Abstract
BackgroundThe performance of different malaria rapid diagnostic tests (RDT) may be influenced by transmission intensity and by the length of time each test requires to become negative after treatment and patient’s recovery.MethodsResults of three RDTs (two HRP2 and one pLDH antigen-based tests) were compared to blood smear microscopy (the gold standard method) in children under 5 years of age living in a high versus low malaria intensity setting in southwestern Uganda. In each setting, 212 children, who tested positive by at least one RDT and by microscopy, were treated with artemether-lumefantrine. RDTs and microscopy were then repeated at fixed intervals to estimate each test’s time to negativity after treatment and patient recovery.ResultsIn the two settings, sensitivities ranged from 98.4 to 99.2 % for the HRP2 tests and 94.7 to 96.1 % for the pLDH test. Specificities were 98.9 and 98.8 % for the HRP2 tests and 99.7 % for the pLDH test in the low-transmission setting and 79.7, 80.7 and 93.9 %, respectively, in the high-transmission setting. Median time to become negative was 35–42 or more days for the HRP2 tests and 2 days for the pLDH test.ConclusionsHigh transmission contexts and a long time to become negative resulted in considerably reduced specificities for the HRP2 tests. Choice of RDT for low- versus high-transmission settings should balance risks and benefits of over-treatment versus missing malaria cases. Trial registration: Registry number at ClinicalTrial.gov: NCT01325974Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-016-1529-6) contains supplementary material, which is available to authorized users.
Highlights
The performance of different malaria rapid diagnostic tests (RDT) may be influenced by transmission intensity and by the length of time each test requires to become negative after treatment and patient’s recovery
Most malaria RDTs are designed to detect a single parasite antigen, the histidine-rich protein 2 (HRP2) or the Plasmodium lactate dehydrogenase, while others are designed to detect both antigens in a single test
A total of 4977 and 521 patients were admitted to the study in Mbarara and Kazo, respectively, of whom 4803 and 459 patients were included in the RDT performance analysis
Summary
The performance of different malaria rapid diagnostic tests (RDT) may be influenced by transmission intensity and by the length of time each test requires to become negative after treatment and patient’s recovery. WHO launched the Product Testing Programme, which evaluates performance of commercialized malaria RDTs against a standardized panel of laboratory-prepared specimens. This programme, which has already completed its fifth round of testing, allows for product comparisons, encourages producers to improve their tests and, in the long run, promotes product quality. WHO acknowledges that its results cannot predict test performance in the field, where other factors such as malaria antigen persistence in the blood and malaria endemicity can influence RDT performance [6].
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