Performance and utility of more highly sensitive malaria rapid diagnostic tests

Area of Science:

• Malariology
• Infectious Diseases
• Diagnostic Technologies

Background:

• A new highly sensitive rapid diagnostic test (HS-RDT) for Plasmodium falciparum malaria was introduced in 2017.
• This HS-RDT has been utilized in numerous global research studies across diverse settings and applications.

Purpose of the Study:

• To assess the performance of the HS-RDT in various malaria diagnostic scenarios.
• Evaluate its utility in prevalence surveys, clinical diagnosis, screening pregnant women, and active case detection.

Main Methods:

• A comprehensive collation of published and unpublished studies utilizing the HS-RDT.
• Logistic regression models were employed using individual-level data from asymptomatic populations to correlate HS-RDT positivity with histidine-rich protein 2 (HRP2) concentration and parasite density.
• Performance in prevalence surveys was determined by comparing sensitivity and positive proportion against polymerase chain reaction (PCR) and conventional malaria RDTs (co-RDTs).

Main Results:

• In prevalence surveys, the HS-RDT demonstrated a mean sensitivity of 56.1% compared to 44.3% for co-RDTs, when using nucleic acid amplification techniques as the reference.
• Prevalence estimates were, on average, 46% higher when using HS-RDT compared to co-RDTs.
• The HS-RDT did not show significantly higher sensitivity than co-RDTs for clinical diagnosis or screening pregnant women.

Conclusions:

• The HS-RDT exhibits greater sensitivity in asymptomatic populations and may offer a slight advantage in clinical diagnosis and screening pregnant women.
• Despite limitations in temperature stability and shelf-life compared to co-RDTs, the HS-RDT, at a similar cost, presents no evidence of negative impacts on malaria misdiagnosis for widespread use.