Quality assurance of malaria rapid diagnostic tests used for routine patient care in rural Tanzania: Microscopy versus real-time polymerase chain reaction

Malaria Journal

Volumn 14, Issue 1, 2015, Pages

  Masanja, Irene M ^a   McMorrow, Meredith L ^b,c   Maganga, Mussa B ^a   Sumari, Debora ^a   Udhayakumar, Venkatachalam ^b   McElroy, Peter D ^b,d   Kachur, S Patrick ^b,c   Lucchi, Naomi W ^b  

^a IFAKARA HEALTH INSTITUTE   (Tanzania)

^b CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^c US Dept of Hlth and Hum Serv   (United States)

^d President's Malaria Initiative   (Tanzania)

Author keywords

Microscopy; qPCR; Quality assurance (QA); Rapid diagnostic test (RDT); Routine malaria tests

Indexed keywords

ARTICLE; BLOOD SAMPLING; BLOOD SMEAR; DIAGNOSTIC TEST; DIAGNOSTIC TEST ACCURACY STUDY; DRIED BLOOD SPOT TESTING; HEALTH CARE FACILITY; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALARIA; MALARIA RAPID TEST; MICROSCOPY; PATIENT CARE; QUALITY CONTROL PROCEDURES; REAL TIME POLYMERASE CHAIN REACTION; RURAL AREA; TANZANIA; COMPARATIVE STUDY; PROCEDURES; QUALITY CONTROL; STANDARDS;

DIAGNOSTIC TESTS, ROUTINE; MICROSCOPY; PATIENT CARE; QUALITY CONTROL; REAL-TIME POLYMERASE CHAIN REACTION; TANZANIA;

EID: 84928670907     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/s12936-015-0597-3     Document Type: Article

References (43)

1. WHO. World Malaria Report 2012. Geneva: World Health Organization; 2012.
2. WHO. Guidelines for the treatment of malaria. 2nd ed. Geneva: World Health Organization; 2010.
3. Harvey SA, Jennings LJ, Chinyama M, Masaninga F, Mulholland K, Bell DR. Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training. Malar J. 2008;7:160.
4. Zurovac D, Njogu J, Akhwale W, Hamer DH, Larson BA, Snow RW. Effects of revised diagnostic recommendations on malaria treatment practices across age groups in Kenya. Trop Med Int Health. 2008;13:784-7.
5. WHO/TDR/FIND. Malaria Rapid Diagnostic Test Performance. Summary results of WHO Malaria RDT Product Testing: Rounds 1-3 (2008-2011). Geneva, Switzerland: World Health Organization; 2011.
6. Nankabirwa J, Zurovac D, Njogu JN, Rwakimari JB, Counihan H, Snow RW, et al. Malaria misdiagnosis in Uganda - implications for policy change. Malar J. 2009;8:66.
7. ® "faint test bands" in a low transmission area of Tanzania. BMC Infect Dis. 2011;11:308.
8. Moody A. Rapid diagnostic tests for malaria parasites. Clin Microbiol Rev. 2002;15:66-78.
9. McMorrow ML, Masanja MI, Abdulla SM, Kahigwa E, Kachur SP. Challenges in routine implementation and quality control of rapid diagnostic tests for malaria-Rufiji District, Tanzania. Am J Trop Med Hyg. 2008;79:385-90.
10. Mason DP, Kawamoto F, Lin K, Laoboonchai A, Wongsrichanalai C. A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. Acta Trop. 2002;82:51-9.
11. Reyburn H, Mbakilwa H, Mwangi R, Mwerinde O, Olomi R, Drakeley C, et al. Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial. BMJ. 2007;334:403.
12. Mueller I, Betuela I, Ginny M, Reeder JC, Genton B. The sensitivity of the OptiMAL rapid diagnostic test to the presence of Plasmodium falciparum gametocytes compromises its ability to monitor treatment outcomes in an area of Papua New Guinea in which malaria is endemic. J Clin Microbiol. 2007;45:545-50.
13. Laurent A, Schellenberg J, Shirima K, Ketende SC, Alonso PL, Mshinda H, et al. Performance of HRP-2 based rapid diagnostic test for malaria and its variation with age in an area of intense malaria transmission in southern Tanzania. Malar J. 2010;9:294.
14. 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.
15. WHO. Update on WHO procedures for selection and use of quality malaria RDTs. Geneva, Switzerland: World Health Organization; 2008.
16. Kachur SP, Nicolas E, Jean-François V, Benitez A, Bloland PB, Jean YS, et al. Prevalence of malaria parasitemia and accuracy of microscopic diagnosis in Haiti, October 1995. Pan Am J Public Health. 1998;3:35-9.
17. Dowling MAC, Shute GT. A comparative study of thick and thin blood films in the diagnosis of scanty malaria parasitaemia. Bull World Health Organ. 1966;34:249-67.
18. Bejon P, Andrews L, Hunt-Cooke A, Sanderson F, Gilbert SC, Hill A V S. Thick blood film examination for Plasmodium falciparum malaria has reduced sensitivity and underestimates parasite density. Malar J. 2006;5:104.
19. Barat L, Chipipa J, Kolczac M, Sukwa T. Does the availability of blood slide microscopy for malaria at health centers improve the management of persons with fever in Zambia? Am J Trop Med Hyg. 1999;60:1024-103.
20. NBS. Tanzania in figures 2010. Dar es Salaam, Tanzania: National Bureau if Statistics, Ministry of Finance, United Republic of Tanzania; 2011.
21. Ohrt C, Obare P, Nanakorn A, Adhiambo C, Awuondo K, O'Meara WP, et al. Establishing a malaria diagnostics centre of excellence in Kisumu, Kenya. Malar J. 2007;6:79.
22. Price RN, Uhlemann AC, Brockman A, McGready R, Ashley E, Phaipun L, et al. Mefloquine resistance in Plasmodium falciparum and increased pfmdr1 gene copy number. Lancet. 2004;364:438-47.
23. WHO/TDR. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1. Geneva, Switzerland: World Health Organization/TDR/FIND; 2008.
24. Grobusch MP, Jelinek T, Hanscheid T. False positivity of rapid antigen detection tests for diagnosis of Plasmodium falciparum malaria: Issue appears to be more complicated than presented. J Clin Microbiol. 1999;37:3781-2.
25. Mayxay M, Pukrittayakamee S, Chotivanich K, Looareesuwan S, White NJ. Persistence of Plasmodium falciparum HRP-2 in successfully treated acute falciparum malaria. Trans R Soc Trop Med Hyg. 2001;95:179-82.
26. Grobusch MP, Alpermann U, Schwenke S, Jelinek T, Warhust DC. Falsepositive tests for malaria in patients with rheumatoid factor. Lancet. 1999;353:297.
27. 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.
28. Leshem E, Keller N, Guthman D, Grossman T, Solomon M, Marva E, et al. Falsepositive Plasmodium falciparum histidine-rich protein 2 immunocapture assay results for acute schistosomiasis caused by Schistosoma mekongi. J Clin Microbiol. 2011;49:2331-2.
29. Gillet P, Mori M, Van Den Ende J, Jacobs J. Buffer substitution in malaria rapid diagnostic tests causes false-positive results. Malar J. 2010;9:215.
30. 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. 2001;101:9-18.
31. District Health Information 2 (DHIS 2) [http://dhis.moh.go.tz/dhis-web-pivot/app/index.html]
32. Gillet P, Scheirlinck A, Stokx J, De Weggheleire A, Chauque HS, Canhanga O D JV, et al. Prozone in malaria rapid diagnostic tests: How many cases are missed? Malar J. 2011;10:166.
33. ® ICT test versus polymerase chain reaction and microscopy for the detection of malaria in returned travellers. Am J Trop Med Hyg. 2003;69:589-92.
34. ™ test with the polymerase chain reaction for the diagnosis of Plasmodium falciparum malaria in travellers. Trans R Soc Trop Med Hyg. 1998;92:166-9.
35. Nicastri E, Bevilacqua N, Schepisi MS, Paglia MG, Meschi S, Ame SM, et al. Accuracy of malaria diagnosis by microscopy, rapid diagnostic test, and PCR methods and evidence of antimalarial overprescription in non-severe febrile patients in two Tanzanian hospitals. Am J Trop Med Hyg. 2009;80:712-7.
36. Lucchi NW, Demas A, Narayanan J, Sumari D, Kabanywanyi A, Kachur SP, et al. Real-time fluorescence loop mediated isothermal amplification for the diagnosis of malaria. PLoS One. 2010;5:e13733.
37. Talundzic E, Maganga M, Masanja IM, Peterson DS, Udhayakumar V, Lucchi NW. Field evaluation of the photo-induced electron transfer fluorogenic primers (PET) real-time PCR for the detection of Plasmodium falciparum in Tanzania. Malar J. 2014;13:31.
38. Hopkins H, Gonzalez IJ, Polley SD, Angutoko P, Ategeka J, Asiimwe C, et al. Highly sensitive detection of malaria parasitemia in a malaria-endemic setting: performance of a new loop-mediated isothermal amplification kit in a remote clinic in Uganda. J Infect Dis. 2013;208:645-52.
39. WHO. Universal access to malaria diagnostic testing: an operational manual. Geneva: World Health Organization; 2011.
40. Ishengoma DS, Lwitiho S, Madebe RA, Nyagonde N, Persson O, Vestergaard LS, et al. Using rapid diagnostic tests as source of malaria parasite DNA for molecular analyses in the era of declining malaria prevalence. Malar J. 2011;10:6.
41. Chandler CI, Jones C, Boniface G, Juma K, Reyburn H, Whitty CJ. Guidelines and mindlines: why do clinical staff over-diagnose malaria in Tanzania? A qualitative study. Malar J. 2008;7:53.
42. WHO. Malaria Rapid Diagnostic tests: RDT Evaluation Programme-Positive Control Wells [http://www.wpro.who.int/malaria/sites/rdt/who-rdt-evaluation/control-wells.html]
43. Aidoo M, Patel JC, Barnwell JW. Dried Plasmodium falciparum-infected samples as positive controls for malaria rapid diagnostic tests. Malar J. 2012;11:239.