Author(s) :

Florent Mupungu Makuala, Blaise Mbembo wa Mbembo, Koto-Te-Nyiwa Ngbolua.

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Abstract :

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.

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