Performance of a High-Sensitivity Rapid Diagnostic Test for Malaria in Asymptomatic Individuals from Uganda and Myanmar and Naive Human Challenge Infections

Overview

Journal Am J Trop Med Hyg

Specialty Tropical Medicine

Date 2017 Aug 19

PMID 28820709

Citations 89

Authors

Smita Das

Ihn Kyung Jang

Becky Barney

Roger Peck

John C Rek

Emmanuel Arinaitwe

Harriet Adrama

Maxwell Murphy

Mallika Imwong

Clare L Ling

Stephane Proux

Warat Haohankhunnatham

Melissa Rist

Annette M Seilie

Amelia Hanron

Glenda Daza

Ming Chang

Tomoka Nakamura

Michael Kalnoky

Paul LaBarre

Sean C Murphy

James S McCarthy

Francois Nosten

Bryan Greenhouse

Sophie Allauzen

Gonzalo J Domingo

Affiliations

Soon will be listed here.

Abstract

Sensitive field-deployable diagnostic tests can assist malaria programs in achieving elimination. The performance of a new Alere™ Malaria Ag P.f Ultra Sensitive rapid diagnostic test (uRDT) was compared with the currently available SD Bioline Malaria Ag P.f RDT in blood specimens from asymptomatic individuals in Nagongera, Uganda, and in a Karen Village, Myanmar, representative of high- and low-transmission areas, respectively, as well as in pretreatment specimens from study participants from four -induced blood-stage malaria (IBSM) studies. A quantitative reverse transcription PCR (qRT-PCR) and a highly sensitive enzyme-linked immunosorbent assay (ELISA) test for histidine-rich protein II (HRP2) were used as reference assays. The uRDT showed a greater than 10-fold lower limit of detection for HRP2 compared with the RDT. The sensitivity of the uRDT was 84% and 44% against qRT-PCR in Uganda and Myanmar, respectively, and that of the RDT was 62% and 0% for the same two sites. The specificities of the uRDT were 92% and 99.8% against qRT-PCR for Uganda and Myanmar, respectively, and 99% and 99.8% against the HRP2 reference ELISA. The RDT had specificities of 95% and 100% against qRT-PCR for Uganda and Myanmar, respectively, and 96% and 100% against the HRP2 reference ELISA. The uRDT detected new infections in IBSM study participants 1.5 days sooner than the RDT. The uRDT has the same workflow as currently available RDTs, but improved performance characteristics to identify asymptomatic malaria infections. The uRDT may be a useful tool for malaria elimination strategies.

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References

Waitumbi J, Gerlach J, Afonina I, Anyona S, Koros J, Siangla J . Malaria prevalence defined by microscopy, antigen detection, DNA amplification and total nucleic acid amplification in a malaria-endemic region during the peak malaria transmission season. Trop Med Int Health. 2011; 16(7):786-93. DOI: 10.1111/j.1365-3156.2011.02773.x. View

Billman Z, Seilie A, Murphy S . Purification of Plasmodium Sporozoites Enhances Parasite-Specific CD8+ T Cell Responses. Infect Immun. 2016; 84(8):2233-2242. PMC: 4962643. DOI: 10.1128/IAI.01439-15. View

Bousema J, Gouagna L, Drakeley C, Meutstege A, Okech B, Akim I . Plasmodium falciparum gametocyte carriage in asymptomatic children in western Kenya. Malar J. 2004; 3:18. PMC: 441400. DOI: 10.1186/1475-2875-3-18. View

Cerutti Jr C, Boulos M, Coutinho A, Hatab M, Falqueto A, Rezende H . Epidemiologic aspects of the malaria transmission cycle in an area of very low incidence in Brazil. Malar J. 2007; 6:33. PMC: 1839104. DOI: 10.1186/1475-2875-6-33. View

Jimenez A, Rees-Channer R, Perera R, Gamboa D, Chiodini P, Gonzalez I . Analytical sensitivity of current best-in-class malaria rapid diagnostic tests. Malar J. 2017; 16(1):128. PMC: 5366122. DOI: 10.1186/s12936-017-1780-5. View

Roshanravan B, Kari E, Gilman R, Cabrera L, Lee E, Metcalfe J . Endemic malaria in the Peruvian Amazon region of Iquitos. Am J Trop Med Hyg. 2003; 69(1):45-52. View

Nyunt M, Kyaw M, Win K, Myint K, Nyunt K . Field evaluation of HRP2 and pan pLDH-based immunochromatographic assay in therapeutic monitoring of uncomplicated falciparum malaria in Myanmar. Malar J. 2013; 12:123. PMC: 3636062. DOI: 10.1186/1475-2875-12-123. View

Cucunuba Z, Guerra A, Rahirant S, Rivera J, Cortes L, Nicholls R . Asymptomatic Plasmodium spp. infection in Tierralta, Colombia. Mem Inst Oswaldo Cruz. 2008; 103(7):668-73. DOI: 10.1590/s0074-02762008000700007. View

Kamya M, Arinaitwe E, Wanzira H, Katureebe A, Barusya C, Kigozi S . Malaria transmission, infection, and disease at three sites with varied transmission intensity in Uganda: implications for malaria control. Am J Trop Med Hyg. 2015; 92(5):903-12. PMC: 4426576. DOI: 10.4269/ajtmh.14-0312. View

10.

Marquart L, Butterworth A, McCarthy J, Gatton M . Modelling the dynamics of Plasmodium falciparum histidine-rich protein 2 in human malaria to better understand malaria rapid diagnostic test performance. Malar J. 2012; 11:74. PMC: 3359291. DOI: 10.1186/1475-2875-11-74. View

11.

Harris I, Sharrock W, Bain L, Gray K, Bobogare A, Boaz L . A large proportion of asymptomatic Plasmodium infections with low and sub-microscopic parasite densities in the low transmission setting of Temotu Province, Solomon Islands: challenges for malaria diagnostics in an elimination setting. Malar J. 2010; 9:254. PMC: 2944341. DOI: 10.1186/1475-2875-9-254. View

12.

Gaye A, Bousema T, Libasse G, Ndiath M, Konate L, Jawara M . Infectiousness of the human population to Anopheles arabiensis by direct skin feeding in an area hypoendemic for malaria in Senegal. Am J Trop Med Hyg. 2015; 92(3):648-52. PMC: 4350567. DOI: 10.4269/ajtmh.14-0402. View

13.

Mouatcho J, Goldring J . Malaria rapid diagnostic tests: challenges and prospects. J Med Microbiol. 2013; 62(Pt 10):1491-1505. DOI: 10.1099/jmm.0.052506-0. View

14.

Alves F, Gil L, Marrelli M, Ribolla P, Camargo E, Silva L . Asymptomatic carriers of Plasmodium spp. as infection source for malaria vector mosquitoes in the Brazilian Amazon. J Med Entomol. 2005; 42(5):777-9. DOI: 10.1093/jmedent/42.5.777. View

15.

Mishra B, Samantaray J, Kumar A, Mirdha B . Study of false positivity of two rapid antigen detection tests for diagnosis of Plasmodium falciparum malaria. J Clin Microbiol. 1999; 37(4):1233. PMC: 88687. DOI: 10.1128/JCM.37.4.1233-1233.1999. View

16.

Bashir I, Otsyula N, Awinda G, Spring M, Schneider P, Waitumbi J . Comparison of PfHRP-2/pLDH ELISA, qPCR and microscopy for the detection of plasmodium events and prediction of sick visits during a malaria vaccine study. PLoS One. 2013; 8(3):e56828. PMC: 3598859. DOI: 10.1371/journal.pone.0056828. View

17.

Spring M, Polhemus M, Ockenhouse C . Controlled human malaria infection. J Infect Dis. 2014; 209 Suppl 2:S40-5. DOI: 10.1093/infdis/jiu063. View

18.

Imwong M, Nguyen T, Tripura R, Peto T, Lee S, Maung Lwin K . The epidemiology of subclinical malaria infections in South-East Asia: findings from cross-sectional surveys in Thailand-Myanmar border areas, Cambodia, and Vietnam. Malar J. 2015; 14:381. PMC: 4590703. DOI: 10.1186/s12936-015-0906-x. View

19.

Hemingway J, Shretta R, Wells T, Bell D, Djimde A, Achee N . Tools and Strategies for Malaria Control and Elimination: What Do We Need to Achieve a Grand Convergence in Malaria?. PLoS Biol. 2016; 14(3):e1002380. PMC: 4774904. DOI: 10.1371/journal.pbio.1002380. View

20.

Laban N, Kobayashi T, Hamapumbu H, Sullivan D, Mharakurwa S, Thuma P . Comparison of a PfHRP2-based rapid diagnostic test and PCR for malaria in a low prevalence setting in rural southern Zambia: implications for elimination. Malar J. 2015; 14:25. PMC: 4340619. DOI: 10.1186/s12936-015-0544-3. View