Diagnostic Performance of Conventional and Ultrasensitive Rapid Diagnostic Tests for Malaria in Febrile Outpatients in Tanzania.

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Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_BF9ED9BE8E73
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Diagnostic Performance of Conventional and Ultrasensitive Rapid Diagnostic Tests for Malaria in Febrile Outpatients in Tanzania.
Journal
The Journal of infectious diseases
Author(s)
Hofmann N.E., Antunes Moniz C., Holzschuh A., Keitel K., Boillat-Blanco N., Kagoro F., Samaka J., Mbarack Z., Ding X.C., González I.J., Genton B., D'Acremont V., Felger I.
ISSN
1537-6613 (Electronic)
ISSN-L
0022-1899
Publication state
Published
Issued date
16/04/2019
Peer-reviewed
Oui
Volume
219
Number
9
Pages
1490-1498
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
A novel ultrasensitive malaria rapid diagnostic test (us-RDT) has been developed for improved active Plasmodium falciparum infection detection. The usefulness of this us-RDT in clinical diagnosis and fever management has not been evaluated.
Diagnostic performance of us-RDT was compared retrospectively to that of conventional RDT (co-RDT) in 3000 children and 515 adults presenting with fever to Tanzanian outpatient clinics. The parasite density was measured by an ultrasensitive qPCR (us-qPCR), and the HRP2 concentration was measured by an enzyme-linked immunosorbent assay.
us-RDT identified few additional P. falciparum-positive patients as compared to co-RDT (276 vs 265 parasite-positive patients detected), with only a marginally greater sensitivity (75% vs 73%), using us-qPCR as the gold standard (357 parasite-positive patients detected). The specificity of both RDTs was >99%. Five of 11 additional patients testing positive by us-RDT had negative results by us-qPCR. The HRP2 concentration was above the limit of detection for co-RDT (>3653 pg of HRP2 per mL of blood) in almost all infections (99% [236 of 239]) with a parasite density >100 parasites per µL of blood. At parasite densities <100 parasites/µL, the HRP2 concentration was above the limits of detection of us-RDT (>793 pg/mL) and co-RDT in 29 (25%) and 24 (20%) of 118 patients, respectively.
There is neither an advantage nor a risk of using us-RDT, rather than co-RDT, for clinical malaria diagnosis. In febrile patients, only a small proportion of infections are characterized by a parasite density or an HRP2 concentration in the range where use of us-RDT would confer a meaningful advantage over co-RDT.
Keywords
Adolescent, Adult, Aged, Aged, 80 and over, Antigens, Protozoan/blood, Biomarkers/blood, Child, Preschool, Cross-Sectional Studies, False Negative Reactions, False Positive Reactions, Fever/blood, Fever/parasitology, Humans, Infant, Limit of Detection, Malaria, Falciparum/blood, Malaria, Falciparum/complications, Malaria, Falciparum/diagnosis, Middle Aged, Parasitemia/blood, Parasitemia/parasitology, Protozoan Proteins/blood, Reagent Kits, Diagnostic, Retrospective Studies, Sensitivity and Specificity, Tanzania, Time Factors, Young Adult, HRP2, Malaria, PCR, RDT, diagnosis, fever, quantitative, ultrasensitive
Pubmed
Web of science
Open Access
Yes
Create date
04/01/2019 15:45
Last modification date
11/01/2020 7:16
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