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Comparative Study
. 2010 Oct 27:9:297.
doi: 10.1186/1475-2875-9-297.

Performance of three multi-species rapid diagnostic tests for diagnosis of Plasmodium falciparum and Plasmodium vivax malaria in Oromia Regional State, Ethiopia

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Comparative Study

Performance of three multi-species rapid diagnostic tests for diagnosis of Plasmodium falciparum and Plasmodium vivax malaria in Oromia Regional State, Ethiopia

Ruth A Ashton et al. Malar J. .

Abstract

Background: Malaria transmission in Ethiopia is unstable and variable, caused by both Plasmodium falciparum and Plasmodium vivax. The Federal Ministry of Health (FMoH) is scaling up parasitological diagnosis of malaria at all levels of the health system; at peripheral health facilities this will be through use of rapid diagnostic tests (RDTs). The present study compared three RDT products to provide the FMoH with evidence to guide appropriate product selection.

Methods: Performance of three multi-species (pf-HRP2/pan-pLDH and pf-HRP2/aldolase) RDTs (CareStart, ParaScreen and ICT Combo) was compared with 'gold standard' microscopy at three health centres in Jimma zone, Oromia Regional State. Ease of RDT use by health extension workers was assessed at community health posts. RDT heat stability was tested in a controlled laboratory setting according to WHO procedures.

Results: A total of 2,383 patients with suspected malaria were enrolled between May and July 2009, 23.2% of whom were found to be infected with Plasmodium parasites by microscopy. All three RDTs were equally sensitive in detecting P. falciparum or mixed infection: 85.6% (95% confidence interval 81.2-89.4). RDT specificity was similar for detection of P. falciparum or mixed infection at around 92%. For detecting P. vivax infection, all three RDTs had similar sensitivity in the range of 82.5 to 85.0%. CareStart had higher specificity in detecting P. vivax (97.2%) than both ParaScreen and ICT Combo (p < 0.001 and p = 0.05, respectively). Health extension workers preferred CareStart and ParaScreen to ICT Combo due to the clear labelling of bands on the cassette, while the 'lab in a pack' style of CareStart was the preferred design. ParaScreen and CareStart passed all heat stability testing, while ICT Combo did not perform as well.

Conclusions: CareStart appeared to be the most appropriate option for use at health posts in Ethiopia, considering the combination of quantitative performance, ease of use and heat stability. When new products become available, the choice of multi-species RDT for Ethiopia should be regularly re-evaluated, as it would be desirable to identify a test with higher sensitivity than the ones evaluated here.

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Figures

Figure 1
Figure 1
Location of Oromia Regional State (solid shading) and Jimma zone (vertical shading) within Ethiopia. Detail of Jimma zone indicates study health centres (filled squares) and health posts (filled circles).
Figure 2
Figure 2
Flowchart of microscopy and RDT results.
Figure 3
Figure 3
Flowchart of microscopy results discrepant between first and second readings.

References

    1. Federal Democratic Republic of Ethiopia MoH. Guideline for malaria epidemic prevention and control in Ethiopia. 2. Addis Ababa, Ethiopia; 2004.
    1. Federal Democratic Republic of Ethiopia MoH. Health and Health Related Indicators. Addis Ababa, Ethiopia; 2007.
    1. Federal Democratic Republic of Ethiopia MoH. National Five Year Strategic Plan for Malaria Prevention and Control in Ethiopia. Addis Ababa, Ethiopia; 2006.
    1. Mekonnen Z, Ali S, Belay G, Suleman S, Chatterjee S. Evaluation of the performance of CareStart Malaria Pf/Pv Combo Rapid Diagnostic Test for the diagnosis of malaria in Jimma, southwestern Ethiopia. Acta Trop. 2010;113:285–288. doi: 10.1016/j.actatropica.2009.12.001. - DOI - PubMed
    1. Sharew B, Legesse M, Animut A, Jima D, Medhin G, Erko B. Evaluation of the performance of CareStart Malaria Pf/Pv Combo and Paracheck Pf tests for the diagnosis of malaria in Wondo Genet, southern Ethiopia. Acta Trop. 2009;111:321–324. doi: 10.1016/j.actatropica.2009.05.014. - DOI - PubMed

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