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Background <p>Accurate malaria diagnosis is critical not only for prescribing correct treatment but also for ensuring effective case management, preventing drug resistance, and interrupting transmission. Despite this importance, laboratory diagnostic error driven by multifactorial causes yielding both false-positive and false-negative results remains a persistent yet underrecognized challenge, particularly in endemic regions. This study aimed to compare routine malaria microscopy with Loop-Mediated Isothermal Amplification (LAMP) to determine the prevalence of malaria misdiagnosis by routine microscopy in Northwest Ethiopia.</p> Methods <p>A health facility–based cross-sectional study was conducted at four selected health centers from July 1 to August 30, 2024. A convenience sampling technique was applied to recruit study participants. A total of 384 malaria-suspected individuals whose routine microscopy results recorded at health centers were re-evaluated using a LAMP molecular assay results performed on venous blood samples. The data were entered into Microsoft Office Excel and exported to SPSS version 27 for analysis. Descriptive statistics were used to estimate malaria misdiagnosis by routine microscopy, and the McNemar’s test was applied to assess statistical significance, with a p-value &lt; 0.05 considered statistically significant.</p> Results <p>Among the 384 study participants (116 microscopy-positive and 268 microscopy-negative), 30.0% of routine malaria microscopy results were discordant when compared with LAMP findings. The discordant results comprised false-positive results (7.6%), false-negative results (18.8%), and species misidentification (3.6%). McNemar’s test demonstrated a statistically significant difference between microscopy and LAMP results (<i>p</i> &lt; 0.001).</p> Conclusions and recommendations <p>The current study showed a high prevalence of malaria misdiagnosis; false negatives, false positives, and species misidentification by routine microscopy. Although this undermines malaria control efforts, microscopy remains the most accessible and WHO-endorsed diagnostic method in resource-limited settings. Strengthening its accuracy through continuous training, quality assurance, and supervision is therefore essential. While molecular methods such as LAMP offer superior sensitivity and specificity, microscopy continues to serve as the operational gold standard due to its practicality and affordability.</p> Clinical trial number <p>Not applicable.</p>

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Unveiling the overlooked burden of malaria misdiagnosis using lamp-based re-evaluation of routine malaria diagnosis in health centers: implications for public health and clinical practice in Northwest Ethiopia

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月16日

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  • Mengistu Tesfa Alula,
  • Banchamlak Tegegne,
  • Abebaw Setegn,
  • Mulat Yimer,
  • Marye Wondimnew Tefera,
  • Solomon Gedfie,
  • Agenagnew Ashagre,
  • Aberham Abere,
  • Mebratu Tamir,
  • Bahriew Mezgebu,
  • Assefa Demsash Abebe,
  • Andargachew Almaw,
  • Dylan R. Pillai,
  • Wossenseged Lemma,
  • Tegegne Eshetu

摘要

Background

Accurate malaria diagnosis is critical not only for prescribing correct treatment but also for ensuring effective case management, preventing drug resistance, and interrupting transmission. Despite this importance, laboratory diagnostic error driven by multifactorial causes yielding both false-positive and false-negative results remains a persistent yet underrecognized challenge, particularly in endemic regions. This study aimed to compare routine malaria microscopy with Loop-Mediated Isothermal Amplification (LAMP) to determine the prevalence of malaria misdiagnosis by routine microscopy in Northwest Ethiopia.

Methods

A health facility–based cross-sectional study was conducted at four selected health centers from July 1 to August 30, 2024. A convenience sampling technique was applied to recruit study participants. A total of 384 malaria-suspected individuals whose routine microscopy results recorded at health centers were re-evaluated using a LAMP molecular assay results performed on venous blood samples. The data were entered into Microsoft Office Excel and exported to SPSS version 27 for analysis. Descriptive statistics were used to estimate malaria misdiagnosis by routine microscopy, and the McNemar’s test was applied to assess statistical significance, with a p-value < 0.05 considered statistically significant.

Results

Among the 384 study participants (116 microscopy-positive and 268 microscopy-negative), 30.0% of routine malaria microscopy results were discordant when compared with LAMP findings. The discordant results comprised false-positive results (7.6%), false-negative results (18.8%), and species misidentification (3.6%). McNemar’s test demonstrated a statistically significant difference between microscopy and LAMP results (p < 0.001).

Conclusions and recommendations

The current study showed a high prevalence of malaria misdiagnosis; false negatives, false positives, and species misidentification by routine microscopy. Although this undermines malaria control efforts, microscopy remains the most accessible and WHO-endorsed diagnostic method in resource-limited settings. Strengthening its accuracy through continuous training, quality assurance, and supervision is therefore essential. While molecular methods such as LAMP offer superior sensitivity and specificity, microscopy continues to serve as the operational gold standard due to its practicality and affordability.

Clinical trial number

Not applicable.