Performance of First Response® and CareStart™ Malaria Rapid Diagnostic Tests for the Detection of Plasmodium falciparum in a Tertiary Hospital in Ghana

Abstract

Background: Malaria poses a major public health problem in sub-Saharan Africa. In Ghana, millions of people are potentially at risk of Plasmodium falciparum infections annually. The current study evaluated the performance of two Histidine rich protein 2 (HRP-2) rapid diagnostic tests (First Response® and CareStart™) using giemsa stained microscopy (microscopy) as the gold standard. This cross-sectional study which took place at the Komfo (KATH) in Kumasi from October 2014 to March, 2015 was done to monitor the performance of RDTs that are used regularly in Ghana. Methodology: A total of 400 children (239 males, 161 females; age range 1-17 years) with fever or history suggestive of malaria were included in the study. First Response® and CareStart™ diagnostic accuracy results were compared with that of microscopy. The strength of agreements (kappa) between the microscopy and the two RDTs were also calculated. Results: Of the 400 blood films that were examined using microscopy, Plasmodium parasites were detected in 33 (8.3%) of them. First Response® showed positive results in 65 (16.3%) and CareStart™ showed positive results in 68 (17.0%). The sensitivities of both First Response® and CareStart™ when compared with microscopy were 97.0% (95% CI: 84.2-99.9) and 97.0% (95% CI: 84.2-99.9) respectively. The specificities were First Response® 91.0% (95% CI: 87.6-93.7) and CareStart™ 90.2% (95% CI: 86.7-93.0). The strength of agreement (kappa) between microscopy and First Response® and CareStart™ with 95% confidence interval was good for the First Response® (giemsa stain microscopy vs First Response®: 0.61) and moderate for CareStart™ (giemsa stain microscopy vs CareStart™: 0.59). Conclusion: The diagnostic accuracy of the First Response® and CareStart™ RDTs to detect malaria was good with no significant differences between the two rapid test kits when compared with microscopy. The RDTs are a suitable alternative to microscopy to test for malaria in rural areas. Therapy (ACT), Special Program for Research and Training in Tropical Disease (TDR), Foundation for Innovative New Diagnostics (FIND), and the Centre for Disease Control and Prevention (CDC), Paediatric Emergency Unit (PEU), Komfo Anokye Teaching Hospital (KATH), Accident and Emergency (A&E), Ethylenediaminetetraacetic acid (EDTA), Complete Blood Count (CBC), High power fields (HPF), White blood cells (WBCs), Red blood cells (RBCs), Positive predictive value (PPV), Negative predictive value (NPV), Plasmodium lactate dehydrogenase (pLDH), Plasmodium aldolase (pAldo), Polymerase chain reaction (PCR).