Volume 96, Issue 2
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



Rapid diagnostic tests (RDTs) are widely used for malaria diagnosis, but lack of quality control at point of care restricts trust in test results. Prototype positive control wells (PCW) containing recombinant malaria antigens have been developed to identify poor-quality RDT lots. This study assessed community and facility health workers' (HW) ability to use PCWs to detect degraded RDTs, the impact of PCW availability on RDT use and prescribing, and preferred strategies for implementation in Lao People's Democratic Republic (Laos) and Uganda. A total of 557 HWs participated in Laos (267) and Uganda (290). After training, most (88% to ≥ 99%) participants correctly performed the six key individual PCW steps; performance was generally maintained during the 6-month study period. Nearly all (97%) reported a correct action based on PCW use at routine work sites. In Uganda, where data for 127,775 individual patients were available, PCW introduction in health facilities was followed by a decrease in antimalarial prescribing for RDT-negative patients ≥ 5 years of age (4.7–1.9%); among community-based HWs, the decrease was 12.2% ( < 0.05) for all patients. Qualitative data revealed PCWs as a way to confirm RDT quality and restore confidence in RDT results. HWs in malaria-endemic areas are able to use prototype PCWs for quality control of malaria RDTs. PCW availability can improve HWs' confidence in RDT results, and benefit malaria diagnostic programs. Lessons learned from this study may be valuable for introduction of other point-of-care diagnostic and quality-control tools. Future work should evaluate longer term impacts of PCWs on patient management.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Article metrics loading...

The graphs shown below represent data from March 2017
Loading full text...

Full text loading...



  1. World Health Organization, 2015. Guidelines for the Treatment of Malaria, 3rd edition. Geneva, Switzerland: World Health Organization. [Google Scholar]
  2. World Health Organization, 2015. World Malaria Report 2015. Geneva, Switzerland: World Health Organization. [Google Scholar]
  3. Bell D, Wongsrichanalai C, Barnwell JW, , 2006. Ensuring quality and access for malaria diagnosis: how can it be achieved? Nat Rev Microbiol 4: 682695.[Crossref] [Google Scholar]
  4. Chiodini PL, Bowers K, Jorgensen P, Barnwell JW, Grady KK, Luchavez J, Moody AH, Cenizal A, Bell D, , 2007. The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Trans R Soc Trop Med Hyg 101: 331337.[Crossref] [Google Scholar]
  5. Jorgensen P, Chanthap L, Rebueno A, Tsuyuoka R, Bell D, , 2006. Malaria rapid diagnostic tests in tropical climates: the need for a cool chain. Am J Trop Med Hyg 74: 750754. [Google Scholar]
  6. Albertini A, Lee E, Coulibaly SO, Sleshi M, Faye B, Mationg ML, Ouedraogo K, Tsadik AG, Feleke SM, Diallo I, Gaye O, Luchavez J, Bennett J, Bell D, , 2012. Malaria rapid diagnostic test transport and storage conditions in Burkina Faso, Senegal, Ethiopia, and the Philippines. Malar J 11: 406.[Crossref] [Google Scholar]
  7. World Health Organization/Foundation for Innovative New Diagnostics/Centers for Disease Control and Prevention, 2015. Summary Results of WHO Product Testing of Malaria RDTs: Rounds 1–6 (2008–2015). Geneva, Switzerland: World Health Organization. [Google Scholar]
  8. Boadu NY, Amuasi J, Ansong D, Einsiedel E, Menon D, Yanow SK, , 2016. Challenges with implementing malaria rapid diagnostic tests at primary care facilities in a Ghanaian district: a qualitative study. Malar J 15: 126.[Crossref] [Google Scholar]
  9. Chandler CI, Whitty CJ, Ansah EK, , 2010. How can malaria rapid diagnostic tests achieve their potential? A qualitative study of a trial at health facilities in Ghana. Malar J 9: 95.[Crossref] [Google Scholar]
  10. Masanja IM, McMorrow ML, Maganga MB, Sumari D, Udhayakumar V, McElroy PD, Kachur SP, Lucchi NW, , 2015. Quality assurance of malaria rapid diagnostic tests used for routine patient care in rural Tanzania: microscopy versus real-time polymerase chain reaction. Malar J 14: 85.[Crossref] [Google Scholar]
  11. McMorrow ML, Masanja MI, Abdulla SM, Kahigwa E, Kachur SP, , 2008. Challenges in routine implementation and quality control of rapid diagnostic tests for malaria: Rufiji District, Tanzania. Am J Trop Med Hyg 79: 385390. [Google Scholar]
  12. McMorrow ML, Masanja MI, Kahigwa E, Abdulla SM, Kachur SP, , 2010. Quality assurance of rapid diagnostic tests for malaria in routine patient care in rural Tanzania. Am J Trop Med Hyg 82: 151155.[Crossref] [Google Scholar]
  13. World Health Organization, 2015. WHO-FIND Malaria RDT Evaluation Programme. Available at: http://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/rdt-evaluation-programme/en/. Accessed February 29, 2016. [Google Scholar]
  14. Aidoo M, Patel JC, Barnwell JW, , 2012. Dried Plasmodium falciparum-infected samples as positive controls for malaria rapid diagnostic tests. Malar J 11: 239.[Crossref] [Google Scholar]
  15. Lon CT, Alcantara S, Luchavez J, Tsuyuoka R, Bell D, , 2005. Positive control wells: a potential answer to remote-area quality assurance of malaria rapid diagnostic tests. Trans R Soc Trop Med Hyg 99: 493498.[Crossref] [Google Scholar]
  16. Tamiru A, Boulanger L, Chang MA, Malone JL, Aidoo M, , 2015. Field assessment of dried Plasmodium falciparum samples for malaria rapid diagnostic test quality control and proficiency testing in Ethiopia. Malar J 14: 11.[Crossref] [Google Scholar]
  17. Versteeg I, Mens PF, , 2009. Development of a stable positive control to be used for quality assurance of rapid diagnostic tests for malaria. Diagn Microbiol Infect Dis 64: 256260.[Crossref] [Google Scholar]
  18. World Health Organization, 2011. Good Practices for Selecting and Procuring Rapid Diagnostic Tests for Malaria. Geneva, Switzerland: World Health Organization. [Google Scholar]
  19. World Health Organization, 2015. Lot Testing of Malaria RDTs. Available at: http://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/lot-testing/en/. Accessed February 29, 2016. [Google Scholar]
  20. World Health Organization, 2009. Parasitological Confirmation of Malaria Diagnosis: Report of a WHO Technical Consultation. Geneva, Switzerland: World Health Organization. [Google Scholar]
  21. Graneheim UH, Lundman B, , 2004. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today 24: 105112.[Crossref] [Google Scholar]
  22. Harvey SA, Jennings L, Chinyama M, Masaninga F, Mulholland K, Bell DR, , 2008. Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training. Malar J 7: 160.[Crossref] [Google Scholar]
  23. Kyabayinze DJ, Asiimwe C, Nakanjako D, Nabakooza J, Bajabaite M, Strachan C, Tibenderana JK, Van Geetruyden JP, , 2012. Programme level implementation of malaria rapid diagnostic tests (RDTs) use: outcomes and cost of training health workers at lower level health care facilities in Uganda. BMC Public Health 12: 291.[Crossref] [Google Scholar]
  24. Counihan H, Harvey SA, Sekeseke-Chinyama M, Hamainza B, Banda R, Malambo T, Masaninga F, Bell D, , 2012. Community health workers use malaria rapid diagnostic tests (RDTs) safely and accurately: results of a longitudinal study in Zambia. Am J Trop Med Hyg 87: 5763.[Crossref] [Google Scholar]
  25. Mukadi P, Gillet P, Lukuka A, Mbatshi J, Otshudiema J, Muyembe JJ, Buyze J, Jacobs J, Lejon V, , 2013. External quality assessment of reading and interpretation of malaria rapid diagnostic tests among 1849 end-users in the Democratic Republic of the Congo through Short Message Service (SMS). PLoS One 8: e71442.[Crossref] [Google Scholar]
  26. Mayxay M, Newton PN, Yeung S, Pongvongsa T, Phompida S, Phetsouvanh R, White NJ, , 2004. Short communication: an assessment of the use of malaria rapid tests by village health volunteers in rural Laos. Trop Med Int Health 9: 325329.[Crossref] [Google Scholar]
  27. Phiri TB, Kaunda-Khangamwa BN, Bauleni A, Chimuna T, Melody D, Kalengamaliro H, Sande JH, Nsona HK, Mathanga DP, , 2016. Feasibility, acceptability and impact of integrating malaria rapid diagnostic tests and pre-referral rectal artesunate into the integrated community case management programme. A pilot study in Mchinji district, Malawi. Malar J 15: 177. [Google Scholar]
  28. Ruizendaal E, Dierickx S, Peeters Grietens K, Schallig HD, Pagnoni F, Mens PF, , 2014. Success or failure of critical steps in community case management of malaria with rapid diagnostic tests: a systematic review. Malar J 13: 229.[Crossref] [Google Scholar]
  29. Cundill B, Mbakilwa H, Chandler CI, Mtove G, Mtei F, Willetts A, Foster E, Muro F, Mwinyishehe R, Mandike R, Olomi R, Whitty CJ, Reyburn H, , 2015. Prescriber and patient-oriented behavioural interventions to improve use of malaria rapid diagnostic tests in Tanzania: facility-based cluster randomised trial. BMC Med 13: 118.[Crossref] [Google Scholar]
  30. Onwujekwe O, Mangham-Jefferies L, Cundill B, Alexander N, Langham J, Ibe O, Uzochukwu B, Wiseman V, , 2015. Effectiveness of provider and community interventions to improve treatment of uncomplicated malaria in Nigeria: a cluster randomized controlled trial. PLoS One 10: e0133832.[Crossref] [Google Scholar]

Data & Media loading...

  • Received : 18 Jun 2016
  • Accepted : 11 Sep 2016
  • Published online : 08 Feb 2017

Most Cited This Month

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error