Abstract
.Sensitive field-deployable diagnostic tests can assist malaria programs in achieving elimination. The performance of a new Alere™ Malaria Ag P.f Ultra Sensitive rapid diagnostic test (uRDT) was compared with the currently available SD Bioline Malaria Ag P.f RDT in blood specimens from asymptomatic individuals in Nagongera, Uganda, and in a Karen Village, Myanmar, representative of high- and low-transmission areas, respectively, as well as in pretreatment specimens from study participants from four Plasmodium falciparum-induced blood-stage malaria (IBSM) studies. A quantitative reverse transcription PCR (qRT-PCR) and a highly sensitive enzyme-linked immunosorbent assay (ELISA) test for histidine-rich protein II (HRP2) were used as reference assays. The uRDT showed a greater than 10-fold lower limit of detection for HRP2 compared with the RDT. The sensitivity of the uRDT was 84% and 44% against qRT-PCR in Uganda and Myanmar, respectively, and that of the RDT was 62% and 0% for the same two sites. The specificities of the uRDT were 92% and 99.8% against qRT-PCR for Uganda and Myanmar, respectively, and 99% and 99.8% against the HRP2 reference ELISA. The RDT had specificities of 95% and 100% against qRT-PCR for Uganda and Myanmar, respectively, and 96% and 100% against the HRP2 reference ELISA. The uRDT detected new infections in IBSM study participants 1.5 days sooner than the RDT. The uRDT has the same workflow as currently available RDTs, but improved performance characteristics to identify asymptomatic malaria infections. The uRDT may be a useful tool for malaria elimination strategies.
Highlights
Half of the world’s population remains at risk for malaria, despite substantial gains in morbidity and mortality from 2001 to 2015.1 The majority of the 212 million cases reported in 2015 were attributed to Plasmodium falciparum, with the greatest incidence in sub-Saharan Africa (90%) followed by the southeast Asia region (7%).[1]
The Ultra Sensitive rapid diagnostic test (uRDT) has the same workflow as currently available rapid diagnostic tests (RDTs), but improved performance characteristics to identify asymptomatic malaria infections
Specimens from Uganda were collected under a study approved by the University of California San Francisco (UCSF) (IRB No.11-05995), Makerere University (IRB No 2011-0167), and London School of Hygiene and Tropical Medicine (LSHTM) (IRB No 5943); those from Myanmar were collected under a study approved by OxTREC, by the Tak Community Advisory Board, and by the relevant village committees
Summary
Half of the world’s population remains at risk for malaria, despite substantial gains in morbidity and mortality from 2001 to 2015.1 The majority of the 212 million cases reported in 2015 were attributed to Plasmodium falciparum, with the greatest incidence in sub-Saharan Africa (90%) followed by the southeast Asia region (7%).[1].
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