Assessment of ultra-sensitive malaria diagnosis versus standard molecular diagnostics for malaria elimination: an in-depth molecular community cross-sectional study

Hofmann, Natalie; Gruenberg, Maria; Nate, Elma; Ura, Alice; Rodríguez-Rodríguez, Daniela; Salib, Mary; Müeller, Ivo; Smith, T.; Laman, Moses; Robinson, Leanne J.; Felger, Ingrid

doi:10.1016/s1473-3099(18)30411-0

Cited by 97 publications

(135 citation statements)

References 30 publications

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“…The results here differ from other studies conducted in non-pregnant populations that showed a significant increase in sensitivity of the uRDT compared to current RDTs. [19,26,30,31]. The most apparent difference between the conflicting results is the target population (pregnant vs non-pregnant) and the storage conditions.…”

Section: Discussionmentioning

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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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: 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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“…A modelling study found that in such areas LLINs alone could not lead to interruption of P. vivax transmission and additional tools are required to accelerate to elimination [27]. Considering the abundance of low level parasitaemia, particularly in P. vivax infections as transmission is reduced, more sensitive diagnostic tools may need to be applied to monitor progress and species composition [28].…”

Section: Discussionmentioning

confidence: 99%

Repeated mosquito net distributions, improved treatment, and trends in malaria cases in sentinel health facilities in Papua New Guinea

Rodríguez-Rodríguez

Maraga

Lorry

et al. 2019

Malar J

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Background: Long-lasting insecticidal nets (LLIN), improved diagnosis and artemisinin-based combination therapy (ACT) have reduced malaria prevalence in Papua New Guinea since 2008. Yet, national incidence trends are inconclusive due to confounding effects of the scale-up of rapid diagnostic tests, and inconsistencies in routine reporting. Methods: Malaria trends and their association with LLIN and ACT roll-out between 2010 and 2014 in seven sentinel health facilities were analysed. The analysis included 35,329 fever patients. Intervention effects were estimated using regression models. Results: Malaria incidence initially ranged from 20 to 115/1000 population; subsequent trends varied by site. Overall, LLIN distributions had a cumulative effect, reducing the number of malaria cases with each round (incidence rate ratio ranging from 0.12 to 0.53 in five sites). No significant reduction was associated with ACT introduction. Plasmodium falciparum remained the dominant parasite in all sentinel health facilities. Resurgence occurred in one site in which a shift to early and outdoor biting of anophelines had previously been documented. Conclusions: LLINs, but not ACT, were associated with reductions of malaria cases in a range of settings, but sustainability of the gains appear to depend on local factors. Malaria programmes covering diverse transmission settings such as Papua New Guinea must consider local heterogeneity when choosing interventions and ensure continuous monitoring of trends.

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“…Das et al 9 reported a uRDT sensitivity of 44% (95% CI: 15-77%) and specificity of 99.8% (95% CI: 99-100%) compared with quantitative reverse transcriptase PCR (qRT-PCR) and compared with a sensitivity of 0% (95% CI: 0-37%) and a specificity of 100% (95% CI: 99-100%) for the cRDT (Bioline, Standard Diagnostics) in whole blood specimens collected from asymptomatic individuals in a cross-sectional survey in Myanmar, where the positivity was 1.8% (9 of 493) by qRT-PCR. An analysis of 247 blood samples from a cross-sectional survey in Papua New Guinea by Hofmann et al 12 reported a uRDT (Malaria Ag P.f Ultra-Sensitive, Standard Diagnostics) sensitivity of 27% compared with 15% for cRDTs (Malaria Ag P.f/P.v, Standard Diagnostics) with qPCR used as a reference method. It should be noted that the PCR techniques used differed between studies and may explain some of the differences in the results.…”

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confidence: 99%

Performance of Ultrasensitive Rapid Diagnostic Tests for Detecting Asymptomatic Plasmodium falciparum

Yeung

McGregor

James

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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Proposed interventions for eliminating drug-resistant Plasmodium falciparum malaria include the targeting of asymptomatic carriers through screening and treatment. We report on the diagnostic performance of the recently developed ultrasensitive rapid diagnostic test (uRDT) compared with screening with conventional RDTs (cRDT) and polymerase chain reaction (PCR) under field conditions in Cambodia in a total of 2,729 individuals. The P. falciparum positivity by quantitative PCR (qPCR) was 3.8% (26/678) in those screened during active case detection and 0.5% (10/2,051) in the cross-sectional survey. Compared with qPCR, the sensitivity of the uRDTs was 53.8% (95% CI: 33.4-73.4%) when used in active case detection and 60.0% (95% CI: 26.2-87.8%) in the cross-sectional survey. The uRDTs did not show a significant improvement in diagnostic performance over cRDTs when used for active case detection and for a malaria prevalence survey in the context of this low-transmission setting.

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Assessment of ultra-sensitive malaria diagnosis versus standard molecular diagnostics for malaria elimination: an in-depth molecular community cross-sectional study

Abstract: Swiss National Science Foundation.

Cited by 97 publications

References 30 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

Repeated mosquito net distributions, improved treatment, and trends in malaria cases in sentinel health facilities in Papua New Guinea

Performance of Ultrasensitive Rapid Diagnostic Tests for Detecting Asymptomatic Plasmodium falciparum

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