Evaluation of ICT malaria immunochromatographic Binax NOW® ICT P.f/P.v test for rapid diagnosis of malaria in a Colombian endemic area
Keywords:
malaria/diagnosis, sensitivity and specificity, Plasmodium falciparum, Plasmodium vivax
Abstract
Introduction. One of the strategies to reduce malarial morbidity and mortality is to make an early diagnosis, using simple rapid tests which are highly sensitive and specific. Furthermore, the tests must be easy to perform and understand by local people in such a way that a suitable and prompt antimalarial treatment is guaranteed.Objective. The sensitivity and specificity was determined for the immuno-chromographic malaria dipstick (ICT Pf/Pv) test for the rapid diagnosis of malaria in Turbo, Antioquia.
Materials and methods. The sample consisted of 171 patients distributed into two groups: the first group was 118 patients with acute febrile syndrome compatible with malaria to which ICT Pf/Pv and thick smears were applied simultaneously; a second group was 53 patients with positive diagnosis by thick smear, with follow-up on the 4th and 7th days after beginning treatment.
Results. Sensitivity and specificity of the ICT Pf/Pv test for Plasmodium falciparum infections were 54.2% (95%CI: 52.0-53.4%) and 93.6% (95%CI: 93.1-94.2%), respectively. In addition, for Plasmodium vivax the sensitivity and specificity were 80% (95%CI: 77.9-82.1%) and 100% (95%CI: 99.5-100%); there was a 21.4% loss of sensitivity for P. falciparum 21.4% and a 33% loss for P. vivax malaria with parasitaemias under 500 parasites/ul. For the confirmatory test, ICT Pf/Pv showed a global sensitivity of 71.6% with 20.7% false positive and 5.6% false negative results. During follow-up, ICT showed 36% and 34% false positive results for day 4 and 7, respectively.
Conclusions. The ICT Pf/Pv test has a poor sensitivity for P. falciparum malaria and its capacity to detect parasitemias under 500 parasites/ul is minimal. As a confirmatory test, the ICT Pf/Pv has a good sensitivity for P. falciparum. Its use for patient follow-up is not recommended.
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References
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25. Iqbal J, Sher A, Rab A. Plasmodium falciparum histidine-rich protein 2-based immunocapture diagnostic assay for malaria: cross-reactivity with rheumatoid factors. J Clin Microbiol. 2000;38:1184-6.
26. Tjitra E, Suprianto S, McBroom J, Currie BJ, Anstey NM. 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. 2001;39:1025-31.
27. Iqbal J, Siddique A, Jameel M, Hira PR. Persistent histidine-rich protein 2, parasite lactate dehydrogenase, and panmalarial antigen reactivity after clearance of Plasmodium falciparum monoinfection. J Clin Microbiol. 2004;42:4237-41.
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2. Organización Panamericana de la Salud, Organización Mundial de la Salud. Informe "Hacer retroceder el paludismo" en la región de la selva húmeda tropical de América del Sur. OPS/HCP/HCT/15/00.
Washington, D.C; OPS, OMS; 1999.
3. World Health Organization. Malaria diagnosis. New perspectives. WHO/CDS/RBM/2000. 14; WHO/MAL/2000.1091. Geneva; WHO: 2000.
4. World Health Organization. A rapid dipstick antigen capture assay for the diagnosis of P. falciparum malaria. WHO/MAL/95.1072. Geneva: WHO; 1995.
5. Zambrano P. Informe final de malaria, semanas 1 a 52, Colombia 2005. Inf Quinc Epidemiol Nac. 2006;11:49-64.
6. Blair S, Londoño B. Malaria y laboratorio. Medicina y Laboratorio. 2000;9:211-20.
7. Iqbal J, Khalid N, Hira PR. Comparison of two commercial assays with expert microscopy for confirmation of symptomatically diagnosed malaria. J Clin Microbiol. 2002;40:4675-8.
8. Moody A. Rapid diagnostic tests for malaria parasites. Clin Microbiol Rev. 2002;15:66-78.
9. World Health Organization. Interim notes on selection of type of malaria rapid diagnostic test in relation to the occurrence of different parasite species. Guidance for National malaria control programmes. Prepared by Roll Back Malaria Department with the collaboration of the Regional Offices for Africa and the Western Pacific. (WHO 2004a). Geneva: WHO; 2003.
10. World Health Organization. Library cataloguing in publication data. The use of malaria rapid diagnostic tests. Geneva: WHO; 2004.
11. Kodisinghe HM, Perera KL, Premawansa S, Naotunne T, Wickramasinghe AR, Mendis KN. The ParaSight-F dipstick test as a routine diagnostic tool for malaria in Sri Lanka. Trans R Soc Trop Med Hyg.
1997;91:398-402.
12. Blair S, Lacharme L, Quiñones J, Realpe T. Diagnóstico de malaria por P. falciparum mediante le detección de la proteína rica en histidina II. Medicina y Laboratorio. 1997;7:519-21.
13. Huong NM, Davis TM, Hewitt S, Huong NV, Uyen TT, Nhan DH, et al. Comparison of three antigen detection methods for diagnosis and therapeutic monitoring of malaria: a field study from southern
Vietnam. Trop Med Int Health. 2002;7:304-8.
14. Funk M, Schlagenhauf P, Tschopp A, Steffen R. MalaQuick versus ParaSight-F as a diagnostic aid in travellers' malaria. Trans R Soc Trop Med Hyg. 1999;93:268-72.
15. Playford EG, Walker 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.
16. Grobusch M, Hanscheid T, Gobels K, Slevogt H, Zoller T, Rogler G, et al. Comparison of three antigen detection tests for diagnosis and follow-up of falciparum malaria in travellers returning to Berlin, Germany. Parasitol Res. 2003;89:354-7.
17. Londoño B, Carmona J, Blair S. Comparación de los métodos Optimal® y gota gruesa para el diagnóstico de malaria en una zona endémica sin epidemia. Biomédica. 2002;22:466-75.
18. Mendoza N, Montoya R, García M, Padilla J, Bruzón L, Mendoza E, et al. Evaluación de campo de una prueba rápida para el diagnóstico de malaria. Biomédica. 2001;21:313-9.
19. Sullivan DJ Jr, Gluzman IY, Goldberg DE. Plasmodium hemozoin formation mediated by histidine-rich proteins. Science. 1996;271:219-22.
20. 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.
21. Zheng X, Tang L, Xu Y, Meng F, Zhu W, Gu Z, et al. Evaluation of immunochromatographic test in the diagnosis of Plasmodium falciparum and Plasmodium vivax. Zhongguo Ji Sheng Chong Xue Yu Ji Sheng
Chong Bing Za Zhi.1999;17:235-6.
22. 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.
23. Mockenhaupt FP, Ulmen U, von Gaertner C, Bedu-Addo G, Bienzle U. Diagnosis of placental malaria. J Clin Microbiol. 2002;40:306-8.
24. Leke RF, Djokam RR, Mbu R, Leke RJ, Fogako J, Megnekou R, et al. Detection of the Plasmodium falciparum antigen histidine-rich protein 2 in blood of pregnant women: implications for diagnosing placental malaria. J Clin Microbiol. 1999;37:2992-6.
25. Iqbal J, Sher A, Rab A. Plasmodium falciparum histidine-rich protein 2-based immunocapture diagnostic assay for malaria: cross-reactivity with rheumatoid factors. J Clin Microbiol. 2000;38:1184-6.
26. Tjitra E, Suprianto S, McBroom J, Currie BJ, Anstey NM. 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. 2001;39:1025-31.
27. Iqbal J, Siddique A, Jameel M, Hira PR. Persistent histidine-rich protein 2, parasite lactate dehydrogenase, and panmalarial antigen reactivity after clearance of Plasmodium falciparum monoinfection. J Clin Microbiol. 2004;42:4237-41.
28. Dirección Seccional de Salud de Antioquia. Eventos de vigilancia epidemiológica, ETV y ambiente. Antioquia, 1994-2003. [Consultado: 13 de diciembre 2006]. Disponible en: http://www.dssa.gov.co/vectores/vectores.htm
29. Carmona-Fonseca J. La malaria en Colombia, Antioquia y las zonas de Urabá y bajo Cauca: panorama para interpretar la respuesta terapéutica antimalárica. Iatreia. 2004;17:34-53.
30. World Health Organization. Basic malaria microscopy. Part I. Learner's Guide. Geneva: WHO; 1991.
31. Pita Fernández S, Pértegas Díaz S. Metodología de la investigación. Pruebas diagnósticas. Cad Aten Primaria 2003;10:120-4. [Consultado: 13 diciembre de 2006]. Disponible en: https://www.fisterra.com/mbe/investiga/pruebas_diagnosticas/pruebas_diagnosticas.htm
32. Servicio de Salud Colombia. Guía de atención de la Malaria (I). [Consultado: 13 diciembre de 2006]. Disponible en: http://www.saludcolombia.com/actual/htmlnormas/ntmalariaI.htm
How to Cite
1.
Pabón A, Álvarez G, Yánez J, Céspedes C, Rodríguez Y, Restrepo Ángela, et al. Evaluation of ICT malaria immunochromatographic Binax NOW® ICT P.f/P.v test for rapid diagnosis of malaria in a Colombian endemic area. Biomed. [Internet]. 2007 Jun. 1 [cited 2025 Apr. 12];27(2):225-35. Available from: https://revistabiomedicaorg.biteca.online/index.php/biomedica/article/view/218
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