镜检、抗原检测和核酸检测方法在疟疾诊断中的应用比较

目的 比较镜检、抗原检测(RDT)和核酸检测(PCR)三种方法对疟原虫的检测效果,为基层选择合适的 诊断方法提供依据。 方法 收集腾冲市 2015-2018 年发热病人的血样进行疟疾检测,以确诊结果为标准,对比分析镜检、RDT 和 PCR 三种疟疾检测方法的敏感性、特异性、阳性预测值、阴性预测值等指标。 结果 610 份血样中,阴性 295 份,阳性 315 份,其中恶性疟 67 份、间日疟 245 份、混合感染 2 份、三日疟 1 份。 与确诊结果比较,镜检、RDT 和 PCR 的灵敏度分别为 95. 87%、94. 60%和 99. 37%,特异度均为 100%;假阴性率分别为 4. 13%、5. 40%和 0. 63%,阴性预 测值分别为 95. 78%、94. 55%和 99. 33%;假阳性率均为 0,阳性预测值均为 100%;三种方法与确诊结果的总符合率分别 为 97. 87%、97. 70%和 99. 67%,Kappa 检验结果显示均与确诊结果高度一致(P 均<0. 001);对单一虫种恶性疟的检测, 镜检、RDT 和 PCR 的符合率分别为 88. 06%、100%和 97. 01%;对其他三种疟原虫检测的符合率,分别为 97. 97%、 93. 9%和 100%。 结论 三种检测方法均具有较高的敏感性和特异性,但综合考虑当前防治工作实际,抗原检测(RDT) 更适宜在基层推广和使用。     

Evaluation of antigen detection tests, microscopy, and polymerase chain reaction for diagnosis of malaria in peripheral blood in asymptomatic pregnant women in nanoro, burkina faso

Abstract. Rapid diagnostics tests (RDTs) detect malaria specific antigen(s) in the circulation, even when parasites are sequestered in the placenta and not visible by microscopy. However, research on their diagnostic accuracy during pregnancy is limited. Pregnant women (n = 418) were screened for malaria during routine antenatal care by using two RDTs that detect histidine-rich protein 2 (HRP2) or Plasmodium lactate dehydrogenase, and enzyme-linked immunosorbent assays with antibodies that detect dihydrofolate reductase-thymidylate synthase or heme-detoxification protein, and compared with real-time polymerase chain reaction (RT-PCR) and microscopy for evaluation of their diagnostic accuracy. Prevalence of malaria infection was high (53% by PCR). The RT-PCR and the HRP2 RDT detected most cases of malaria during pregnancy, whereas microscopy, the Plasmodium lactate dehydrogenase RDT, and enzyme-linked immunosorbent assays for dihydrofolate reductase-thymidylate synthase and heme-detoxification protein antibodies did not detect several low-density infections. Therefore, the HRP2 RDT could be a useful tool in high-transmission areas for diagnosis of malaria in asymptomatic pregnant women.     

应用巢式PCR评价低流行区疟疾诊断结果

目的初步评价大连市疾控人员对疟疾的诊断能力,为低流行区疟疾诊断方法的选择提供理论依据。方法收集2010--2012年大连市上报的27例疟疾阳性病例的血液样本．应用巢式PCR（nest—PCR）方法对诊断结果进行复核：以复核结果为标准,比较镜检和快速诊断试剂盒（rapid diagnosistest．RDT）方法的检测敏感性及对虫种鉴定的正确率。结果27份样本的巢式PCR结果为恶性疟23份,间日疟2份,卵形疟l份,阴性1份,无混合感染。镜检对阳性样本的敏感度为76．9％（20／26）,远低于RDT方法的96．2％（25／26）;镜检和RDT联合使用,敏感度可达100％。对虫种的鉴别,镜检对阳性样本的正确检测率为50％（13／26）：RDT方法仅能鉴别恶性疟和非恶性疟．对恶性疟阳性样本的正确检测率为100％（23／23）。结论采用镜检和RDT联合应用的方法,能够提高检测的敏感性。建议在有条件的疾控单位建立人体疟原虫的分子检测体系．更有效地防止对疟疾病例的漏诊和误诊。     

Rapid malaria screening and targeted treatment of United States-bound Montagnard refugees from Cambodia in 2002

In 2002, a group of Montagnard refugees living in Cambodia was accepted for resettlement in the United States. Pre-departure malaria screening and targeted treatment was conducted to prevent morbidity, and minimize the potential for local malaria transmission post-arrival. We screened 902 of 906 refugees using rapid diagnostic tests (RDTs), microscopy, and polymerase chain reaction (PCR) analysis. Twelve (1.3%) RDT results were positive and 28 (3.1%) were indeterminate. Microscopy confirmed Plasmodium species in two of the positive RDT and one of the indeterminate results. Among a random 10% sample of negative RDT results (n = 86), none were positive by microscopy. The PCR confirmed the two microscopically (and RDT) positive specimens. The PCR result was negative for all other specimens tested. Eighteen (2.0%) refugees were treated with antimalarials. The RDTs were useful in this setting, facilitating timely, sensitive diagnosis and targeted treatment. Evaluations to determine the most appropriate interventions in other refugee settings should include cost-effectiveness analyses of alternative strategies.     

山东省14例输入性卵形疟原虫wallikeri亚种的鉴定

目的 对山东省14例输入性卵形疟原虫wallikeri亚种进行鉴定分析。方法 收集14例输入性疟疾病例,进行快速疟疾诊断试纸条检测(RDT)、血涂片镜检、NP-1993常规巢式PCR鉴定和卵形疟原虫wallikeri(P. ovale wallikeri)亚种的特异性PCR检测。PCR扩增产物测序后,进行Blast比对分析。结果 14例患者RDT检测结果:泛疟原虫(非恶性疟)阳性12例,阴性2例;镜检结果,13例卵形疟原虫,1例间日疟原虫;NP-1993常规巢式PCR结果,14例样本4种疟原虫引物扩增结果均为阴性。P. ovale wallikeri亚种的特异性PCR检测结果:14例样本均能扩增到P. ovale wallikeri亚种特异性条带780 bp。Blast分析测序结果,检索结果为P. ovale wallikeri亚种。结论 14 例镜检阳性、NP-1993常规巢式PCR检测阴性的输入性疟疾病例均确诊为P. ovale wallikeri亚种感染。     

国产试剂RDT诊断疟疾效果评价

目的将国产试剂疟疾快速诊断试验（RDT）检测结果与镜检结果及进口试剂RDT和PCR结果进行比较,评价国产试剂RDT诊断疟疾的效果。方法收集160例疟疾病人或疑似疟疾病人血样,分别采用两种RDT、镜检和PCR进行检测,对检测结果进行比较。结果160份血样采用国产、进口试剂RDT及镜检和PCR检测疟疾感染,阳性率分别为45．00％、47．50％、41．25％和42．50％,经配对资料的Х^2检验,差异无统计学意义（P〉0．05）;镜检和PCR法均检出2例卵形疟,而国产和进口试剂RDT均为阴性。以镜检为标准．到产试剂RDT检测间日疟和恶性疟的敏感度为94％,特异度87%,假阳性率13％,假阴性率6％,阳性预测值83％,阴性预测值95％;以PCR为标准,国产试剂RDT检测间日疟和恶性疟的敏感度为94％,特异度89％,假阳性率11％,假阴性率6％,阳性预测值83％,阴性预测值95％。国产试剂RDT与进口试剂RDT检测结果比较差异无统计学意义（Kappa=0．95,P〉0．05）。结论国产试剂RDT与进口试剂RDT检测结果高度一致,在基层可取代进口试剂RDT进行疟疾病例主动监测。     

Detection of Mixed-Species Infections of Plasmodium falciparum and Plasmodium vivax by Nested PCR and Rapid Diagnostic Tests in Southeastern Iran

Coexistence of two species of Plasmodium in a single host has disrupted the diagnosis and treatment of malaria. This study was designed to evaluate the ability of rapid diagnostic test (RDT) kits for the diagnosis of mixed-species malaria infections in southeastern Iran. A total of 100 malaria patients were included in the study out of 164 randomly suspected symptomatic malaria patients from May to November 2012. Nested polymerase chain reaction (PCR) was also used to judge the ability of microscopy versus RDT kits for detecting mixed species. The sensitivity of light microscopy for the detection of mixed-species malaria infections was 16.6% (95% confidence interval [CI] = 3–49.1). Nested PCR revealed 12 patients with mixed-species infection. The CareStart Pv/Pf Combo kit detected 58% of the mixed-species infections, which were determined by nested PCR (sensitivity = 58.3%; 95% CI = 28.5–83.5). For identifying P. falciparum, P. vivax, and mixed-species infections, the concordance rates (kappa statistics) of microscopy and CareStart Pv/Pf Combo kit with nested PCR were 0.76 and 0.79, respectively (P = 0.001). This study underlines the effectiveness of RDT kits to improve the differentiation of mixed-species malaria infections in endemic areas where the prevalence of chloroquine resistance is high.     

2015年重庆市3例输入性卵形疟原虫wallikeri亚种感染病例的实验室诊断

目的   分析重庆市2015年3例输入性卵形疟原虫wallikeri亚种感染病例病原、抗原及核酸检测过程,减少卵形疟原虫的漏诊和误诊。 方法  收集流行性病学资料及血样,按照WS259-2015疟疾的诊断标准对3例血样进行血涂片镜检、快速疟疾诊断试纸条检测（RDT）及巢式PCR检测。 结果  3例患者均为非洲务工归国人员,并都有疟疾发病史。血涂片镜检结果,3例血样均为疟原虫阳性。RDT检测结果3例均为除恶性疟以外其他疟原虫阳性。国家参比实验室推荐的巢式PCR检测DNA,3例均为阴性。用卵形疟原虫wallikeri亚种的种特异性引物的PCR检测,3例均为阳性。 结论  根据镜检、RDT和卵形疟原虫wallikeri亚种种特异性PCR检测确定,重庆市2015年首次发现了3例卵形疟原虫wallikeri亚种感染输入病例,为重庆地区首次发现。     

Malaria among adult inpatients in two Tanzanian referral hospitals: A prospective study

Most malaria research in sub-Saharan Africa has focused on children and pregnant women, but malaria among hospitalized adults in this region is poorly characterized. In this prospective study, we assessed the prevalence and clinical characteristics of malaria among the inpatient adults in two hospitals in Tanzania. We enrolled adults admitted with suspected malaria and performed routine thick blood smear (BS) and malaria rapid diagnostic tests (RDT). We also assessed malaria parasite clearance rates. We considered malaria status ‘confirmed’ or ‘excluded’ only in patients with two concordant tests. Malaria polymerase chain reaction (PCR) was performed in a subset of patients with discordant BS and RDT. After BS and RDT were performed on 579 adults with suspected malaria, malaria was excluded in 458/579 (79.1%) and confirmed in 16/579 (2.8%). One hundred and five out of 579 (18.1%) had discordant results. The prevalences of positive BS and positive RDT were 102/579 (17.6%) and 35/579 (6.0%), respectively, with only fair agreement (Kappa = 0.354, p < 0.0001). PCR results agreed with RDT in 35/35 (100%) of patients with a negative RDT but positive BS. PCR results also agreed with RDT in 9/13 (69.2%) of cases with a positive RDT but negative BS. Clinical correlates of malaria by multivariable analysis included subjective fever (OR 3.6 [1.0–12.3], p = 0.04), headache (OR 3.1 [1.2–8.0], p = 0.02) and vomiting (OR 2.7 [1.2–6.4], p = 0.02). Malaria parasite clearance was significantly delayed in the HIV-infected group. Our study demonstrated only fair agreement between RDT and BS malaria tests among Tanzanian adult inpatients with suspected malaria. PCR generally agreed with RDT results. HIV was associated with delayed parasite clearance in adults with malaria. We recommend the routine use of RDTs for malaria diagnosis among adults admitted to hospitals in sub-Saharan Africa.     

上海市1例输血性三日疟病例的实验室检测分析与诊断

目的 目的 对1例感染源不明的三日疟病例进行实验室检测分析并确诊。 方法 方法 收集该病例的临床资料, 并进行流行病学调查。对患者及其供血者的血样进行血涂片病原学检查、 疟疾快速诊断检测 （RDT） 和巢式PCR检测, 并对阳性结果进行测序比对。 结果 结果 该患者无疟疾流行区居留史和既往疟疾感染史, 有外科手术时大量输血史。外周血涂片镜检查见三日疟原虫。流行病学调查显示, 该患者接受了3位供血者的血液, 但3位供血者血样经血涂片镜检、 RDT和巢式 PCR检测均未查见疟原虫, 后经改进的巢式?多重PCR检测及结果测序比对后显示, 与其中1名非洲籍留学生供血者的阳性扩增条带具100%同源性。 结论 结论 该病例因输血而感染三日疟。实验室检测疟疾疑难病例需经多方法验证方可确诊, 改进的巢式?多重PCR方法对低密度疟原虫感染有较好的检测效果。     

套式/多重PCR方法应用于疟疾诊断与监测的初步评价

目的 与镜检法比较评价标签引物-套式/多重PCR（UT-PCR）在疟疾监测中的应用价值。 方法 在海南、云南省恶性疟和间日疟混合流行区和广西疟疾控制区的疟疾监测中,采集初诊为疟疾或疑似疟疾的发热患者的血片与滤纸血样400份,在双盲条件下比较镜检法与UT-PCR的初检结果,对结果不一致的血片再次镜检复查,同时对其滤纸血样重复PCR 2～3次;评估UT-PCR与镜检法的敏感性和特异性。 结果 400例发热患者血样中,镜检法初检检出疟原虫阳性234例,其中恶性疟125例,间日疟109例;UT-PCR检出疟原虫阳性235例,其中恶性疟124例,间日疟109例;恶性疟和间日疟混合感染2例。两法初检结果一致的血样占92.5%（370/400）,其中阴性154例,阳性216例（间日疟117例,恶性疟99例）。复查25份初检结果不一致的血样,包括镜检阴性PCR阳性11例,镜检阳性PCR阴性10例,镜检为恶性疟PCR为间日疟3例,镜检为间日疟而PCR为混合感染1例,其中15份与UT-PCR的初检结果一致,7份“假阳性”原因不明,仅3份为PCR的假阴性。根据复查结果评估PCR的敏感性为99.6%,特异性为98.8%。 结论 采用更敏感的UT?鄄PCR疟疾诊断方法有助于解决疟疾诊断与鉴别诊断中的疑难问题,提高疟疾监测的质量和效率。     

Detection of Plasmodium vivax infection in the Republic of Korea by loop-mediated isothermal amplification (LAMP)

Loop-mediated isothermal amplification (LAMP) is a novel technique that rapidly amplifies target DNA in isothermal conditions. In a previous study, the sensitivities and specificities of LAMP, microscopy, and nested PCR were compared in the context of rapid malaria detection. In the present study, LAMP detected vivax malaria parasites in 115 of 117 microscopically positive samples (sensitivity, 98.3%; 95% CI, 97.4-100%), which agreed well with the nested PCR results (sensitivity, 99.1%; 95% CI: 96.0-100%). No positive cases of malaria were detected by LAMP or nested PCR in 50 consecutive feverish patients other than malaria from malaria endemic areas. LAMP performed on DNA extracted from heat-treated blood had a sensitivity of 93.3% (28/30, 95% CI: 84.4-100%) and specificity of 100% (30/30, 95% CI: 100%). The present study shows that LAMP based assays have high sensitivity, specificity, and amplification efficiencies for Plasmodium vivax detection. The authors recommend that LAMP can be considered as a rapid nucleic acid amplification assay for the molecular diagnosis of P. vivax in both clinical laboratories and malaria clinics in areas where vivax malaria is endemic.     

In areas of low transmission, is the presumptive treatment of febrile but bloodsmear-negative patients for malaria validated by the results of PCR-based testing?

Presumptive malaria treatment (PMT) is a common strategy in many areas of the world, especially in settings where the facilities for diagnosis are limited. The subjects of a recent study in central Sudan, in an area with a low level of Plasmodium falciparum transmission, were 322 individuals who had each presented at one of seven suburban health facilities, complaining of repeated febrile episodes. Although all were found bloodsmear-negative for malarial parasites, all were presumptively diagnosed as cases of malaria and prescribed artemisinin-based combination therapy. When pretreatment samples of blood were, however, checked for P. falciparum histidine-rich protein 2, using a rapid diagnostic test (RDT), and for Plasmodium DNA, using a PCR-based assay, only one (0.03%) of the cases was found RDT-positive and none was found PCR-positive. Although more studies are needed, in different areas and seasons, to see if these results mirror the general situation, it appears that the wide use of PMT in central Sudan, among patients who are bloodsmear-negative, is unjustified, of little, if any, benefit, and a waste of resources that are already limited. An international consortium for the revision of the conceptual aspects of malaria diagnosis and PMT is suggested.     

Genetic variability in Plasmodium vivax aldolase gene in Korean isolates and the sensitivity of the Binax Now malaria test

Introduction of rapid malaria diagnostic tests (RDT) initiated numerous field evaluations in various epidemiologic settings. But the efficiency of some RTD kits based on aldolase raised reservations for direct implementation of RDT into clinical settings. We performed Binax Now malaria test in 84 Korean Plasmodium vivax isolates and compared it with the traditional Giemsa stain microscopy test as the reference standard. The sensitivity of Binax Now was 62.0% for P. vivax cases (52/84, 95% CI 51.2-71.6%) with 100.0% specificity (50/50, 95% confidence interval 92.9-100%). After the aldolase gene sequence analysis of 84 isolates, two synonymous mutations in aldolase gene were identified in both Binax Now positive and negative samples. No significant association between the mutations and Binax Now malaria tests was found. Thus, the genetic variability would not explain the poor performance of P. vivax RDTs by detecting aldolase in ROK isolates.     

A single-step,PCR-based method for the detection and differentiation of Plasmodium vivax and P. falciparum

The ability to detect and differentiate between Plasmodium falciparum and P. vivax is of great importance for the routine laboratory diagnosis of malaria, donor-blood screening and epidemiological studies. Most PCR-based methods for the discrimination of these two species require nested protocols or an additional hybridization reaction, leading to high labour costs and long turn-around times. A simple, time-effective and yet sensitive and specific technique, based on a multiplex PCR, has now been developed for the simultaneous detection and differentiation of P. falciparum and P. vivax in blood samples. Compared with the 'gold standard' of microscopy, this method had a sensitivity and specificity of 100%, with a detection limit of just one P. falciparum or three P. vivax parasites/microl blood.     

Challenges in routine implementation and quality control of rapid diagnostic tests for malaria--Rufiji District, Tanzania

Rapid diagnostic tests (RDTs) represent an alternative to microscopy for malaria diagnosis and have shown high sensitivity and specificity in a variety of study settings. Current World Health Organization (WHO) guidelines for quality control of RDTs provide detailed instructions on pre-field testing, but offer little guidance for quality assurance once RDTs are deployed in health facilities. From September 2006 to April 2007, we introduced a histidine-rich protein II (HRP2)-based RDT (Paracheck) for suspected malaria cases five years of age and older in nine health facilities in Rufiji District, Tanzania, to assess sensitivity and specificity of RDTs in routine use at rural health facilities. Thick blood smears were collected for all patients tested with RDTs and stained and read by laboratory personnel in each facility. Thick smears were subsequently reviewed by a reference microscopist to determine RDT sensitivity and specificity. In all nine health facilities, there were significant problems with the quality of staining and microscopy. Sensitivity and specificity of RDTs were difficult to assess given the poor quality of routine blood smear staining. Mean operational sensitivity of RDTs based on reference microscopy was 64.8%, but varied greatly by health facility, range 18.8-85.9%. Sensitivity of RDTs increased with increasing parasite density. Specificity remained high at 87.8% despite relatively poor slide quality. Institution of quality control of RDTs based on poor quality blood smear staining may impede reliable measurement of sensitivity and specificity and undermine confidence in the new diagnostic. There is an urgent need for the development of alternative quality control procedures for rapid diagnostic tests that can be performed at the facility level.     

Automated detection of malaria-associated intraleucocytic haemozoin by Cell-Dyn CD4000 depolarization analysis

Laboratory tests for malaria are only performed if there is clinical suspicion of the disease, and a missed diagnosis contributes substantially to morbidity and mortality. Malaria parasites produce haemozoin, which is able to depolarize light and this allows the automated detection of malaria during routine complete blood count analysis (CBC) with some Abbott Cell-Dyn instruments. In this study, we evaluated the Cell-Dyn CD4000 with 831 blood samples submitted for malaria investigations. Samples were categorized as malaria negative (n = 417), convalescent malaria (n = 64) or malaria positive (n = 350) by reference to thin/thick film microscopy, 'rapid test' procedures, polymerase chain reaction analysis and clinical history. With regard to CD4000 depolarization analysis, a malaria positive CD4000 pattern was ascribed to samples that showed one or more abnormal depolarizing purple events, which corresponded to monocytes containing ingested malaria pigment (haemozoin). Positive CD4000 patterns were observed in 11 of 417, 50 of 64 and 281 of 350 of malaria negative, convalescent malaria and malaria positive samples respectively. The specificity and positive predictive values for malaria (active and convalescent) were very high (97.4 and 96.8%, respectively), while sensitivity and negative predictive values were 80.0 and 83.0% respectively. Depolarization analysis was particularly effective for Plasmodium falciparum malaria but there was lower detection sensitivity for White compared with Black African patients. CD4000 90 degrees depolarization vs 0 degrees analysis revealed a proportion of samples with small nonleucocyte-associated depolarizing particles. Appearance of such events in the form of a discrete cluster was associated with P. vivax rather than P. falciparum infection.     

Quality Assurance of Rapid Diagnostic Tests for Malaria in Routine Patient Care in Rural Tanzania

Histidine-rich protein II (HRP2)-based malaria rapid diagnostic tests (RDTs) have shown high sensitivity and specificity for detecting Plasmodium falciparum malaria in a variety of study settings. However, RDTs are susceptible to heat and humidity and variation in individual performance, which may affect their use in field settings. We evaluated sensitivity and specificity of RDTs during routine use for malaria case management in peripheral health facilities. From December 2007 to October 2008, HRP2-based ParaHIT-f RDTs were introduced in 12 facilities without available microscopy in Rufiji District, Tanzania. Health workers received a single day of instruction on how to perform an RDT and thick blood smear. Job aids, Integrated Management of Childhood Illness guidelines, and national malaria treatment algorithms were reviewed. For quality assurance (QA), thick blood smears for reference microscopy were collected for 2 to 3 days per week from patients receiving RDTs; microscopy was not routinely performed at the health facilities. Slides were stained and read centrally within 72 hours of collection by a reference microscopist. When RDT and blood smear results were discordant, blood smears were read by additional reference microscopists blinded to earlier results. Facilities were supervised monthly by the district laboratory supervisor or a member of the study team. Ten thousand six hundred fifty (10,650) patients were tested with RDTs, and 51.5% (5,488/10,650) had a positive test result. Blood smear results were available for 3,914 patients, of whom 40.1% (1,577/3,914) were positive for P. falciparum malaria. Overall RDT sensitivity was 90.7% (range by facility 85.7–96.5%) and specificity was 73.5% (range 50.0–84.3%). Sensitivity increased with increasing parasite density. Successful implementation of RDTs was achieved in peripheral health facilities with adequate training and supervision. Quality assurance is essential to the adequate performance of any laboratory test. Centralized staining and reading of blood smears provided useful monitoring of RDT performance. However, this level of QA may not be sustainable nationwide.     

Evaluation of loop-mediated isothermal amplification (LAMP) for malaria diagnosis in a field setting

We used the loop-mediated isothermal amplification (LAMP) method developed by our group for malaria diagnosis with genus-specific and species-specific primers for the four human malaria parasites at a field clinic in comparison with standard microscopy. Among 110 blood samples collected from the malaria clinic in Thailand, LAMP detected 59 of 60 samples positive by microscopy (sensitivity = 98.3%) and none of the 50 microscopy-negative samples (specificity = 100%). Negative predictive value (NPV) and positive predictive value (PPV) of LAMP were 98% and 100%, respectively. These results indicate that LAMP is an effective tool for malaria diagnosis at a field clinic in a field setting.     

Performance of a histidine-rich protein 2 rapid diagnostic test, Paracheck Pf®, for detection of malaria infections in Ugandan pregnant women

Improved laboratory diagnosis is critical to reduce the burden of malaria in pregnancy. Peripheral blood smears appear less sensitive than Plasmodium falciparum histidine-rich protein 2-based rapid diagnostic tests (RDTs) for placental malaria infections in studies conducted at delivery. In this study, 81 women in Uganda in the second or third trimester of pregnancy were followed-up until delivery. At each visit, peripheral blood was tested by blood smear, RDT, and nested species-specific polymerase chain reaction (PCR). Sensitivity and specificity of the tests was calculated with PCR, which detected 22 infections of P. falciparum, as the gold standard. The sensitivity and specificity of blood smears were 36.4% (95% confidence interval [CI] = 18.0-59.2%) and 99.6% (95% CI = 97.7-100%), respectively. The corresponding values for RDT were 31.8% (95% CI = 14.7-54.9%) and 100% (95% CI = 98.3-100%). The RDTs could replace blood smears for diagnosis of malaria in pregnancy by virtue of their relative ease of use. Field-based sensitive tests for malaria in pregnancy are urgently needed.