Performance of second- and third-generationRIBAs for confirmation of third-generationHCV EIA-reactive blood donations

Authors: Tobler, L.H.; Lee, S.R.; Stramer, S.L.; Peterson, J.; Kochesky, R.; Watanabe, K.; Quan, S.; Polito, A.; Busch, M.P.

Source: Transfusion, Volume 40, Number 8, August 2000 , pp. 917-923(7)

Publisher: Wiley-Blackwell

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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.

Keywords: ARC = American Red Cross; BCP = Blood Centers of the Pacific; REDS = Retrovirus Epidemiology Donor Study; RR = repeatably reactive; S:C = signal-to-cutoff (ratio); SOD = superoxide dismutase

Document Type: Research article

DOI: http://dx.doi.org/10.1046/j.1537-2995.2000.40080917.x

Affiliations: 1: From the Blood Centers of the Pacific—Irwin Center; and the University of California, San Francisco, California; Ortho Clinical Diagnostics, Raritan, New Jersey; American Red Cross; and Westat, Inc., Rockville, Maryland; PraxSys BioSystems, Inc., San Ramon, California; and Chiron Corporation, Emeryville, California.

Publication date: 2000-08-01

Performance of second- and third-generationRIBAs for confirmation of third-generationHCV EIA-reactive blood donations

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