Table 3.
Performances and differences in performances among study sites and RDTs
Test parameter | Site | SD Bioline HRP2 | CareStart HRP2 | CareStart pLDH | SD Bioline HRP2 vs CareStart HRP2 | SD Bioline HRP2 vs CareStart pLDH | CareStart HRP2 vs CareStart pLDH | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | [95 % CI] | % | [95 % CI] | % | [95 % CI] | Diff % | [95 % CI] | Diff % | [95 % CI] | Diff % | [95 % CI] | ||
Sensitivity | Mbarara | 98.4 | [96.0 to 99.6] | 98.8 | [96.6 to 99.8] | 96.1 | [92.9 to 98.1] | −0.4 | [−1.5 to 0.8] | 2.3 | [−0.2 to 4.9] | 2.7 | [0.3 to 5.1]* |
Kazo | 99.2 | [97.3 to 99.9] | 98.9 | [96.7 to 99.8] | 94.7 | [91.2 to 97.0] | 0.4 | [−0.7 to 1.5] | 4.6 | [1.7 to 7.5]*** | 4.2 | [1.2 to 7.2]** | |
Diff | −0.8 | [−2.6 to 1.0] | 0.0 | [−1.9 to 1.8] | 1.4 | [−2.2 to 5.0] | |||||||
Specificity | Mbarara | 98.9 | [98.5 to 99.2] | 98.8 | [98.5 to 99.1] | 99.8 | [99.6 to 99.9] | 0.0 | [−0.1 to 0.2] | −0.9 | [−1.2 to −0.6]*** | −0.9 | [−1.2 to −0.6]*** |
Kazo | 79.7 | [73.4 to 85.1] | 80.7 | [74.5 to 86.0] | 93.9 | [89.6 to 96.8] | −1.0 | [−2.9 to 0.9] | −14.2 | [−19.8 to −8.6]*** | −13.2 | [−18.6 to −7.8]*** | |
Diff | 19.2 | [13.6 to 24.8]$$$ | 18.1 | [12.6 to 23.6]$$$ | 5.8 | [2.5 to 9.2]$$$ | |||||||
Misclassification | Mbarara | 1.1 | [0.9 to 1.5] | 1.2 | [0.9 to 1.5] | 0.4 | [0.3 to 0.7] | 0.0 | [−0.1 to 0.1] | 0.7 | [0.4 to 1.0]*** | 0.7 | [0.4 to 1.0]*** |
Kazo | 9.2 | [6.7 to 12.2] | 8.9 | [6.5 to 11.9] | 5.7 | [3.7 to 8.2] | 0.2 | [−0.7 to 1.2] | 3.5 | [0.5 to 6.5]* | 3.3 | [0.3 to 6.2]* | |
Diff | −8.0 | [−10.7 to −5.4]$$$ | −7.8 | [−10.4 to −5.1]$$$ | −5.2 | [−7.4 to −3.1]$$$ | |||||||
Positive predictive value | Mbarara | 83.2 | [78.5 to 87.2] | 82.7 | [70.0 to 86.7] | 95.7 | [92.5 to 97.8] | – | – | – | |||
Kazo | 86.7 | [82.3 to 90.3] | 87.2 | [82.9 to 90.8] | 95.4 | [92.1 to 97.6] | – | – | – | ||||
Diff | −3.5 | [−9.2 to 2.2] | −4.5 | [−10.2 to 1.2] | 0.3 | [−3.2 to 3.9] | |||||||
Negative predictive value | Mbarara | 99.9 | [99.8 to 100.0] | 99.9 | [99.8 to 100.0] | 99.8 | [99.6 to 99.9] | – | – | – | |||
Kazo | 98.7 | [95.5 to 99.8] | 98.1 | [94.7 to 99.6] | 93.0 | [88.5 to 96.1] | – | – | – | ||||
Diff | 1.2 | [−0.6 to 2.9]$ | 1.8 | [−0.3 to 3.9]$ | 6.8 | [3.3 to 10.4]$$$ |
* Exact McNemar’s p value <0.05
** Exact McNemar’s p value <0.01
*** Exact McNemar’s p value <0.001
$ Fisher’s exact p value <0.05
$$ Fisher’s exact p value <0.01
$$$ Fisher’s exact p value <0.001