology , biology , gene , genetics
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.