Accuracy of rapid diagnostic test to diagnose malaria in children under 5 years of age, a meta-analysis

Hu, Jun‐Jun; Zhang, Chenyang; Wang, Song; Chen, Xiaofei; Hu, Jiayi; Liu, Xin

doi:10.1016/j.diagmicrobio.2021.115351

Cited by 3 publications

(3 citation statements)

References 38 publications

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“…From a recent meta-analysis study regarding the precision of HRP2 and pLDH rapid diagnostic tests in diagnosing malaria, the combined sensitivity and specificity were 0.92 (95% CI 0.83-0.96) and 0.92 (0.86-0.95), the pLDH-based assays were 0.96 (0.85-0.98) and 0.93 (0.86-0.95), and the HRP2-based assays were 0.94 (0.84-0.98) and 0.86 (0.77-0.91), respectively (Hu et al, 2021).…”

Section: Sample Size Determinationmentioning

confidence: 99%

HRP2 and pLDH performance comparison as rapid diagnostic tools for symptomatic malaria patients at Rugazi HC IV in Rubirizi District

Nakavuma,

Musau,

Lumu

et al. 2023

Preprint

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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.

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Section: Sample Size Determinationmentioning

confidence: 99%

HRP2 and pLDH performance comparison as rapid diagnostic tools for symptomatic malaria patients at Rugazi HC IV in Rubirizi District

Nakavuma,

Musau,

Lumu

et al. 2023

Preprint

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“…Moreover, the age of the patient also affect the performance of mRDT kits. Children less than 5 years have either low or no immunity to malaria, and for that matter, malaria parasitemia could get to high densities in no time, leading to better mRDT kits performance [35][36][37].…”

Section: Plos Onementioning

confidence: 99%

Comparative evaluation of the diagnostic accuracies of four different malaria rapid diagnostic test kits available in Ghana

Aninagyei,

Deku,

Yemofio

et al. 2024

PLoS ONE

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Malaria rapid diagnostic test (mRDT) kit is one of the techniques for diagnosing malaria. Due to its inherent advantages over the microscopy technique, several brands of the kit have flooded malaria endemic countries, without prior in-country evaluation. Two of such mRDT kits are Oscar (India) and Standard Q (Korea Republic). In this study, the performance of Oscar and Standard Q mRDT kits were compared to First Response (India) and CareStart (USA) mRDTs, which have been evaluated and deployed for use approved by the Ministry of Health (MOH). In this comparative study, whole blood samples were collected from patients suspected of malaria. Plasmodium falciparum was detected in each sample using nested polymerase chain reaction (nPCR), microscopy and the four mRDTs. The sensitivities, specificities, accuracies, positive and negative predictive values and accuracies of the mRDTs were determined using nPCR as a reference technique. Kappa statistic was used to determine the level of agreement among the techniques. Two hundred (200) blood samples were analyzed in this study. The overall detection rates of P. falciparum by microscopy, First Response, CareStart, Oscar-PfHRP2, Standard Q mRDT kits and nPCR were 31.5%, 34.5%, 33.5%, 32%, 31% and 43% (x2 = 6.1, p = 0.046), respectively. The accuracies of CareStart and First Response were comparable (90.5% vs. 89.5%). Further, comparing their sensitivities, Oscar-PfHRP2 was 74.4% (95% confidence interval (CI): 63.9–83.2) while that of Standard Q was 72.1% (95% CI: 61.4–81.2), with comparable accuracies (Oscar-PfHRP2–89% and Standard Q -88%). Apart from First Response that was 98.3% specific, the others were 100% specific. Kappa test revealed perfect diagnostic agreement (κ = 0.90–0.98) among the four mRDTs. That notwithstanding, Oscar-PfHRP2 agreed better with CareStart (κ = 0.94) and First Response (κ = 0.92) compared to the agreement between Standard Q and, CareStart (κ = 0.92) and First Response (κ = 0.90). Taken together, the diagnostic performance of the four mRDT kits were statistically similar. That notwithstanding, new mRDT kits should be evaluated prior to deployment for use.

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“…This was calculated using the diagnostic accuracy test's formula for two proportions (Akoglu, 2022): From a recent meta-analysis study regarding the precision of HRP2 and pLDH rapid diagnostic tests in diagnosing malaria, the combined sensitivity and specificity were 0.92 (95% CI 0.83-0.96) and 0.92 (0.86-0.95), the pLDH-based assays were 0.96 (0.85-0.98) and 0.93 (0.86-0.95), and the HRP2-based assays were 0.94 (0.84-0.98) and 0.86 (0.77-0.91), 116 respectively (Hu et al, 2021).…”

Section: Sample Size Determinationmentioning

confidence: 99%

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

2024

Int Internal Med J

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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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Accuracy of rapid diagnostic test to diagnose malaria in children under 5 years of age, a meta-analysis

Cited by 3 publications

References 38 publications

HRP2 and pLDH performance comparison as rapid diagnostic tools for symptomatic malaria patients at Rugazi HC IV in Rubirizi District

HRP2 and pLDH performance comparison as rapid diagnostic tools for symptomatic malaria patients at Rugazi HC IV in Rubirizi District

Comparative evaluation of the diagnostic accuracies of four different malaria rapid diagnostic test kits available in Ghana

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

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