Summary of findings'. 'New Summary of results table.
| What is the diagnostic accuracy of Rapid Diagnostic Tests for detecting malaria? What are the best types of tests? | ||||||
| Patients/populations | People presenting with symptoms suggestive of uncomplicated malaria | |||||
| Prior testing | None | |||||
| Settings | Ambulatory healthcare settings in P. falciparum malaria endemic areas in Asia, Africa and South America | |||||
| Index tests | Immunochromatography‐based rapid diagnostic tests for P. falciparum malaria | |||||
| Reference standard | Conventional microscopy or PCR | |||||
| Importance | Accurate and fast diagnosis allows appropriate and quick treatment for malaria to be provided | |||||
| Studies | Consecutive series of patients; 74 studies presented 111 test evaluations based on 60,396 patient test results | |||||
| Quality concerns | Poor reporting of patient characteristics, sampling method and reference standard methods were common concerns | |||||
| Test types | Quantity of evidence | Brands (studies) | Average pooled results | Consequences in a cohort of 1000 | ||
| P. falciparum prevalence | Missed cases | Overtreated non‐cases | ||||
| HRP‐2 antibody‐based tests compared with microscopy | ||||||
|
Type 1 HRP‐2 (P. falciparum specific) |
71 evaluations 40,062 participants 11,966 malaria cases |
Paracheck‐Pf (27), ParaSight (17), ICT Malaria Pf (16), ParaHIT‐F (4), PATH (2), Determine Malaria Pf (1), Rapid Test Malaria (1), Diaspot Malaria (1), New mini‐Pf (1), and Hexagon Malaria (1) | sens = 94.8% (93.1% to 96.1%) | 30% | 16 | 34 |
| spec = 95.2% (93.2% to 96.7%) | 50% | 26 | 24 | |||
|
Type 2 HRP‐2 (P. falciparum specific) and aldolase (pan‐specific) |
8 evaluations 3397 participants 790 malaria cases |
ICT Malaria Pf/Pv (6) and NOW ICT Malaria (2) | sens = 96.0% (94.0% to 97.3%) | 30% | 12 | 33 |
| spec = 95.3% (87.3% to 98.3%) | 50% | 20 | 24 | |||
|
Type 3 HRP‐2 (P. falciparum specific) and pLDH (pan‐specific) |
5 evaluations 958 participants 330 malaria cases |
SD Malaria Antigen Bioline (2), Parascreen (2), and First Response Malaria (1) | sens = 99.5% (71.0% to 100.0%) | 30% | 12 | 62 |
| spec = 90.6% (80.5% to 95.7%) | 50% | 20 | 44 | |||
| pLDH antibody‐based tests compared with microscopy | ||||||
|
Type 4 pLDH (P. falciparum specific) and pLDH (pan‐specific) |
17 evaluations 13,010 participants 4274 malaria cases |
OptiMAL (10), OptiMAL‐IT(3), Parabank (2) and Carestart Malaria Pf/Pan (2) | sens = 91.5% (84.7% to 95.3%) | 30% | 26 | 9 |
| spec = 98.7% (96.9% to 99.5%) | 50% | 43 | 7 | |||
|
Type 5 pLDH (P. falciparum specific) and pLDH (P. vivax‐specific) |
3 evaluations 1777 participants 400 malaria cases |
Carestart Pf/Pv (2), and ParaSight Pf/Pv (1) | sens = 98.4% (95.1% to 99.5%) | 30% | 5 | 18 |
| spec = 97.5% (93.5% to 99.1%) | 50% | 8 | 13 | |||
| Comparisons | ||||||
| Comparison | Comparison type | Quantity of evidence and overall finding | Sensitivity | Specificity | ||
| Type 1 vs Type 4 | All studies | 65 Type 1 vs 16 Type 4 Overall significant difference in accuracy P = 0.009 |
Type 1 3.3% more sensitive than Type 4 (P = 0.20) | Type 4 3.5% more specific than Type 1 (P < 0.001) | ||
| Within studies | 7 comparative studies No overall significant difference in accuracy P = 0.26 |
Type 1 2.5% more sensitive than Type 4 (P = 0.51) | Type 4 2.9% more specific than Type 1 (P = 0.31) | |||
| HRP‐2 vs pLDH | All studies | 75 HRP‐2 vs 19 pLDH Overall significant difference in accuracy P = 0.01 |
HRP‐2 1.8% more sensitive than pLDH (P = 0.34) | pLDH 3.3% more specific than HRP‐2 (P = 0.01) | ||
| Within studies | 9 comparative studies No overall significant difference in accuracy P = 0.35 |
HRP‐2 0.8% more sensitive than pLDH (P = 0.60) | pLDH 2.3% more specific than HRP‐2 (P = 0.22) | |||