Department of Biological, Environmental and Occupational Health Sciences, School of Public Health, College of Health Sciences, University of Ghana, Legon, Accra, Ghana.
Centre for Tropical Clinical Pharmacology and Therapeutics, School of Medicine and Dentistry, University of Ghana, Accra, Ghana.
Malar J. 2018 Dec 14;17(1):468. doi: 10.1186/s12936-018-2613-x.
This study seeks to compare the performance of HRP2 (First Response) and pLDH/HRP2 (Combo) RDTs for falciparum malaria against microscopy and PCR in acutely ill febrile children at presentation and follow-up.
This is an interventional study that recruited children < 5 years who reported to health facilities with a history of fever within the past 72 h or a documented axillary temperature of 37.5 °C. Using a longitudinal approach, recruitment and follow-up of participants was done between January and May 2012. Based on results of HRP2-RDT screening, the children were grouped into one of the following three categories: (1) tested positive for malaria using RDT and received anti-malarial treatment (group 1, n = 85); (2) tested negative for malaria using RDT and were given anti-malarial treatment by the admitting physician (group 2, n = 74); or, (3) tested negative for malaria using RDT and did not receive any anti-malarial treatment (group 3, n = 101). Independent microscopy, PCR and Combo-RDT tests were done for each sample on day 0 and all follow-up days.
Mean age of the study participants was 22 months and females accounted for nearly 50%. At the time of diagnosis, the mean body temperature was 37.9 °C (range 35-40.1 °C). Microscopic parasite density ranged between 300 and 99,500 parasites/µL. With microscopy as gold standard, the sensitivity of HRP2 and Combo-RDTs were 95.1 and 96.3%, respectively. The sensitivities, specificities and predictive values for RDTs were relatively higher in microscopy-defined malaria cases than in PCR positive-defined cases. On day 0, participants who initially tested negative for HRP2 were positive by microscopy (n = 2), Combo (n = 1) and PCR (n = 17). On days 1 and 2, five of the children in this group (initially HRP2-negative) tested positive by PCR alone. On day 28, four patients who were originally HRP2-negative tested positive for microscopy (n = 2), Combo (n = 2) and PCR (n = 4).
The HRP2/pLDH RDTs showed comparable diagnostic accuracy in children presenting with an acute febrile illness to health facilities in a hard-to-reach rural area in Ghana. Nevertheless, discordant results recorded on day 0 and follow-up visits using the recommended RDTs means improved malaria diagnostic capability in malaria-endemic regions is necessary.
本研究旨在比较 HRP2(First Response)和 pLDH/HRP2(Combo)RDT 在急性发热儿童就诊时和随访时对恶性疟原虫疟疾的表现,与显微镜和 PCR 进行比较。
这是一项干预性研究,招募了年龄<5 岁的儿童,这些儿童在过去 72 小时内有发热史或有记录的腋温为 37.5°C。采用纵向方法,于 2012 年 1 月至 5 月间招募并随访参与者。根据 HRP2-RDT 筛查结果,将儿童分为以下三组之一:(1)RDT 检测疟疾阳性并接受抗疟治疗(组 1,n=85);(2)RDT 检测疟疾阴性且经主治医生给予抗疟治疗(组 2,n=74);或(3)RDT 检测疟疾阴性且未接受任何抗疟治疗(组 3,n=101)。在第 0 天和所有随访日,对每组样本均进行独立的显微镜检查、PCR 和 Combo-RDT 检测。
研究参与者的平均年龄为 22 个月,女性占近 50%。在诊断时,平均体温为 37.9°C(范围 35-40.1°C)。镜检寄生虫密度范围为 300 至 99500 个寄生虫/μL。以显微镜检查为金标准,HRP2 和 Combo-RDT 的敏感性分别为 95.1%和 96.3%。在显微镜定义的疟疾病例中,RDT 的敏感性、特异性和预测值相对较高,而在 PCR 阳性定义的病例中则较低。在第 0 天,最初 HRP2 检测为阴性的参与者在显微镜检查(n=2)、Combo(n=1)和 PCR(n=17)中呈阳性。在第 1 天和第 2 天,该组中有 5 名最初 HRP2 检测为阴性的儿童仅在 PCR 检测中呈阳性。在第 28 天,最初 HRP2 检测为阴性的 4 名患者在显微镜检查(n=2)、Combo(n=2)和 PCR(n=4)中呈阳性。
在加纳偏远农村地区的医疗机构就诊的急性发热儿童中,HRP2/pLDH RDT 显示出相当的诊断准确性。然而,在第 0 天和随访时使用推荐的 RDT 记录到不一致的结果,这意味着在疟疾流行地区需要提高疟疾诊断能力。