Table 1: Ideal requirements for a malaria rapid diagnostic test (RDT).

Common requirements

Rapid results ( 20 minutes)
Easy to use with minimal training and simple instructions
Environmentally stable device (heat, humidity, air movement, lighting) during use and storage
Reproducible results including quality manufacturing
Detect below parasite density of 100 parasites/ L with appropriate specificity

Region-specific requirements

Sub-Saharan AfricaOther malaria endemic areasMalaria free countries

P. falciparum-specific+++
Detects all human malaria+++++++
Plasmodium species specific+++++++
Able to detect mixed infections+++++++
High sensitivity ( 50 parasites/ L)++++++
High specificity++++++
Able to monitor response to therapy++++ (if drug-resistant P. falciparum)+

Assay specifications:

Stable to 40°C++++++
Long shelf life+++++++++
Point-of-care use (CLIA waived)+++
Cost $1 per test$1–3 per test microscopy (~$20/test)

+++ (high priority), + (low priority), − (not necessary), International Conference on Harmonization (ICH); Good Manufacturing Practices (GMP); Clinical Laboratory Improvement Amendment (CLIA).