Performance and utility of more highly sensitive malaria rapid diagnostic tests

BMC Infectious Diseases

Sophia Knudson¹  Gonzalo J. Domingo¹  Hannah C. Slater²  Sabine Dittrich³  Xavier C. Ding³  Laurence Slutsker⁴  Adam Bennett⁵  Martin De Smet⁶  Neil J. Saad⁷  Hawela Moonga⁸  Daniel J. Bridges⁹ 

[1]Diagnostics Program, PATH, Seattle, WA, USA

[2]Diagnostics Program, PATH, Seattle, WA, USA

[3]Malaria and Neglected Tropical Diseases, PATH, Seattle, WA, USA

[4]Foundation for Innovative New Diagnostics, Geneva, Switzerland

[5]Malaria and Neglected Tropical Diseases, PATH, Seattle, WA, USA

[6]Malaria and Neglected Tropical Diseases, PATH, Seattle, WA, USA

[7]Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA

[8]Médecins Sans Frontières, Brussels, Belgium

[9]Médecins Sans Frontières, Phnom Penh, Preah Vihear, Cambodia

[10]National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia

[11]PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia

关键词: HS-RDT;    Rapid diagnostic test;    Malaria diagnosis;    Cross-sectional surveys;   

DOI  :  10.1186/s12879-021-07023-5

来源: Springer

【 摘 要 】

BackgroundA new more highly sensitive rapid diagnostic test (HS-RDT) for Plasmodium falciparum malaria (Alere™/Abbott Malaria Ag P.f RDT [05FK140], now called NxTek™ Eliminate Malaria Ag Pf) was launched in 2017. The test has already been used in many research studies in a wide range of geographies and use cases.MethodsIn this study, we collate all published and available unpublished studies that use the HS-RDT and assess its performance in (i) prevalence surveys, (ii) clinical diagnosis, (iii) screening pregnant women, and (iv) active case detection. Two individual-level data sets from asymptomatic populations are used to fit logistic regression models to estimate the probability of HS-RDT positivity based on histidine-rich protein 2 (HRP2) concentration and parasite density. The performance of the HS-RDT in prevalence surveys is estimated by calculating the sensitivity and positive proportion in comparison to polymerase chain reaction (PCR) and conventional malaria RDTs.ResultsWe find that across 18 studies, in prevalence surveys, the mean sensitivity of the HS-RDT is estimated to be 56.1% (95% confidence interval [CI] 46.9–65.4%) compared to 44.3% (95% CI 32.6–56.0%) for a conventional RDT (co-RDT) when using nucleic acid amplification techniques as the reference standard. In studies where prevalence was estimated using both the HS-RDT and a co-RDT, we found that prevalence was on average 46% higher using a HS-RDT compared to a co-RDT. For use in clinical diagnosis and screening pregnant women, the HS-RDT was not significantly more sensitive than a co-RDT.ConclusionsOverall, the evidence presented here suggests that the HS-RDT is more sensitive in asymptomatic populations and could provide a marginal improvement in clinical diagnosis and screening pregnant women. Although the HS-RDT has limited temperature stability and shelf-life claims compared to co-RDTs, there is no evidence to suggest, given this test has the same cost as current RDTs, it would have any negative impacts in terms of malaria misdiagnosis if it were widely used in all four population groups explored here.

【 授权许可】

CC BY