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Reference Manager
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-
1.
World Health Organization, 2015. Malaria Rapid Diagnostic Test Performance: Results of WHO Product Testing of Malaria RDTs: Round 6 (2014–2015). Geneva, Switzerland: WHO.
-
2.
Sahu S, Gunasekaran K, Jambulingam P, 2015. Field performance of malaria rapid diagnostic test for the detection of Plasmodium falciparum infection in Odisha State, India. Indian J Med Res 142: 52.
-
3.
Tiono AB, Ouédraogo A, Diarra A, Coulibaly S, Soulama I, Konaté AT, Barry A, Mukhopadhyay A, Sirima SB, Hamed K, 2014. Lessons learned from the use of HRP-2 based rapid diagnostic test in community-wide screening and treatment of asymptomatic carriers of Plasmodium falciparum in Burkina Faso. Malar J 13: 30.
-
4.
Falade CO et al. 2016. Malaria rapid diagnostic tests and malaria microscopy for guiding malaria treatment of uncomplicated fevers in Nigeria and prereferral cases in 3 African countries. Clin Infect Dis 63: S290–S297.
-
5.
Phommasone K et al. 2016. Asymptomatic Plasmodium infections in 18 villages of southern Savannakhet Province, Lao PDR (Laos). Malar J 15: 296.
-
6.
Elbadry MA et al. 2015. High prevalence of asymptomatic malaria infections: a cross-sectional study in rural areas in six departments in Haiti. Malar J 14: 510.
-
7.
Schachterle SE et al. 2011. Prevalence and density-related concordance of three diagnostic tests for malaria in a region of Tanzania with hypoendemic malaria. J Clin Microbiol 49: 3885–3891.
-
8.
Wu L, van den Hoogen LL, Slater H, Walker PGT, Ghani AC, Drakeley CJ, Okell LC, 2015. Comparison of diagnostics for the detection of asymptomatic Plasmodium falciparum infections to inform control and elimination strategies. Nature 528: S86–S93.
-
9.
Plucinski M et al. 2017. Malaria surveys using rapid diagnostic tests and validation of results using post hoc quantification of Plasmodium falciparum histidine-rich protein 2. Malar J 16: 451.
-
10.
World Health Organization, 2017. WHO World Malaria Report 2017. Geneva, Switzerland: WHO.
-
11.
Rougemont M, Van Saanen M, Sahli R, Hinrikson HP, Bille J, Jaton K, 2004. Detection of four Plasmodium species in blood from humans by 18S rRNA gene subunit-based and species-specific real-time PCR assays. J Clin Microbiol 42: 5636–5643.
-
12.
Mohammed H, Kassa M, Kebede A, Endeshaw T, 2012. Paracheck-pf® test versus microscopy in the diagnosis of falciparum malaria in Arbaminch Zuria Woreda of south Ethiopia. Ethiop J Health Sci 22: 93–98.
-
13.
Kyabayinze DJ, Tibenderana JK, Odong GW, Rwakimari JB, Counihan H, 2008. Operational accuracy and comparative persistent antigenicity of HRP2 rapid diagnostic tests for Plasmodium falciparum malaria in a hyperendemic region of Uganda. Malar J 7: 221.
-
14.
Bell DR, Wilson DW, Martin LB, 2005. False-positive results of a Plasmodium falciparum histidine-rich protein 2—detecting malaria rapid diagnostic test due to high sensitivity in a community with fluctuating low parasite density. Am J Trop Med Hyg 73: 199–203.
-
15.
Das S et al. 2017. Performance of a high-sensitivity rapid diagnostic test for Plasmodium falciparum malaria in asymptomatic individuals from Uganda and Myanmar and naive human challenge infections. Am J Trop Med Hyg 97: 1540–1550.
-
16.
Jimenez A, Rees-Channer RR, Perera R, Gamboa D, Chiodini PL, González IJ, Mayor A, Ding XC, 2017. Analytical sensitivity of current best-in-class malaria rapid diagnostic tests. Malar J 16: 128.
-
17.
Marquart L, Butterworth A, McCarthy JS, Gatton ML, 2012. Modelling the dynamics of Plasmodium falciparum histidine-rich protein 2 in human malaria to better understand malaria rapid diagnostic test performance. Malar J 11: 74.
-
18.
Tjitra E, Suprianto S, McBroom J, Currie BJ, Anstey NM, 2001. 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 39: 1025–1031.
-
19.
Lau R, Phuong M, Ralevski F, Boggild AK, 2015. Correlating quantitative real-time PCR to rapid diagnostic test and RNA transcript expression in isolated gametocytemia and asexual parasitemia of Plasmodium falciparum malaria. Trop Dis Travel Med Vaccines 1: 8.
-
20.
Mason DP, Kawamoto F, Lin K, Laoboonchai A, Wongsrichanalai C, 2002. A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. Acta Trop 82: 51–59.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 269 | 251 | 30 |
| Full Text Views | 1322 | 7 | 0 |
| PDF Downloads | 68 | 11 | 0 |
Using Reference Quantitative Polymerase Chain Reaction to Assess the Clinical Performance of the Paracheck-Pf® Rapid Diagnostic Test in a Field Setting in Uganda
Catherine J. Mitran
Catherine J. Mitran
School of Public Health, University of Alberta, Edmonton, Canada;
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Anthony K. Mbonye
Anthony K. Mbonye
Ministry of Health, Kampala, Uganda;
School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda;
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School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda;
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Michael Hawkes
Michael Hawkes
Department of Pediatrics, University of Alberta, Edmonton, Canada;
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Stephanie K. Yanow
Stephanie K. Yanow
School of Public Health, University of Alberta, Edmonton, Canada;
Department of Medical Microbiology and Immunology, University of Alberta, Edmonton, Canada
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Department of Medical Microbiology and Immunology, University of Alberta, Edmonton, Canada
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PubMed
Malaria rapid diagnostic tests (RDTs) are widely used in clinical and surveillance settings. However, the performance of most RDTs has not been characterized at parasite densities below detection by microscopy. We present findings from Uganda, where RDT results from 491 participants with suspected malaria were correlated with quantitative polymerase chain reaction (qPCR)-defined parasitemia. Compared with qPCR, the sensitivity and specificity of the RDT for Plasmodium falciparum mono-infections were 76% (95% confidence interval [CI]: 68–83%) and 95% (95% CI: 92–97%), respectively. The sensitivity of the RDT at parasite densities between 0.2 and 200 parasites/μL was surprisingly high (87%, 95% CI: 74–94%). The high sensitivity of the RDT is likely because of histidine-rich protein 2 from submicroscopic infections, gametocytes, or sequestered parasites. These findings underscore the importance of evaluating different RDTs in field studies against qPCR reference testing to better define the sensitivity and specificity, particularly at low parasite densities.
Author Notes
Financial support: S. K. Y. reports grants from Canadian Institutes of Health Research and Alberta Economic Development and Trade.
Authors’ addresses: Catherine J. Mitran, School of Public Health, University of Alberta, Edmonton, Alberta, Canada, E-mail: mitran@ualberta.ca. Anthony K. Mbonye, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda, E-mail: akmbonye@yahoo.com. Michael Hawkes, Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada, E-mail: mthawkes@ualberta.ca. Stephanie K. Yanow, School of Public Health, University of Alberta, Edmonton, Alberta, Canada, and Department of Medical Microbiology and Immunology, University of Alberta, Edmonton, Alberta, Canada, E-mail: yanow@ualberta.ca.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
World Health Organization, 2015. Malaria Rapid Diagnostic Test Performance: Results of WHO Product Testing of Malaria RDTs: Round 6 (2014–2015). Geneva, Switzerland: WHO.
-
2.
Sahu S, Gunasekaran K, Jambulingam P, 2015. Field performance of malaria rapid diagnostic test for the detection of Plasmodium falciparum infection in Odisha State, India. Indian J Med Res 142: 52.
-
3.
Tiono AB, Ouédraogo A, Diarra A, Coulibaly S, Soulama I, Konaté AT, Barry A, Mukhopadhyay A, Sirima SB, Hamed K, 2014. Lessons learned from the use of HRP-2 based rapid diagnostic test in community-wide screening and treatment of asymptomatic carriers of Plasmodium falciparum in Burkina Faso. Malar J 13: 30.
-
4.
Falade CO et al. 2016. Malaria rapid diagnostic tests and malaria microscopy for guiding malaria treatment of uncomplicated fevers in Nigeria and prereferral cases in 3 African countries. Clin Infect Dis 63: S290–S297.
-
5.
Phommasone K et al. 2016. Asymptomatic Plasmodium infections in 18 villages of southern Savannakhet Province, Lao PDR (Laos). Malar J 15: 296.
-
6.
Elbadry MA et al. 2015. High prevalence of asymptomatic malaria infections: a cross-sectional study in rural areas in six departments in Haiti. Malar J 14: 510.
-
7.
Schachterle SE et al. 2011. Prevalence and density-related concordance of three diagnostic tests for malaria in a region of Tanzania with hypoendemic malaria. J Clin Microbiol 49: 3885–3891.
-
8.
Wu L, van den Hoogen LL, Slater H, Walker PGT, Ghani AC, Drakeley CJ, Okell LC, 2015. Comparison of diagnostics for the detection of asymptomatic Plasmodium falciparum infections to inform control and elimination strategies. Nature 528: S86–S93.
-
9.
Plucinski M et al. 2017. Malaria surveys using rapid diagnostic tests and validation of results using post hoc quantification of Plasmodium falciparum histidine-rich protein 2. Malar J 16: 451.
-
10.
World Health Organization, 2017. WHO World Malaria Report 2017. Geneva, Switzerland: WHO.
-
11.
Rougemont M, Van Saanen M, Sahli R, Hinrikson HP, Bille J, Jaton K, 2004. Detection of four Plasmodium species in blood from humans by 18S rRNA gene subunit-based and species-specific real-time PCR assays. J Clin Microbiol 42: 5636–5643.
-
12.
Mohammed H, Kassa M, Kebede A, Endeshaw T, 2012. Paracheck-pf® test versus microscopy in the diagnosis of falciparum malaria in Arbaminch Zuria Woreda of south Ethiopia. Ethiop J Health Sci 22: 93–98.
-
13.
Kyabayinze DJ, Tibenderana JK, Odong GW, Rwakimari JB, Counihan H, 2008. Operational accuracy and comparative persistent antigenicity of HRP2 rapid diagnostic tests for Plasmodium falciparum malaria in a hyperendemic region of Uganda. Malar J 7: 221.
-
14.
Bell DR, Wilson DW, Martin LB, 2005. False-positive results of a Plasmodium falciparum histidine-rich protein 2—detecting malaria rapid diagnostic test due to high sensitivity in a community with fluctuating low parasite density. Am J Trop Med Hyg 73: 199–203.
-
15.
Das S et al. 2017. Performance of a high-sensitivity rapid diagnostic test for Plasmodium falciparum malaria in asymptomatic individuals from Uganda and Myanmar and naive human challenge infections. Am J Trop Med Hyg 97: 1540–1550.
-
16.
Jimenez A, Rees-Channer RR, Perera R, Gamboa D, Chiodini PL, González IJ, Mayor A, Ding XC, 2017. Analytical sensitivity of current best-in-class malaria rapid diagnostic tests. Malar J 16: 128.
-
17.
Marquart L, Butterworth A, McCarthy JS, Gatton ML, 2012. Modelling the dynamics of Plasmodium falciparum histidine-rich protein 2 in human malaria to better understand malaria rapid diagnostic test performance. Malar J 11: 74.
-
18.
Tjitra E, Suprianto S, McBroom J, Currie BJ, Anstey NM, 2001. 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 39: 1025–1031.
-
19.
Lau R, Phuong M, Ralevski F, Boggild AK, 2015. Correlating quantitative real-time PCR to rapid diagnostic test and RNA transcript expression in isolated gametocytemia and asexual parasitemia of Plasmodium falciparum malaria. Trop Dis Travel Med Vaccines 1: 8.
-
20.
Mason DP, Kawamoto F, Lin K, Laoboonchai A, Wongsrichanalai C, 2002. A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. Acta Trop 82: 51–59.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 269 | 251 | 30 |
| Full Text Views | 1322 | 7 | 0 |
| PDF Downloads | 68 | 11 | 0 |