SYSTEMATIC REVIEW: EVALUATION OF DIAGNOSTIC ACCURACY AND PRACTICAL USEFULNESS OF RAPID DIAGNOSTIC TESTS FOR MALARIA
Abstrak
Malaria remains a significant global health concern, with 249 million cases and 608,000 deaths reported in 2022. Early detection, especially in endemic and resource-limited settings, is crucial to interrupt transmission. Rapid Diagnostic Tests (RDTs) are widely used due to their speed and practicality, requiring no laboratory infrastructure. This review aimed to evaluate the diagnostic accuracy (sensitivity and specificity) of conventional RDTs (HRP2, pLDH, combination) and ultra-sensitive RDTs (uRDTs), and compare their effectiveness across different populations and clinical settings. Literature searches were conducted in PubMed, ScienceDirect, and Cochrane (2020–2025), including studies in English or Indonesian. A total of 30 studies were included based on the PRISMA guidelines, with study populations encompassing children, neonates, adults, pregnant women, clinical patients, and community members in both endemic and imported settings (involving more than 50,000 individuals in total). Most RDTs demonstrated high specificity (>90%), but sensitivity varied widely (0 to >95%), influenced by parasitemia level and population characteristics. HRP2-based RDTs were effective for Plasmodium falciparum, but HRP2 gene deletions caused false negatives. pLDH-based RDTs performed better in multi-species infections. U-RDTs improved the detection of low-density parasitemia, especially in pregnant women and asymptomatic individuals. However, sensitivity declined in neonates and adults with low parasitemia. While some RDTs outperformed microscopy in clinical sensitivity, PCR remains the gold standard, especially for detecting subclinical infections. In conclusion, RDTs provide rapid and specific detection, particularly for moderate to high-density P. falciparum infections. However, in low-density or asymptomatic cases, their limited sensitivity necessitates confirmatory testing using microscopy or PCR.
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Referensi
1. Collins KA, Ouedraogo A, Guelbeogo WM, et al. Effect of weekly fever-screening and treatment and monthly RDT testing and treatment on the infectious reservoir of malaria parasites in Burkina Faso: a cluster-randomised trial. Lancet Microbe. 2024;5(9). doi:10.1016/S2666-5247(24)00114-9
2. Feleke DG, Alemu Y, Yemanebirhane N. Performance of rapid diagnostic tests, microscopy, loop-mediated isothermal amplification (LAMP) and PCR for malaria diagnosis in Ethiopia: a systematic review and meta-analysis. Malar J. 2021;20(1). doi:10.1186/s12936-021-03923-8
3. Christian M, Ekawati LL, Pratama AR, et al. Evaluation of CareStartTM malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density. Malaria Journal . 2025;24(1). doi:10.1186/s12936-025-05276-y
4. Kabbale KD, Nsengimaana B, Semakuba FD, et al. Field evaluation of the Bioline Malaria Ag P.f/Pan rapid diagnostic test: causes of microscopy discordance and performance in Uganda. Malaria Journal . 2025;24(1). doi:10.1186/s12936-025-05379-6
5. Amoah LE, Cheng NI, Acquah FK, et al. Diagnostic performance of an ultra-sensitive RDT and a conventional RDT in malaria mass testing, treatment and tracking interventions in southern Ghana. Parasit Vectors. 2024;17(1). doi:10.1186/s13071-024-06354-x
6. Bird C, Hayward GN, Turner PJ, et al. A Diagnostic Accuracy Study to Evaluate Standard Rapid Diagnostic Test (RDT) Alone to Safely Rule Out Imported Malaria in Children Presenting to UK Emergency Departments. J Pediatric Infect Dis Soc. 2023;12(5):290-297. doi:10.1093/jpids/piad024
7. Irshad M, Khan I, LNU A, Shah G, Sadiq R, Khan FR. Evaluating the Diagnostic Accuracy of Rapid Malaria Tests in Pediatric Patients: A Retrospective Cohort Study. Cureus. Published online October 4, 2024. doi:10.7759/cureus.70817
8. Yuniatun SR, Haryatmi D. Sensitivity and Specificity of Malaria Rapid Diagnostic Test (RDT). Indonesian Journal of Global Health Research. 2025;7(4):393-400. doi:10.37287/ijghr.v7i4.6362
9. Opoku Afriyie S, Addison TK, Gebre Y, et al. Accuracy of diagnosis among clinical malaria patients: comparing microscopy, RDT and a highly sensitive quantitative PCR looking at the implications for submicroscopic infections. Malar J. 2023;22(1). doi:10.1186/s12936-023-04506-5
10. Parr JB, Kieto E, Phanzu F, et al. Analysis of false-negative rapid diagnostic tests for symptomatic malaria in the Democratic Republic of the Congo. Sci Rep. 2021;11(1). doi:10.1038/s41598-021-85913-z
11. Maketa V, Kabalu J, Kabena M, et al. Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG. Trials. 2022;23(1). doi:10.1186/s13063-022-06884-8
12. Unwin VT, Ahmed R, Noviyanti R, et al. Use of a highly-sensitive rapid diagnostic test to screen for malaria in pregnancy in Indonesia. Malar J. 2020;19(1). doi:10.1186/s12936-020-3110-6
13. Gorret AM, Muhindo R, Baguma E, et al. Comparison of Capillary Versus Venous Blood for the Diagnosis of Plasmodium falciparum Malaria Using Rapid Diagnostic Tests. Journal of Infectious Diseases. 2021;224(1):109-113. doi:10.1093/infdis/jiab032
14. Adeniji YR, Jalo I, Okonkwo I, et al. Diagnostic value of rapid test for malaria among febrile neonates in a tertiary hospital in North-East Nigeria: A prospective cross-sectional study. Arch Dis Child. 2024;109(1):11-15. doi:10.1136/archdischild-2023-325906
15. Opoku-Bamfoh O, Kwarteng SA, Owusu FAN, et al. Repellent and Larvicidal Properties of Selected Indigenous Plants in the Control of Anopheles Mosquitoes. Vol 61.; 2024.
16. Aninagyei E, Deku JG, Yemofio KT, et al. Comparative evaluation of the diagnostic accuracies of four different malaria rapid diagnostic test kits available in Ghana. PLoS One. 2024;19(5 MAY). doi:10.1371/journal.pone.0302840
17. Benié EMA, Silué KD, Ding XC, et al. Accuracy of a rapid diagnosis test, microscopy and loop-mediated isothermal amplification in the detection of asymptomatic Plasmodium infections in Korhogo, Northern Côte d’Ivoire. Malar J. 2022;21(1). doi:10.1186/s12936-022-04133-6
18. Charpentier E, Benichou E, Pagès A, et al. Performance evaluation of different strategies based on microscopy techniques, rapid diagnostic test and molecular loop-mediated isothermal amplification assay for the diagnosis of imported malaria. Clinical Microbiology and Infection. 2020;26(1):115-121. doi:10.1016/j.cmi.2019.05.010
19. Tshiongo JK, Khote FL, Kabena M, et al. Intermittent screening using ultra-sensitive malaria rapid diagnostic test and treatment with pyronaridine-artesunate compared to standard preventive treatment with sulfadoxine-pyrimethamine for malaria prevention in pregnant women in Kinshasa, DRC. Malaria Journal . 2025;24(1). doi:10.1186/s12936-025-05260-6
20. Ngalame AL, Watching D, Kibu OZ, Zeukóo EM, Nsagha DS. Assessment of the diagnostic performance of the SD Bioline Malaria antigen test for the diagnosis of malaria in the Tombel health district, Southwest region of Cameroon. PLoS One. 2025;20(3 March). doi:10.1371/journal.pone.0298992
21. Bosco AB, Nankabirwa JI, Yeka A, et al. Limitations of rapid diagnostic tests in malaria surveys in areas with varied transmission intensity in Uganda 2017-2019: Implications for selection and use of HRP2 RDTs. PLoS One. 2020;15(12 December 2020). doi:10.1371/journal.pone.0244457
22. Shankar H, Singh MP, Phookan S, Singh K, Mishra N. Diagnostic performance of rapid diagnostic test, light microscopy and polymerase chain reaction during mass survey conducted in low and high malaria-endemic areas from two North-Eastern states of India. Parasitol Res. 2021;120(6):2251-2261. doi:10.1007/s00436-021-07125-8
23. Rogers CL, Bain BJ, Garg M, Fernandes S, Mooney C, Chiodini PL. British Society for Haematology guidelines for the laboratory diagnosis of malaria. Br J Haematol. 2022;197(3):271-282. doi:10.1111/bjh.18092
24. Golden A, Slater HC, Jang IK, et al. Analytical Sensitivity Analysis and Clinical Impact Modeling of Rapigen Rapid Diagnostic Tests for Malaria. Am J Trop Med Hyg. Published online September 3, 2024. doi:10.4269/ajtmh.24-0003
25. Kiemde F, Compaore A, Koueta F, et al. Development and evaluation of an electronic algorithm using a combination of a two-step malaria RDT and other rapid diagnostic tools for the management of febrile illness in children under 5 attending outpatient facilities in Burkina Faso. Trials. 2022;23(1). doi:10.1186/s13063-022-06717-8
26. Breton G, Maïga I, Maïga A, et al. Successful Integration of Community-Based Rapid Antigen Testing for COVID-19 and Malaria in Mali. American Journal of Tropical Medicine and Hygiene. 2025;112(4):3-9. doi:10.4269/ajtmh.23-0855
27. Shelus V, Mumbere N, Masereka A, et al. “Testing for malaria does not cure any pain” A qualitative study exploring low use of malaria rapid diagnostic tests at drug shops in rural Uganda. PLOS Global Public Health. 2022;2(12). doi:10.1371/journal.pgph.0001235
28. Slater HC, Ding XC, Knudson S, et al. Performance and utility of more highly sensitive malaria rapid diagnostic tests. BMC Infect Dis. 2022;22(1). doi:10.1186/s12879-021-07023-5
29. Ali IM, Nji AM, Bonkum JC, et al. Diagnostic accuracy of carestartTM malaria hrp2 and sd bioline pf/pan for malaria in febrile outpatients in varying malaria transmission settings in cameroon. Diagnostics. 2021;11(9). doi:10.3390/diagnostics11091556
30. Mortazavi SE, Lugaajju A, Ivarsson AC, Karlsson Söbirk S, Norrgren H, Persson KEM. High rate of false positive malaria rapid diagnostic tests in a district hospital in Uganda. Frontiers in Malaria. 2025;3. doi:10.3389/fmala.2025.1545825
31. Eyong EM, Etutu SJM, Jerome FC, Nyasa RB, Kwenti TE, Moyeh MN. Plasmodium falciparum histidine-rich protein 2 and 3 gene deletion in the Mount Cameroon region. IJID Regions. 2022;3:300-307. doi:10.1016/j.ijregi.2022.05.006
32. Aidoo M, Incardona S. Ten Years of Universal Testing: How the Rapid Diagnostic Test Became a Game Changer for Malaria Case Management and Improved Disease Reporting. American Journal of Tropical Medicine and Hygiene. 2022;106(1):29-32. doi:10.4269/ajtmh.21-0643
33. Slater HC, Ding XC, Knudson S, et al. Performance and utility of more highly sensitive malaria rapid diagnostic tests. BMC Infect Dis. 2022;22(1). doi:10.1186/s12879-021-07023-5
34. Iqbal A, Qureshi NA, Alhewairini SS, Shaheen N, Hamid A, Qureshi MZ. Biocidal action, characterization, and molecular docking of Mentha piperita (Lamiaceae) leaves extract against Culex quinquefasciatus (Diptera: Culicidae) larvae. PLoS One. 2022;17(7 July). doi:10.1371/journal.pone.0270219
35. Harris I, Sharrock WW, Bain LM, et al. A Large Proportion of Asymptomatic Plasmodium Infections with Low and Sub-Microscopic Parasite Densities in the Low Transmission Setting of Temotu Province, Solomon Islands: Challenges for Malaria Diagnostics in an Elimination Setting.; 2010. http://www.malariajournal.com/content/9/1/254
36. Kotepui M, Kotepui KU, De Jesus Milanez G, Masangkay FR. Summary of discordant results between rapid diagnosis tests, microscopy, and polymerase chain reaction for detecting Plasmodium mixed infection: a systematic review and meta-analysis. Sci Rep. 2020;10(1). doi:10.1038/s41598-020-69647-y
2. Feleke DG, Alemu Y, Yemanebirhane N. Performance of rapid diagnostic tests, microscopy, loop-mediated isothermal amplification (LAMP) and PCR for malaria diagnosis in Ethiopia: a systematic review and meta-analysis. Malar J. 2021;20(1). doi:10.1186/s12936-021-03923-8
3. Christian M, Ekawati LL, Pratama AR, et al. Evaluation of CareStartTM malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density. Malaria Journal . 2025;24(1). doi:10.1186/s12936-025-05276-y
4. Kabbale KD, Nsengimaana B, Semakuba FD, et al. Field evaluation of the Bioline Malaria Ag P.f/Pan rapid diagnostic test: causes of microscopy discordance and performance in Uganda. Malaria Journal . 2025;24(1). doi:10.1186/s12936-025-05379-6
5. Amoah LE, Cheng NI, Acquah FK, et al. Diagnostic performance of an ultra-sensitive RDT and a conventional RDT in malaria mass testing, treatment and tracking interventions in southern Ghana. Parasit Vectors. 2024;17(1). doi:10.1186/s13071-024-06354-x
6. Bird C, Hayward GN, Turner PJ, et al. A Diagnostic Accuracy Study to Evaluate Standard Rapid Diagnostic Test (RDT) Alone to Safely Rule Out Imported Malaria in Children Presenting to UK Emergency Departments. J Pediatric Infect Dis Soc. 2023;12(5):290-297. doi:10.1093/jpids/piad024
7. Irshad M, Khan I, LNU A, Shah G, Sadiq R, Khan FR. Evaluating the Diagnostic Accuracy of Rapid Malaria Tests in Pediatric Patients: A Retrospective Cohort Study. Cureus. Published online October 4, 2024. doi:10.7759/cureus.70817
8. Yuniatun SR, Haryatmi D. Sensitivity and Specificity of Malaria Rapid Diagnostic Test (RDT). Indonesian Journal of Global Health Research. 2025;7(4):393-400. doi:10.37287/ijghr.v7i4.6362
9. Opoku Afriyie S, Addison TK, Gebre Y, et al. Accuracy of diagnosis among clinical malaria patients: comparing microscopy, RDT and a highly sensitive quantitative PCR looking at the implications for submicroscopic infections. Malar J. 2023;22(1). doi:10.1186/s12936-023-04506-5
10. Parr JB, Kieto E, Phanzu F, et al. Analysis of false-negative rapid diagnostic tests for symptomatic malaria in the Democratic Republic of the Congo. Sci Rep. 2021;11(1). doi:10.1038/s41598-021-85913-z
11. Maketa V, Kabalu J, Kabena M, et al. Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG. Trials. 2022;23(1). doi:10.1186/s13063-022-06884-8
12. Unwin VT, Ahmed R, Noviyanti R, et al. Use of a highly-sensitive rapid diagnostic test to screen for malaria in pregnancy in Indonesia. Malar J. 2020;19(1). doi:10.1186/s12936-020-3110-6
13. Gorret AM, Muhindo R, Baguma E, et al. Comparison of Capillary Versus Venous Blood for the Diagnosis of Plasmodium falciparum Malaria Using Rapid Diagnostic Tests. Journal of Infectious Diseases. 2021;224(1):109-113. doi:10.1093/infdis/jiab032
14. Adeniji YR, Jalo I, Okonkwo I, et al. Diagnostic value of rapid test for malaria among febrile neonates in a tertiary hospital in North-East Nigeria: A prospective cross-sectional study. Arch Dis Child. 2024;109(1):11-15. doi:10.1136/archdischild-2023-325906
15. Opoku-Bamfoh O, Kwarteng SA, Owusu FAN, et al. Repellent and Larvicidal Properties of Selected Indigenous Plants in the Control of Anopheles Mosquitoes. Vol 61.; 2024.
16. Aninagyei E, Deku JG, Yemofio KT, et al. Comparative evaluation of the diagnostic accuracies of four different malaria rapid diagnostic test kits available in Ghana. PLoS One. 2024;19(5 MAY). doi:10.1371/journal.pone.0302840
17. Benié EMA, Silué KD, Ding XC, et al. Accuracy of a rapid diagnosis test, microscopy and loop-mediated isothermal amplification in the detection of asymptomatic Plasmodium infections in Korhogo, Northern Côte d’Ivoire. Malar J. 2022;21(1). doi:10.1186/s12936-022-04133-6
18. Charpentier E, Benichou E, Pagès A, et al. Performance evaluation of different strategies based on microscopy techniques, rapid diagnostic test and molecular loop-mediated isothermal amplification assay for the diagnosis of imported malaria. Clinical Microbiology and Infection. 2020;26(1):115-121. doi:10.1016/j.cmi.2019.05.010
19. Tshiongo JK, Khote FL, Kabena M, et al. Intermittent screening using ultra-sensitive malaria rapid diagnostic test and treatment with pyronaridine-artesunate compared to standard preventive treatment with sulfadoxine-pyrimethamine for malaria prevention in pregnant women in Kinshasa, DRC. Malaria Journal . 2025;24(1). doi:10.1186/s12936-025-05260-6
20. Ngalame AL, Watching D, Kibu OZ, Zeukóo EM, Nsagha DS. Assessment of the diagnostic performance of the SD Bioline Malaria antigen test for the diagnosis of malaria in the Tombel health district, Southwest region of Cameroon. PLoS One. 2025;20(3 March). doi:10.1371/journal.pone.0298992
21. Bosco AB, Nankabirwa JI, Yeka A, et al. Limitations of rapid diagnostic tests in malaria surveys in areas with varied transmission intensity in Uganda 2017-2019: Implications for selection and use of HRP2 RDTs. PLoS One. 2020;15(12 December 2020). doi:10.1371/journal.pone.0244457
22. Shankar H, Singh MP, Phookan S, Singh K, Mishra N. Diagnostic performance of rapid diagnostic test, light microscopy and polymerase chain reaction during mass survey conducted in low and high malaria-endemic areas from two North-Eastern states of India. Parasitol Res. 2021;120(6):2251-2261. doi:10.1007/s00436-021-07125-8
23. Rogers CL, Bain BJ, Garg M, Fernandes S, Mooney C, Chiodini PL. British Society for Haematology guidelines for the laboratory diagnosis of malaria. Br J Haematol. 2022;197(3):271-282. doi:10.1111/bjh.18092
24. Golden A, Slater HC, Jang IK, et al. Analytical Sensitivity Analysis and Clinical Impact Modeling of Rapigen Rapid Diagnostic Tests for Malaria. Am J Trop Med Hyg. Published online September 3, 2024. doi:10.4269/ajtmh.24-0003
25. Kiemde F, Compaore A, Koueta F, et al. Development and evaluation of an electronic algorithm using a combination of a two-step malaria RDT and other rapid diagnostic tools for the management of febrile illness in children under 5 attending outpatient facilities in Burkina Faso. Trials. 2022;23(1). doi:10.1186/s13063-022-06717-8
26. Breton G, Maïga I, Maïga A, et al. Successful Integration of Community-Based Rapid Antigen Testing for COVID-19 and Malaria in Mali. American Journal of Tropical Medicine and Hygiene. 2025;112(4):3-9. doi:10.4269/ajtmh.23-0855
27. Shelus V, Mumbere N, Masereka A, et al. “Testing for malaria does not cure any pain” A qualitative study exploring low use of malaria rapid diagnostic tests at drug shops in rural Uganda. PLOS Global Public Health. 2022;2(12). doi:10.1371/journal.pgph.0001235
28. Slater HC, Ding XC, Knudson S, et al. Performance and utility of more highly sensitive malaria rapid diagnostic tests. BMC Infect Dis. 2022;22(1). doi:10.1186/s12879-021-07023-5
29. Ali IM, Nji AM, Bonkum JC, et al. Diagnostic accuracy of carestartTM malaria hrp2 and sd bioline pf/pan for malaria in febrile outpatients in varying malaria transmission settings in cameroon. Diagnostics. 2021;11(9). doi:10.3390/diagnostics11091556
30. Mortazavi SE, Lugaajju A, Ivarsson AC, Karlsson Söbirk S, Norrgren H, Persson KEM. High rate of false positive malaria rapid diagnostic tests in a district hospital in Uganda. Frontiers in Malaria. 2025;3. doi:10.3389/fmala.2025.1545825
31. Eyong EM, Etutu SJM, Jerome FC, Nyasa RB, Kwenti TE, Moyeh MN. Plasmodium falciparum histidine-rich protein 2 and 3 gene deletion in the Mount Cameroon region. IJID Regions. 2022;3:300-307. doi:10.1016/j.ijregi.2022.05.006
32. Aidoo M, Incardona S. Ten Years of Universal Testing: How the Rapid Diagnostic Test Became a Game Changer for Malaria Case Management and Improved Disease Reporting. American Journal of Tropical Medicine and Hygiene. 2022;106(1):29-32. doi:10.4269/ajtmh.21-0643
33. Slater HC, Ding XC, Knudson S, et al. Performance and utility of more highly sensitive malaria rapid diagnostic tests. BMC Infect Dis. 2022;22(1). doi:10.1186/s12879-021-07023-5
34. Iqbal A, Qureshi NA, Alhewairini SS, Shaheen N, Hamid A, Qureshi MZ. Biocidal action, characterization, and molecular docking of Mentha piperita (Lamiaceae) leaves extract against Culex quinquefasciatus (Diptera: Culicidae) larvae. PLoS One. 2022;17(7 July). doi:10.1371/journal.pone.0270219
35. Harris I, Sharrock WW, Bain LM, et al. A Large Proportion of Asymptomatic Plasmodium Infections with Low and Sub-Microscopic Parasite Densities in the Low Transmission Setting of Temotu Province, Solomon Islands: Challenges for Malaria Diagnostics in an Elimination Setting.; 2010. http://www.malariajournal.com/content/9/1/254
36. Kotepui M, Kotepui KU, De Jesus Milanez G, Masangkay FR. Summary of discordant results between rapid diagnosis tests, microscopy, and polymerase chain reaction for detecting Plasmodium mixed infection: a systematic review and meta-analysis. Sci Rep. 2020;10(1). doi:10.1038/s41598-020-69647-y
Penulis
Hayati, T., Rahman, F. F., Harlinda, R. A., Yukahadi, A. L., Maghfiroh, D., Ichwan, F. P., Azzahra, G., Amabel, I. M. G., H, M. R. G., Pahlevi, M. D., Urrahmah, N., & Rini, O. D. S. (2025). SYSTEMATIC REVIEW: EVALUATION OF DIAGNOSTIC ACCURACY AND PRACTICAL USEFULNESS OF RAPID DIAGNOSTIC TESTS FOR MALARIA. JURNAL RISET KESEHATAN POLTEKKES DEPKES BANDUNG, Online ISSN 2579-8103, 17(2), 613–622. https://doi.org/10.34011/juriskesbdg.v17i2.3019
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