Abstract：
BACKGROUND: The large dengue (DENV) and chikungunya (CHIKV) outbreaks observed during the last decade across the world, as well as local transmissions in non-endemic areas are a growing concern for blood safety. The aim of this study was to evaluate and compare the sensitivity of nucleic acid tests (NAT) detecting DENV and CHIKV RNA.
METHODS: Using DENV 1 to 4 International Standards, the limits of detection (LODs) calculated by probit analysis of two NAT assays; the cobas CHIKV/DENV assay (Roche Diagnostics) and the Procleix Dengue Virus Assay (Grifols) were compared. In addition, CHIKV-RNA LOD of the cobas CHIKV/DENV assay was evaluated.
RESULTS: For dengue, the 95% LOD of the cobas assay ranged between 4.10 [CI95%: 2.70-8.19] IU/mL (DENV-2) and 7.07 [CI95%: 4.34-14.89] IU/mL (DENV-4), and between 2.19 [CI95%: 1.53-3.83] IU/mL (DENV-3) and 5.84 [CI95%: 3.84-10.77] IU/mL (DENV-1) for Procleix assay. The Procleix assay had a significant lower LOD for DENV-3 (2.19 vs. 5.89 IU/mL) when compared to the cobas assay (p = 0.005). The 95% LOD for CHIKV-RNA detection of the cobas assay was 4.76 [CI95%: 3.08-8.94] IU/mL.
CONCLUSIONS: The two NAT assays developed for blood donor screening evaluated in this study demonstrated high and similar analytical performance. Subject to an appropriate risk-benefit assessment, they can be used to support blood safety during outbreaks in endemic areas or in non-endemic areas as an alternative to deferring blood donors during local transmission likely to affect the blood supply. The development of multiplex assays is expected to optimize laboratory organization.
METHODS: Using DENV 1 to 4 International Standards, the limits of detection (LODs) calculated by probit analysis of two NAT assays; the cobas CHIKV/DENV assay (Roche Diagnostics) and the Procleix Dengue Virus Assay (Grifols) were compared. In addition, CHIKV-RNA LOD of the cobas CHIKV/DENV assay was evaluated.
RESULTS: For dengue, the 95% LOD of the cobas assay ranged between 4.10 [CI95%: 2.70-8.19] IU/mL (DENV-2) and 7.07 [CI95%: 4.34-14.89] IU/mL (DENV-4), and between 2.19 [CI95%: 1.53-3.83] IU/mL (DENV-3) and 5.84 [CI95%: 3.84-10.77] IU/mL (DENV-1) for Procleix assay. The Procleix assay had a significant lower LOD for DENV-3 (2.19 vs. 5.89 IU/mL) when compared to the cobas assay (p = 0.005). The 95% LOD for CHIKV-RNA detection of the cobas assay was 4.76 [CI95%: 3.08-8.94] IU/mL.
CONCLUSIONS: The two NAT assays developed for blood donor screening evaluated in this study demonstrated high and similar analytical performance. Subject to an appropriate risk-benefit assessment, they can be used to support blood safety during outbreaks in endemic areas or in non-endemic areas as an alternative to deferring blood donors during local transmission likely to affect the blood supply. The development of multiplex assays is expected to optimize laboratory organization.
摘要：
背景：在过去十年中，全球范围内观察到了大型登革热（DENV）和基孔肯雅热（CHIKV）爆发，以及非流行地区的局部传播越来越受到血液安全的关注。这项研究的目的是评估和比较核酸测试（NAT）检测DENV和CHIKVRNA的敏感性。
方法：使用DENV1至4国际标准，通过两种NAT测定的概率分析计算的检测限(LOD);比较了cobasCHIKV/DENV测定(RocheDiagnostics)和Procleix登革病毒测定(Grifols).此外,评估cobasCHIKV/DENV测定的CHIKV-RNALOD。
结果：对于登革热，cobas测定的95％LOD介于4.10[CI95％：2.70-8.19]IU/mL（DENV-2）和7.07[CI95％：4.34-14.89]IU/mL（DENV-4）之间，和2.19[CI95%:1.53-3.83]IU/mL(DENV-3)和5.84[CI95%:3.84-10.77]IU/mL(DENV-1)之间的Procleix测定。Procleix测定法对DENV-3的LOD显着降低（2.19vs.5.89IU/mL），与cobas测定法（p=0.005）相比。cobas测定的CHIKV-RNA检测的95%LOD为4.76[CI95%:3.08-8.94]IU/mL。
结论：在本研究中评估的为献血者筛选开发的两种NAT测定法显示出高且相似的分析性能。经过适当的风险收益评估，它们可用于在流行地区或非流行地区爆发期间支持血液安全，作为在可能影响血液供应的局部传播期间推迟献血者的替代方案。多重测定的发展有望优化实验室组织。
方法：使用DENV1至4国际标准，通过两种NAT测定的概率分析计算的检测限(LOD);比较了cobasCHIKV/DENV测定(RocheDiagnostics)和Procleix登革病毒测定(Grifols).此外,评估cobasCHIKV/DENV测定的CHIKV-RNALOD。
结果：对于登革热，cobas测定的95％LOD介于4.10[CI95％：2.70-8.19]IU/mL（DENV-2）和7.07[CI95％：4.34-14.89]IU/mL（DENV-4）之间，和2.19[CI95%:1.53-3.83]IU/mL(DENV-3)和5.84[CI95%:3.84-10.77]IU/mL(DENV-1)之间的Procleix测定。Procleix测定法对DENV-3的LOD显着降低（2.19vs.5.89IU/mL），与cobas测定法（p=0.005）相比。cobas测定的CHIKV-RNA检测的95%LOD为4.76[CI95%:3.08-8.94]IU/mL。
结论：在本研究中评估的为献血者筛选开发的两种NAT测定法显示出高且相似的分析性能。经过适当的风险收益评估，它们可用于在流行地区或非流行地区爆发期间支持血液安全，作为在可能影响血液供应的局部传播期间推迟献血者的替代方案。多重测定的发展有望优化实验室组织。
