Table I.
Sensitivity and specificity of the included rapid antigen detection tests on validation, and the SD Biosensor assay on implementation
| Biosynex | Biotical | Orient Gene (validation) | Panbio | SD Biosensor | SD Biosensor (implementation) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sensitivity | Ct value | Median Ct | Range | Median Ct | Range | ||||||
| <20 | 17.7 | 14.6–19.2 | 14/14 (100%) |
14/14 (100%) |
14/14 (100%) |
13/13a (100%) |
14/14 (100%) |
18.4 | 11.7–19.9 | 61/61 (100%) |
|
| 20–<26 | 21.7 | 20.3–25.4 | 18/18 (100%) |
16/18 (88.9%) |
18/18 (100%) |
17/18 (94.4%) |
18/18 (100%) |
23.1 | 20.0–25.9 | 100/108 (92.6%) |
|
| 26–<30 | 28.5 | 26.2–29.9 | 16/18 (88.9%) |
8/18 (44.4%) |
13/18 (72.2%) |
13/18 (72.2%) |
13/18 (72.2%) |
28.2 | 26.1–29.9 | 35/64 (54.7%) |
|
| 30–<36 | 31.3 | 30.8–35.5 | 4/8 (50.0%) |
1/8 (12.5%) |
3/8 (37.5%) |
2/8 (25.0%) |
3/8 (37.5%) |
33.2 | 30.0–35.9 | 4/84 (4.8%) |
|
| >36 | 37.6 | 36.1–42.0 | 0/52 (0.0%) |
||||||||
| Overall | 52/58 (89.7%) |
39/58 (67.2%) |
48/58 (82.8%) |
45/57 (78.9%) |
48/58 (82.8%) |
200/369 (54.2%) |
|||||
| Specificity | Negative samples | 7/23a (69.6%) |
0/24 (100%) |
2/24 (91.7%) |
0/24 (100%) |
0/24 (100%) |
|||||
| Cross-reactivity samples | 14/16 (12.5%) |
0/16 (100%) |
1/16 (93.8%) |
0/16 (100%) |
0/16 (100%) |
||||||
| Overall | 21/39 (46.2%) |
0/40 (100%) |
3/40 (92.5%) |
0/40 (100%) |
0/40 (100%) |
3814/3826 (99.7%) |
Ct, cycle threshold.
a
One sample with insufficient volume to perform the test.