HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.
HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.
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DOI：
10.1371/journal.pone.0156954
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发表时间：
2016
期刊：
影响因子：
3.7
通讯作者：
Bell D
中科院分区：
文献类型：
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作者：
Kyabayinze DJ;Zongo I;Cunningham J;Gatton M;Angutoko P;Ategeka J;Compaoré YD;Muehlenbachs A;Mulondo J;Nakalembe M;Somé FA;Ouattara A;Rouamba N;Ouédraogo JB;Hopkins H;Bell D
妊娠期疟疾间歇性筛查和治疗（IST）已被提议作为妊娠期间歇性预防性治疗（IPTp）的替代方案，其中IPTp由于耐药性而失败。然而，产前寄生虫血症往往是非常低的，最合适的筛选测试IST尚未确定。我们对990名未感染艾滋病毒的妇女进行了一项多中心前瞻性研究，这些妇女在乌干达东部的托罗罗地区医院和布基纳法索西部的科尔萨马健康中心的两个不同的疟疾传播环境中参加了ANC。这些妇女在怀孕的第二个或第三个三个月参加了这项研究，并跟踪分娩，产生了2,597份血液样本用于分析。筛选试验包括靶向富组氨酸蛋白2（HRP 2）和寄生虫乳酸脱氢酶（pLDH）的快速诊断试验（RDTs）和显微镜检查，并与作为参考标准的nPCR进行比较。入组时，乌干达通过HRP 2/pan pLDH RDT、Pf pLDH/pan pLDH RDT、显微镜检查和PCR检测恶性疟原虫呈阳性的孕妇比例分别为38%、29%、36%和44%，布基纳法索分别为21%、16%、15%和35%。随访期间所有检测阳性率均下降。与PCR相比，HRP 2/pan pLDH RDT、Pf pLDH/pan pLDH RDT和显微镜检查的敏感性在乌干达分别为75.7%、60.1%和69.7%，在布基纳法索分别为55.8%、42.6%和55.8%。所有三种检测的特异性均大于96%。使用广义估计方程的准确性比较显示，HRP 2检测RDT在两种设置中是最准确的测试。该研究表明，基于HRP 2的RDT是目前可用于妊娠期间的最合适的即时检测，特别是对于有症状的女性，但仍然会错过一些PCR阳性的女性。这些极低密度感染的临床意义需要更好地定义。
Intermittent screening and treatment (IST) of malaria during pregnancy has been proposed as an alternative to intermittent preventive treatment in pregnancy (IPTp), where IPTp is failing due to drug resistance. However, the antenatal parasitaemias are frequently very low, and the most appropriate screening test for IST has not been defined. We conducted a multi-center prospective study of 990 HIV-uninfected women attending ANC in two different malaria transmission settings at Tororo District Hospital, eastern Uganda and Colsama Health Center in western Burkina Faso. Women were enrolled in the study in the second or third trimester of pregnancy and followed to delivery, generating 2,597 blood samples for analysis. Screening tests included rapid diagnostic tests (RDTs) targeting histidine-rich protein 2 (HRP2) and parasite lactate dehydrogenase (pLDH) and microscopy, compared to nPCR as a reference standard. At enrolment, the proportion of pregnant women who were positive for P. falciparum by HRP2/pan pLDH RDT, Pf pLDH/pan pLDH RDT, microscopy and PCR was 38%, 29%, 36% and 44% in Uganda and 21%, 16%, 15% and 35% in Burkina Faso, respectively. All test positivity rates declined during follow-up. In comparison to PCR, the sensitivity of the HRP2/pan pLDH RDT, Pf pLDH/pan pLDH RDT and microscopy was 75.7%, 60.1% and 69.7% in Uganda, 55.8%, 42.6% and 55.8% in Burkina Faso respectively for all antenatal visits. Specificity was greater than 96% for all three tests. Comparison of accuracy using generalized estimating equation revealed that the HRP2- detecting RDT was the most accurate test in both settings. The study suggests that HRP2-based RDTs are the most appropriate point-of-care test currently available for use during pregnancy especially for symptomatic women, but will still miss some PCR-positive women. The clinical significance of these very low density infections needs to be better defined.