Silva Rafael Xavier da, Campos Karoline Rodrigues, Caterino-de-Araujo Adele
Coordenadoria de Controle de Doença, Secretaria de Estado da Saúde de São Paulo, Brazil.
Rev Inst Med Trop Sao Paulo. 2020;62:e27. doi: 10.1590/s1678-9946202062027. Epub 2020 May 11.
Identifying the true prevalence of human T-cell lymphotropic virus, mostly type 1 (HTLV-1), and the number of patients with HTLV-1-associated diseases, in addition to introducing HTLV-1/2 serology during the prenatal of pregnant women and in individuals infected with other viruses that share transmission routes with HTLV-1, are actions that could help to recognize the importance of this virus by WHO and national health organizations, and to control its transmission/dissemination. As Brazil is endemic to HTLV and there is an increase in health care expenditure, but resources are limited, any strategy that could reduce the cost of HTLV screening is needed and welcomed. This study aimed to determine whether the strategy of pooling sera for HTLV antibody determination is feasible and reduces the costs. Two enzyme immunoassays (EIA Murex HTLV-I+II, Diasorin, UK, and Gold ELISA HTLV-1+2, REM Ind. Com. Ltda., SP, Brazil), and serum samples that resulted in different levels of HTLV-1/2 antibodies by EIA and of which a volume allowed assay validation were employed for analysis. The diagnostic sensitivity and specificity and Cohen's Kappa value, as well as the accuracy and precision were analyzed. After validating the five-sample pool using the EIA Murex (Cohen's Kappa = 1.0), the technique was employed for individual cost comparison in 2,625 serum samples from populations at risk of HTLV infections (HBV, HCV, and HIV-infected individuals). The results from individual and pooled samples confirmed the diagnostic sensitivity (100%) and specificity (100%) of the pooling and a cost minimization varying from 60.7% to 73.6%. In conclusion, the results of this study suggest the use of pooling sera in sero-epidemiological surveillance studies and possibly in prenatal care screening programs in Brazil.
确定人类嗜T细胞病毒(主要是1型,即HTLV-1)的真实流行率以及HTLV-1相关疾病的患者数量,此外,在孕妇产前检查以及感染与HTLV-1有共同传播途径的其他病毒的个体中开展HTLV-1/2血清学检测,这些举措有助于世界卫生组织和各国卫生组织认识到这种病毒的重要性,并控制其传播。由于巴西是HTLV的流行地区,且医疗保健支出不断增加,但资源有限,因此任何能够降低HTLV筛查成本的策略都是必要且受欢迎的。本研究旨在确定血清混合用于HTLV抗体检测的策略是否可行并能降低成本。采用了两种酶免疫测定法(英国Diasorin公司的Murex HTLV-I+II酶免疫测定法和巴西圣保罗REM Ind. Com. Ltda.公司的Gold ELISA HTLV-1+2酶免疫测定法),以及通过酶免疫测定法得出不同水平HTLV-1/2抗体且其体积允许进行测定验证的血清样本进行分析。分析了诊断敏感性、特异性和科恩kappa值,以及准确性和精密度。在用Murex酶免疫测定法验证五样本混合检测(科恩kappa = 1.0)后,该技术用于对来自有HTLV感染风险人群(乙肝、丙肝和艾滋病毒感染者)的2625份血清样本进行个体成本比较。个体样本和混合样本的结果证实了混合检测的诊断敏感性(100%)和特异性(100%),成本降低了60.7%至73.6%。总之,本研究结果表明在巴西的血清流行病学监测研究以及可能的产前检查筛查项目中可采用血清混合检测。