Deki Reader Version | RDT brand | Result compared to SOC | bConcordance n (%) | ||||
---|---|---|---|---|---|---|---|
HIV positive | HIV negative | Deki & HCW invalid (true invalid)a | |||||
True | False | True | False | ||||
Intra-instrument reproducibility (5 specimens read 3 times on the same instrument (n = 3 instruments)) | |||||||
V100 (n = 45) | c First Response® HIV-1-2-0 | 25 | d 1 | 16 | – | – | 41 (97.6) |
Determine™ HIV-1/2 Ag/Ab Combo | 29 | – | – | – | 16 | 45 (100) | |
c,g Uni-Gold HIV | 24 | – | 9 | d 1 | – | 33 (97.1) | |
Overall (n = 121c,g) | 78 | 1 | 25 | 1 | 16 | 119 (98.3) | |
Intra-instrument reproducibility (5 specimens read 5 times on the same instrument) | |||||||
V200 (n = 50) | First Response® HIV-1-2-0 | 25 | – | 25 | – | – | 50 (100) |
One Step Anti-HIV (1&2) | 25 | e 1 | 24 | – | – | 49 (98.0) | |
HIV 1/2/0 Tri-Line | 25 | – | 25 | – | – | 50 (100) | |
Overall (n = 150) | 75 | 1 | 74 | – | – | 149 (99.3) | |
Inter-instrument reproducibility (5 specimens read across 3 instruments (3 reads per instrument)) | |||||||
V100 (n = 45) | c First Response® HIV-1-2-0 | 25 | d 1 | 16 | – | – | 41 (97.6) |
Determine™ HIV-1/2 Ag/Ab Combo | 29 | – | – | – | 16 | 45 (100) | |
c,g Uni-Gold HIV | 24 | – | 9 | e 1 | – | 33 (97.1) | |
Overall (n = 121c,g) | 78 | 1 | 25 | 1 | 16 | 119 (98.3) | |
Inter-instrument reproducibility (10 specimens read across 5 instruments) | |||||||
V200 (n = 50) | f First Response® HIV-1-2-0 | 21 | – | 25 | – | – | 46 (100) |
One Step Anti-HIV (1&2) | 25 | – | 24 | d 1 | – | 49 (98.0) | |
f HIV 1/2/0 Tri-Line | 21 | – | 25 | – | – | 46 (100) | |
Overall (n = 142f) | 67 | 0 | 74 | – | – | 141 (99.2) |