Evaluation of three rapigen biocredit point-of-care tests for malaria case management in Lagos, Nigeria
DOI:
https://doi.org/10.3855/jidc.19314Keywords:
Cross-sectional studies, humans, microscopy, Plasmodium falciparum, histidine-rich protein, malariaAbstract
Introduction: Histidine-rich protein 2 (HRP2) antigen kits are widely used for malaria diagnosis in tropical regions due to their heat stability. The Plasmodium Lactate Dehydrogenase (pLDH) used in BIOCREDIT® malaria test kit is claimed to be heat-stable. This study aimed to evaluate the heat stability and field performance of three BIOCREDIT® kits.
Methodology: A cross-sectional community survey of malaria infection was carried out in Agbowa and Ikosi communities in Lagos State. Finger-prick blood was used to assess the performance of three BIOCREDIT® kits: Kit 1 (PfpLDH), Kit 2 (PfLDH/HRP2), and Kit 3 (PfLDH/PvLDH). Malaria microscopy and a reference mRDT (SD BIOLINE®PfHRP2) were used as comparators. Heat stability testing was performed using Plasmodium falciparum panels after exposure to 35oC and 45oC for 60 days. A total of 834 participants were recruited.
Results: The sensitivity of BIOCREDIT® kits were: Kit 1 (PfLDH) 88.4%; Kit 2 PfHRP2 92% and PfLDH 86.6%; Kit 3 (PfLDH) 88.4%. The specificity of kits was: Kit 1 (Pf LDH) 91.7%; Kit 2 (PfHRP2) 82.3%) and (PfLDH) 92.1%; Kit 3 (PfLDH) 91.6%. The sensitivity and specificity of the reference kit were 92.9% and 85.9%. The three BIOCREDIT® Kits were stable. No potential case of pfhrp2 gene deletion was observed.
Conclusions: The sensitivities of the three BIOCREDIT® malaria test kits were similar to the reference kit (SD BIOLINE mRDT). However, the specificities of PfLDH kits were significantly higher than the specificities of PfHRP2 kits. The BIOCREDIT® kits are suitable to be deployed in malaria-endemic tropical regions.
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Copyright (c) 2024 Dr Oluwagbemiga O. Aina, Chimere O. Agomo, Olusola Ajibaye, Celestina Onyinye Okoyenta, Dr Nnenna Ogbulafor, Simon Ijezie, Akwaowo B. Orok, Chinedum T. Oparaugo, Samuel K. Akindele, Damilare J. Bamgbose, Susan A. Holdbrooke, Olaide K. Kareem, Yetunde A. Olukosi, Isaac Ola
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