Performance of a highly sensitive rapid diagnostic test (HS-RDT) for detecting malaria in peripheral and placental blood samples from pregnant women in Colombia

Vásquez, Ana María; Medina, A.; Tobón-Castaño, Alberto; Posada, Maritza; Vélez, Gabriel; Campillo, Ana; González, Iveth J.; Ding, Xavier C.

doi:10.1371/journal.pone.0201769

Cited by 43 publications

(56 citation statements)

References 33 publications

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“…These results are supported by a study in Colombia, which also used stored samples from pregnant women. Although they note a trend of increased sensitivity by the uRDT, it was not found to be significantly different from the Standard Bioline RDT (sdRDT) [20]. A Tanzanian study in febrile children and adult outpatients also found no difference between uRDT and sdRDT performance, although febrile patients tend to have higher parasitaemia [29].…”

Section: Discussionmentioning

confidence: 93%

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Use of a highly-sensitive rapid diagnostic test to screen for malaria in pregnancy in Indonesia

Unwin

Ahmed

Noviyanti

et al. 2020

Malar J

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Background: The sensitivity of rapid diagnostic tests (RDTs) for malaria is inadequate for detecting low-density, often asymptomatic infections, such as those that can occur when screening pregnant women for malaria. The performance of the Alere ™ Ultra-sensitive Malaria Ag Plasmodium falciparum RDT (uRDT) was assessed retrospectively in pregnant women in Indonesia. Methods:The diagnostic performance of the uRDT and the CareStart ™ Malaria HRP2/pLDH VOM (Plasmodium vivax, Plasmodium ovale and Plasmodium malariae) Combo RDT (csRDT) were assessed using 270 stored red blood cell pellets and plasma samples from asymptomatic pregnant women. These included 112 P. falciparum negative and 158 P. falciparum positive samples detected by a composite test (qPCR, LAMP, nPCR) as reference standard. Diagnostic indicators: sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), diagnostic odds ratio (DOR) and the level of agreement (kappa) were calculated for comparison. Results:Compared with the reference test, the uRDT had a sensitivity of 19.6% (95% CI 13.9-26.8) and specificity of 98.2% (93.1-99.7%). The csRDT was 22.8% (16.7-30.3) sensitive and 95.5% (89.4-98.3) specific for P. falciparum infections. Performance of the uRDT was non-significantly different to the csRDT (p = 0.169). RDT outcome was stratified by qPCR cycling threshold (Ct), and performance of the RDTs was found to be comparable across parasite loads. Conclusion:The uRDT performed similarly to the currently used csRDTs in detecting P. falciparum infections in asymptomatic pregnant women. In these settings, molecular diagnostics are currently the most sensitive for malaria. Publisher's NoteSpringer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Section: Discussionmentioning

confidence: 93%

“…The only study in pregnant women did not observe notable differences in sensitivity between the uRDT and existing SD Bioline RDTs. [20].…”

Section: Introductionmentioning

confidence: 99%

Use of a highly-sensitive rapid diagnostic test to screen for malaria in pregnancy in Indonesia

Unwin

Ahmed

Noviyanti

et al. 2020

Malar J

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“…In low malaria transmission settings, where both symptomatic and asymptomatic patients should be identified and treated, the conventional RDTs miss important proportions of infections. New combination, highly sensitive RDTs able to identify all infected individuals, will support countries implementing active case detection strategies,20 but their use and added benefit for malaria case management in pregnancy will need to be assessed 21. The high maternal mortality ratio (437/100 000) and perinatal mortality rate (39.3/1000) observed in the study cohort suggest that the risk factors for adverse birth outcomes in this community are multifactorial, including a weak health system.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of intermittent screening and treatment for the control of malaria in pregnancy: a cluster randomised trial in India

et al. 2019

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BackgroundThe control of malaria in pregnancy (MiP) in India relies on testing women who present with symptoms or signs suggestive of malaria. We hypothesised that intermittent screening and treatment for malaria at each antenatal care visit (ISTp) would improve on this approach and reduce the adverse effects of MiP.MethodsA cluster randomised controlled trial comparing ISTp versus passive case detection (PCD) was conducted in Jharkhand state. Pregnant women of all parities with a gestational age of 18–28 weeks were enrolled. Women in the ISTp group were screened with a rapid diagnostic test (RDT) for malaria at each antenatal clinic visit and those in the PCD group were screened only if they had symptoms or signs suggestive of malaria. All RDT positive women were treated with artesunate/sulfadoxine–pyrimethamine. The primary endpoint was placental malaria, determined by placental histology, and the key secondary endpoints were birth weight, gestational age, vital status of the newborn baby and maternal anaemia.ResultsBetween April 2012 and September 2015, 6868 women were enrolled; 3300 in 46 ISTp clusters and 3568 in 41 PCD clusters. In the ISTp arm, 4.9% of women were tested malaria positive and 0.6% in the PCD arm. There was no difference in the prevalence of placental malaria in the ISTp (87/1454, 6.0%) and PCD (65/1560, 4.2%) groups (6.0% vs 4.2%; OR 1.34, 95% CI 0.78 to 2.29, p=0.29) or in any of the secondary endpoints.ConclusionISTp detected more infections than PCD, but monthly ISTp with the current generation of RDT is unlikely to reduce placental malaria or impact on pregnancy outcomes. ISTp trials with more sensitive point-of-care diagnostic tests are needed.

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“…Indeed, currently malaria diagnosis is mainly based on light microscopy (LM) and rapid diagnostic tests (RDTs); however, those tools, even though very useful, have some limitations in the elimination context. Recently, highly sensitive RDTs (HS-RDTs) have been developed and have been shown to improve performance in detecting low-density infections compared to LM or RDTs [6][7][8]. Nevertheless, more sensitive diagnostic tools may be required to detect transmissible very low parasites densities [9][10][11], and the emergence and spread of parasite with HRP2/3 deletion could definitely compromise the use of this new HS-RDT in some settings [12,13].…”

Section: Introductionmentioning

confidence: 99%

Strengthening Surveillance Systems for Malaria Elimination by Integrating Molecular and Genomic Data

Nsanzabana

2019

TropicalMed

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Unprecedented efforts in malaria control over the last 15 years have led to a substantial decrease in both morbidity and mortality in most endemic settings. However, these progresses have stalled over recent years, and resurgence may cause dramatic impact on both morbidity and mortality. Nevertheless, elimination efforts are currently going on with the objective of reducing malaria morbidity and mortality by 90% and malaria elimination in at least 35 countries by 2030. Strengthening surveillance systems is of paramount importance to reach those targets, and the integration of molecular and genomic techniques into routine surveillance could substantially improve the quality and robustness of data. Techniques such as polymerase chain reaction (PCR) and quantitative PCR (qPCR) are increasingly available in malaria endemic countries, whereas others such as sequencing are already available in a few laboratories. However, sequencing, especially next-generation sequencing (NGS), requires sophisticated infrastructure with adequate computing power and highly trained personnel for data analysis that require substantial investment. Different techniques will be required for different applications, and cost-effective planning must ensure the appropriate use of available resources. The development of national and sub-regional reference laboratories could help in minimizing the resources required in terms of equipment and trained staff. Concerted efforts from different stakeholders at national, sub-regional, and global level are needed to develop the required framework to establish and maintain these reference laboratories.

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Performance of a highly sensitive rapid diagnostic test (HS-RDT) for detecting malaria in peripheral and placental blood samples from pregnant women in Colombia

Cited by 43 publications

References 33 publications

Use of a highly-sensitive rapid diagnostic test to screen for malaria in pregnancy in Indonesia

Use of a highly-sensitive rapid diagnostic test to screen for malaria in pregnancy in Indonesia

Effectiveness of intermittent screening and treatment for the control of malaria in pregnancy: a cluster randomised trial in India

Strengthening Surveillance Systems for Malaria Elimination by Integrating Molecular and Genomic Data

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