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Published in: Malaria Journal 1/2018

Open Access 01-12-2018 | Research

Implementation of a malaria rapid diagnostic test in a rural setting of Nanoro, Burkina Faso: from expectation to reality

Authors: Francois Kiemde, Marc Christian Tahita, Massa dit Achille Bonko, Petra F. Mens, Halidou Tinto, Michael Boele van Hensbroek, Henk D. F. H. Schallig

Published in: Malaria Journal | Issue 1/2018

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Abstract

Background

Malaria rapid diagnostic tests (RDTs) are nowadays widely used in malaria endemic countries as an alternative to microscopy for the diagnosis of malaria. However, quality control of test performance and execution in the field are important in order to ensure proper use and adequate diagnosis of malaria. The current study compared the performance of a histidine-rich protein 2-based RDT used at peripheral health facilities level in real life conditions with that performed at central reference laboratory level with strict adherence to manufacturer instructions.

Methods

Febrile children attending rural health clinics were tested for malaria with a RDT provided by the Ministry of Health of Burkina Faso as recommended by the National Malaria Control Programme. In addition, a blood sample was collected in an EDTA tube from all study cases for retesting with the same brand of RDT following the manufacturer’s instructions with expert malaria microscopy as gold standard at the central reference laboratory. Fisher exact test was used to compare the proportions by estimating the p-value (p ≤ 0.05) as statistically significant.

Results

In total, 407 febrile children were included in the study and malaria was diagnosed in 59.9% (244/407) of the cases with expert malaria microscopy. The sensitivity of malaria RDT testing performed at health facilities was 97.5% and comparable to that achieved at the laboratory (98.8%). The number of malaria false negatives was not statistically significant between the two groups (p = 0.5209). However, the malaria RDT testing performed at health facilities had a specificity issue (52.8%) and was much lower compared to RDT testing performed at laboratory (74.2%). The number of malaria false positives was statistically significantly different between the two groups (p = 0.0005).

Conclusion

Malaria RDT testing performed at the participating rural health facilities resulted in more malaria false positives compared to those performed at central laboratory. Several factors, including storage and transportation conditions but also training of health workers, are most likely to influence test performance. Therefore, it is very important to have appropriate quality control and training programmes in place to ensure correct performance of RDT testing.
Literature
1.
go back to reference Programme National de Lutte contre le Paludisme. Directives nationales pour la prise en charge du paludisme dans les formations sanitaires du Burkina Faso. Burkina Faso: Ouagadougou; 2014. Programme National de Lutte contre le Paludisme. Directives nationales pour la prise en charge du paludisme dans les formations sanitaires du Burkina Faso. Burkina Faso: Ouagadougou; 2014.
2.
go back to reference WHO. Guidelines for the treatment of malaria. 2nd ed. Geneva: World Health Organization; 2010. p. 197. WHO. Guidelines for the treatment of malaria. 2nd ed. Geneva: World Health Organization; 2010. p. 197.
4.
go back to reference Maltha J, Gillet P, Bottieau E, Cnops L, van Esbroeck M, Jacobs J. Evaluation of a rapid diagnostic test (CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test) for the diagnosis of malaria in a reference setting. Malar J. 2010;9:171.CrossRefPubMedPubMedCentral Maltha J, Gillet P, Bottieau E, Cnops L, van Esbroeck M, Jacobs J. Evaluation of a rapid diagnostic test (CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test) for the diagnosis of malaria in a reference setting. Malar J. 2010;9:171.CrossRefPubMedPubMedCentral
6.
go back to reference WHO. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 6 (2014–2015). Geneva: World Health Organization; 2015. WHO. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 6 (2014–2015). Geneva: World Health Organization; 2015.
7.
go back to reference WHO. World malaria report 2011. Geneva: World Health Organization; 2011. WHO. World malaria report 2011. Geneva: World Health Organization; 2011.
8.
go back to reference Albertini A, Lee E, Coulibaly SO, Sleshi M, Faye B, Mationg ML, et al. Malaria rapid diagnostic test transport and storage conditions in Burkina Faso, Senegal, Ethiopia and the Philippines. Malar J. 2012;11:406.CrossRefPubMedPubMedCentral Albertini A, Lee E, Coulibaly SO, Sleshi M, Faye B, Mationg ML, et al. Malaria rapid diagnostic test transport and storage conditions in Burkina Faso, Senegal, Ethiopia and the Philippines. Malar J. 2012;11:406.CrossRefPubMedPubMedCentral
9.
go back to reference Rennie W, Phetsouvanh R, Lupisan S, Vanisaveth V, Hongvanthong B, Phompida S, et al. Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. Trans R Soc Trop Med Hyg. 2007;101:9–18.CrossRefPubMed Rennie W, Phetsouvanh R, Lupisan S, Vanisaveth V, Hongvanthong B, Phompida S, et al. Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. Trans R Soc Trop Med Hyg. 2007;101:9–18.CrossRefPubMed
10.
go back to reference Masanja IM, Maganga M, Sumari D, Lucchi N, Udhayakumar V, McMorrow M, et al. Evaluation of two quality assurance approaches for malaria rapid diagnostic tests in peripheral health facilities in rural tanzania. Am J Trop Med Hyg. 2012;Conference:255. Masanja IM, Maganga M, Sumari D, Lucchi N, Udhayakumar V, McMorrow M, et al. Evaluation of two quality assurance approaches for malaria rapid diagnostic tests in peripheral health facilities in rural tanzania. Am J Trop Med Hyg. 2012;Conference:255.
11.
12.
go back to reference Tjitra E, Suprianto S, McBroom J, Currie BJ, Anstey NM. Persistent ICT malaria P.f/P.v Panmalarial and HRP2 antigen reactivity after treatment of Plasmodium falciparum malaria is associated with gametocytemia and results in false-positive diagnoses of Plasmodium vivax in convalescence. J Clin Microbiol. 2001;39:1025–31.CrossRefPubMedPubMedCentral Tjitra E, Suprianto S, McBroom J, Currie BJ, Anstey NM. Persistent ICT malaria P.f/P.v Panmalarial and HRP2 antigen reactivity after treatment of Plasmodium falciparum malaria is associated with gametocytemia and results in false-positive diagnoses of Plasmodium vivax in convalescence. J Clin Microbiol. 2001;39:1025–31.CrossRefPubMedPubMedCentral
13.
go back to reference Kattenberg JH, Tahita CM, Versteeg IAJ, Tinto H, Traore-Coulibaly M, Schallig HDFH, et al. Antigen persistence of rapid diagnostic tests in pregnant women in Nanoro, Burkina Faso, and the implications for the diagnosis of malaria in pregnancy. Trop Med Int Health. 2012;17:550–7.CrossRefPubMed Kattenberg JH, Tahita CM, Versteeg IAJ, Tinto H, Traore-Coulibaly M, Schallig HDFH, et al. Antigen persistence of rapid diagnostic tests in pregnant women in Nanoro, Burkina Faso, and the implications for the diagnosis of malaria in pregnancy. Trop Med Int Health. 2012;17:550–7.CrossRefPubMed
14.
go back to reference Maltha J, Guiraud I, Lompo P, Kabore B, Gillet P, Van Geet C, et al. Accuracy of PfHRP2 versus Pf-pLDH antigen detection by malaria rapid diagnostic tests in hospitalized children in a seasonal hyperendemic malaria transmission area in Burkina Faso. Malar J. 2014;13:20.CrossRefPubMedPubMedCentral Maltha J, Guiraud I, Lompo P, Kabore B, Gillet P, Van Geet C, et al. Accuracy of PfHRP2 versus Pf-pLDH antigen detection by malaria rapid diagnostic tests in hospitalized children in a seasonal hyperendemic malaria transmission area in Burkina Faso. Malar J. 2014;13:20.CrossRefPubMedPubMedCentral
15.
go back to reference Hendriksen ICE, Mtove G, Pedro AJ, Gomes E, Silamut K, Lee SJ, et al. Evaluation of a PfHRP2 and a pLDH-based rapid diagnostic test for the diagnosis of severe malaria in 2 populations of african children. Clin Infect Dis. 2011;52:1100–7.CrossRefPubMedPubMedCentral Hendriksen ICE, Mtove G, Pedro AJ, Gomes E, Silamut K, Lee SJ, et al. Evaluation of a PfHRP2 and a pLDH-based rapid diagnostic test for the diagnosis of severe malaria in 2 populations of african children. Clin Infect Dis. 2011;52:1100–7.CrossRefPubMedPubMedCentral
16.
go back to reference Barber BE, William T, Grigg MJ, Piera K, Yeo TW, Anstey NM. Evaluation of the sensitivity of a pLDH-based and an aldolase-based rapid diagnostic test for diagnosis of uncomplicated and severe malaria caused by PCR-confirmed Plasmodium knowlesi, Plasmodium falciparum, and Plasmodium vivax. J Clin Microbiol. 2013;51:1118–23.CrossRefPubMedPubMedCentral Barber BE, William T, Grigg MJ, Piera K, Yeo TW, Anstey NM. Evaluation of the sensitivity of a pLDH-based and an aldolase-based rapid diagnostic test for diagnosis of uncomplicated and severe malaria caused by PCR-confirmed Plasmodium knowlesi, Plasmodium falciparum, and Plasmodium vivax. J Clin Microbiol. 2013;51:1118–23.CrossRefPubMedPubMedCentral
17.
go back to reference Ochola LB, Vounatsou P, Smith T, Mabaso ML, Newton CR. The reliability of diagnostic techniques in the diagnosis and management of malaria in the absence of a gold standard. Lancet Infect Dis. 2006;6:582–8.CrossRefPubMed Ochola LB, Vounatsou P, Smith T, Mabaso ML, Newton CR. The reliability of diagnostic techniques in the diagnosis and management of malaria in the absence of a gold standard. Lancet Infect Dis. 2006;6:582–8.CrossRefPubMed
20.
go back to reference Diallo MA, Diongue K, Ndiaye M, Gaye A, Deme A, Badiane AS, et al. Evaluation of CareStart™ Malaria HRP2/pLDH (Pf/pan) Combo Test in a malaria low transmission region of Senegal. Malar J. 2017;16:328.CrossRefPubMedPubMedCentral Diallo MA, Diongue K, Ndiaye M, Gaye A, Deme A, Badiane AS, et al. Evaluation of CareStart™ Malaria HRP2/pLDH (Pf/pan) Combo Test in a malaria low transmission region of Senegal. Malar J. 2017;16:328.CrossRefPubMedPubMedCentral
21.
go back to reference District Sanitaire de Nanoro. Plan Strategique 2016 du District Sanitaire de Nanoro; 2016. District Sanitaire de Nanoro. Plan Strategique 2016 du District Sanitaire de Nanoro; 2016.
22.
go back to reference Kiemde F, Bonko MDA, Tahita MC, Lompo P, Rouamba T, Tinto H, et al. Accuracy of a Plasmodium falciparum specific histidine-rich protein 2 rapid diagnostic test in the context of the presence of non-malaria fevers, prior anti-malarial use and seasonal malaria transmission. Malar J. 2017;16:294.CrossRefPubMedPubMedCentral Kiemde F, Bonko MDA, Tahita MC, Lompo P, Rouamba T, Tinto H, et al. Accuracy of a Plasmodium falciparum specific histidine-rich protein 2 rapid diagnostic test in the context of the presence of non-malaria fevers, prior anti-malarial use and seasonal malaria transmission. Malar J. 2017;16:294.CrossRefPubMedPubMedCentral
23.
go back to reference Tinto H, Ouedraogo JB, Traore M, Guiguemde TR. [Parasitological resistance of Plasmodium falciparum to antimalarial drugs: what physicians should keep in mind. Sante. 2004;14:69–73.PubMed Tinto H, Ouedraogo JB, Traore M, Guiguemde TR. [Parasitological resistance of Plasmodium falciparum to antimalarial drugs: what physicians should keep in mind. Sante. 2004;14:69–73.PubMed
24.
go back to reference McMorrow ML, Aidoo M, Kachur SP. Malaria rapid diagnostic tests in elimination settings-can they find the last parasite? Clin Microbiol Infect. 2011;17:1624–31.CrossRefPubMedPubMedCentral McMorrow ML, Aidoo M, Kachur SP. Malaria rapid diagnostic tests in elimination settings-can they find the last parasite? Clin Microbiol Infect. 2011;17:1624–31.CrossRefPubMedPubMedCentral
25.
go back to reference Koita OA, Doumbo OK, Ouattara A, Tall LK, Konaré A, Diakité M, et al. False-negative rapid diagnostic tests for malaria and deletion of the histidine-rich repeat region of the hrp2 gene. Am J Trop Med Hyg. 2012;86:194–8.CrossRefPubMedPubMedCentral Koita OA, Doumbo OK, Ouattara A, Tall LK, Konaré A, Diakité M, et al. False-negative rapid diagnostic tests for malaria and deletion of the histidine-rich repeat region of the hrp2 gene. Am J Trop Med Hyg. 2012;86:194–8.CrossRefPubMedPubMedCentral
26.
go back to reference Wurtz N, Fall B, Bui K, Pascual A, Fall M, Camara C, et al. Pfhrp2 and pfhrp3 polymorphisms in Plasmodium falciparum isolates from Dakar, Senegal: impact on rapid malaria diagnostic tests. Malar J. 2013;12:34.CrossRefPubMedPubMedCentral Wurtz N, Fall B, Bui K, Pascual A, Fall M, Camara C, et al. Pfhrp2 and pfhrp3 polymorphisms in Plasmodium falciparum isolates from Dakar, Senegal: impact on rapid malaria diagnostic tests. Malar J. 2013;12:34.CrossRefPubMedPubMedCentral
27.
go back to reference Deme AB, Park DJ, Bei AK, Sarr O, Badiane A, Gueye PEH, et al. Analysis of pfhrp2 genetic diversity in Senegal and implications for use of rapid diagnostic tests. Malar J. 2014;13:34.CrossRefPubMedPubMedCentral Deme AB, Park DJ, Bei AK, Sarr O, Badiane A, Gueye PEH, et al. Analysis of pfhrp2 genetic diversity in Senegal and implications for use of rapid diagnostic tests. Malar J. 2014;13:34.CrossRefPubMedPubMedCentral
28.
go back to reference Meatherall B, Preston K, Pillai DR. False positive malaria rapid diagnostic test in returning traveler with typhoid fever. BMC Infect Dis. 2014;14:377.CrossRefPubMedPubMedCentral Meatherall B, Preston K, Pillai DR. False positive malaria rapid diagnostic test in returning traveler with typhoid fever. BMC Infect Dis. 2014;14:377.CrossRefPubMedPubMedCentral
29.
go back to reference Haberichter KL, Johnson PC, Chittick PJ, Millward P, Robinson-Dunn B, Boyanton BL. The brief case: false-positive rapid malaria antigen test result in a returned traveler. J Clin Microbiol. 2017;55:2294–7.CrossRefPubMedPubMedCentral Haberichter KL, Johnson PC, Chittick PJ, Millward P, Robinson-Dunn B, Boyanton BL. The brief case: false-positive rapid malaria antigen test result in a returned traveler. J Clin Microbiol. 2017;55:2294–7.CrossRefPubMedPubMedCentral
30.
go back to reference Iqbal J, Sher A, Rab A. Plasmodium falciparum histidine-rich protein 2-based immunocapture diagnostic assay for malaria: cross-reactivity with rheumatoid factors. J Clin Microbiol. 2000;38:1184–6.PubMedPubMedCentral Iqbal J, Sher A, Rab A. Plasmodium falciparum histidine-rich protein 2-based immunocapture diagnostic assay for malaria: cross-reactivity with rheumatoid factors. J Clin Microbiol. 2000;38:1184–6.PubMedPubMedCentral
31.
go back to reference Maltha J, Gillet P, Cnops L, Bottieau E, Van Esbroeck M, Bruggeman C, et al. Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting. Malar J. 2011;10:7.CrossRefPubMedPubMedCentral Maltha J, Gillet P, Cnops L, Bottieau E, Van Esbroeck M, Bruggeman C, et al. Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting. Malar J. 2011;10:7.CrossRefPubMedPubMedCentral
32.
go back to reference Leshem E, Keller N, Guthman D, Grossman T, Solomon M, Marva E, et al. False-positive Plasmodium falciparum histidine-rich protein 2 immunocapture assay results for acute schistosomiasis caused by Schistosoma mekongi. J Clin Microbiol. 2011;49:2331–2.CrossRefPubMedPubMedCentral Leshem E, Keller N, Guthman D, Grossman T, Solomon M, Marva E, et al. False-positive Plasmodium falciparum histidine-rich protein 2 immunocapture assay results for acute schistosomiasis caused by Schistosoma mekongi. J Clin Microbiol. 2011;49:2331–2.CrossRefPubMedPubMedCentral
33.
go back to reference Gillet P, Mumba Ngoyi D, Lukuka A, Kande V, Atua B, van Griensven J, et al. False positivity of non-targeted infections in malaria rapid diagnostic tests: the case of human African trypanosomiasis. PLoS Negl Trop Dis. 2013;7:e2180.CrossRefPubMedPubMedCentral Gillet P, Mumba Ngoyi D, Lukuka A, Kande V, Atua B, van Griensven J, et al. False positivity of non-targeted infections in malaria rapid diagnostic tests: the case of human African trypanosomiasis. PLoS Negl Trop Dis. 2013;7:e2180.CrossRefPubMedPubMedCentral
34.
go back to reference Lee J-H, Jang JW, Cho CH, Kim JY, Han ET, Yun SG, et al. False-positive results for rapid diagnostic tests for malaria in patients with rheumatoid factor. J Clin Microbiol. 2014;52:3784–7.CrossRefPubMedPubMedCentral Lee J-H, Jang JW, Cho CH, Kim JY, Han ET, Yun SG, et al. False-positive results for rapid diagnostic tests for malaria in patients with rheumatoid factor. J Clin Microbiol. 2014;52:3784–7.CrossRefPubMedPubMedCentral
35.
go back to reference Grobusch M, Alpermann U, Schwenke S, Jelinek T, Warhurst D, Vugt M. False-positive rapid tests for malaria in patients with rheumatoid factor. Lancet. 1999;353:297.CrossRefPubMed Grobusch M, Alpermann U, Schwenke S, Jelinek T, Warhurst D, Vugt M. False-positive rapid tests for malaria in patients with rheumatoid factor. Lancet. 1999;353:297.CrossRefPubMed
36.
go back to reference Laferi H, Kandel K, Pichler H. False positive dipstick test for malaria. N Engl J Med. 1997;337:1635–6.CrossRefPubMed Laferi H, Kandel K, Pichler H. False positive dipstick test for malaria. N Engl J Med. 1997;337:1635–6.CrossRefPubMed
37.
go back to reference Ruizendaal E, Schallig HDFH, Scott S, Traore-Coulibaly M, Bradley J, Lompo P, et al. Evaluation of malaria screening during pregnancy with rapid diagnostic tests performed by community health workers in Burkina Faso. Am J Trop Med Hyg. 2017;97:1190–7.CrossRefPubMedPubMedCentral Ruizendaal E, Schallig HDFH, Scott S, Traore-Coulibaly M, Bradley J, Lompo P, et al. Evaluation of malaria screening during pregnancy with rapid diagnostic tests performed by community health workers in Burkina Faso. Am J Trop Med Hyg. 2017;97:1190–7.CrossRefPubMedPubMedCentral
38.
go back to reference Gnouregma Urbain Yameogo. Etat de reference des observatoires de la mare d’Oursi et de la reserve de la biosphere de la mare aux hippopotames; 2011. Gnouregma Urbain Yameogo. Etat de reference des observatoires de la mare d’Oursi et de la reserve de la biosphere de la mare aux hippopotames; 2011.
39.
go back to reference Chiodini PL, Bowers K, Jorgensen P, Barnwell JW, Grady KK, Luchavez J, et al. The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Trans R Soc Trop Med Hyg. 2007;101:331–7.CrossRefPubMed Chiodini PL, Bowers K, Jorgensen P, Barnwell JW, Grady KK, Luchavez J, et al. The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Trans R Soc Trop Med Hyg. 2007;101:331–7.CrossRefPubMed
41.
go back to reference Sandeu MM, Bayibéki AN, Tchioffo MT, Abate L, Gimonneau G, Awono-Ambéné PH, et al. Do the venous blood samples replicate malaria parasite densities found in capillary blood? A field study performed in naturally-infected asymptomatic children in Cameroon. Malar J. 2017;16:345.CrossRefPubMedPubMedCentral Sandeu MM, Bayibéki AN, Tchioffo MT, Abate L, Gimonneau G, Awono-Ambéné PH, et al. Do the venous blood samples replicate malaria parasite densities found in capillary blood? A field study performed in naturally-infected asymptomatic children in Cameroon. Malar J. 2017;16:345.CrossRefPubMedPubMedCentral
42.
go back to reference Schofield L, Hackett F. Signal transduction in host cells by a glycosylphosphatidylinositol toxin of malaria parasites. J Exp Med. 1993;177:145–53.CrossRefPubMed Schofield L, Hackett F. Signal transduction in host cells by a glycosylphosphatidylinositol toxin of malaria parasites. J Exp Med. 1993;177:145–53.CrossRefPubMed
43.
Metadata
Title
Implementation of a malaria rapid diagnostic test in a rural setting of Nanoro, Burkina Faso: from expectation to reality
Authors
Francois Kiemde
Marc Christian Tahita
Massa dit Achille Bonko
Petra F. Mens
Halidou Tinto
Michael Boele van Hensbroek
Henk D. F. H. Schallig
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Malaria Journal / Issue 1/2018
Electronic ISSN: 1475-2875
DOI
https://doi.org/10.1186/s12936-018-2468-1

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