1. Evaluation of three rapigen biocredit point-of-care tests for malaria case management in Lagos, Nigeria.
- Author
-
Aina OO, Agomo CO, Ajibaye O, Okoyenta CO, Ogbulafor N, Ijezie S, Orok AB, Oparaugo CT, Akindele SK, Bamgbose DJ, Holdbrooke SA, Kareem OK, Olukosi YA, and Ola I
- Subjects
- Humans, Nigeria, Cross-Sectional Studies, Male, Female, Adult, Adolescent, Child, Young Adult, Child, Preschool, Middle Aged, Plasmodium falciparum isolation & purification, Protozoan Proteins blood, Protozoan Proteins genetics, Protozoan Proteins analysis, Case Management, Infant, L-Lactate Dehydrogenase blood, Aged, Point-of-Care Testing, Point-of-Care Systems, Malaria diagnosis, Sensitivity and Specificity, Malaria, Falciparum diagnosis, Antigens, Protozoan blood, Reagent Kits, Diagnostic standards
- Abstract
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., Competing Interests: No Conflict of Interest is declared, (Copyright (c) 2024 Oluwagbemiga O Aina, Chimere O Agomo, Olusola Ajibaye, Celestina O Okoyenta, 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.)
- Published
- 2024
- Full Text
- View/download PDF