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Background <p>The World Health Organization (WHO) recommends parasitological confirmation before treating suspected malaria cases. However, diagnosing malaria in pregnancy (MiP) remains challenging due to parasite sequestration in the placenta, which results in low peripheral parasite density often undetectable by point-of-care diagnostic tools. Studies have reported conflicting findings on the relationship between ABO blood groups, anaemia, and MiP. This study investigated the performance of microscopy and the First Response™ Malaria Ag PAN/Pf rapid diagnostic test (mRDT) compared to quantitative polymerase chain reaction (qPCR) in diagnosing MiP. It also explored the associations between MiP, ABO blood groups, and anaemia.</p> Methods <p>This cross-sectional study enrolled 236 women delivering at Sio Port and Port Victoria Sub-County Hospitals, Busia County, Kenya (April 2023–March 2024). Peripheral blood was tested for malaria using microscopy, mRDT, and qPCR while placental blood was analyzed using microscopy and qPCR. ABO blood groups and haemoglobin levels were determined from peripheral samples.</p> Results <p>Peripheral malaria prevalence was 7.2% (16/223), 8.1% (18/223), and 9.0% (20/223) as determined by microscopy, mRDT, and qPCR, respectively. Placental malaria prevalence was 7.2% (17/236) by microscopy and 15.7% (37/236) by qPCR. When compared with peripheral blood qPCR, mRDT demonstrated higher sensitivity (90% (95% CI: 0.77–1.0)) but lower specificity (80% (95% CI: 0.74–0.85)) than microscopy (80% (95% CI: 0.63–0.97) sensitivity; 89% (95% CI: 0.85–0.93) specificity). <i>Plasmodium falciparum</i> predominated in placental (58.8%, 10/17) and peripheral (81.3%, 13/16) samples by microscopy. Mean haemoglobin ± SD was 10.5 ± 1.45&#xa0;g/dL, with 69.9% (95% CI 65.2–71.6) anaemia prevalence (Hb ≤ 11&#xa0;g/dL). Blood group O + was most common among the participants (43.2%, 102/236). No significant associations were observed between MiP and ABO blood groups or anaemia (<i>P</i> &gt; 0.05).</p> Conclusion <p>mRDTs demonstrated superior performance compared to microscopy in detecting malaria in pregnancy, although diagnostic limitations remain. Anaemia remained highly prevalent reflecting broader maternal health issues. These findings emphasize the need for integrated maternal health strategies during antenatal care in malaria endemic regions.</p> Clinical trial number <p>Not applicable.</p>

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Evaluation of microscopy and first response™ malaria Ag PAN/Pf RDT compared to qPCR and hemoglobin levels in pregnant women at delivery in Busia County, Western Kenya

  • 期刊论文

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  • 发表日期：

    2026年5月23日

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  • Dickson Kipchirchir,
  • Dancan M. Wakoli,
  • George Imbusi,
  • Rakel Makandi,
  • Everlyne Chimwani,
  • Stellah A. Chumbe,
  • Musie Ghebremichael,
  • John M. Ong’echa,
  • Joel L. Bargul,
  • Azza H. Idris,
  • Bartholomew N. Ondigo

摘要

Background

The World Health Organization (WHO) recommends parasitological confirmation before treating suspected malaria cases. However, diagnosing malaria in pregnancy (MiP) remains challenging due to parasite sequestration in the placenta, which results in low peripheral parasite density often undetectable by point-of-care diagnostic tools. Studies have reported conflicting findings on the relationship between ABO blood groups, anaemia, and MiP. This study investigated the performance of microscopy and the First Response™ Malaria Ag PAN/Pf rapid diagnostic test (mRDT) compared to quantitative polymerase chain reaction (qPCR) in diagnosing MiP. It also explored the associations between MiP, ABO blood groups, and anaemia.

Methods

This cross-sectional study enrolled 236 women delivering at Sio Port and Port Victoria Sub-County Hospitals, Busia County, Kenya (April 2023–March 2024). Peripheral blood was tested for malaria using microscopy, mRDT, and qPCR while placental blood was analyzed using microscopy and qPCR. ABO blood groups and haemoglobin levels were determined from peripheral samples.

Results

Peripheral malaria prevalence was 7.2% (16/223), 8.1% (18/223), and 9.0% (20/223) as determined by microscopy, mRDT, and qPCR, respectively. Placental malaria prevalence was 7.2% (17/236) by microscopy and 15.7% (37/236) by qPCR. When compared with peripheral blood qPCR, mRDT demonstrated higher sensitivity (90% (95% CI: 0.77–1.0)) but lower specificity (80% (95% CI: 0.74–0.85)) than microscopy (80% (95% CI: 0.63–0.97) sensitivity; 89% (95% CI: 0.85–0.93) specificity). Plasmodium falciparum predominated in placental (58.8%, 10/17) and peripheral (81.3%, 13/16) samples by microscopy. Mean haemoglobin ± SD was 10.5 ± 1.45 g/dL, with 69.9% (95% CI 65.2–71.6) anaemia prevalence (Hb ≤ 11 g/dL). Blood group O + was most common among the participants (43.2%, 102/236). No significant associations were observed between MiP and ABO blood groups or anaemia (P > 0.05).

Conclusion

mRDTs demonstrated superior performance compared to microscopy in detecting malaria in pregnancy, although diagnostic limitations remain. Anaemia remained highly prevalent reflecting broader maternal health issues. These findings emphasize the need for integrated maternal health strategies during antenatal care in malaria endemic regions.

Clinical trial number

Not applicable.