Evaluation of malaria rapid diagnostic tests among children in a malaria endemic region in coastal Kenya

George O. Osanjo, Irene A Onyango, Josephine Kimani, James Ochanda, Julius Oyugi

Abstract


Background: In Kenya, malaria case management is based on clinical suspicion and detection of parasite in blood by parasitological or confirmatory diagnosis. Confirmatory diagnosis can be achieved with either microscopy or Rapid diagnostic tests (RDTs). RDTs are relatively new technologies, and their performance in actual conditions of use needs to be evaluated to provide information for appropriate use and to support decision making in procurement.

Objectives: To evaluate performance and operational characteristics of three malaria RDTs: CareStart™, First Response®, and SD Bioline™ in the field for diagnosis of infection by Plasmodium falciparum monospecies as well as mixed infections with P. ovale and P. malariae.

Methodology: A prospective study with blind comparisons to a gold standard was carried out at Pingilikani dispensary in Kilifi County, Kenya. Blood samples were obtained from 500 febrile children. Three RDTs: CareStart™, First Response® and SD Bioline™ were evaluated against microscopy of Giemsa stained blood films for detection of Plasmodium falciparum and non-falciparum malarial parasites. RDTs specific for P. falciparum only (HRP2 RDTs) and non-falciparum malarial parasites (HRP2/pLDH (Pf/pan) RDTs) were evaluated.

Results: Plasmodium sp were detected by microscopy in 242 (48.40%) study participants. Plasmodium falciparum species were the most prevalent (93.3%) in comparison with other Plasmodium species: P. ovale and P. malariae whose prevalence were 2.89% and 3.71% respectively. Compared to microscopy the sensitivities of CareStart™, SD Bioline™, and First Response® RDTs for Plasmodium falciparum using Pf (mono species) kits were: 95.04% (95% CI: 92.34 - 97.73), 95.04% (95% CI: 92.34 - 97.73) and 94.21% (95% CI: 91.3 - 97.11) respectively while the specificities were 78.12% (95% CI: 72.98 - 83.25), 81.10% (95% CI: 76.23 - 85.96) and 78.74%  (95% CI: 73.65 - 83.82) respectively. Sensitivities of CareStart™, SD Bioline™ and First Response® RDTs for Plasmodium falciparum using Pf/Pan kits were: 99.02% (95% CI: 98.92 - 99.15), 99.04% (95% CI: 98.92 – 99.15) and 97.56% (95% CI: 97.78 – 97.99), respectively while the specificities were 78.46% (95% CI: 77.61 - 79.30), 78.46% (95% CI: 75.78 - 81.13) and 80.28% (95% CI: 76.73 - 83.82) respectively. CareStart™, SD Bioline™, and First Response® RDTs for non-falciparum sp using Pf/Pan kits both had 100% sensitivity and specificity.

Conclusion: Data from this study demonstrate that CareStart™, SD Bioline™ and First Response® RDTs have good operational characteristics and are reliable alternatives to microscopy for diagnosing malaria in children.

Key words: malaria, rapid diagnostic tests, microscopy, Plasmodium


References


Bell D, Wongsrichanalai C and Barnwell JW (2006). Ensuring quality and access for malaria diagnosis: how can it be achieved? Nat. Rev. Microbiol. 4: S7-S20.

Bell DR, Wilson DW and Martin LB (2005). False positive results of a Plasmodium falciparum histidine rich protein 2 detecting malaria rapid diagnostic test due to high sensitivity in a community with fluctuating low parasite density. Am. J. Trop. Med. Hyg. 73:199-203.

Craig MH, Bredenkamp BL, Williams CH, Rossouw EJ, Kelly VJ, Kleinschmidt I, Martineau A and Henry GF (2002). Field and laboratory comparative evaluation of ten rapid diagnostic tests. Trans. R. Soc. Trop. Med. Hyg. 96:258-265.

Dyer ME, Tjitra E, Currie BJ and Anstey NM (2000). Failure of 'pan malarial' antibody of the ICT malaria Pf/Pv immunochromatographic test to detect symptomatic Plasmodium malariae infection. Trans. R. Soc. Trop. Med Hyg. 94:518.

Gillet P, Mori M, Van Esbroeck M, Van den Ende J and Jacobs J (2009). Assessment of the prozone effect in malaria rapid diagnostic tests. Malar. J. 8: 271.

Hopkins H, Bebell L, Kambale W, Dokomajilar C, Rosenthal PJ and Dorsey G (2008). Rapid diagnostic tests for malaria at sites of varying transmission intensity in Uganda. J. Infect. Dis. 197: 510-518.

Hopkins L (2011). Blood transfer devices for malaria rapid diagnostic tests: evaluation of accuracy, safety and ease of use. Malaria J. 10:30.

Jeremiah ZA and Uko EK (2007). Comparative analysis of malaria parasite density using actual and assumed white blood cell counts. Annals Trop. Paed. 27:75-79.

Kilian AH, Metzger WG, Mutschelknauss EJ, Kabagambe G, Langi P, Korte R and von Sonnenburg F (2000). Reliability of malaria microscopy in epidemiological studies: results of quality control. Trop. Med. Int. Health. 5:3-8.

Koita OA, Doumbo OK, Ouattara A, Tall LK, Konaré A, Diakité M, Diallo M, Sagara I, Masinde GL, Doumbo SN, Dolo A, Tounkara A, Traoré I and Krogstad DJ (2012). False-negative rapid diagnostic tests for malaria and deletion of the histidine-rich repeat region of the hrp2 gene. Am. J. Trop. Med. Hyg. 2:194-8.

Kumar N, Singh JP, Pande V, Mishra N, Srivastava B, Kapoor R, Valecha N and Anvikar AR (2012). Genetic variation in histidine rich proteins among Indian Plasmodium falciparum population: possible cause of variable sensitivity of malaria rapid diagnostic tests. Malaria J. 11:298.

Leke RFG, Djokam RR, Mbu R, Leke RJ, Fogako J, Megnekou R, Metenou SG and Zhou Y (1999). Detection of the Plasmodium antigens histidine rich protein2 in blood of pregnant women: implications for diagnosing placental malaria. J. Clin. Microbiol. 37: 2992-2996.

Luchavez J, Baker J, Alcantara S, Belizario V, Cheng Q, McCarthy JS and Bell D (2011). Laboratory demonstration of a prozone-like effect in HRP2-detecting malaria rapid diagnostic tests: implications for clinical management. Malaria J. 10: 286.

Mbogo CM, Mwangangi JM, Nzovu J, Githure JI, Yan G and Beier JC (2003). Spatial and temporal heterogeneity of Anopheles mosquitoes and Plasmodium falciparum transmission along the Kenyan coast. Am. J. Trop. Med. Hyg. 68:734-42.

Murray CK, Gasser RA Jr, Magill AJ and Miller RS (2008). Update on rapid diagnostic testing for malaria. Clin. Microbiol. Rev. 21:97-110.

Mwangi TW, Mohammed M, Dayo H, Snow RW and Marsh K. (2005). Clinical algorithms for malaria diagnosis lack utility among people of different age groups. Trop. Med. Int. Health. 10:530-536.

Palmer CJ, Lindo JF, Klaskala WI, Quesada JA, Kaminsky R, Baun MK and Ager AL (1998). Evaluation of the OptiMAL test for rapid diagnosis of Plasmodium vivax and Plasmodium falciparum malaria. J. Clin. Microbiol. 36:203-206.

Reyburn H, Mbakilwa H, Mwangi R, Mwerinde O, Olomi R, Drakeley C and Whitty CJ (2007). Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial. BMJ 334:403.

Singh N, Bharti PK, Singh MP, Mishra S, Shukla MM, Sharma RK and Singh RK (2013). Comparative evaluation of bivalent malaria rapid diagnostic tests versus traditional methods in field with special reference to heat stability testing in central India. PloS One. 8:e58080.

Tjitra E, Suprianto S, McBroom J, Currie BJ and Anstey NM (2001). Persistent ICT malaria P.f/P.v pan malarial 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. 39: 1025-1031.

Wongsrichanalai C, Barcus MJ, Muth S, Sutamihardja A and Wernsdorfer WH (2007). A review of malaria diagnostic tools: microscopy and rapid diagnostic test (RDT). Am. J. Trop. Med. Hyg. 77: 119-127.

World Malaria Report (2009). Geneva, World Health Organization, 2009.

World Health Organization (WHO) (2011). Malaria Rapid Diagnostic test performance: result of WHO product testing of malaria RDTs round 3 (2010-2011). www.who.tdr/publications/documents/rdt3.pdf.

World Health Organization (WHO): RDT evaluation programme. www.wpro.who.int/malaria/sites/rdt/who_rdt_evaluation/2013


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