PDF(Pubmed)
Abstract：
The present study compares the ability of distinct immunological assays (chemiluminescence immunoassay-CLIA, western blot-WB and flow cytometry-FC-Simplex and Duplex) to detect anti-HTLV (human T-lymphotropic virus) antibodies in candidates for blood donations at the Amazonas State Blood Center (Brazil) between January 2018 and December 2022. Overall, 257,942 samples from candidates for blood donations were screened using CLIA, which led to 0.15% seropositivity for HTLV (409 samples). A total of 151 candidates for blood donations were enrolled for retesting with CLIA followed by additional testing using WB and FC-Simplex and Duplex analysis. Our results demonstrated that 62% (93/151), 20% (30/151) and 17% (26/151) of the samples presented positive results with retesting using CLIA, WB and FC-Simplex analysis, respectively. Additional analysis of the CLIA, WB and FC-Simplex results revealed an overall agreement of 56% for CLIA and WB (22 co-negative; 30 co-positive samples), 48% for CLIA and FC-Simplex (21 co-negative; 24 co-positive samples) and 80% for WB and FC-Simplex (51 co-negative; 23 co-positive samples). Considering the WB as the reference standard for the diagnosis of infection with HTLV-1/2, we observed that the CLIA results of ≤3.0 RLU and >10.0 RLU in the retest can be used define a negative or positive result, respectively, and could be used as new specific cut-off values. The overall agreement between WB and FC-Duplex for accomplishing the differential diagnosis was evaluated and demonstrated 100% correspondence for the diagnosis of HTLV-1 (15/15) and HTLV-2 (7/7). Our findings demonstrate that gaps in the diagnosis of infection with HTLV-1/2 could be overcome by the simultaneous use of distinct immunological assays during retesting of candidates for blood donations.
摘要：
本研究比较了不同免疫测定(化学发光免疫测定-CLIA，Westernblot-WB和流式细胞术-FC-Simplex和Duplex）在2018年1月至2022年12月之间在亚马逊州血液中心（巴西）的献血候选人中检测抗HTLV（人类T淋巴细胞病毒）抗体。总的来说,使用CLIA筛选了来自献血候选人的257,942个样本，这导致了0.15%的HTLV血清阳性(409个样本)。总共招募了151名献血候选人进行CLIA重新测试，然后使用WB和FC-Simplex和Duplex分析进行其他测试。我们的结果表明，62%(93/151)，20％（30/151）和17％（26/151）的样品在使用CLIA进行重新测试时呈现阳性结果，WB和FC-Simplex分析，分别。对CLIA的补充分析，WB和FC-Simplex结果显示，CLIA和WB的总体一致性为56%(22个共阴性；30个共阳性样本)，CLIA和FC-Simplex为48%(21个共阴性;24个共阳性样品),WB和FC-Simplex为80%(51个共阴性;23个共阳性样品)。考虑到WB作为HTLV-1/2感染诊断的参考标准，我们观察到，CLIA结果≤3.0RLU和>10.0RLU的复测可用于定义阴性或阳性结果。分别,并可用作新的特定截止值。评估了WB和FC-Duplex之间完成鉴别诊断的总体一致性，并证明了HTLV-1（15/15）和HTLV-2（7/7）的诊断具有100％的一致性。我们的发现表明，在重新测试献血者时，可以通过同时使用不同的免疫学方法来克服HTLV-1/2感染诊断的差距。
