Exactitude diagnostique de deux tests rapides du paludisme par rapport à la PCR à Kinshasa : profils cliniques et implications pour l’assurance qualité des laboratoires
DOI:
https://doi.org/10.59228/rcst.026.v5.i4.351Keywords:
Point-of-care testing, molecular reference method, diagnostic accuracy, quality assurance, febrile illnessAbstract
Malaria remains a major public health concern in the Democratic Republic of the Congo, where rapid diagnostic tests are widely used
in routine care. Their value depends not only on the test itself, but also on the conditions in which it is stored, performed and interpreted.
This study compared an Abbott malaria rapid diagnostic test (RTDR1NX) with the routine rapid diagnostic test (RTDR2) used in
selected healthcare facilities in Kinshasa, using polymerase chain reaction (PCR) as the analytical reference. We analysed data from
498 patients with suspected malaria who were enrolled in the Bandalungwa and Kasa-Vubu health zones between April 2022 and
September 2023. The analysis examined test positivity, associations with age, sex and axillary temperature, and diagnostic performance
based on sensitivity, specificity, predictive values and kappa agreement. PCR was positive in 57.0% of participants, compared with
34.9% for RTDR1NX and 25.9% for RTDR2. RTDR2 positivity was associated with sex and axillary temperature, whereas RTDR1NX
positivity was associated with temperature. PCR positivity was not associated with age, sex or temperature. RTDR1NX showed a
sensitivity of 38.7% and a specificity of 70.1%, while RTDR2 showed a sensitivity of 28.9% and a specificity of 78.0%. Agreement
with PCR was poor for both tests (κ = 0.08 and 0.06). RTDR1NX identified more PCR-positive cases than RTDR2, but with lower
specificity. Both rapid tests missed a substantial proportion of PCR-positive participants. These findings highlight the need to verify
RDT performance locally and to pay close attention to quality assurance, storage, test handling, staff competency and confirmatory
testing when clinically appropriate.
Downloads
References
Albertini, A., Lee, E., Coulibaly, S. O., Sleshi, M., Faye,
B., Mationg, M. L., Ouedraogo, K., Tsadik, A. G.,
Feleke, S. M., Diallo, I., Gaye, O., Luchavez, J.,
Bennett, J., & Bell, D. (2012). Malaria rapid
diagnostic test transport and storage conditions in
Burkina Faso, Senegal, Ethiopia and the Philippines.
Malaria Journal, 11, 406.
https://doi.org/10.1186/1475-2875-11-406
François, R., Mwandagalirwa Kashamuka, M., Banek, K.,
Bala, J. A., Nkalani, M., Kihuma, G., Atibu, J.,
Mahilu, G. E., Thwai, K. L., Assefa, A., Bailey, J. A.,
Dinglasan, R. R., Juliano, J. J., Tshefu, A. K., & Parr,
J. B. (2023). Plasmodium falciparum with pfhrp2/3
deletion not detected in a 2018–2021 malaria
longitudinal cohort study in Kinshasa Province,
Democratic Republic of the Congo. American Journal
of Tropical Medicine and Hygiene, 109(2), 273–276.
https://doi.org/10.4269/ajtmh.22-0715
François-Zafka, R., Westreich, D., Banek, K.,
Mwandagalirwa Kashamuka, M., White, S. J., Bala, J.
A., Nkalani, M., Kihuma, G., Atibu, J., Mahilu, G. E.,
Thwai, K. L., Kokolomami, J., Emch, M., Edwards, J.,
Juliano, J. J., Tshefu, A., & Parr, J. B. (2026).
Challenges in malaria diagnosis and treatment in
Kinshasa Province, Democratic Republic of the
Congo. Clinical Infectious Diseases, 83(1), e196–
e205. https://doi.org/10.1093/cid/ciag262
Ilombe, G., Maketa, V., Mavoko, H. M., da Luz, R. I.,
Lutumba, P., & Van Geertruyden, J.-P. (2014).
Performance of HRP2-based rapid test in children
attending the health centre compared to asymptomatic
children in the community. Malaria Journal, 13, 308.
https://doi.org/10.1186/1475-2875-13-308
Kabalu Tshiongo, J., Luzolo, F., Kabena, M., Kuseke, L.,
Djimde, M., Mitashi, P., Lumbala, C., Kayentao, K.,
Menting, S., Mens, P. F., Schallig, H. D. F. H.,
Lutumba, P., Tinto, H., Mavoko, H. M., & Maketa, V.
(2023). Performance of ultra-sensitive malaria rapid
diagnostic test to detect Plasmodium falciparum
infection in pregnant women in Kinshasa, the
Democratic Republic of the Congo. Malaria Journal,
22, 322. https://doi.org/10.1186/s12936-023-04749-2
Linsuke, S., Nabazungu, G., Ilombe, G., Ahuka, S.,
Muyembe, J.-J., & Lutumba, P. (2020). Medical
laboratories and quality of care: The most neglected
components of rural hospitals in the Democratic
Republic of the Congo. Pan African Medical Journal,
35, 22.
https://doi.org/10.11604/pamj.2020.35.22.18755
Muhindo, H. M., Ilombe, G., Meya, R., Mitashi, P. M.,
Kutekemeni, A., Gasigwa, D., Lutumba, P., & Van
Geertruyden, J.-P. (2012). Accuracy of malaria rapid
diagnosis test Optimal-IT® in Kinshasa, the
Democratic Republic of Congo. Malaria Journal, 11,
224. https://doi.org/10.1186/1475-2875-11-224
Mukadi, P., Gillet, P., Lukuka, A., Mbatchi, J.,
Otshudiema, J., Muyembe, J.-J., Buyze, J., Jacobs, J.,
& Lejon, V. (2013). External quality assessment of
reading and interpretation of malaria rapid diagnostic
tests among 1849 end-users in the Democratic
Republic of the Congo through Short Message Service
(SMS). PLOS ONE, 8(8), e71442.
https://doi.org/10.1371/journal.pone.0071442
Mukadi, P., Gillet, P., Barbé, B., Luamba, J., Lukuka, A.,
Likwela, J., Mumba, D., Muyembe, J.-J., Lutumba, P.,
& Jacobs, J. (2015). SMS photograph-based external
quality assessment of reading and interpretation of
malaria rapid diagnostic tests in the Democratic
Republic of the Congo. Malaria Journal, 14, 26.
https://doi.org/10.1186/s12936-014-0535-9
Mukadi-Kaningu, P., Muele, F. K., Tshimanga, N.,
Unandu, J., Mbamba, B. M., & Sompwe, E. M. (2024).
Unravelling the quality of malaria microscopy across Kinshasa, DR Congo. MalariaWorld Journal, 15, 2.
https://doi.org/10.5281/zenodo.10630995
Murray, C. K., Gasser, R. A., Jr., Magill, A. J., & Miller,
R. S. (2008). Update on rapid diagnostic testing for
malaria. Clinical Microbiology Reviews, 21(1), 97–
110. https://doi.org/10.1128/CMR.00035-07
Parr, J. B., Verity, R., Doctor, S. M., Janko, M., CareyEwend, K., Turman, B. J., Keeler, C., Slater, H. C.,
Whitesell, A. N., Mwandagalirwa, M. K., Ghani, A.
C., Likwela, J. L., Tshefu, A. K., Emch, M., Meshnick,
S. R., & Juliano, J. J. (2017). Pfhrp2-deleted
Plasmodium falciparum parasites in the Democratic
Republic of the Congo: A national cross-sectional
survey. Journal of Infectious Diseases, 216(1), 36–44.
https://doi.org/10.1093/infdis/jiw538
Sugg, K. N., Mpata, F. W., Humes, M. D., Aliango
Marachto, D., Rajan, R., & Winch, P. J. (2026).
Positive tests are all alike, every negative test is
negative in its own way: Lack of confidence in
negative malaria rapid diagnostic tests in the
Democratic Republic of the Congo. Malaria Journal,
25, 133. https://doi.org/10.1186/s12936-026-05802-6
World Health Organization. (2011). Laboratory quality
management system: Handbook.
https://www.who.int/publications/i/item/9789241548
274
World Health Organization. (2022). Quality and safety
practices for malaria rapid testing services.
https://www.who.int/publications/i/item/9789240058
972
World Health Organization. (2023). Methods manual for
laboratory quality control testing of malaria rapid
diagnostic tests (Version 10).
World Health Organization. (2025). WHO guidelines for
malaria.
https://www.who.int/publications/i/item/guidelinesfor-malaria
World Health Organization. (2026). Malaria 2025
Democratic Republic of the Congo country profile.
https://www.who.int/publications/m/item/malaria2025-democratic-republic-of-the-congo-country-profile
Downloads
Published
Issue
Section
License
Copyright (c) 2026 Makuala et al.
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
