Abstract

Introduction: Several rapid diagnostic tools for malaria are currently available in local markets. However, diagnostic accuracy varies widely. The present study was conducted to evaluate a cheaply and easily available rapid diagnostic malaria test (ParaHIT-f) in rural Tanzania.

Methodology: Participants presenting with fever at health centers in the Kilimanjaro and Manyara regions were eligible. Parasitological thin and thick smears were examined from finger-prick blood samples and compared to ParaHIT-f test results. Sensitivity, specificity and predictive values were calculated using microscopic parasitological examination as the gold standard.

Results: In total, 236/743 (31.8%) individuals had a positive malaria microscopy, and 25/715 (3.4%) were positive in the rapid diagnostic test. The sensitivity of ParaHIT-f was 10.7% (95% CI, 6.7-14.7) and specificity was 100% (95% CI, 97.4-102), with positive and negative predictive values (PPV and NPV) of 100% (95% CI, 99.1-100.2) and 70.9% (95% CI, 66.9-74.9) respectively. Sensitivity of ParaHIT-f increased with increasing P. falciparum density (P > 0.003) from 5.8% (95% CI, 0-12.9) at < 100 parasites/μl to 20.5% (95% CI, 13.5-27) at ≥ 100 parasites/μl.

Conclusions: Sensitivity of the ParaHIT-f rapid test was very low in this setting, therefore concomitant use of rapid diagnostic tests and microscopy is recommended. In the case of positive test results, confirmation by parasitological techniques is not necessary. Further monitoring of ParaHIT-f in various epidemiological settings in Tanzania is warranted.