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首页> 外文期刊>Transfusion: The Journal of the American Association of Blood Banks >Performance of second- and third-generation RIBAs for confirmation of third-generation HCV EIA-reactive blood donations. Retrovirus Epidemiology Donor Study.
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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.

机译：第二代和第三代RIBA用于确认第三代HCV EIA反应性献血的性能。逆转录病毒流行病学捐助者研究。

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摘要

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.
机译：背景：无需同时进行补充补充测定（即RIBA HCV 3.0条带免疫印迹测定[RIBA-3]）的增强型HCV筛查测定（HCV 3.0 EIA）的许可就可以使筛选和补充检测脱钩。 1998年3月，FDA生物学评估和研究中心（CBER）建议将RIBA-3用于HCV EIA 3.0筛选的RIBA HCV 2.0条带免疫印迹测定法（RIBA-2）-不明确的单位。研究设计和方法：在进行HCV 3.0 EIA筛选后立即鉴定的HCV 3.0 EIA重复反应（RR）单元的测试中，比较了RIBA-2和RIBA-3的敏感性。评估了两种方案：通过RIBA-2和RIBA-3并行测试HCV 3.0 EIA-RR单元，以及通过RIBA-2进行HCV 3.0 EIA-RR和RIBA-3确认阳性单元的反射测试。所有具有不一致RIBA-2和RIBA-3结果的样本以及具有一致RIBA结果的代表性样本均通过PCR进行了测试。结果：在平行测试方案中，筛选了99,777例捐赠，其中包括245 HCV 3.0 EIA-RR标本。在166个RIBA-2阳性样品中，有165个在RIBA-3中测试为阳性（1个样品与RIBA-3中的对照超氧化物歧化酶抗原发生了反应）。在RIBA-3中呈阳性的43个RIBA-2不确定样本中的32个（74％）和36个RIBA-2阴性样本中的4个（11％）。 HCV RNA在32例RIBA-2不确定/ RIBA-3-阳性捐赠中有5例（16％），在37例RIBA-2 / RIBA-3一致捐赠中26例（70％）中被鉴定。在反射测试方案中，筛选了292,459例捐赠，其中包括709例HCV 3.0 EIA-RR标本。 RIBA-3测试产生了517个（73％）阳性标本，其中RIBA-2中有50个（9.7％）的不确定样品和15个（2.9％）的阴性样品。在RIBA不一致的样本中，有10个（20％）RIBA-2不确定样本和1个（7％）RIBA-2阴性样本在PCR中呈阳性。相比之下，在78个一致的RIBA-2 / RIBA-3-阳性单位中，有60个（77％）在PCR中呈阳性。结论：在HCV 3.0 EIA筛查的捐赠测试中，RIBA-3比RIBA-2敏感得多。在本手稿的审阅过程中，FDA批准了RIBA-3测试。

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