Evaluation of CareStart™ Malaria HRP2/pLDH (Pf/pan) Combo Test in a malaria low transmission region of Senegal
Evaluation of CareStart™ Malaria HRP2/pLDH (Pf/pan) Combo Test in a malaria low transmission region of Senegal
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DOI：
10.1186/s12936-017-1980-z
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发表时间：
2017-08-10
期刊：
影响因子：
3
通讯作者：
Ndiaye, Daouda
中科院分区：
文献类型：
--
作者：
Diallo, Mamadou Alpha;Diongue, Khadim;Ndiaye, Daouda
背景：本研究缘于观察到塞内加尔疟疾低传播区用快速诊断试验（RDT） （CareStart （TM）疟疾HRP2/pLDH组合试验）获得的疟疾流行率高于显微镜检查。然后进行PCR以评估RDT在临床环境中与显微镜相比的性能。方法：选取达喀尔两个近郊地区215例疑似疟疾患者为研究对象。采用RDT （CareStart (TM) Malaria HRP2/pLDH组合检测）对手指采集的血样进行检测。采集静脉血进行光镜和PCR（金标准）检测。计算敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）作为性能特征。结果：以PCR为金标准，CareStart (TM) RDT检测具有较高的灵敏度（97.3%）和特异性（94.1%），PPV和NPV分别为97.3和94.1%，镜检的灵敏度和特异性分别为93.2和100%，PPV和NPV分别为100和87.2%。结论：疟疾CareStart (TM) RDT检测与显微镜相比具有更高的灵敏度，是疟疾诊断的金标准。即使在流行率较低的地区，CareStart RDT对疑似疟疾患者也是一种有用的工具。
Background: This study was initiated from the observation that prevalence of malaria obtained with rapid diagnostic test (RDT) (CareStart (TM) Malaria HRP2/pLDH Combo Test) was higher than in microscopy in a malaria low transmission area of Senegal. PCR was then performed to evaluate the performance of the RDT compared to microscopy in clinical settings.Methods: The study included 215 patients suspected of malaria in two peri-urban area of Dakar. Finger-pick blood samples were tested using RDT (CareStart (TM) Malaria HRP2/pLDH Combo Test). Venous blood samples were collected for light microscopy and PCR (gold standard). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated as performance characteristics.Results: Considering PCR as the gold standard, CareStart (TM) RDT showed high sensitivity (97.3%) and specificity (94.1%) with PPV and NPV of 97.3 and 94.1%, respectively, while microscopy had a sensitivity and specificity of 93.2 and 100%, respectively, and PPV and NPV of 100 and 87.2%, respectively.Conclusions: Malaria CareStart (TM) RDT test demonstrated a superior sensitivity compared to microscopy, which is the gold standard for malaria diagnosis. CareStart (TM) RDT could be a useful tool in individuals suspected of malaria even in areas where prevalence is low.