Currently, malaria rapid diagnostic tests (mRDTs) are increasingly used for the diagnosis of malaria, particularly in communities where microscopy-based diagnosis is not practical. However, the diagnostic accuracy of mRDTs performed by community health workers (CHWs) remains unknown. This study was conducted to determine the accuracy of mRDT results performed by CHWs in Ngoma district, eastern province of Rwanda. This was a cross sectional prospective study. A total of 420 blood samples of patients self-reported to CHWs for malaria diagnosis were collected and analyzed by CHWs using mRDT, and quality control tests were performed by using microscopy as a reference test. The study was conducted from 22 April to 08 July 2021. Among the 420 patients, 234 (55.71%) were females, and 186 (44.29%) were males. Malaria test positivity was 2.62% by using mRDT and 1.67% by using microscopic tests. The sensitivity and specificity of mRDT were 85.71% and 98.78%, respectively. The negative predictive value, positive predictive value and accuracy of mRDTs were 99.75%, 54.54% and 98.57%, respectively. The sensitivity of mRDT was below the WHO recommended sensitivity (>95%), although the specificity (98.78%) was within the WHO recommended specificity (>=90). There was substantial agreement between the mRDT and malaria microscopic test results, k=0.642. mRDTs continue to be an appropriate choice for malaria diagnosis in the absence of microscopy.
| Published in | Central African Journal of Public Health (Volume 8, Issue 1) |
| DOI | 10.11648/j.cajph.20220801.12 |
| Page(s) | 6-12 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2024. Published by Science Publishing Group |
Quality Assurance, Malaria Rapid Diagnostic Test, Microscopy, Sensitivity, Specificity, Accuracy
| [1] | SERVICES VC, Cooperative M of PHCR of G. FINAL NATIONAL MALARIA PROGRAMME STRATEGIC PLAN 2015-2020 [Internet]. Guyana; 2018. Available from: https://docs.bvsalud.org/biblioref/2018/07/906525/arbo-guy-005.pdf. |
| [2] | WHO. World malaria report 2020 [Internet]. 2020. Available from: https://www.who.int/publications/i/item/9789240015791. |
| [3] | USAID. PRESIDENT’S MALARIA INITIATIVE RWANDA Malaria Operational Plan FY 2018 [Internet]. 2018. Available from: https://reliefweb.int/sites/reliefweb.int/files/resources/fy-2018-rwanda-malaria-operational-plan.pdf. |
| [4] | Rudasingwa G, Cho S Il. Determinants of the persistence of malaria in Rwanda. Malar J [Internet]. 2020; 19 (36): 1–10. Available from: https://doi.org/10.1186/s12936-020-3117-z. |
| [5] | WHO. Protocol for the Performance Evaluation of Malaria Rapid Diagnostic Tests for WHO Prequalification Assessment [Internet]. Geneve, Switzerland; 2020. Available from: https://www.who.int/diagnostics_laboratory/evaluations/alter/180814_protocol_pqdx_317_malaria_rdts_v1.0.pdf. |
| [6] | WHO. New Perspectives Malaria Diagnosis [Internet]. Geneva; 2000. Available from: https://www.who.int/tdr/publications/documents/malaria-diagnosis.pdf. |
| [7] | Thompson S. Helpdesk Report: Malaria and Rapid Diagnostic Tests [Internet]. UK; 2012. Available from: http: //www.heart-resources.org/wp-content/uploads/2012/08/Malaria-and-Rapid-Diagnostic-Tests-August-2012.pdf. |
| [8] | Kozycki CT, Umulisa N, Rulisa S, Mwikarago EI, Musabyimana JP, Habimana JP, et al. False - negative malaria rapid diagnostic tests in Rwanda: impact of Plasmodium falciparum isolates lacking hrp2 and declining malaria transmission. Malar J [Internet]. 2017; 16 (123): 1–11. Available from: https://malariajournal.biomedcentral.com/track/pdf/10.1186/s12936-017-1768-1.pdf. |
| [9] | Watson OJ, Sumner KM, Janko M, Goel V, Winskill P, Slater HC, et al. False-negative malaria rapid diagnostic test results and their impact on community-based malaria surveys in sub-Saharan Africa. BMJ Glob Heal [Internet]. 2019; 4 (e001582): 1–9. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6666813/pdf/bmjgh-2019-001582.pdf. |
| [10] | Simon IN, Malau MB, David MY, Emile NJ. Performance of Four Malaria Rapid Diagnostic Tests (RDTs) in the Diagnosis of Malaria in North Central Nigeria. Int J Infect Dis Ther [Internet]. 2020; 5 (4): 106–11. Available from: http: //www.sciencepublishinggroup.com/journal/paperinfo?journalid=280&doi=10.11648/j.ijidt.20200504.11. |
| [11] | Nwajei AI, Centre FM. Sensitivity and specificity of malaria rapid diagnostic test (mRDT CareStat TM) compared with microscopy amongst under five children attending a primary care clinic in southern Nigeria. African J Prim Heal Care Fam Med [Internet]. 2020; Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7380062/pdf/PHCFM-12-2212.pdf. |
| [12] | Abdulkadir I, Rufai HA, Ochapa SO, Malam MS, Garba BI. Malaria rapid diagnostic test in children: The Zamfara, Nigeria experience. Niger Med J [Internet]. 2015; 56 (4): 278–82. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697217/. |
| [13] | Bah MS. The Relationship Between Malaria Status in Under-five Children and Some Household Demographic, Socioeconomic and Environmental Factors Associated with the Disease in Sierra Leone [Internet]. Georgia State University; 2020. Available from: https://core.ac.uk/download/pdf/322920575.pdf. |
| [14] | Edem EN, Mbong EO, Hussain S. Accuracy of Malaria Diagnosis by RDT using Microscopy as gold standard amongst Pregnant Women Attending Antenatal Clinic in Eket. Rem Publ LLC [Internet]. 2020; 2 (1): 1–4. Available from: https://www.longdom.org/open-access/accuracy-of-malaria-diagnosis-by-microscopy-and-rdt-methods-amongst-pregnant-women-attending-antenatal-clinic-in-eket.pdf. |
| [15] | Jegede FE. Evaluation of standard diagnostic rapid test kits for malaria diagnosis among HIV patients in Kano, Nigeria. Afr J Lab Med [Internet]. 2018; 7 (1): 1–8. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6295795/pdf/AJLM-7-698.pdf. |
| [16] | Ilesanmi RI, Olalubi OA, Adetunde OT, Ilesanmi AO, Effedua H, Amoo AO. Comparative assessment of malaria rapid diagnostic tests (RDT) in Ibadan, Nigeria. MalariaWorld J [Internet]. 2017; 8 (17): 1–7. Available from: https://malariaworld.org/sites/default/files/mwjournal/article/MWJ2017_8_17.pdf. |
| [17] | Mbabazi P, Hopkins H, Osilo E, Kalungu M, Byakika-kibwika P, Kamya MR. Accuracy of Two Malaria Rapid Diagnostic Tests (RDTS) for Initial Diagnosis and Treatment Monitoring in a High Transmission Setting in Uganda. Am Soc Trop Med Hyg Accuracy [Internet]. 2015; 92 (3): 530–6. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4350543/pdf/tropmed-92-530.pdf. |
| [18] | Ishengoma DS, Francis F, Mmbando BP, Lusingu JPA, Magistrado P, Alifrangis M, et al. Accuracy of malaria rapid diagnostic tests in community studies and their impact on treatment of malaria in an area with declining malaria burden in north-eastern Tanzania. Malar J [Internet]. 2011; 10 (176): 1–13. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3145609/pdf/1475-2875-10-176.pdf. |
| [19] | Dalrymple U, Arambepola R, Gething PW, Cameron E. How long do rapid diagnostic tests remain positive after anti - malarial treatment? Malar J [Internet]. 2018; 17 (228): 1–14. Available from: https://doi.org/10.1186/s12936-018-2371-9. |
| [20] | Zimmerman PA, Howes RE. Malaria diagnosis for malaria elimination. Curr Opin Infect Dis [Internet]. 2015; 28 (5): 446–54. Available from: https://journals.lww.com/co-infectiousdiseases/Fulltext/2015/10000/Malaria_diagnosis_for_malaria_elimination.7.aspx. |
| [21] | Albertini A, Lee E, Coulibaly SO, Sleshi M, Faye B, Mationg ML, et al. Malaria rapid diagnostic test transport and storage conditions in Burkina Faso, Senegal, Ethiopia and the Philippines. Malar J [Internet]. 2012; 11 (406): 1–9. Available from: https://malariajournal.biomedcentral.com/track/pdf/10.1186/1475-2875-11-406.pdf. |
| [22] | Misbah G, Habtu M, Mochama M, Kansiime C, Asiimwe B. Factors Associated with Malaria Test Preference among Households in Rubavu District, Rwanda: A Cross-sectional Study. J Med Diagnostic Methods [Internet]. 2017; 6 (4): 6–11. Available from: https://www.longdom.org/open-access/factors-associated-with-malaria-test-preference-among-households-inrubavu-district-rwanda-a-crosssectional-study-2168-9784-1000261.pdf. |
| [23] | Habimana A, Harerimana A, Asingizwe D, Nyandwi T, Njunwa KJ. Community Health Workers ’ Knowledge, Attitudes and Practices about Malaria Prevention in Gicumbi District, Rwanda. Rwanda J Med Heal Sci [Internet]. 2016; 3 (1): 27–35. Available from: https://www.ajol.info/index.php/rj/article/view/147018. |
| [24] | Niyibizi JB, Gatera EK. Diagnostic Performance between Histidine-Rich Protein 2 (HRP-2), a Rapid Malaria Diagnostic Test and Microscopic-Based Staining Techniques for Diagnosis of Malaria. J Trop Med [Internet]. 2020; 2020: 2–7. Available from: https://downloads.hindawi.com/journals/jtm/2020/5410263.pdf. |
| [25] | Ilombe G, Maketa V, Mavoko HM, Inocêncio R, Lutumba P. Performance of HRP2-based rapid test in children attending the health centre compared to asymptomatic children in the community. 2013; 13 (308): 1–8. |
| [26] | UNIVERSITY OF FLORIDA. Using Published Tables Using Formulas To Calculate A Sample Size Using A Census For Small Populations. In: Determining Sample Size [Internet]. p. 1–5. Available from: https://www.tarleton.edu/academicassessment/documents/samplesize.pdf. |
| [27] | World Health Organization. MALARIA MICROSCOPY Quality Assurance Manual. Version 2 [Internet]. Geneva, Switzerland; 2016. Available from: https://www.who.int/docs/default-source/documents/publications/gmp/malaria-microscopy-quality-assurance-manual.pdf?sfvrsn=dfe54d47_2. |
| [28] | World Health Organization. Malaria parasite counting [Internet]. 2016. Available from: https://www.who.int/publications/i/item/HTM-GMP-MM-SOP-09. |
| [29] | Edem EN, Mbong EO, Hussain S. Accuracy of Malaria Diagnosis by RDT using Microscopy as gold standard amongst Pregnant Women Attending Antenatal Clinic in Eket. Ann Clin Immunol Microbiol. 2020; 2 (1): 1–4. |
| [30] | Vyankatesh T. Anchinmane RTS. A Review of Malaria Diagnostic Tools: Microscopy and Rapid Diagnostic Test. ASIAN J Med Sci [Internet]. 2010; 2: 75–9. Available from: https://www.researchgate.net/publication/273266189_A_Review_of_Malaria_Diagnostic_Tools_Microscopy_and_Rapid_Diagnostic_Test/link/5ef1219d299bf1faac6f1f86/download. |
| [31] | Bisoffi Z, Gobbi F, Van Den Ende J. Rapid diagnostic tests for malaria. Am Soc Microbiol. 2014; 348 (1): 66–78. |
| [32] | Acquah FK, Donu D, Obboh EK, Bredu D, Mawuli B, Amponsah JA, et al. Diagnostic performance of an ultrasensitive HRP2 - based malaria rapid diagnostic test kit used in surveys of afebrile people living in Southern Ghana. Malar J [Internet]. 2021; 20 (125): 1–11. Available from: https://doi.org/10.1186/s12936-021-03665-7. |
| [33] | Medina AC, Tobo A, Posada M, Campillo A, Gonza IJ, Ding X. Performance of a highly sensitive rapid diagnostic test (HS-RDT) for detecting malaria in peripheral and placental blood samples from pregnant women in Colombia. PLoS One. 2018; 13 (8): 1–14. |
| [34] | Boyce MR, Menya D, Turner EL, Laktabai J, Meara WPO. Evaluation of malaria rapid diagnostic test (RDT) use by community health workers: a longitudinal study in western Kenya. Malar J [Internet]. 2018; 17 (206): 1–11. Available from: https://doi.org/10.1186/s12936-018-2358-6. |
| [35] | Rennie W, Phetsouvanh R, Lupisan S, Vanisaveth V, Hongvanthong B, Phompida S, et al. Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. Trans R Soc Trop Med Hyg. 2007 Jan; 101 (1): 9–18. |
| [36] | Kiemde F, Tahita MC, Bonko A, Mens PF, Tinto H, Hensbroek MB Van, et al. Implementation of a malaria rapid diagnostic test in a rural setting of Nanoro, Burkina Faso: from expectation to reality. Malar J [Internet]. 2018; 1–7. Available from: https://doi.org/10.1186/s12936-018-2468-1. |
| [37] | Lee J, Jang W, Cho H, Kim Y, Han T, Yun G, et al. False-Positive Results for Rapid Diagnostic Tests for Malaria in Patients with Rheumatoid Factor. J Clin Microbiol [Internet]. 2014; 52 (10): 3784–7. Available from: https://www.ghdonline.org/uploads/FP_RDT_zjm3784.pdf. |
APA Style
Metuschelah Habimana, Vedaste Ndahindwa, Stella Matutina Umuhoza, Jared Omolo, Schifra Uwamungu, et al. (2022). Quality Assurance Assessment for Malaria Rapid Diagnostic Test in Ngoma District, Eastern Province of Rwanda: A Cross-sectional Prospective Study. Central African Journal of Public Health, 8(1), 6-12. https://doi.org/10.11648/j.cajph.20220801.12
ACS Style
Metuschelah Habimana; Vedaste Ndahindwa; Stella Matutina Umuhoza; Jared Omolo; Schifra Uwamungu, et al. Quality Assurance Assessment for Malaria Rapid Diagnostic Test in Ngoma District, Eastern Province of Rwanda: A Cross-sectional Prospective Study. Cent. Afr. J. Public Health 2022, 8(1), 6-12. doi: 10.11648/j.cajph.20220801.12
AMA Style
Metuschelah Habimana, Vedaste Ndahindwa, Stella Matutina Umuhoza, Jared Omolo, Schifra Uwamungu, et al. Quality Assurance Assessment for Malaria Rapid Diagnostic Test in Ngoma District, Eastern Province of Rwanda: A Cross-sectional Prospective Study. Cent Afr J Public Health. 2022;8(1):6-12. doi: 10.11648/j.cajph.20220801.12
Share This Article
Twitter
Linked In
Facebook
Copy
Download@article{10.11648/j.cajph.20220801.12,
author = {Metuschelah Habimana and Vedaste Ndahindwa and Stella Matutina Umuhoza and Jared Omolo and Schifra Uwamungu and Naomi Wangui Lucchi and James Humuza},
title = {Quality Assurance Assessment for Malaria Rapid Diagnostic Test in Ngoma District, Eastern Province of Rwanda: A Cross-sectional Prospective Study},
journal = {Central African Journal of Public Health},
volume = {8},
number = {1},
pages = {6-12},
doi = {10.11648/j.cajph.20220801.12},
url = {https://doi.org/10.11648/j.cajph.20220801.12},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.cajph.20220801.12},
abstract = {Currently, malaria rapid diagnostic tests (mRDTs) are increasingly used for the diagnosis of malaria, particularly in communities where microscopy-based diagnosis is not practical. However, the diagnostic accuracy of mRDTs performed by community health workers (CHWs) remains unknown. This study was conducted to determine the accuracy of mRDT results performed by CHWs in Ngoma district, eastern province of Rwanda. This was a cross sectional prospective study. A total of 420 blood samples of patients self-reported to CHWs for malaria diagnosis were collected and analyzed by CHWs using mRDT, and quality control tests were performed by using microscopy as a reference test. The study was conducted from 22 April to 08 July 2021. Among the 420 patients, 234 (55.71%) were females, and 186 (44.29%) were males. Malaria test positivity was 2.62% by using mRDT and 1.67% by using microscopic tests. The sensitivity and specificity of mRDT were 85.71% and 98.78%, respectively. The negative predictive value, positive predictive value and accuracy of mRDTs were 99.75%, 54.54% and 98.57%, respectively. The sensitivity of mRDT was below the WHO recommended sensitivity (>95%), although the specificity (98.78%) was within the WHO recommended specificity (>=90). There was substantial agreement between the mRDT and malaria microscopic test results, k=0.642. mRDTs continue to be an appropriate choice for malaria diagnosis in the absence of microscopy.},
year = {2022}
}
TY - JOUR T1 - Quality Assurance Assessment for Malaria Rapid Diagnostic Test in Ngoma District, Eastern Province of Rwanda: A Cross-sectional Prospective Study AU - Metuschelah Habimana AU - Vedaste Ndahindwa AU - Stella Matutina Umuhoza AU - Jared Omolo AU - Schifra Uwamungu AU - Naomi Wangui Lucchi AU - James Humuza Y1 - 2022/02/25 PY - 2022 N1 - https://doi.org/10.11648/j.cajph.20220801.12 DO - 10.11648/j.cajph.20220801.12 T2 - Central African Journal of Public Health JF - Central African Journal of Public Health JO - Central African Journal of Public Health SP - 6 EP - 12 PB - Science Publishing Group SN - 2575-5781 UR - https://doi.org/10.11648/j.cajph.20220801.12 AB - Currently, malaria rapid diagnostic tests (mRDTs) are increasingly used for the diagnosis of malaria, particularly in communities where microscopy-based diagnosis is not practical. However, the diagnostic accuracy of mRDTs performed by community health workers (CHWs) remains unknown. This study was conducted to determine the accuracy of mRDT results performed by CHWs in Ngoma district, eastern province of Rwanda. This was a cross sectional prospective study. A total of 420 blood samples of patients self-reported to CHWs for malaria diagnosis were collected and analyzed by CHWs using mRDT, and quality control tests were performed by using microscopy as a reference test. The study was conducted from 22 April to 08 July 2021. Among the 420 patients, 234 (55.71%) were females, and 186 (44.29%) were males. Malaria test positivity was 2.62% by using mRDT and 1.67% by using microscopic tests. The sensitivity and specificity of mRDT were 85.71% and 98.78%, respectively. The negative predictive value, positive predictive value and accuracy of mRDTs were 99.75%, 54.54% and 98.57%, respectively. The sensitivity of mRDT was below the WHO recommended sensitivity (>95%), although the specificity (98.78%) was within the WHO recommended specificity (>=90). There was substantial agreement between the mRDT and malaria microscopic test results, k=0.642. mRDTs continue to be an appropriate choice for malaria diagnosis in the absence of microscopy. VL - 8 IS - 1 ER -
Email: