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富含组氨酸蛋白2(HRP-2)这种快速疟疾诊断检测方法与基于显微镜的染色技术在疟疾诊断中的诊断性能比较。

Diagnostic Performance between Histidine-Rich Protein 2 (HRP-2), a Rapid Malaria Diagnostic Test and Microscopic-Based Staining Techniques for Diagnosis of Malaria.

作者信息

Niyibizi Jean Baptiste, Gatera Emmanuel Kamana

机构信息

Department of Medical Laboratory Sciences, Mount Kenya University, Kigali Campus, Kigali, Rwanda.

University of Global Health Equity, Basic Medical Sciences, Butaro-Kigali, Kigali, Rwanda.

出版信息

J Trop Med. 2020 Mar 27;2020:5410263. doi: 10.1155/2020/5410263. eCollection 2020.

DOI:10.1155/2020/5410263
PMID:32280351
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7140128/
Abstract

Malaria presents a diagnostic challenge in most tropical countries such as Rwanda. Microscopy remains the gold standard for diagnosing malaria, but it is labor intensive and depends upon the skill of the examiner. Malaria rapid diagnostic tests (RDTs) have been developed as an easy, convenient alternative to microscopy. This cross-sectional study was conducted at Rukara Health Center which is located in Eastern Province, Kayonza district, Rwanda. One hundred and fifty suspected cases of malaria, who attended Rukara Health Centre, during the period, from 21 June to 30th July 2018, were included in this study. HRP-2 RDTs (CareStart™ Malaria HRP-2 (Access Bio, Inc., Somerset, New Jersey, USA)), for malaria were performed. Thick smears were prepared and Giemsa-stained as recommended; then slides were observed under microscopy and reported quantitatively; RDTs were reported qualitatively (positive or negative). Both RDTs and thick smear results were recorded on data collection sheet. This study included a total of 150 study participants, 87 (58%) females and 63 (42%) males. The patients included in the study did not receive any antimalarial drug. The mean age of the study participants was 31.6 ± 12.4 with the majority of participants being between 25 and 44 years and the minority being above 65 years. The sensitivity of RDT (HRP-2) was calculated and found to be 95.0%, whereas the sensitivity of Giemsa microscopy was 100%. The specificity of RDT (HRP-2) was calculated and found to be 59.2%, whereas the specificity of Giemsa microscopy was 100%. Negative and positive predictive values of RDT are 85.4% and 82.7%, respectively. Negative and positive predictive values of Giemsa microscopy were both 100%. According to the results of the current study, the sensitivity, specificity, and both positive and negative predictive values of Giemsa microscopy are higher than those of histidine-rich protein 2-based rapid diagnostic test for malaria. The results obtained in histidine-rich protein 2-based rapid diagnostic test for malaria parasites should be confirmed with tests with high specificity. Further studies should determine the most appropriate type of rapid diagnostic test of malaria diagnosis to be used in combination with Giemsa microscopy. In addition, sensitivity and specificity of RDT (HRP-2) and Giemsa microscopy should be assessed against molecular biology techniques.

摘要

在卢旺达等大多数热带国家,疟疾的诊断颇具挑战。显微镜检查仍是疟疾诊断的金标准,但它劳动强度大且依赖检查人员的技能。疟疾快速诊断检测(RDTs)已被开发出来,作为一种比显微镜检查更简便、便捷的替代方法。这项横断面研究在位于卢旺达基扬扎区东部省的鲁卡拉健康中心开展。本研究纳入了2018年6月21日至7月30日期间到鲁卡拉健康中心就诊的150例疑似疟疾病例。采用了用于疟疾诊断的HRP - 2 RDTs(CareStart™ Malaria HRP - 2(美国新泽西州萨默塞特的Access Bio公司))。按照推荐方法制备厚涂片并进行吉姆萨染色;然后在显微镜下观察玻片并进行定量报告;RDTs进行定性报告(阳性或阴性)。RDTs和厚涂片结果均记录在数据收集表上。本研究共纳入150名研究参与者,其中87名(58%)为女性,63名(42%)为男性。纳入研究的患者未接受任何抗疟药物治疗。研究参与者的平均年龄为31.6±12.4岁,大多数参与者年龄在25至44岁之间,少数年龄在65岁以上。计算得出RDT(HRP - 2)的敏感性为95.0%,而吉姆萨显微镜检查的敏感性为100%。计算得出RDT(HRP - 2)的特异性为59.2%,而吉姆萨显微镜检查的特异性为100%。RDT的阴性和阳性预测值分别为85.4%和82.7%。吉姆萨显微镜检查的阴性和阳性预测值均为100%。根据本研究结果,吉姆萨显微镜检查的敏感性、特异性以及阴性和阳性预测值均高于基于富含组氨酸蛋白2的疟疾快速诊断检测。基于富含组氨酸蛋白2的疟原虫快速诊断检测所获得的结果应以高特异性检测进行确认。进一步的研究应确定与吉姆萨显微镜检查联合使用的最合适的疟疾诊断快速诊断检测类型。此外,应针对分子生物学技术评估RDT(HRP - 2)和吉姆萨显微镜检查的敏感性和特异性。

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