- Introduction
- Materials and Methods
- Results
- Microscopy
- Sensitivity, specificity, and positive and negative predictive values for the HRP2-based RDT
- Smear-positive specimens negative with the HRP2-based RDT
- Parasite densities (asexual parasite counts) and HRP2-based RDT results
- Parasite density and multiplicity of infection
- Clinical illness and false-negative HRP2-based RDT results
- False-negative RDT results and MOI
- Discussion
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Cooke AH, Chiodini PL, Doherty T, Moody AH, Ries J, Pinder M, 1999. Comparison of a parasite lactate dehydrogenase-based immunochromatographic antigen detection assay (OptiMAL) with microscopy for the detection of malaria parasites in human blood samples. Am J Trop Med Hyg 60: 173–176.
-
2.
Beadle C, Long GW, Weiss WR, McElroy PD, Maret SM, Oloo AJ, Hoffman SL, 1994. Diagnosis of malaria by detection of P. falciparum HRP2 antigen with a rapid dipstick antigen-capture assay. Lancet 343: 564–568.
-
3.
Bechem NN, Leke RFG, Tietche F, Taylor DWT, 1999. Evaluation of a rapid test for histidine rich protein 2 for diagnosis of Plasmodium falciparum infection in Cameroonian children. Trans R Soc Trop Med Hyg 93: 46.
-
4.
Dietze R, Perkins M, Boulos M, Luz F, Reller B, Corey GR, 1995. The diagnosis of Plasmodium falciparum infection using a new antigen detection system. Am J Trop Med Hyg 52: 45–49.
-
5.
Premji Z, Minjas JN, Shiff CJ, 1994. Laboratory diagnosis of malaria by village health workers using the rapid manual ParaSight™F test. Trans R Soc Trop Med Hyg 88: 418.
-
6.
Shiff CJ, Premji Z, Minjas JN, 1993. A new diagnostic tool for Plasmodium falciparum infection. Trans R Soc Trop Med Hyg 87: 646–648.
-
7.
Watson PA, Laidoueu AB, Kacou G, Traoré M, 1998. Comparison of a rapid dipstick test and thick blood films for detecting parasites of Plasmodium falciparum used under typical conditions at a semi-rural hospital in Cote d'Ivoire. Trop Doct 28: 85–88.
-
8.
Payne D, 1988. Use and limitations of light microscopy for diagnosis of malaria at the primary health care level. Bull World Health Organ 66: 621–626.
-
9.
Wooden J, Gould EE, Pauli AT, Sibley CH, 1992. Plasmodium falciparum: a simple polymerase chain reaction method for differentiating strains. Exp Parasitol 72: 207–212.
-
10.
Morata P, Queipo-Ortuno MI, de Dios Colmenero J, 1998. Strategy for optimizing DNA amplification in a peripheral blood assay used for diagnosis of human brucellosis. J Clin Microbiol 36: 2443–2446.
-
11.
Snounou G, 1996. Detection and identification of the four malaria parasite species infecting humans by PCR amplification. Methods Mol Biol 50: 263–291.
-
12.
Bouvier P, Rougemont A, Breslow N, Doumbo O, Delley V, Dicko A, Diakite M, Mauris A, Robert CF, 1997. Seasonality and malaria in a West African village: does high parasite density predict fever incidence? Am J Epidemiol 145: 850–857.
-
13.
Bartoloni A, Strohmeyer M, Sabatinelli G, Benucci M, Serni U, Parasidi F, 1998. False positive ParaSight™F test for malaria patients with rheumatoid factor. Trans R Soc Trop Med Hyg 92: 33–34.
-
14.
Pologe LG, Ravetch JV, 1986. A chromosomal rearrangement in a P. falciparum histidine-rich protein gene is associated with the knobless phenotype. Nature 322: 473–477.
-
15.
Kemp DJ, Thompson JK, Walliker D, Corcoran LM, 1987. Molecular karyotype of Plasmodium falciparum: conserved linkage groups and expendable histidine-rich protein genes. Proc Natl Acad Sci USA 84: 7672–7676.
-
16.
Biggs BA, Kemp DJ, Brown GV, 1989. Subtelomeric chromosome deletions in field isolates of Plasmodium falciparum and their relationship to loss of cytoadherence in vitro. Proc Natl Acad Sci USA 86: 2428–2432.
-
17.
Gamboa D, Ho M-F, Bendezu J, Torres K, Chiodini PL, Barnwell JW, Incardona S, Perkins M, Bell D, McCarthy J, Cheng Q, 2010. A large proportion of P. falciparum isolates in the Amazon region of Peru lack pfhrp2 and pfhrp3: implications for malaria rapid diagnostic tests. PLoS One 5: e8091.
-
18.
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.
-
19.
Howard RJ, Uni S, Aikawa M, Aley SB, Leech JH, Lew AM, Wellems TE, Rener J, Taylor DW, 1986. Secretion of a malarial Histidine-rich Protein (PfHRPII) from Plasmodium falciparum infected erythrocytes. J Cell Biol 103: 1269–1277.
-
20.
Hopkins H, Kambale W, Kamya MR, Staedke SG, Dorsey G, Rosenthal PJ, 2007. Comparison of HRP2 and pLDH-based rapid diagnostic tests for malaria with longitudinal follow-up in Kampala, Uganda. Am J Trop Med Hyg 76: 1092–1097.
-
21.
Hopkins H, Bebell L, Kambale W, Dokomajilar C, Rosenthal PJ, Dorsey G, 2008. Rapid diagnostic tests for malaria at sites of varying transmission intensity in Uganda. J Infect Dis 197: 510–518.
-
22.
Murray CK, Gasser RA Jr, Magill AJ, Miller RS, 2008. Update on rapid diagnostic testing for malaria. Clin Microbiol Rev 21: 97–110.
-
23.
Sayang C, Soula G, Tahar R, Basco LK, Gazin P, Moyou-Somo R, Delmont J, 2009. Use of a histidine-rich protein 2-based rapid diagnostic test for malaria by health personnel during routine consultation of febrile outpatients in a peripheral health facility in Yaoundé, Cameroon. Am J Trop Med Hyg 81: 343–347.
-
24.
Swarthout TD, Counihan H, Senga RKK, van den Broek I, 2007. Paracheck-Pf® accuracy and recently treated Plasmodium falciparum infections: is there a risk of over-diagnosis? Malar J 6: 58.
-
25.
World Health Organization, 2008. Malaria Rapid Diagnostic Test Performance: Results of WHO Product Performance Testing: Round 1, 2008. Available at: http://www.finddiagnostics.orgexport/sites/default/media/press/pdf/Full-report-malaria-RDTs.pdf. Accessed August 8, 2010.
-
26.
World Health Organization, 2009. List of Products Submitted to the WHO Malaria RDT Testing Programme—Round 1. Available at: . Accessed August 8, 2010.
-
27.
Makler MT, Hinrichs DH, 1993. Measurement of the lactate dehydrogenase activity of Plasmodium falciparum as an assessment of parasitemia. Am J Trop Med Hyg 48: 205–210.
-
28.
Makler MT, Piper RC, Milhous WK, 1998. Lactate dehydrogenase and the diagnosis of malaria. Parasitol Today 14: 376–377.
-
29.
Maltha J, Gillet P, Bottieau E, Cnops L, van Esbroeck L, Jacobs J, 2010. Evaluation of a rapid diagnostic test (CareStart™ Malaria HRP-2/pLDH (Pf Pan) Combo Test for the diagnosis of malaria in a reference setting. Malar J 9: 171.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1400 | 1211 | 66 |
| Full Text Views | 984 | 18 | 0 |
| PDF Downloads | 454 | 15 | 0 |
False-Negative Rapid Diagnostic Tests for Malaria and Deletion of the Histidine-Rich Repeat Region of the hrp2 Gene
Ousmane A. Koita
Ousmane A. Koita
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Ogobara K. Doumbo
Ogobara K. Doumbo
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Amed Ouattara
Amed Ouattara
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Lalla K. Tall
Lalla K. Tall
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Aoua Konaré
Aoua Konaré
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Mahamadou Diakité
Mahamadou Diakité
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Mouctar Diallo
Mouctar Diallo
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Issaka Sagara
Issaka Sagara
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Godfred L. Masinde
Godfred L. Masinde
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Safiatou N. Doumbo
Safiatou N. Doumbo
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Amagana Dolo
Amagana Dolo
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Anatole Tounkara
Anatole Tounkara
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Issa Traoré
Issa Traoré
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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Donald J. Krogstad
Donald J. Krogstad
Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali; School of Public Health and Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, Louisiana
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We identified 480 persons with positive thick smears for asexual Plasmodium falciparum parasites, of whom 454 had positive rapid diagnostic tests (RDTs) for the histidine-rich protein 2 (HRP2) product of the hrp2 gene and 26 had negative tests. Polymerase chain reaction (PCR) amplification for the histidine-rich repeat region of that gene was negative in one-half (10/22) of false-negative specimens available, consistent with spontaneous deletion. False-negative RDTs were found only in persons with asymptomatic infections, and multiplicities of infection (MOIs) were lower in persons with false-negative RDTs (both P < 0.001). These results show that parasites that fail to produce HRP2 can cause patent bloodstream infections and false-negative RDT results. The importance of these observations is likely to increase as malaria control improves, because lower MOIs are associated with false-negative RDTs and false-negative RDTs are more frequent in persons with asymptomatic infections. These findings suggest that the use of HRP2-based RDTs should be reconsidered.
Author Notes
Authors' addresses: Ousmane A. Koita, Laboratory of Applied Molecular Biology, Faculty of Science and Techniques, University of Bamako, Bamako, Mali, E-mail: okoita@icermali.org. Ogobara K. Doumbo, Amed Ouattara, Lalla K. Tall, Aoua Konaré, Mahamadou Diakité, Mouctar Diallo, Issaka Sagara, Godfred L. Masinde, Safiatou N. Doumbo, Amagana Dolo, Anatole Tounkara, and Issa Traoré, Mali–Tulane Tropical Medicine Research Center, Faculty of Medicine, Pharmacy, and Dentistry, University of Bamako and the National Transfusion Centre, Bamako, Mali, E-mails: okd@icermali.org, aouattara@medicine.umaryland.edu, lallakass@yahoo.com, gafouk@yahoo.fr, mdiakite@icermali.org, mouctard@icermali.org, isagara@icermali.org, sdoumbo@icermali.org, adolo@icermali.org, anatol@icermali.org, and issacely@yahoo.fr. Godfred L. Masinde and Donald J. Krogstad, Department of Tropical Medicine and the Center for Infectious Diseases, Tulane University, New Orleans, LA, E-mail: gmasinde@hotmail.com and krogstad@tulane.edu.
- Introduction
- Materials and Methods
- Results
- Microscopy
- Sensitivity, specificity, and positive and negative predictive values for the HRP2-based RDT
- Smear-positive specimens negative with the HRP2-based RDT
- Parasite densities (asexual parasite counts) and HRP2-based RDT results
- Parasite density and multiplicity of infection
- Clinical illness and false-negative HRP2-based RDT results
- False-negative RDT results and MOI
- Discussion
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Cooke AH, Chiodini PL, Doherty T, Moody AH, Ries J, Pinder M, 1999. Comparison of a parasite lactate dehydrogenase-based immunochromatographic antigen detection assay (OptiMAL) with microscopy for the detection of malaria parasites in human blood samples. Am J Trop Med Hyg 60: 173–176.
-
2.
Beadle C, Long GW, Weiss WR, McElroy PD, Maret SM, Oloo AJ, Hoffman SL, 1994. Diagnosis of malaria by detection of P. falciparum HRP2 antigen with a rapid dipstick antigen-capture assay. Lancet 343: 564–568.
-
3.
Bechem NN, Leke RFG, Tietche F, Taylor DWT, 1999. Evaluation of a rapid test for histidine rich protein 2 for diagnosis of Plasmodium falciparum infection in Cameroonian children. Trans R Soc Trop Med Hyg 93: 46.
-
4.
Dietze R, Perkins M, Boulos M, Luz F, Reller B, Corey GR, 1995. The diagnosis of Plasmodium falciparum infection using a new antigen detection system. Am J Trop Med Hyg 52: 45–49.
-
5.
Premji Z, Minjas JN, Shiff CJ, 1994. Laboratory diagnosis of malaria by village health workers using the rapid manual ParaSight™F test. Trans R Soc Trop Med Hyg 88: 418.
-
6.
Shiff CJ, Premji Z, Minjas JN, 1993. A new diagnostic tool for Plasmodium falciparum infection. Trans R Soc Trop Med Hyg 87: 646–648.
-
7.
Watson PA, Laidoueu AB, Kacou G, Traoré M, 1998. Comparison of a rapid dipstick test and thick blood films for detecting parasites of Plasmodium falciparum used under typical conditions at a semi-rural hospital in Cote d'Ivoire. Trop Doct 28: 85–88.
-
8.
Payne D, 1988. Use and limitations of light microscopy for diagnosis of malaria at the primary health care level. Bull World Health Organ 66: 621–626.
-
9.
Wooden J, Gould EE, Pauli AT, Sibley CH, 1992. Plasmodium falciparum: a simple polymerase chain reaction method for differentiating strains. Exp Parasitol 72: 207–212.
-
10.
Morata P, Queipo-Ortuno MI, de Dios Colmenero J, 1998. Strategy for optimizing DNA amplification in a peripheral blood assay used for diagnosis of human brucellosis. J Clin Microbiol 36: 2443–2446.
-
11.
Snounou G, 1996. Detection and identification of the four malaria parasite species infecting humans by PCR amplification. Methods Mol Biol 50: 263–291.
-
12.
Bouvier P, Rougemont A, Breslow N, Doumbo O, Delley V, Dicko A, Diakite M, Mauris A, Robert CF, 1997. Seasonality and malaria in a West African village: does high parasite density predict fever incidence? Am J Epidemiol 145: 850–857.
-
13.
Bartoloni A, Strohmeyer M, Sabatinelli G, Benucci M, Serni U, Parasidi F, 1998. False positive ParaSight™F test for malaria patients with rheumatoid factor. Trans R Soc Trop Med Hyg 92: 33–34.
-
14.
Pologe LG, Ravetch JV, 1986. A chromosomal rearrangement in a P. falciparum histidine-rich protein gene is associated with the knobless phenotype. Nature 322: 473–477.
-
15.
Kemp DJ, Thompson JK, Walliker D, Corcoran LM, 1987. Molecular karyotype of Plasmodium falciparum: conserved linkage groups and expendable histidine-rich protein genes. Proc Natl Acad Sci USA 84: 7672–7676.
-
16.
Biggs BA, Kemp DJ, Brown GV, 1989. Subtelomeric chromosome deletions in field isolates of Plasmodium falciparum and their relationship to loss of cytoadherence in vitro. Proc Natl Acad Sci USA 86: 2428–2432.
-
17.
Gamboa D, Ho M-F, Bendezu J, Torres K, Chiodini PL, Barnwell JW, Incardona S, Perkins M, Bell D, McCarthy J, Cheng Q, 2010. A large proportion of P. falciparum isolates in the Amazon region of Peru lack pfhrp2 and pfhrp3: implications for malaria rapid diagnostic tests. PLoS One 5: e8091.
-
18.
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.
-
19.
Howard RJ, Uni S, Aikawa M, Aley SB, Leech JH, Lew AM, Wellems TE, Rener J, Taylor DW, 1986. Secretion of a malarial Histidine-rich Protein (PfHRPII) from Plasmodium falciparum infected erythrocytes. J Cell Biol 103: 1269–1277.
-
20.
Hopkins H, Kambale W, Kamya MR, Staedke SG, Dorsey G, Rosenthal PJ, 2007. Comparison of HRP2 and pLDH-based rapid diagnostic tests for malaria with longitudinal follow-up in Kampala, Uganda. Am J Trop Med Hyg 76: 1092–1097.
-
21.
Hopkins H, Bebell L, Kambale W, Dokomajilar C, Rosenthal PJ, Dorsey G, 2008. Rapid diagnostic tests for malaria at sites of varying transmission intensity in Uganda. J Infect Dis 197: 510–518.
-
22.
Murray CK, Gasser RA Jr, Magill AJ, Miller RS, 2008. Update on rapid diagnostic testing for malaria. Clin Microbiol Rev 21: 97–110.
-
23.
Sayang C, Soula G, Tahar R, Basco LK, Gazin P, Moyou-Somo R, Delmont J, 2009. Use of a histidine-rich protein 2-based rapid diagnostic test for malaria by health personnel during routine consultation of febrile outpatients in a peripheral health facility in Yaoundé, Cameroon. Am J Trop Med Hyg 81: 343–347.
-
24.
Swarthout TD, Counihan H, Senga RKK, van den Broek I, 2007. Paracheck-Pf® accuracy and recently treated Plasmodium falciparum infections: is there a risk of over-diagnosis? Malar J 6: 58.
-
25.
World Health Organization, 2008. Malaria Rapid Diagnostic Test Performance: Results of WHO Product Performance Testing: Round 1, 2008. Available at: http://www.finddiagnostics.orgexport/sites/default/media/press/pdf/Full-report-malaria-RDTs.pdf. Accessed August 8, 2010.
-
26.
World Health Organization, 2009. List of Products Submitted to the WHO Malaria RDT Testing Programme—Round 1. Available at: . Accessed August 8, 2010.
-
27.
Makler MT, Hinrichs DH, 1993. Measurement of the lactate dehydrogenase activity of Plasmodium falciparum as an assessment of parasitemia. Am J Trop Med Hyg 48: 205–210.
-
28.
Makler MT, Piper RC, Milhous WK, 1998. Lactate dehydrogenase and the diagnosis of malaria. Parasitol Today 14: 376–377.
-
29.
Maltha J, Gillet P, Bottieau E, Cnops L, van Esbroeck L, Jacobs J, 2010. Evaluation of a rapid diagnostic test (CareStart™ Malaria HRP-2/pLDH (Pf Pan) Combo Test for the diagnosis of malaria in a reference setting. Malar J 9: 171.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1400 | 1211 | 66 |
| Full Text Views | 984 | 18 | 0 |
| PDF Downloads | 454 | 15 | 0 |