Performance comparison of CareStart™ HRP2/pLDH combo rapid malaria test with light microscopy in north-western Tigray, Ethiopia: a cross-sectional study

Background: Rapid diagnostic tests (RDTs) are alternative methods for microscopy in the diagnosis of malaria in resource limited settings. Among commercially available RDTs, CareStart (TM) Malaria test was found to show reliable results. This study evaluated the performance of CareStartp (TM) Malaria Combo test kit in Northwestern Tigray in Ethiopia. Methods: Blood samples were collected from 320 malaria-suspected patients at Mayani Hospital in Northwestern Tigray from December 2015 to March 2016. All blood samples were examined using both light microscopy and CareStart (TM) Malaria HRP2/pLDH Combo Test kit. Statistical analyses were performed using SPSS version 20. Results: The overall parasite positivity using light microscopy and CareStart (TM) RDT was 41 (12.8%) and 43 (13.4%), respectively. The sensitivity and specificity of CareStart (TM) RDT, regardless of species, were found to be 95.4 and 99.3%, respectively. Furthermore, the sensitivity of CareStart (TM) RDT for Plasmodium falciparum or mixed infection and non-falciparum malaria parasites was 94.4 and 85.0%, respectively while the specificity was found to be 98.9 and 99.7%, respectively. The agreement between the two test methods was "excellent" with a kappa value of 0.92. Conclusion: CareStart (TM) RDT has very good sensitivity and specificity for malaria diagnosis. The test kit also has an excellent agreement with light microscopy. It is therefore useful in resource-limited areas where microscopy is not available.