Quality Assurance of Rapid Diagnostic Tests for Malaria in Routine Patient Care in Rural Tanzania

Meredith L. McMorrow U.S. Public Health Service and Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia; Ifakara Health Institute, Dar es Salaam, Tanzania

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M. Irene Masanja U.S. Public Health Service and Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia; Ifakara Health Institute, Dar es Salaam, Tanzania

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Elizeus Kahigwa U.S. Public Health Service and Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia; Ifakara Health Institute, Dar es Salaam, Tanzania

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Salim M. K. Abdulla U.S. Public Health Service and Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia; Ifakara Health Institute, Dar es Salaam, Tanzania

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S. Patrick Kachur U.S. Public Health Service and Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia; Ifakara Health Institute, Dar es Salaam, Tanzania

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Histidine-rich protein II (HRP2)-based malaria rapid diagnostic tests (RDTs) have shown high sensitivity and specificity for detecting Plasmodium falciparum malaria in a variety of study settings. However, RDTs are susceptible to heat and humidity and variation in individual performance, which may affect their use in field settings. We evaluated sensitivity and specificity of RDTs during routine use for malaria case management in peripheral health facilities. From December 2007 to October 2008, HRP2-based ParaHIT-f RDTs were introduced in 12 facilities without available microscopy in Rufiji District, Tanzania. Health workers received a single day of instruction on how to perform an RDT and thick blood smear. Job aids, Integrated Management of Childhood Illness guidelines, and national malaria treatment algorithms were reviewed. For quality assurance (QA), thick blood smears for reference microscopy were collected for 2 to 3 days per week from patients receiving RDTs; microscopy was not routinely performed at the health facilities. Slides were stained and read centrally within 72 hours of collection by a reference microscopist. When RDT and blood smear results were discordant, blood smears were read by additional reference microscopists blinded to earlier results. Facilities were supervised monthly by the district laboratory supervisor or a member of the study team. Ten thousand six hundred fifty (10,650) patients were tested with RDTs, and 51.5% (5,488/10,650) had a positive test result. Blood smear results were available for 3,914 patients, of whom 40.1% (1,577/3,914) were positive for P. falciparum malaria. Overall RDT sensitivity was 90.7% (range by facility 85.7–96.5%) and specificity was 73.5% (range 50.0–84.3%). Sensitivity increased with increasing parasite density. Successful implementation of RDTs was achieved in peripheral health facilities with adequate training and supervision. Quality assurance is essential to the adequate performance of any laboratory test. Centralized staining and reading of blood smears provided useful monitoring of RDT performance. However, this level of QA may not be sustainable nationwide.

Author Notes

*Address correspondence to Meredith L. McMorrow, Malaria Branch, Division of Parasitic Diseases, Centers for Disease Control and Prevention, 4770 Buford Highway, Mailstop F-22, Atlanta, GA 30341. E-mail: mmcmorrow@cdc.gov
†In the WHO evaluation, parasite detection rate was defined as the percentage of malaria samples in a test panel giving a positive result by two RDTs per lot at the lower parasite density (200 parasites/µL), and a single RDT per lot at the higher parasite density (2,000 or 5,000 parasites/µL). Thus, it is a combined measure of positivity rate, along with inter-test and inter-lot consistency.

Financial support: This work was financially supported through the U.S. Centers for Disease Control and Prevention and the U.S. President's Malaria Initiative (PMI).

Disclaimer: The findings and conclusions in this report are those of the author(s) and do not necessarily represent the views of the Centers for Disease Control and Prevention.

Authors' addresses: Meredith L. McMorrow and S. Patrick Kachur, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, E-mails: mmcmorrow@cdc.gov and spk0@cdc.gov. M. Irene Masanja, Elizeus Kahigwa, and Salim M. K. Abdulla, Ifakara Health Institute, Dar es Salaam, Tanzania, E-mails: imasanja@ihi.or.tz, ekahigwa@ihi.or.tz, and sabdulla@ihi.or.tz.

  • 1.

    Chandramohan D, Jaffar S & Greenwood B 2002. Use of clinical algorithms for diagnosing malaria. Trop Med Int Health 7: 4552.

  • 2.

    O'Dempsey TJ, McArdle TF, Laurence BE, Lamont AC, Todd JE, Greenwood BM, 1993. Overlap in the clinical features of pneumonia and malaria in African children. Trans R Soc Trop Med Hyg 87: 662665.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3.

    Källander K, Nsungwa-Sabiiti J, Peterson S, 2004. Symptom overlap for malaria and pneumonia–policy implications for home management strategies. Acta Trop 90: 211214.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4.

    Font F, Alonso Gonzalez M, Nathan R, Kimario J, Lwilla F, Ascaso C, Tanner M, Menendez C, Alonso PL, 2001. Diagnostic accuracy and case management of clinical malaria in the primary health services of a rural area in south-eastern Tanzania. Trop Med Int Health 6: 423428.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5.

    Reyburn H, Mbatia R, Drakeley C, Carneiro I, Mwakasungula E, Mwerinde O, Saganda K, Shao J, Kitua A, Olomi R, Greenwood BM, Whitty CJM, 2004. Overdiagnosis of malaria in patients with severe febrile illness in Tanzania: a prospective study. BMJ 329: 1212.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6.

    Moody A, 2002. Rapid diagnostic tests for malaria parasites. Clin Microbiol Rev 15: 6678.

  • 7.

    Proux S, Hkirijareon L, Ngamngonkiri C, McConnel S, Nosten F, 2001. Paracheck-Pf®: a new, inexpensive and reliable rapid test for P. falciparum malaria. Trop Med Int Health 6: 99101.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8.

    World Health Organization, 2009. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1 (2008). Available at: http://www.wpro.who.int/NR/rdonlyres/9B0FC23F-720A-4096-A9B4-AD03C14A82C4/0/WHOMalariaRDTProductTestingRd1Fullreport.pdf. Accessed May 12, 2009.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9.

    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.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10.

    World Health Organization, 2008. Update on WHO procedures for selection and use of quality malaria RDTs. World Health Organization Western Pacific Regional Office RDT website. Available at: http://www.wpro.who.int/NR/rdonlyres/3659F207-C0B3-4D59-83BD-446CD9847ED1/0/WHOmalariaQAupdate_052008.pdf. Accessed May 12, 2009.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11.

    Rufiji DSS, 2001. Tanzanian Ministry of Health and Tanzania Essential Health Interventions Project. INDEPTH Monograph: Volume 1 Part C. Available at: http://www.indepth-network.org/dss_site_profiles/rufiji.pdf. Accessed May 15, 2009.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 12.

    Njama-Meya D, Clark TD, Nzarubara B, Staedke S, Kamya MR, Dorsey G, 2007. Treatment of malaria restricted to laboratory-confirmed cases: a prospective cohort study in Ugandan children. Malar J 6: 7.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13.

    D'Acremont V, Kahama-Maro J, Mtasiwa D, Lengeler C, Genton B, 2008. Withdrawing antimalarials in febrile children with a negative rapid diagnostic test is safe in a moderately endemic area of Tanzania [abstract 397]. ASTMH 57th Annual Meeting, New Orleans, LA.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 14.

    Bisoffi Z, Sirima BS, Angheben A, Lodesani C, Gobbi F, Tinto H, Van den Ende J, 2009. Rapid malaria diagnostic tests vs. clinical management of malaria in rural Burkina Faso: safety and effect on clinical decisions. A randomized trial. Trop Med Int Health 14: 491498.

    • PubMed
    • Search Google Scholar
    • Export Citation
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