Table 3.
Laboratory evaluation of the Deki Reader comparing device versus SOC results
| Deki Reader Version | RDT brand | Result compared to SOC | aConcordance n (%) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| HIV positive | HIV negative |
aSensitivity % (95%CI) |
aSpecificity % (95%CI) |
Deki & HCW invalid (true) | Deki invalid (false) | |||||
| True | False | True | False | |||||||
| bV100 |
First Response® HIV-1-2-0 (n = 253) |
128 | – | 118 | – |
100 (97.2–100) |
100 (96.9–100) |
7 | – | 253 (100) |
| Determine™ HIV-1/2 Ag/Ab Combo (n = 259) | 135 | c 2 | 94 | d 1 |
99.3 (96.0–100) |
97.9 (92.7–99.8) |
27 | – | 256 (98.8) | |
|
e Uni-Gold HIV (n = 262) |
132 | – | 127 | d 1 |
99.3 (95.9–100) |
100 (97.1–100) |
– | – | 259 (99.6) | |
| Overall (n = 772) | 395 | 2 | 339 | 2 |
99.5 (98.2–99.9) |
99.4 (97.9–99.9) |
34 | – | 768 (99.5) | |
| V200 | First Response® HIV-1-2-0 (n = 158) | 113 | 2 | 43 | – |
100 (96.8–100) |
95.6 (84.9–99.5) |
– | – | 156 (98.7) |
| One Step Anti-HIV (1&2) (n = 158) | 109 | 2 | 40 | – |
100 (96.7–100) |
95.2 (83.8–99.4) |
1 | f 6 | 150 (94.9) | |
|
HIV 1/2/0 Tri-Line (n = 158) |
114 | 5 | 39 | – |
100 (96.8–100) |
88.6 (75.4–96.2) |
– | – | 153 (96.8) | |
| Overall (n = 474) | 336 | 9 | 122 | – |
100 (98.9–100) |
93.1 (87.4–96.8) |
1 | 6 | 459 (96.8) | |
aConcordance includes invalid specimens, but excludes errors and specimens that were not processed. Sensitivity and specificity only includes specimens that gave a valid positive or negative result
bDeki Reader data was adjudicated by Fio as part of the process to optimise the output data (software optimisation)
cAir bubble over control line, linked to RDT
dLine < 50% of width, software adjustments required
eDeki Reader v100 error (n = 2)
fDeki Reader v200 invalid control line