Bayesian evaluation of the performance of three diagnostic tests for Plasmodium falciparum infection in a low-transmission setting in Kilifi County, Kenya

Abstract

Background: Central to the successful elimination of Plasmodium falciparum malaria, are tests with superior capability of diagnosing low-density parasitaemias. Empirical evidence on the performance of the commonly available diagnostics (light microscopy (LM), rapid diagnostic tests (RDT) and polymerase chain reaction (PCR)) is needed to better inform case management and surveillance activities within primary health care settings where elimination of falciparum malaria is targeted. The objective of this study was to estimate the sensitivity (Se) and specificity (Sp) and predictive values of LM, RDT and PCR tests for P. falciparum infection in children, while evaluating the effect of specific covariates on the accuracy of the tests. Methods: The study enrolled 1,563 children presenting with fever (axillary temperature ≥ 37.50C) to the Ngerenya dispensary, Kilifi County between March and December 2014. A Bayesian latent class model (BLCM) was fitted to the participants’ diagnostic data obtained from blood samples that were screened for the presence of P. falciparum using the three tests. Results: The PCR assay registered a higher Se (97.6% [92.0; 99.7]) than LM (84.0% [74.8; 91.0]) but similar to RDT (92.2% [84.4; 97.0]). However, the assay showed a similar Sp (98.9% [98.2; 99.4]) to both RDT (99.4% [98.9; 99.7]) and LM (99.5% [99.0; 99.8]). Regarding predictive values, the tests yielded statistically similar estimates of positive and negative predictive values (PPV and NPV). A serial interpretation of the results of RDT and LM raised the PPVs and NPVs to >98%. Conclusions: LM and RDT afford high Se and Sp in a low P. falciparum prevalence setting. A serial combination of the tests assures high PPV and NPV estimates. These elements, coupled with the wide deployment and affordability of the tests, lend the tests useful for guiding clinical care and surveillance activities for P. falciparum within elimination settings.