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. 2019 Aug 27;18(1):288.
doi: 10.1186/s12936-019-2929-1.

Field performance of the malaria highly sensitive rapid diagnostic test in a setting of varying malaria transmission

Julia Mwesigwa  1 , Hannah Slater  2   3 , John Bradley  4 , Binta Saidy  5 , Fatima Ceesay  5 , Charles Whittaker  2 , Ballah Kandeh  6 , Davis Nkwakamna  5 , Chris Drakeley  7 , Jean-Pierre Van Geertruyden  8 , Teun Bousema  9 , Jane Achan  5 , Umberto D'Alessandro  5
Affiliations

Field performance of the malaria highly sensitive rapid diagnostic test in a setting of varying malaria transmission

Julia Mwesigwa et al. Malar J. .

Abstract

Background: The Gambia has successfully reduced malaria transmission. The human reservoir of infection could further decrease if malaria-infected individuals could be identified by highly sensitive, field-based, diagnostic tools and then treated.

Methods: A cross-sectional survey was done at the peak of the 2017 malaria season in 47 Gambian villages. From each village, 100 residents were randomly selected for finger-prick blood samples to detect Plasmodium falciparum infections using highly sensitive rapid diagnostic tests (HS-RDT) and PCR. The sensitivity and specificity of the HS-RDT were estimated (assuming PCR as the gold standard) across varying transmission intensities and in different age groups. A deterministic, age-structured, dynamic model of malaria transmission was used to estimate the impact of mass testing and treatment (MTAT) with HS-RDT in four different scenarios of malaria prevalence by PCR: 5, 15, 30, and 60%, and with seasonal transmission. The impact was compared both to MTAT with conventional RDT and mass drug administration (MDA).

Results: Malaria prevalence by HS-RDT was 15% (570/3798; 95% CI 13.9-16.1). The HS-RDT sensitivity and specificity were 38.4% (191/497, 95% CI 34.2-42.71) and 88.5% (2922/3301; 95% CI 87.4-89.6), respectively. Sensitivity was the highest (50.9%, 95% CI 43.3-58.5%) in high prevalence villages (20-50% by PCR). The model predicted that in very low transmission areas (≤ 5%), three monthly rounds of MTAT with HS-RDT, starting towards the end of the dry season and testing 65 or 85% of the population for 2 consecutive years, would avert 62 or 78% of malaria cases (over 2 years), respectively. The effect of the intervention would be lower in a moderate transmission setting. In all settings, MDA would be superior to MTAT with HS-RDT which would be superior to MTAT with conventional RDT.

Conclusion: The HS-RDT's field sensitivity was modest and varied by transmission intensity. In low to very low transmission areas, three monthly rounds per year of MTAT with HS-RDT at 85% coverage for 2 consecutive years would reduce malaria prevalence to such low levels that additional strategies may achieve elimination. The model prediction would need to be confirmed by cluster-randomized trials.

Keywords: Highly sensitive rapid diagnostic test; Malaria; Mass testing and treatment; Plasmodium falciparum; Transmission areas.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study sites in upper river region-south bank and Plasmodium falciparum infection prevalence by PCR. Filled light blue circle: very low prevalence (< 5%), filled dark blue circle: low-moderate transmission (5 to < 20%), filled red circle: high prevalence (20–50%)
Fig. 2
Fig. 2
Association between the highly sensitive rapid diagnostic test sensitivity and Plasmodium falciparum infection prevalence by PCR. Filled pink circle: each pink dot represents a village and the grey horizontal and vertical lines are 95% confidence intervals associated with the prevalence and sensitivity estimates, blue solid line: the fitted relationship between the two quantities derived from a log-odds regression model between PCR and HS-RDT prevalence implemented within a Bayesian framework. Full details of model structure have been previously published [25]
Fig. 3
Fig. 3
Performance of highly sensitive rapid diagnostic test by transmission intensity
Fig. 4
Fig. 4
Prevalence of Plasmodium falciparum infections as determined by highly sensitive rapid diagnostic test and PCR by village. Dark blue bar: proportions of PCR positive HS-RDT positive infections, dark yellow bar: proportions of PCR negative HS-RDT positive infections, light blue bar: proportion of PCR positive HS-RDT negative infections, grey bar: proportions of PCR negative HS-RDT negative infections
Fig. 5
Fig. 5
Performance of highly sensitive rapid diagnostic test by age. a Dark blue bar: percentage of population that are PCR positive HS-RDT positive, dark yellow bar: percentage of population that are PCR negative HS-RDT positive, light blue bar: percentage of population that are PCR positive HS-RDT negative, grey bar: percentage of population that are PCR negative HS-RDT negative. b Solid blue line: sensitivity of HS-RDT (compared to PCR) for different age groups, with 95% confidence intervals, solid red line: percentage of the population that are PCR negative and HS-RDT positive for different age groups, with 95% confidence intervals
Fig. 6
Fig. 6
Mathematical model simulation of the predicted impact of the interventions (MTAT with HS-RDT, MTAT with conventional RDT, and MDA) implemented for three monthly rounds for 2 consecutive years on PCR prevalence. The intervention is implemented in a seasonal transmission setting with four levels of transmission intensity. The orange arrows indicate the timing of each MTAT/MDA round. Solid grey line: no MTAT, dashed light blue line: co-RDT MTAT, 65% coverage, solid light blue line: co-RDT MTAT, 85% coverage, dashed red line: HS-RDT MTAT, 65% coverage, solid red line: HS-RDT MTAT, 85% coverage, dashed dark blue line: MDA, 65% coverage, dashed solid dark blue line: MDA, 85% coverage
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