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