Table 1.
Precision of the Deki Reader using laboratory derived specimens
| 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) | |
aNumbers indicate concordant invalid results from both Deki Reader and HCW. No false invalid specimens were observed
bConcordance includes invalid specimens, but excludes errors and specimens that were not processed
cSpecimens not uploaded to Fionet™ (First Response® HIV 1–2-0 n = 3; Uni-Gold HIV n = 9)
dPresence of artefact
eHCW transcription error
fSpecimens not captured by HCW (First Response® HIV-1-2-0 n = 4; HIV 1/2/0 Tri-Line n = 4)
g Deki Reader error (n = 2)