Analytical Sensitivity Analysis and Clinical Impact Modeling of Rapigen Rapid Diagnostic Tests for Malaria
Issued Date
2024-11-06
Resource Type
eISSN
14761645
Scopus ID
2-s2.0-85208772603
Pubmed ID
39226907
Journal Title
The American journal of tropical medicine and hygiene
Volume
111
Issue
5
Start Page
956
End Page
966
Rights Holder(s)
SCOPUS
Bibliographic Citation
The American journal of tropical medicine and hygiene Vol.111 No.5 (2024) , 956-966
Suggested Citation
Golden A., Slater H.C., Jang I.K., Walke S., Phan T.T., Bizilj G.T., Rashid A., Barney R., Das S., Rist M.J., McCarthy J.S., Nosten F., Landier J., Imwong M., Hume J.C.C., Sagara I., Healy S.A., Duffy P.E., Ntuku H., Mumbengegwi D., Hsiang M.S., Murphy S.C., Rek J., Torres K., Gamboa D., Domingo G.J. Analytical Sensitivity Analysis and Clinical Impact Modeling of Rapigen Rapid Diagnostic Tests for Malaria. The American journal of tropical medicine and hygiene Vol.111 No.5 (2024) , 956-966. 966. doi:10.4269/ajtmh.24-0003 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/102073
Title
Analytical Sensitivity Analysis and Clinical Impact Modeling of Rapigen Rapid Diagnostic Tests for Malaria
Author's Affiliation
Université des Sciences, des Techniques et des Technologies de Bamako
Faculty of Tropical Medicine, Mahidol University
Mahidol Oxford Tropical Medicine Research Unit
Infectious Diseases Research Collaboration
The Peter Doherty Institute for Infection and Immunity
Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale
University of Namibia
Universidad Peruana Cayetano Heredia
PATH Seattle
QIMR Berghofer Medical Research Institute
University of California, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
University of Washington
Nuffield Department of Medicine
Faculty of Tropical Medicine, Mahidol University
Mahidol Oxford Tropical Medicine Research Unit
Infectious Diseases Research Collaboration
The Peter Doherty Institute for Infection and Immunity
Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale
University of Namibia
Universidad Peruana Cayetano Heredia
PATH Seattle
QIMR Berghofer Medical Research Institute
University of California, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
University of Washington
Nuffield Department of Medicine
Corresponding Author(s)
Other Contributor(s)
Abstract
Laboratory benchmarking allows objective analysis of the analytical performance of malaria rapid diagnostic tests (RDTs). We present the analytical detection limits of the Rapigen BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH), the Rapigen BIOCREDIT Malaria Ag Pf (pLDH/HRPII), and two best-in-class WHO-prequalified comparator RDTs, generated using standardized panels containing recombinant antigen, in vitro cultured parasites, international standards, and clinical samples. Detection limit antigen concentrations of HRP2, PfLDH, and PvLDH were determined for the Rapigen and comparator RDTs. Detection of antigens in international units (IU)/mL was also evaluated. The Rapigen Ag Pf (pLDH/HRPII) detected 3.9 and 3.9 IU/mL for PfLDH and HRP2, respectively, and the Ag Pf/Pv (pLDH/pLDH) detected 3.9 and 5.0 IU/mL for PfLDH and PvLDH, respectively. The comparator HRP2/PfLDH and HRP2/PvLDH detected 15.6 and 31.3 IU/mL for HRP2 and PfLDH and 15.6 and 50.0 IU/mL for HRP2 and PvLDH, respectively. The RDT clinical sensitivity was predicted through application of analytical detection limits to antigen concentration distributions from clinical symptomatic and asymptomatic cases. Febrile cases would be detected in a majority by both standard and Rapigen RDTs, but incremental increases in sensitivity in the Rapigen RDTs may be important for clinical cases currently missed by microscopy. Rapigen RDTs were predicted to have improved detection of asymptomatic cases and infections with parasites carrying hrp2 deletions through more sensitive PfLDH detection. Through the benchmarking and simulation of clinical sensitivity, a method for rapidly assessing the ability of new RDTs to meet clinical needs using high-sensitivity antigen distribution data is presented.