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1
Chandramohan D, Jaffar S, Greenwood B, 2002. Use of clinical algorithms for diagnosing malaria. Trop Med Int Health 7 :45–52.
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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 :662–665.
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3
Källander K, Nsungwa-Sabiiti J, Peterson S, 2004. Symptom overlap for malaria and pneumonia–policy implications for home management strategies. Acta Trop 90 :211–214.
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4
Font F, Alonso Gonzalez M, Nathan R, Kimario J, Lwilla F, Ascaso C, Tanner M, MeneÂndez 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 :423–428.
-
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.
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6
Moody A, 2002. Rapid diagnostic tests for malaria parasites. Clin Microbiol Rev 15 :66–78.
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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 :99–101.
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8
Reyburn H, Mbakilwa H, Mwangi R, Mwerinde O, Olomi R, Drakeley C, Whitty CJM, 2007. Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial. BMJ 334 :403–409.
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9
Establishing QA Systems for Malaria Rapid Diagnostic Tests, 2005. World Health Organization Western Pacific Regional Office RDT website. Available at: http://www.wpro.who.int/NR/rdonlyres/549ED281-9487-4FD3-8E83-1370258DF09A/0/EstablishingQAsystemsforMRDTs.pdf. Accessed December 19, 2007.
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10
World Health Organization, 2006. Manual of Standard Operating Procedures for Laboratory-based Quality Control Testing of Malaria Rapid Diagnostic Tests Using Stored Dilutions of Malaria Parasites. Version 4. Available at: http://www.wpro.who.int/NR/rdonlyres/B5446BF5-BCFA-427D-B9FE-CEA57D36B92B/0/RDTQCMethodsManualV4final3WEBVERSION.pdf. Accessed December 19, 2007.
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11
United Republic of Tanzania Ministry of Health and Social Welfare. National Guidelines for Malaria Diagnosis and Treatment 2006. National Malaria Control Programme of the Ministry of Health and Social Welfare, Dar es Salaam, Tanzania, January 2006.
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12
Rufiji DSS, 1999. Tanzania. 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 December 20, 2007.
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13
Baker J, McCarthy J, Gatton M, Kyle DE, Belizario V, Luchavez J, Bell D, Cheng Q, 2005. Genetic diversity of Plasmodium falciparum histidine-rich protein 2 (PfHRP2) and its effect on the performance of PfHRP2-based rapid diagnostic tests. J Infect Dis 192 :870–877.
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14
Rock EP, Marsh K, Saul AJ, Wellems TE, Taylor DW, Maloy WL, Howard RJ, 1987. Comparative analysis of the Plasmodium falciparum histidine-rich proteins HRP-I, HRP-II, and HRP-III in malaria parasites of diverse origin. Parasitology 95 :209–227.
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15
Baik F, Bell D, 2007. Forecasting Global Procurement of Malaria Rapid Diagnostic Tests: Estimates and Uncertainties. World Health Organization Western Pacific Regional Office. Available at: http://www.wpro.who.int/NR/rdonlyres/A15EBA35-91E1-4D8F-9798-5352CEBC7395/0/20_May_2007_RDT_Forecast_report.pdf. Accessed December 19, 2007.
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Challenges in Routine Implementation and Quality Control of Rapid Diagnostic Tests for Malaria–Rufiji District, Tanzania
Meredith L. McMorrow
Meredith L. McMorrow
Malaria Branch, Division of Parasitic Diseases, National Center for Zoonotic Vector-borne and Enteric Diseases, US Centers for Disease Control and Prevention; Ifakara Health Research and Development Centre, Dares-Salaam, Tanzania
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M. Irene Masanja
M. Irene Masanja
Malaria Branch, Division of Parasitic Diseases, National Center for Zoonotic Vector-borne and Enteric Diseases, US Centers for Disease Control and Prevention; Ifakara Health Research and Development Centre, Dares-Salaam, Tanzania
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Salim M. K. Abdulla
Salim M. K. Abdulla
Malaria Branch, Division of Parasitic Diseases, National Center for Zoonotic Vector-borne and Enteric Diseases, US Centers for Disease Control and Prevention; Ifakara Health Research and Development Centre, Dares-Salaam, Tanzania
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Elizeus Kahigwa
Elizeus Kahigwa
Malaria Branch, Division of Parasitic Diseases, National Center for Zoonotic Vector-borne and Enteric Diseases, US Centers for Disease Control and Prevention; Ifakara Health Research and Development Centre, Dares-Salaam, Tanzania
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S. Patrick Kachur
S. Patrick Kachur
Malaria Branch, Division of Parasitic Diseases, National Center for Zoonotic Vector-borne and Enteric Diseases, US Centers for Disease Control and Prevention; Ifakara Health Research and Development Centre, Dares-Salaam, Tanzania
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Rapid diagnostic tests (RDTs) represent an alternative to microscopy for malaria diagnosis and have shown high sensitivity and specificity in a variety of study settings. Current World Health Organization (WHO) guidelines for quality control of RDTs provide detailed instructions on pre-field testing, but offer little guidance for quality assurance once RDTs are deployed in health facilities. From September 2006 to April 2007, we introduced a histidine-rich protein II (HRP2)-based RDT (Paracheck) for suspected malaria cases five years of age and older in nine health facilities in Rufiji District, Tanzania, to assess sensitivity and specificity of RDTs in routine use at rural health facilities. Thick blood smears were collected for all patients tested with RDTs and stained and read by laboratory personnel in each facility. Thick smears were subsequently reviewed by a reference microscopist to determine RDT sensitivity and specificity. In all nine health facilities, there were significant problems with the quality of staining and microscopy. Sensitivity and specificity of RDTs were difficult to assess given the poor quality of routine blood smear staining. Mean operational sensitivity of RDTs based on reference microscopy was 64.8%, but varied greatly by health facility, range 18.8–85.9%. Sensitivity of RDTs increased with increasing parasite density. Specificity remained high at 87.8% despite relatively poor slide quality. Institution of quality control of RDTs based on poor quality blood smear staining may impede reliable measurement of sensitivity and specificity and undermine confidence in the new diagnostic. There is an urgent need for the development of alternative quality control procedures for rapid diagnostic tests that can be performed at the facility level.
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-
1
Chandramohan D, Jaffar S, Greenwood B, 2002. Use of clinical algorithms for diagnosing malaria. Trop Med Int Health 7 :45–52.
-
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 :662–665.
-
3
Källander K, Nsungwa-Sabiiti J, Peterson S, 2004. Symptom overlap for malaria and pneumonia–policy implications for home management strategies. Acta Trop 90 :211–214.
-
4
Font F, Alonso Gonzalez M, Nathan R, Kimario J, Lwilla F, Ascaso C, Tanner M, MeneÂndez 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 :423–428.
-
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.
-
6
Moody A, 2002. Rapid diagnostic tests for malaria parasites. Clin Microbiol Rev 15 :66–78.
-
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 :99–101.
-
8
Reyburn H, Mbakilwa H, Mwangi R, Mwerinde O, Olomi R, Drakeley C, Whitty CJM, 2007. Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial. BMJ 334 :403–409.
-
9
Establishing QA Systems for Malaria Rapid Diagnostic Tests, 2005. World Health Organization Western Pacific Regional Office RDT website. Available at: http://www.wpro.who.int/NR/rdonlyres/549ED281-9487-4FD3-8E83-1370258DF09A/0/EstablishingQAsystemsforMRDTs.pdf. Accessed December 19, 2007.
-
10
World Health Organization, 2006. Manual of Standard Operating Procedures for Laboratory-based Quality Control Testing of Malaria Rapid Diagnostic Tests Using Stored Dilutions of Malaria Parasites. Version 4. Available at: http://www.wpro.who.int/NR/rdonlyres/B5446BF5-BCFA-427D-B9FE-CEA57D36B92B/0/RDTQCMethodsManualV4final3WEBVERSION.pdf. Accessed December 19, 2007.
-
11
United Republic of Tanzania Ministry of Health and Social Welfare. National Guidelines for Malaria Diagnosis and Treatment 2006. National Malaria Control Programme of the Ministry of Health and Social Welfare, Dar es Salaam, Tanzania, January 2006.
-
12
Rufiji DSS, 1999. Tanzania. 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 December 20, 2007.
-
13
Baker J, McCarthy J, Gatton M, Kyle DE, Belizario V, Luchavez J, Bell D, Cheng Q, 2005. Genetic diversity of Plasmodium falciparum histidine-rich protein 2 (PfHRP2) and its effect on the performance of PfHRP2-based rapid diagnostic tests. J Infect Dis 192 :870–877.
-
14
Rock EP, Marsh K, Saul AJ, Wellems TE, Taylor DW, Maloy WL, Howard RJ, 1987. Comparative analysis of the Plasmodium falciparum histidine-rich proteins HRP-I, HRP-II, and HRP-III in malaria parasites of diverse origin. Parasitology 95 :209–227.
-
15
Baik F, Bell D, 2007. Forecasting Global Procurement of Malaria Rapid Diagnostic Tests: Estimates and Uncertainties. World Health Organization Western Pacific Regional Office. Available at: http://www.wpro.who.int/NR/rdonlyres/A15EBA35-91E1-4D8F-9798-5352CEBC7395/0/20_May_2007_RDT_Forecast_report.pdf. Accessed December 19, 2007.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 39 | 39 | 13 |
| Full Text Views | 378 | 97 | 0 |
| PDF Downloads | 180 | 26 | 0 |