Table 2. RDT test line specificities for diagnosis of malaria infection in controls and HAT.
Malaria RDT | Test line | % specificity controlsa | % specificity HATb | p-valuec | |
1 | Paracheck Pf | HRP-2 | 100 (95.4–100) | 98.8 (93.5–100) | 1 |
2 | ICT Malaria Pf Cassette Test | HRP-2 | 98.7 (93.1–100) | 87.9 (80.0–94.1)d | 0.009 |
3 | Advantage Pan Malaria Card | pan-pLDH | 86.3 (76.2–93.2) | 30.0 (20.3–41.3) | <0.001 |
4 | Malaria Antigen Pf (HRP-2/pLDH) | HRP-2 | 97.5 (91.1–99.7) | 83.3 (73.6–90.6) | 0.003 |
Pf-pLDH | 100 (95.4–100) | 98.8 (93.5–100) | 1 | ||
Combined | 97.5 (91.1–99.7) | 83.3 (73.6–90.6) | 0.003 | ||
5 | SD malaria Ag Pf/Pan | HRP-2 | 100 (95.4–100) | 90.5 (82.1–95.8) | 0.007 |
pan-pLDH | 100 (95.1–100) | 80.0 (69.6–88.1) | <0.001 | ||
Combined | 100 (95.1–100) | 76.3 (65.4–85.1) | <0.001 | ||
6 | SD Malaria Antigen Pf | Pf-pLDH | 97.5 (91.2–99.7) | 97.6 (91.6–99.7) | 1 |
pan-pLDH | 97.3 (90.5–99.7) | 96.3 (89.4–99.2) | 1 | ||
Combined | 97.3 (90.5–99.7) | 96.3 (89.4–99.2) | 1 | ||
7 | ICT Malaria Combo Cassette Test | HRP-2 | 87.3 (78.0–93.8) | 67.9 (56.8–77.6) | 0.005 |
pan-pLDH | 86.3 (76.2–93.2) | 13.8 (7.1–23.3) | <0.001 | ||
Combined | 79.5 (68.4–88.0) | 11.3 (5.3–20.3) | <0.001 | ||
8 | Carestart Malaria HRP2/pLDH (Pf/Pan) Combo Test | HRP-2 | 92.6 (84.2–97.2) | 79.8 (69.6–87.7) | 0.03 |
pan-pLDH | 98.6 (92.6–99.8) | 76.3 (65.4–85.1) | <0.001 | ||
Combined | 91.8 (83.0–96.9) | 61.3 (50.5–72.0) | <0.001 | ||
9 | Carestart Malaria pLDH (Pf/pan) | Pf-pLDH | 100 (95.4–100) | 100% (95.7–100) | 1 |
pan-pLDH | 100 (95.1–100) | 97.5 (91.3–99.7) | 0.5 | ||
Combined | 100 (95.1–100) | 97.5 (91.3–99.7) | 0.5 | ||
10 | First Response Malaria Ag (pLDH/HRP2) Combo Rapid Diagnostic Test | HRP-2 | 98.7 (93.1–100) | 95.2 (88.3–98.7) | 0.4 |
pan-pLDH | 98.6 (92.6–99.8) | 88.8 (79.7–94.7) | 0.02 | ||
Combined | 97.3 (90.5–99.7) | 86.3 (76.7–92.9) | 0.02 |
HRP-2 and Pf-pLDH N = 79 Pf-PCR negative controls, pan-pLDH test lines n = 73 malaria-PCR negative controls.
HRP-2 and Pf-pLDH N = 84/85 Pf-PCR negative HAT patients (1 blood sample missing), pan-pLDH N = 80/81 malaria-PCR negative HAT patients (1 blood sample missing).
p values for Fisher exact test.
N = 83. The test line for 1 sample could not be scored due to poor background clearance of the test strip.