三种基于组氨酸丰富蛋白-2 的快速诊断检测试剂、显微镜检查和 PCR 用于指导尼日利亚西南部伊巴丹疟疾治疗的比较评估

Comparative evaluation of three histidine-rich Protein-2 based rapid diagnostic tests, microscopy and PCR for guiding malaria treatment in Ibadan, Southwest Nigeria.

机构信息

Institute of Child Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.

Department of Pharmacology and Therapeutics, College of Medicine, University of Ibadan; Department of Pharmacy Technician Studies, Bayelsa State College of Health Technology, Ibadan, Nigeria.

出版信息

Niger J Clin Pract. 2021 Apr;24(4):496-504. doi: 10.4103/njcp.njcp_491_20.

DOI:10.4103/njcp.njcp_491_20

PMID:33851670

Abstract

BACKGROUND

Malaria rapid diagnostic tests (mRDTs) are the preferred option for programmatic deployment.

AIMS

There are numerous mRDTs on the Nigerian market and there is a need to guide practitioners on the relative performance of the commonly used brands of mRDT in Nigeria.

SUBJECTS AND METHODS

The performance of three commonly used Histidine-Rich-Protein-2-based mRDTs (SD-Bioline™, Carestart™ and Paracheck-Pf™) against microscopy of Giemsa stained blood and polymerase chain reaction (PCR) was evaluated among 190 febrile under-5 children in Ibadan, Nigeria. We calculated the sensitivity, specificity, predictive values, accuracy, and agreements.

RESULTS

There were 53.2% males. The prevalence of malaria parasite by microscopy was 46.8% and 57.9% by PCR. Malaria parasite detection by SD-Bioline™ was 60.5%, Carestart™: 60.0% and Paracheck-Pf™ 60.0%. Using microscopy as the gold standard, the sensitivities of SD-Bioline™, Carestart™ and Paracheck-Pf™ mRDT were 97.8%, 96.7% and 97.8% respectively while the specificities were 73.0%, 72.0% and 74.0% respectively. Using PCR as the gold standard, the sensitivity for both SD-Bioline™ and Paracheck-Pf™ was 85.5% and for CareStart was 84.6% while the specificity of SD-Bioline™, Carestart™, and Paracheck-Pf™ was 73.8%, 72.4%, and 75.0% respectively. The test accuracy was 81.0% for both SD-Bioline™ and Paracheck-Pf™ and 80.0% for Caresatrt™. The kappa coefficient of agreement between PCR and each of SD-Bioline™, Carestart, ParaCheck™ and microscopy was 0.597, 0.578, 0.609 and 0.739 respectively.

CONCLUSION

The performance of the three mRDTs is a proof that any of the three is suitable for use in the diagnosis of malaria in the southwest of Nigeria.

摘要

背景

疟疾快速诊断检测（mRDT）是方案部署的首选方案。

目的

尼日利亚市场上有许多 mRDT，有必要指导从业者了解尼日利亚常用 mRDT 品牌的相对性能。

受试者和方法

在尼日利亚伊巴丹，对 190 名发热 5 岁以下儿童进行了三种常用组氨酸丰富蛋白 2 基 mRDT（SD-Bioline™、Carestart™和 Paracheck-Pf™）与吉姆萨染色血镜检和聚合酶链反应（PCR）的比较评估。我们计算了敏感性、特异性、预测值、准确性和一致性。

结果

男性占 53.2%。镜检疟原虫的患病率为 46.8%，PCR 为 57.9%。SD-Bioline™检测疟原虫的比例为 60.5%，Carestart™：60.0%，Paracheck-Pf™：60.0%。以镜检为金标准，SD-Bioline™、Carestart™和 Paracheck-Pf™ mRDT 的敏感性分别为 97.8%、96.7%和 97.8%，特异性分别为 73.0%、72.0%和 74.0%。以 PCR 为金标准，SD-Bioline™和 Paracheck-Pf™的检测灵敏度均为 85.5%，CareStart 为 84.6%，而 SD-Bioline™、Carestart™和 Paracheck-Pf™的特异性分别为 73.8%、72.4%和 75.0%。SD-Bioline™和 Paracheck-Pf™的检测准确率均为 81.0%，CareStart™为 80.0%。PCR 与 SD-Bioline™、Carestart、ParaCheck™和显微镜之间的kappa 一致性系数分别为 0.597、0.578、0.609 和 0.739。