Evaluation of two rapid diagnostic tests, NOW® ICT Malaria Pf/Pv and OptiMAL®, for diagnosis of malaria
Keywords:
malaria/diagnosis, sensitivity and specificity, parasitemia, Plasmodium vivax, Plasmodium falciparum, Colombia
Abstract
Introduction. To increase the accessibility of malaria diagnosis, the Instituto Nacional de Salud de Colombia undertook a field trial to evaluate the sensitivity and specificity of two rapid diagnostic tests.Objective. The sensitivity, specificity and concordance was compared for two rapid diagnostic tests for malaria, NOW® ICT Malaria Pf/Pv and OptiMAL®,
Materials and methods. A descriptive and concordance study was performed with 214 patients in the southwestern coastal city of Tumaco, Colombia, each of whom presented at least one of the symptoms of the classical malaria triad. Two strategies were applied for patient recruitment-one by passive search and a second through local health brigades.
Results. NOW® ICT showed a general sensitivity of 98.4% (95%CI: 90.3-99.9), and a general specificity of 98.0% (95%CI: 93.9-99.5). For Plasmodium falciparum, the sensitivity was 98.2% (95%CI: 89.4-99.9) and the specificity 98.1% (95%CI: 94.1-99.5). The sensitivity was lower (80.0%) when parasitemia ranged from 200 to 4,000 parasites/ μl. The sensitivity and specificity of the NOW® ICT for P. vivax malaria were 100%. The sensitivity for this test was not affected for the established ranges of parasitemia for P. vivax. The overall figures for OptiMAL® were 95.2% (95%CI: 85.8-98.8) sensitivity and 99.3% (95%CI: 95.8-100.0) specificity. For P. falciparum malaria OptiMAL® showed 94.7% (95%CI: 84.5-98.6) sensitivity and 99.4% (95%CI: 96.0-100.0) specificity. The sensitivity was lower (60.0%) when samples with 200-4,000 parasites/μl were tested. For P. vivax, OptiMAL® presented a 66.7% (95%CI: 24.1-94.0) sensitivity, which diminished to 50% with a parasitemia between 300-2.500 parasites/ μL.
Conclusions. Good results for sensitivity and specificity were obtained for malaria diagnosis using NOW® ICT and OptiMAL®, with NOW®ICT showing higher sensitivity and specificity values than OptiMAL®.
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References
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2. Ministerio de Salud. Informe ejecutivo semanal. Malaria en Córdoba: situación epidemiológica y medidas de intervención, Colombia. Inf Quinc Epidemiol Nal. 2001;6:49-64.
3. World Heath Organization. Malaria diagnosis. New perspectives. WHO/MAL/200.1091. Geneva: WHO; 2000.
4. Mason DP, Wongsrichanalai Lin K, Miller RS, Kawamoto F. The panmalarial antigen detected by the ICT malaria Pf/Pv immunochromatography test is expressed by Plasmodium malariae. J Clin Microbiol.
2001;39:2035.
5. Win TT, Tantular IS, Pusarawati S, Kerong H, Lin K, Matsuoka H, et al. Detection of Plasmodium ovale by ICT malaria P.f/P.v. immunochromatographic test. Acta Trop. 2001;80:283-4.
6. Tjitra E, Suprianto S, Dyer M, Currie BJ, Anstey NM. Field evaluation of the ICT Malaria P.f/P.v immunochromatographic test for detection of Plasmodium falciparum and Plasmodium vivax in
patients with a presumptive clinical diagnosis of malaria in eastern Indonesia. J Clin Microbiol. 1999;37:2412-7.
7. García C, Moreno L, García H. Evaluación de pruebas diagnósticas. En: Moreno L, Cano F, García H, editores. Epidemiología clínica. 3a ed. Atlampa: Editorial Interamericana S.A; 1994.
8. Ministerio de Salud del Perú/Instituto Nacional de Salud del Perú. Evaluación de una prueba rápida inmunocromatográfica por promotores de salud para el diagnóstico de malaria en áreas rurales de la Amazonía peruana, 1999. Informe técnico. Lima: Ministerio de Salud del Perú/Instituto Nacional de Salud del Perú: 1999.
9. Ferro BE, Gonzalez IJ, Carvajal F, Palma GI, Saravia NG. Performance of OptiMAL ® in the diagnosis of Plasmodium vivax and Plasmodium falciparum infections in a malaria referral center in Colombia. Mem Inst Oswaldo Cruz. 2002;97:731-5.
10. van den Broek I, Hill O, Gordillo F, Angarita B, Hamade P, Counihan H, et al. Evaluation of three rapid tests for diagnosis of P. falciparum and P. vivax malaria in Colombia. Am J Trop Med Hyg. 2006;75: 1209-15.
11. Wongsrichanalai C, Arevalo I, Laoboonchai A, Yingyuen K, Miller RS, Magill AJ, et al. Rapid diagnostic devices for malaria: field evaluation of a new prototype immunochromatographic assay for the
detection of Plasmodium falciparum and non-falciparum Plasmodium. Am J Trop Med Hyg. 2003;69:26-30.
12. Fernando SD, Karunaweera ND, Fernando WP. Evaluation of a rapid whole blood immunochromatographic assay for the diagnosis of Plasmodium falciparum and Plasmodium vivax malaria. Ceylon Med J. 2004;49:7-11.
13. Playford EG, Walter J. Evaluation of the ICT malaria Pf/Pv and the OptiMal rapid diagnostic tests for malaria in febrile returned travellers. J Clin Microbiol. 2002;40:4166-71.
14. Londoño B, Camona J, Blair S. Comparación de los métodos Optimal® y gota gruesa para el diagnóstico de malaria en una zona endémica sin epidemia. Biomédica. 2002;21:466-75.
15. Singh N, Saxena A, Valecha N. Field evaluation of the ICT malaria Pf/Pv immunochromatographic test for diagnosis of Plasmodium falciparum and P. vivax infection in forest villages of Chhindwara, central India. Trop Med Int Health. 2000;5:765-70.
16. Cooke AH, Chiodini PL, Doherty T, Moody AH, Ries J, Pinder M. 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. 1999;60:173-6.
17. Soto Tarazona A, Solari Zerpa L, Mendoza Requena D, Llanos-Cuentas A, Magill A. Evaluation of the rapid diagnosis test Optimal for diagnosis of malaria due to Plasmodium vivax. Braz J Infect Dis. 2004,8:151-5.
18. Pabón A, Álvarez G, Yánez J, Céspedes C, Rodríguez Y, Restrepo A, et al. Evaluación de la prueba rápida inmunocromatográfica Binax NOW® ICT Pf/Pv para el diagnóstico de paludismo en un área
endémica de Colombia. Biomédica. 2007;27:225-35.
19. Makler MT, Palmer CJ, Age AL. A review of practical techniques for the diagnosis of malaria. Ann Trop Med Parasitol. 1998;92:419-33.
20. World Health Organization. Malaria rapid diagnosis. Making it work. RS/2003/GE/05(PHL). Geneva: WHO; 2003.
2. Ministerio de Salud. Informe ejecutivo semanal. Malaria en Córdoba: situación epidemiológica y medidas de intervención, Colombia. Inf Quinc Epidemiol Nal. 2001;6:49-64.
3. World Heath Organization. Malaria diagnosis. New perspectives. WHO/MAL/200.1091. Geneva: WHO; 2000.
4. Mason DP, Wongsrichanalai Lin K, Miller RS, Kawamoto F. The panmalarial antigen detected by the ICT malaria Pf/Pv immunochromatography test is expressed by Plasmodium malariae. J Clin Microbiol.
2001;39:2035.
5. Win TT, Tantular IS, Pusarawati S, Kerong H, Lin K, Matsuoka H, et al. Detection of Plasmodium ovale by ICT malaria P.f/P.v. immunochromatographic test. Acta Trop. 2001;80:283-4.
6. Tjitra E, Suprianto S, Dyer M, Currie BJ, Anstey NM. Field evaluation of the ICT Malaria P.f/P.v immunochromatographic test for detection of Plasmodium falciparum and Plasmodium vivax in
patients with a presumptive clinical diagnosis of malaria in eastern Indonesia. J Clin Microbiol. 1999;37:2412-7.
7. García C, Moreno L, García H. Evaluación de pruebas diagnósticas. En: Moreno L, Cano F, García H, editores. Epidemiología clínica. 3a ed. Atlampa: Editorial Interamericana S.A; 1994.
8. Ministerio de Salud del Perú/Instituto Nacional de Salud del Perú. Evaluación de una prueba rápida inmunocromatográfica por promotores de salud para el diagnóstico de malaria en áreas rurales de la Amazonía peruana, 1999. Informe técnico. Lima: Ministerio de Salud del Perú/Instituto Nacional de Salud del Perú: 1999.
9. Ferro BE, Gonzalez IJ, Carvajal F, Palma GI, Saravia NG. Performance of OptiMAL ® in the diagnosis of Plasmodium vivax and Plasmodium falciparum infections in a malaria referral center in Colombia. Mem Inst Oswaldo Cruz. 2002;97:731-5.
10. van den Broek I, Hill O, Gordillo F, Angarita B, Hamade P, Counihan H, et al. Evaluation of three rapid tests for diagnosis of P. falciparum and P. vivax malaria in Colombia. Am J Trop Med Hyg. 2006;75: 1209-15.
11. Wongsrichanalai C, Arevalo I, Laoboonchai A, Yingyuen K, Miller RS, Magill AJ, et al. Rapid diagnostic devices for malaria: field evaluation of a new prototype immunochromatographic assay for the
detection of Plasmodium falciparum and non-falciparum Plasmodium. Am J Trop Med Hyg. 2003;69:26-30.
12. Fernando SD, Karunaweera ND, Fernando WP. Evaluation of a rapid whole blood immunochromatographic assay for the diagnosis of Plasmodium falciparum and Plasmodium vivax malaria. Ceylon Med J. 2004;49:7-11.
13. Playford EG, Walter J. Evaluation of the ICT malaria Pf/Pv and the OptiMal rapid diagnostic tests for malaria in febrile returned travellers. J Clin Microbiol. 2002;40:4166-71.
14. Londoño B, Camona J, Blair S. Comparación de los métodos Optimal® y gota gruesa para el diagnóstico de malaria en una zona endémica sin epidemia. Biomédica. 2002;21:466-75.
15. Singh N, Saxena A, Valecha N. Field evaluation of the ICT malaria Pf/Pv immunochromatographic test for diagnosis of Plasmodium falciparum and P. vivax infection in forest villages of Chhindwara, central India. Trop Med Int Health. 2000;5:765-70.
16. Cooke AH, Chiodini PL, Doherty T, Moody AH, Ries J, Pinder M. 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. 1999;60:173-6.
17. Soto Tarazona A, Solari Zerpa L, Mendoza Requena D, Llanos-Cuentas A, Magill A. Evaluation of the rapid diagnosis test Optimal for diagnosis of malaria due to Plasmodium vivax. Braz J Infect Dis. 2004,8:151-5.
18. Pabón A, Álvarez G, Yánez J, Céspedes C, Rodríguez Y, Restrepo A, et al. Evaluación de la prueba rápida inmunocromatográfica Binax NOW® ICT Pf/Pv para el diagnóstico de paludismo en un área
endémica de Colombia. Biomédica. 2007;27:225-35.
19. Makler MT, Palmer CJ, Age AL. A review of practical techniques for the diagnosis of malaria. Ann Trop Med Parasitol. 1998;92:419-33.
20. World Health Organization. Malaria rapid diagnosis. Making it work. RS/2003/GE/05(PHL). Geneva: WHO; 2003.
How to Cite
1.
Mendoza NM, García M, Cortés LJ, Vela C, Erazo R, Pérez P, et al. Evaluation of two rapid diagnostic tests, NOW® ICT Malaria Pf/Pv and OptiMAL®, for diagnosis of malaria. biomedica [Internet]. 2007 Dec. 1 [cited 2024 May 18];27(4):571-80. Available from: https://revistabiomedica.org/index.php/biomedica/article/view/174
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Published
2007-12-01
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Section
Original articles
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