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Performance of second- and third-generation RIBAs for confirmation of third-generation HCV EIA-reactive blood donations. Retrovirus Epidemiology Donor Study.
Pubmed ID: 10960517
Journal: Transfusion
Publication Date: Aug. 1, 2000
MeSH Terms: Humans, Blood Donors, Hepacivirus, Immunoenzyme Techniques, Immunoblotting
Authors: Busch MP, Tobler LH, Stramer SL, Lee SR, Peterson J, Kochesky R, Watanabe K, Quan S, Polito A
Cite As: Tobler LH, Lee SR, Stramer SL, Peterson J, Kochesky R, Watanabe K, Quan S, Polito A, Busch MP. Performance of second- and third-generation RIBAs for confirmation of third-generation HCV EIA-reactive blood donations. Retrovirus Epidemiology Donor Study. Transfusion 2000 Aug;40(8):917-23.
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: Licensure of an enhanced HCV screening assay (HCV 3.0 EIA) without concurrent licensure of a complementary supplemental assay (i.e., RIBA HCV 3.0 strip immunoblot assay [RIBA-3]) decoupled screening and supplemental testing. In March 1998, the FDA Center for Biologics Evaluation and Research (CBER) recommended the use of RIBA-3 on RIBA HCV 2.0 strip immunoblot assay (RIBA-2)-indeterminate units screened with HCV EIA 3.0. STUDY DESIGN AND METHODS: The sensitivity of RIBA-2 and RIBA-3 was compared in tests on HCV 3.0 EIA-repeatably reactive (RR) units identified immediately after the implementation of HCV 3.0 EIA screening. Two protocols were evaluated: parallel testing of HCV 3.0 EIA-RR units by RIBA-2 and RIBA-3 and reflex testing of HCV 3.0 EIA-RR and RIBA-3-confirmed-positive units by RIBA-2. All specimens with discordant RIBA-2 and RIBA-3 results and a representative sampling with concordant RIBA results were tested by PCR. RESULTS: In the parallel testing protocol, 99,777 donations were screened, with 245 HCV 3.0 EIA-RR specimens included in the study. Of 166 RIBA-2-positive samples, 165 tested positive in RIBA-3 (1 sample reacted to the control superoxide dismutase antigen in RIBA-3). Thirty-two (74%) of 43 RIBA-2-indeterminate specimens and 4 (11%) of 36 RIBA-2-negative specimens tested positive in RIBA-3. HCV RNA was identified in 5 (16%) of 32 RIBA-2-indeterminate/RIBA-3-positive donations, as well as in 26 (70%) of 37 concordant RIBA-2/RIBA-3-positive donations. In the reflex testing protocol, 292,459 donations were screened, with 709 HCV 3.0 EIA-RR specimens included in the study. RIBA-3 testing yielded 517 (73%) positive specimens, of which 50 (9.7%) tested indeterminate and 15 (2.9%) tested negative in RIBA-2. Among the RIBA-discordant specimens, 10 (20%) RIBA-2-indeterminate specimens and 1 (7%) RIBA-2-negative specimens tested positive in PCR; in comparison, 60 (77%) of 78 concordant RIBA-2/RIBA-3-positive units tested positive in PCR. CONCLUSIONS: RIBA-3 is significantly more sensitive than RIBA-2 in testing of HCV 3.0 EIA-screened donations. During the review process of this manuscript, the FDA licensed the RIBA-3 test.