HRP2 and PLDH Performance Comparison as Rapid Diagnostic Tools for Symptomatic Malaria Patients at Rugazi HC IV in Rubirizi District

International Internal Medicine Journal Pub Date : 2024-02-13 DOI:10.33140/iimj.02.02.02

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Abstract

Background: Rapid and precise laboratory diagnosis is essential for effectively diagnosing and managing malaria patients. Malaria rapid diagnostic tests (mRDTs) play a critical role in malaria diagnosis in resource-constrained settings with limited access to labs and trained staff. The efficiency of two mRDTs (HRP2 and pLDH) was compared against microscopy, the gold standard for malaria diagnosis, in this study. Methods: In a cross-sectional study, 308 participants were tested for malaria parasites using two mRDTs and blood smear microscopy as the gold standard. STATA software version 17 was used for data analysis. Results: Out of the 308 participants, 82 tested positive for HRP2 mRDT (26.62% (95% CI: 21.97-31.86) positivity rate, 73.38% (95% CI: 68.14-78.83) negativity rate), and 99 tested positive for pLDH mRDT (32.14% (95% CI: 27.14-37.59) positivity rate, 67.86% (95% CI: 62.41-72.86) negativity rate). Using microscopy as the gold standard, the sensitivity, specificity, PPV, and NPV were determined. For HRP2 mRDT, sensitivity was 77.78% (95%CI: 73.13-82.42), specificity 97.61% (95%CI: 95.90 - 99.31), PPV 93.90% (95%CI: 91.23 – 96.56), and NPV 90.27% (95%CI: 86.96-93.58). For pLDH mRDT, the sensitivity was 94.95% (95% CI: 92.50-97.40), specificity was 97.61% (95% CI: 95.90-99.31), PPV was 94.95% (95% CI: 92.50 – 97.40), and NPV was 97.61% (95% CI: 95.90 - 99.31). The dominant malaria species was Plasmodium falciparum (74.7%), followed by Plasmodium vivax (12.1%) and Plasmodium ovale (1%). Mixed infections of plasmodium falciparum and plasmodium vivax (7.1%) and plasmodium falciparum and plasmodium ovale (5.1%) were also observed. Conclusion: There was no significant difference in the positivity rate, negativity rate, specificity or PPV in both mRDTs. However, a significant difference in the NPV and sensitivity of HRP2 and pLDH mRDTs was observed where HRP2’s sensitivity was below the WHO recommendation of ≥95% in this study population; thus, there is a need to improve the sensitivity of this mRDT kit. In our study, most malaria infections were caused by Plasmodium falciparum, followed by P. vivax and P. ovale. We therefore recommend the use of pLDH mRDTs over HRP2 mRDTs based on the results of our study

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鲁比里齐县鲁加齐第四急诊室将 HRP2 和 PLDH 作为无症状疟疾患者的快速诊断工具进行性能比较

背景：快速准确的实验室诊断对于有效诊断和管理疟疾患者至关重要。疟疾快速诊断检测（mRDTs）在资源有限、实验室和训练有素的工作人员有限的环境中对疟疾诊断起着至关重要的作用。本研究比较了两种 mRDT（HRP2 和 pLDH）与疟疾诊断的金标准显微镜检查的效率。研究方法在一项横断面研究中，使用两种 mRDT 和作为金标准的血液涂片显微镜对 308 名参与者进行了疟原虫检测。使用 STATA 软件 17 版进行数据分析。结果：在 308 名参与者中，82 人的 HRP2 mRDT 检测呈阳性（阳性率为 26.62%（95% CI：21.97-31.86），阴性率为 73.38%（95% CI：68.14-78.83）），99 人的 pLDH mRDT 检测呈阳性（阳性率为 32.14%（95% CI：27.14-37.59），阴性率为 67.86%（95% CI：62.41-72.86））。以显微镜为金标准，确定了灵敏度、特异性、PPV 和 NPV。HRP2 mRDT 的灵敏度为 77.78%（95%CI：73.13-82.42），特异性为 97.61%（95%CI：95.90-99.31），PPV 为 93.90%（95%CI：91.23-96.56），NPV 为 90.27%（95%CI：86.96-93.58）。pLDH mRDT 的灵敏度为 94.95%（95% CI：92.50-97.40），特异性为 97.61%（95% CI：95.90-99.31），PPV 为 94.95%（95% CI：92.50-97.40），NPV 为 97.61%（95% CI：95.90-99.31）。主要的疟疾种类是恶性疟原虫（74.7%），其次是间日疟原虫（12.1%）和卵形疟原虫（1%）。此外，还观察到恶性疟原虫和间日疟原虫（7.1%）以及恶性疟原虫和卵形疟原虫（5.1%）的混合感染。结论两种 mRDT 的阳性率、阴性率、特异性和 PPV 均无明显差异。然而，在本研究人群中，HRP2 和 pLDH mRDT 的 NPV 和灵敏度存在明显差异，其中 HRP2 的灵敏度低于世界卫生组织建议的≥95%；因此，有必要提高这种 mRDT 试剂盒的灵敏度。在我们的研究中，大多数疟疾感染是由恶性疟原虫引起的，其次是间日疟原虫和卵形疟原虫。因此，根据我们的研究结果，我们建议使用 pLDH mRDT，而不是 HRP2 mRDT。

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International Internal Medicine Journal

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