SYSTEMATIC REVIEW: EVALUATION OF DIAGNOSTIC ACCURACY AND PRACTICAL USEFULNESS OF RAPID DIAGNOSTIC TESTS FOR MALARIA
Abstract
Malaria masih menjadi masalah kesehatan global yang signifikan, dengan 249 juta kasus dan 608.000 kematian dilaporkan pada tahun 2022. Deteksi dini, terutama di daerah endemis dan terbatas sumber daya, sangat penting untuk menghentikan penularan. Tes Diagnostik Cepat (RDT) banyak digunakan karena kecepatan dan kepraktisannya, tidak memerlukan infrastruktur laboratorium. Tinjauan ini bertujuan untuk mengevaluasi akurasi diagnostik (sensitivitas dan spesifisitas) RDT konvensional (HRP2, pLDH, kombinasi) dan RDT ultra-sensitif (uRDT), dan membandingkan efektivitasnya di berbagai populasi dan pengaturan klinis. Pencarian literatur dilakukan di PubMed, ScienceDirect, dan Cochrane Library (2020–2025), termasuk studi primer dalam bahasa Inggris atau Indonesia yang melibatkan kasus malaria yang dikonfirmasi. Sebanyak 30 studi disertakan berdasarkan pedoman PRISMA dengan populasi yaitu anak-anak, neonatus, dewasa, ibu hamil, pasien klinis, serta komunitas di daerah endemis maupun impor (total lebih dari 50.000 individu). Sebagian besar RDT menunjukkan spesifisitas tinggi (>90%), tetapi sensitivitas sangat bervariasi (0 hingga >95%), dipengaruhi oleh tingkat parasitemia dan karakteristik populasi. RDT berbasis HRP2 efektif untuk Plasmodium falciparum, tetapi delesi gen HRP2 menyebabkan hasil negatif palsu. RDT berbasis pLDH bekerja lebih baik pada infeksi multispesies. uRDT meningkatkan deteksi parasitemia berdensitas rendah, terutama pada wanita hamil dan asimtomatik. Namun, sensitivitas menurun pada neonatus dan orang dewasa dengan parasitemia rendah. Sementara beberapa RDT mengungguli mikroskopi dalam sensitivitas klinis, PCR menjadi standar emas, untuk mendeteksi infeksi subklinis. Sebagai kesimpulan, RDT memberikan deteksi cepat dan spesifik, terutama untuk infeksi P. falciparum berdensitas sedang hingga tinggi. Namun, pada kasus berdensitas rendah atau tanpa gejala, sensitivitasnya yang terbatas memerlukan pengujian konfirmasi menggunakan mikroskopi atau PCR.
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References
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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
Authors
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, 17(2), 613–622. https://doi.org/10.34011/juriskesbdg.v17i2.3019
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