Table 4.
Sensitivity, specificity, positive and negative predictive values of CareStart™ Malaria 3 line pLDH (Pan, Pf) and OptiMAL-IT® results compared to microscopy
| CareStart™ Malaria pLDH (Pan, PF) | OptiMAL-IT® | |||||||
| Sensitivity | Specificity | Positive Predictive Value | Negative Predictive Value | Sensitivity | Specificity | Positive Predictive Value | Negative Predictive Value | |
| Pf +/- other1 | 93.5 [87.8-96.7] |
97.4 [96.3-98.2] |
78.9 [71.6-84.7] |
99.3 [98.7-99.7] |
95.2 [89.8-97.9] |
94.7 [93.3-95.8] |
65.2 [58.0-71.8] |
99.5 [98.9-99.8] |
| Pf +/- other2 | 89.1 [82.8-93.3] |
98 [97-98.6] |
83.7 [76.9-88.8] |
98.7 [97.9-99.2] |
91.8 [85.9-95.4] |
95.4 [94.1-96.5] |
69.5 [62.4-75.8] |
99 [98.3-99.5] |
| Non-Pf1 | 78.5 [73-83.1] |
97.8 [96.8-98.6] |
89.5 [84.8-92.9] |
95.1 [93.6-96.2] |
90 [85.7-93.1] |
96.5 [95.3-97.5] |
85.9 [81.1-89.6] |
97.6 [96.5-98.4] |
| Non-Pf2 | 77 [71.5-81.8] |
97.9 [96.9-98.6] |
90 [85.3-95.3] |
94.6 [93.1-95.8] |
90.2 [86-93.3] |
97.1 [95.9-97.9] |
88.2 [83.7-91.5] |
97.6 [96.5-98.4] |
| Pf mono-infection1 | 94.7 [88.9-97.5] |
- | - | - | 94.7 [88.9-97.5] |
- | - | - |
| Pf mono-infection2 | 90.5 [84.1-94.5] |
- | - | - | 92.1 [86-95.6] |
- | - | - |
| Pv mono-infection1 | 80.6 [74.9-85.3] |
- | - | - | 91.8 [87.4-94.8] |
- | - | - |
| Pv mono-infection2 | 78.9 [73.2-83.7] |
- | - | - | 92.1 [87.8-94.9] |
- | - | - |
Note
1337 CareStart™ Malaria 3 line pLDH (Pan, PF) tests performed; 21 (1.6%) were invalid, results were missing for 4 (0.3%) tests, thus results of 1312 tests were evaluated.
1328 OptiMAL-IT® tests performed; 10 (0.8%) were invalid, results were missing for 1 (0.1%) test, thus results of 1317 tests were evaluated.
Results expressed as % with 95% confidence intervals in brackets
Specificity not calculated since false positives for species individually cannot be estimated.
1 Solitary gametocytaemia considered as a negative result for that species
2Solitary gametocytaemia considered as a positive result for that species