Rapid Diagnosis of Malaria

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/𝜇L with appropriate specificity
Region-specific requirements
	Sub-Saharan Africa	Other malaria endemic areas	Malaria free countries
P. falciparum-specific	+++	−	−
Detects all human malaria	+	+++	+++
Plasmodium species specific	+	+++	+++
Able to detect mixed infections	+	+++	+++
High sensitivity ( <50 parasites/ 𝝁 L)	−	+++	+++
High specificity	−	+++	+++
Semi-quantitative	−	−	+++
Able to monitor response to therapy	+	+++ (if drug-resistant P. falciparum)	+
Assay specifications:
ICH GMP	−	−	+++
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).