Table 4.
Clinical evaluation of the Deki Reader v100
| RDT brand | Result compared to SOC | aConcordance n (%) | Error/not analysed (Deki) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| HIV positive | HIV negative | aSensitivity % (95%CI) | aSpecificity % (95%CI) | Deki & HCW invalid (true) | |||||
| True | False | True | False | ||||||
| Algorithm 1: Screening: Advanced Quality Anti-HIV (1&2); Confirmatory: HIV 1/2/0 Tri-Line | |||||||||
| Advanced Quality Anti-HIV (1&2) (n = 2463) | 386 | 15 | 1817 | 2 |
99.5 (98.2–99.9) |
99.2 (98.7–99.5) |
32 | 2252 (99.3) | 196 |
| HIV 1/2/0 Tri-Line (n = 352) | 261 | b 1 | 15 | – |
100 (98.6–99.8) |
93.8 69.8–99.8) |
5 | 281 (99.7) | 70 |
| Algorithm 2: Screening: HIV 1/2/0 Tri-Line Confirmatory: First Response® HIV-1-2-0 | |||||||||
| HIV 1/2/0 Tri-Line (n = 1997) | 153 | 64 | 1588 | – |
100 (97.6–100) |
96.1 (95.1–97.0) |
- | 1741 (96.5) | 192 |
| First Response® HIV 1–2-0 (n = 129) | 115 | – | 1 | – |
100 (96.8–100) |
100 (2.5–100) |
1 | 117 (100) | 12 |
| Overall RDTs (n = 4941) | 915 | 80 | 3421 | 2 |
99.8 (99.2–100) |
97.7 (97.2–98.2) |
38 | 4374 (97.8) | 470 |
aConcordance includes invalid specimens, but excludes errors and specimens that were not analysed. Sensitivity and specificity only includes specimens that gave a valid positive or negative result
bSOC positive and Deki Reader invalid. Specimen was incorrectly processed and reported; this a HCW error. See Fig. 3c