Malaria is a fatal life-threatening parasitic infection and a leading cause of morbidity and mortality. The present study was aimed to evaluate simple, inexpensive, accurate, reliable, easily available better diagnostic for rapid detection of malaria at point of care (POC). The study includes 1403 samples collected from the patients, of which 1227 were clinically suspected cases and 176 from consecutive feverish patients. Among the suspected cases only 338 samples were confirmed positive and 889 samples were negative for Plasmodium species by PCR. All the 889 samples showed negative result for plasmodium species by microscopy, Malarial Ag rapid kits but only 867 samples were confirmed negative with malarial Ab rapid kits. Of the 338 PCR positive samples, 337 samples were confirmed positive by microscopy and Malarial Ag rapid kits, but only 284 samples were confirmed positive using malarial Ab rapid kits. Overall the microscopy and the malaria antigen-based lateral flow assay exhibited similar sensitivity, specificity, PPV, NPV and efficiency, respectively, whereas the PCR assay had 100% sensitivity, specificity, PPV, NPV and efficiency. But the evolutionary data for malaria antibody lateral flow assay has 92.81% sensitivity, 94.13% specificity, 84.02% PPV, 97.52% NPV and 93.80% efficiency. The developed Malaria pf/pv antigen and antibody field-deployable kits are simple, rapid, accurate, reliable, inexpensive, user friendly, POC. In addition the kits are highly sensitive and species-specific. The pf/pv antigen kit is found to be more accurate with 99.7% sensitivity and 100% specificity than to Malaria pf/pv antibody rapid kits. Of the two rapid kits developed, Malaria pf/pv antigen kit is found be more accurate with 99.7% sensitivity and 100% specificity than to Malaria pf/pv antibody rapid kits.
Point of care (POC) Immuno chromatographic test (ICT) Plasmodium Lactate Dehydrogenase (pLDH) Histidine Rich Protein II (HRPII) Plasmodium falciparum (pf) Plasmodium vivax (pv) Antigen (Ag) Antibody (Ab) Rapid diagnostic test (RDT) Polymerase chain reaction (PCR)
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The authors are very thankful to DBT, Govt. of India for the financial support for this research work awarded under SIBRI network project on malarial diagnostics.
This work was supported and funded by Ministry of Science and Technology, Department of Biotechnology, Govt. of India under SIBRI Project on Malarial Diagnostics.
Compliance with ethical standards
The study was approved by the Organizational Human Ethical Committee.
Conflict of interest
There is no conflict of interest related to this study.
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