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Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor screening.
Pubmed ID: 14507279
Journal: Transfusion
Publication Date: Oct. 1, 2003
MeSH Terms: Humans, RNA, Viral, Blood Donors, Hepatitis C, Hepatitis C Antibodies, Immunoenzyme Techniques
Grants: N01-HB-47114
Authors: Busch MP, Kleinman SH, Tobler LH, Phelps BH, Stramer SL, Lee SR, Masecar BL, Peterson JE, Davis EA, Andrews WE, Brodsky JP
Cite As: Tobler LH, Stramer SL, Lee SR, Masecar BL, Peterson JE, Davis EA, Andrews WE, Brodsky JP, Kleinman SH, Phelps BH, Busch MP. Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor screening. Transfusion 2003 Oct;43(10):1452-9.
Studies:
- Retrovirus Epidemiology Donor Study (REDS) Allogeneic Donor and Recipient Repository (RADAR)
- Retrovirus Epidemiology Donor Study (REDS) General Leukocyte/Plasma Repository (GLPR)
- Retrovirus Epidemiology Donor Study (REDS) HTLV Cohort (HTLV)
- Retrovirus Epidemiology Donor Study (REDS) Human Herpes Virus 8 Special Collection from the General Leukocyte/Plasma Repository (HHV8)
- Retrovirus Epidemiology Donor Study (REDS): Special Repository Collections (SR)
- Retrovirus Epidemiology Donor Study-II (REDS II) Donation and Deferral Database (CORE)
- Retrovirus Epidemiology Donor Study-II (REDS II) Donor Iron Status Evaluation Study (RISE)
- Retrovirus Epidemiology Donor Study-II (REDS II) Leukocyte Antibodies Prevalence Study (LAPS)
- Retrovirus Epidemiology Donor Study-II (REDS II) Molecular Surveillance (MS)
Abstract
BACKGROUND: In 1996, the Ortho HCV Version 3.0 ELISA Test System (HCV 3.0 EIA) was licensed in the United States for donor screening but was neither mandated nor universally implemented. Data from two studies comparing the differential performance of HCV 3.0 EIA and HCV 2.0 EIA are presented. The first study evaluated the differential performance in a cross-section of screened whole-blood donors after implementation of HCV 3.0 EIA; the second study evaluated the differential performance of HCV 3.0 EIA in plasma donors acutely infected with HCV, identified during routine Abbott HCV 2.0 EIA and HCV NAT (using Roche Ampliscreen plate assay) donor screening. STUDY DESIGN AND METHODS: The first study evaluated HCV 3.0 EIA repeat-reactive donations from four US blood centers, identified during the first 5 months of HCV 3.0 EIA implementation. HCV EIA repeat-reactive donations confirmed by RIBA HCV 3.0 SIA were retested using both Ortho HCV Version 2.0 ELISA Test System and Abbott HCV 2.0 EIA. All EIA-discordant donations were tested by polymerase chain reaction (PCR). In the second study, Abbott HCV 2.0 EIA-nonreactive, HCV PCR-positive donors were enrolled in a follow-up study in which the index and follow-up samples were re-evaluated by HCV 3.0 EIA. RESULTS: In the first study, of 292,459 donations, 501 (0.17%) confirmed HCV 3.0 EIA-reactive donations were identified; 15 (0.005%) were nonreactive by Ortho HCV 2.0 EIA and were all HCV RNA negative. In the second study, Ortho HCV 3.0 EIA retesting of Abbott HCV 2.0 EIA-nonreactive, RNA-positive index donations identified 16 (23%) as 3.0 EIA reactive. In 42 panels with a discordant time of seroconversion, HCV 3.0 EIA sero-conversion preceded HCV 2.0 EIA in all cases (p < 0.001). Two donors with HCV 3.0 EIA-reactive index donations never seroconverted by HCV 2.0 EIA during 160 to 180 days of follow-up. CONCLUSION: These studies demonstrate that HCV 3.0 EIA compared to HCV 2.0 EIA can better detect 1) remote nonviremic HCV infections, 2) acute infection, and 3) HCV antibodies in cases of atypical seroconversion.