Background
Methods
Study site and population
Sample collection
Laboratory procedures
Malaria rapid diagnostic test evaluated
Monitoring and quality control
Additional analysis: polymerase chain reaction (PCR)
Data management, definitions and analysis
Ethical issues
Results
Study population and malaria microscopy results
All year | Rainy season | Post-rainy season | Dry season | |
---|---|---|---|---|
Number | 694 | 398 | 151 | 145 |
Age, median months (IQR) | 20 (11–37) | 21 (12–37) | 16 (9–35) | 17 (9–39) |
Female sex, n (%) | 310 (44.7) | 176 (44.2) | 79 (52.3) | 55 (37.9) |
Prior antimalarial treatment, n (%) | 302 (43.5) | 156 (39.2) | 87 (57.6) | 59 (40.7) |
Microscopy Pf positive | 376 (54.2) | 304 (76.4) | 55 (36.4) | 17 (11.7) |
Pf parasite density/μl, median | 42,331 | 49,962.5 | 18,256 | 7,549 |
Pf parasite density/μl, range | 25 - 702,500 | 62 - 702,500 | 99 - 259,685 | 25 - 112,465 |
Blood culture positive, n (%) | 60 (8.7%) | 19 (4.8) | 27 (17.9) | 14 (9.7) |
Confirmed meningitis, n (%) | 6 (0.9) | 1 (0.3) | 2 (1.3) | 3 (2.1) |
Co-infections | 7 (1.0) | 4 (1.0) | 3 (2.0) | 0 |
Diagnostic accuracy of PfHRP2 and Pf-pLDH
Pf HRP2 pos | Pf HRP2 neg | ||||
---|---|---|---|---|---|
Microscopy | Number | Pf-pLDH pos | Pf-pLDH neg | Pf-pLDH pos | Pf-pLDH neg |
1 - 100 | 3 | 2 | 1 | ||
101 - 1,000 | 25 | 25 | |||
1,001 - 10,000 | 66 | 66 | |||
10,001 - 100,000 | 199 | 199 | |||
> 100,000 | 83 | 83 | |||
pure gametocytemia | 13 | 8 | 4 | 1 | |
Microscopy negative | 303 | 17 | 110 | 1 | 175 |
P. ovale
| 2 | 2 | |||
Total | 694 | 400 | 115 | 4 | 175 |
Pf HRP2 | Pf-pLDH | p-value | |
---|---|---|---|
RDT pos, n (%) | 515 (74.2) | 404 (54.2) | |
SE (95% CI) | 100.0 (94.7 - 100.0) | 98.7 (93.5-99.9) | 1.0 |
Sp (95% CI) | 70.9 (67.4 - 70.9) | 94.0 (90.6 - 94.8) | < 0.001 |
PPV (95% CI) | 69.4 (65.7 - 69.4) | 91.6 (86.8 - 92.7) | < 0.001 |
NPV (95% CI) | 100.0 (95.1 - 100.0) | 99.1 (95.5 - 100.0) | 1.0 |
Pf HRP2 and Pf- pLDH performance by age group
Nr | Slide Pf pos (%) | Pf HRP2 | Pf-pLDH | |||||||
---|---|---|---|---|---|---|---|---|---|---|
SE | Sp | PPV | NPV | SE | Sp | PPV | NPV | |||
(95% C.I.) | (95% C.I.) | (95% C.I.) | (95% C.I.) | (95% C.I.) | (95% C.I.) | (95% C.I.) | (95% C.I.) | |||
Age (m)
| ||||||||||
1 – 11 | 194 | 39.7 | 100.0 | 70.9 | 69.4 | 100.0 | 98.7 | 94.0 | 91.6 | 99.1 |
94.7-100.0 | 67.4-70.9 | 65.7-69.4 | 95.1-100.0 | 93.5-99.9 | 90.6-94.8 | 86.8-92.7 | 95.5-100.0 | |||
12 – 59 | 401 | 64.1 | 100.0 | 39.6 | 74.7 | 100.0 | 100.0 | 86.8 | 93.1 | 100.0 |
98.3-100.0 | 36.6-39.6 | 73.5-74.7 | 92.5-100.0 | 98.4-100.0 | 84.0-86.8 | 91.6-93.1 | 96.7-100.0 | |||
≥ 60 | 99 | 42.4 | 100.0 | 68.4 | 70.0 | 100.0 | 100.0 | 94.7 | 93.3 | 100.0 |
91.1-100.0 | 61.9-68.4 | 63.8-70.0 | 90.4-100.0 | 92.3-100.0 | 89.1-94.7 | 86.2-93.3 | 94.0-100.0 | |||
Season
| ||||||||||
Rainy | 398 | 76.4 | 100.0 | 35.1 | 83.3 | 100.0 | 99.7 | 85.1 | 95.6 | 98.8 |
98.7-100.0 | 30.8-35.1 | 82.2-83.3 | 87.6-100.0 | 98.2-100.0 | 80.5-86.1 | 94.2-95.9 | 93.4-99.9 | |||
Post-rainy | 151 | 36.4 | 100.0 | 46.9 | 51.9 | 100.0 | 100.0 | 87.5 | 82.1 | 100.0 |
92.7-100.0 | 42.7-46.9 | 48.1-51.9 | 91.1-100.0 | 93.2-100.0 | 83.6-87.5 | 76.5-82.1 | 95.5-100.0 | |||
Hot dry | 145 | 11.7 | 100.0 | 78.9 | 38.6 | 100.0 | 100.0 | 97.7 | 85.0 | 100.0 |
78.7-100.0 | 76.1-78.9 | 30.4-38.6 | 96.4-100.0 | 81.7-100.0 | 95.2-97.7 | 69.5-85.0 | 97.5-100.0 |