Welcome to the next generation of Malaria Rapid Diagnostic Tests: Comparative Analysis of NxTek Eliminate Malaria P.f, Biocredit Malaria Ag Pf, and SD Bioline Malaria Ag Pf for Plasmodium falciparum Diagnosis in Ghana.

Autor: Kayode TA; University of Notre Dame., Addo AKA; Kwame Nkrumah University of Science and Technology., Addison TK; Kwame Nkrumah University of Science and Technology., Tweneboah A; Kwame Nkrumah University of Science and Technology., Afriyie SO; Kwame Nkrumah University of Science and Technology., Abass DA; Kwame Nkrumah University of Science and Technology., Seth A; The Ohio State University., Badu-Tawiah AK; The Ohio State University., Badu K; Kwame Nkrumah University of Science and Technology., Koepfli C; University of Notre Dame.
Jazyk: angličtina
Zdroj: Research square [Res Sq] 2023 Oct 19. Date of Electronic Publication: 2023 Oct 19.
DOI: 10.21203/rs.3.rs-3459263/v1
Abstrakt: Background: Accurate diagnosis and timely treatment are crucial in combating malaria.
Methods: We evaluated the diagnostic performance of three Rapid Diagnostic Tests (RDTs) in diagnosing febrile patients, namely: Abbott NxTek Eliminate Malaria Ag Pf (detecting HRP2), Rapigen Biocredit Malaria Ag Pf (detecting HRP2 and LDH on separate bands), and SD Bioline Malaria Ag Pf (detecting HRP2). Results were compared to qPCR.
Results: Among 449 clinical patients, 45.7% (205/449) tested positive by qPCR for P. falciparum with a mean parasite density of 12.5parasites/μL. The sensitivity of the Biocredit RDT was 52.2% (107/205), NxTek RDT was 49.3% (101/205), and Bioline RDT was 40.5% (83/205). When samples with parasite densities lower than 20 parasites/uL were excluded (n=116), a sensitivity of 88.8% (79/89, NxTek), 89.9% (80/89, Biocredit), and 78.7% (70/89, Bioline) was obtained. All three RDTs demonstrated specificity above 95%. The limits of detection was 84 parasites/μL (NxTek), 56 parasites/μL (Biocredit, considering either HRP2 or LDH), and 331 parasites/μL (Bioline). None of the three qPCR-confirmed P. falciparum positive samples, identified solely through the LDH target, carried hrp2/3 deletions.
Conclusion: The Biocredit and NxTek RDTs demonstrated comparable diagnostic efficacies and both RDTs performed better than Bioline RDT.
Competing Interests: Competing interests The authors declare that they have no competing interests.
Databáze: MEDLINE