Feleke Daniel Getacher, Tarko Shambel, Hadush Haftom
Department of Biomedical Sciences, College of Health Sciences and Referral Hospital, Aksum University, Aksum, Ethiopia.
School of Nursing, College of Health Sciences and Referral Hospital, Aksum University, Aksum, Ethiopia.
BMC Infect Dis. 2017 Jun 6;17(1):399. doi: 10.1186/s12879-017-2503-9.
Rapid diagnostic tests (RDTs) are alternative methods for microscopy in the diagnosis of malaria in resource limited settings. Among commercially available RDTs, CareStart™ Malaria test was found to show reliable results. This study evaluated the performance of CareStart™ Malaria Combo test kit in Northwestern Tigray in Ethiopia.
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™ Malaria HRP2/pLDH Combo Test kit. Statistical analyses were performed using SPSS version 20.
The overall parasite positivity using light microscopy and CareStart™ RDT was 41 (12.8%) and 43 (13.4%), respectively. The sensitivity and specificity of CareStart™ RDT, regardless of species, were found to be 95.4 and 99.3%, respectively. Furthermore, the sensitivity of CareStart™ 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.
CareStart™ 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.
在资源有限的环境中，快速诊断测试（RDTs）是疟疾诊断中显微镜检查的替代方法。在市售的RDTs中，发现CareStart™疟疾检测显示出可靠的结果。本研究评估了CareStart™疟疾联合检测试剂盒在埃塞俄比亚提格雷西北部的性能。
2015年12月至2016年3月，在提格雷西北部的马亚尼医院从320名疑似疟疾患者中采集血样。所有血样均使用光学显微镜和CareStart™疟疾HRP2/pLDH联合检测试剂盒进行检测。使用SPSS 20版进行统计分析。
使用光学显微镜和CareStart™ RDT检测的总体寄生虫阳性率分别为41例（12.8%）和43例（13.4%）。发现CareStart™ RDT的敏感性和特异性，无论疟原虫种类如何，分别为95.4%和99.3%。此外，CareStart™ RDT对恶性疟原虫或混合感染以及非恶性疟原虫的敏感性分别为94.4%和85.0%，而特异性分别为98.9%和99.7%。两种检测方法之间的一致性“极佳”，kappa值为0.92。
CareStart™ RDT对疟疾诊断具有非常好的敏感性和特异性。该检测试剂盒与光学显微镜也具有极佳的一致性。因此，它在无法进行显微镜检查的资源有限地区很有用。
