Table 2.
HIV-1 and HIV-2 results (RDTs with separate target lines for HIV-1 and HIV-2)
| Deki Reader Version | RDT brand | HIV-1 Result | HIV-2 Result | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Positive | Negative |
aConcordance n (%) |
Positive | Negative |
a Concordance n (%) |
||||||
| True | False | True | False | True | False | True | False | ||||
| Intra-instrument reproducibility (5 specimens read 3 times on the same instrument (n = 3 instruments)) | |||||||||||
|
bV100 (n = 42) |
First Response® HIV-1-2-0 | 12 | 0 | 30 | 0 | 42 (100) | 13 | d 1 | 28 | – | 41 (97.6) |
| Intra-instrument reproducibility (5 specimens read 5 times on the same instrument) | |||||||||||
|
V200 (n = 50) |
First Response® HIV-1-2-0 | 25 | 0 | 25 | 0 | 50 (100) | 0 | d 5 | 45 | 0 | 45 (90.0) |
| HIV 1/2/0 Tri-Line | 25 | 0 | 25 | 0 | 50 (100) | e 10 | 0 | 40 | 0 | 50 (100) | |
| Inter-instrument reproducibility (5 specimens read across 3 instruments (3 reads per instrument)) | |||||||||||
| bV100 (n = 42) | First Response® HIV-1-2-0 | 12 | 0 | 30 | 0 | 42 (100) | 13 | d 1 | 28 | 0 | 41 (97.6) |
| Inter-instrument reproducibility (10 specimens read across 5 instruments) | |||||||||||
|
cV200 (n = 46) |
First Response® HIV-1-2-0 | 21 | 0 | 25 | 0 | 46 (100) | e 4 | d 1 | 41 | 0 | 45 (97.8) |
| HIV 1/2/0 Tri-Line | 21 | 0 | 25 | 0 | 46 (100) | e 6 | 0 | 40 | 0 | 46 (100) | |
| Laboratory-derived specimen concordance (n = 158) | |||||||||||
|
V200 (n = 158) |
First Response® HIV-1-2-0 | 110 | f,g 5 | 43 | 0 | 153 (96.8) | 13 | g 6 | 137 | f 2 | 150 (94.9) |
| HIV 1/2/0 Tri-Line | 112 | f,g 7 | 39 | 0 | 151 (95.6) | 45 | g 5 | 101 | f 7 | 146 (92.4) | |
aConcordance includes invalid specimens, but excludes errors and specimens that were not processed
bSpecimens not uploaded to Fionet™ (n = 3)
cSpecimens not captured (n = 4)
dPresence of artefact: discordant HIV-2 positive results affecting overall HIV result
ePresence of cross reactivity: concordant HIV-2 positive results (this was linked to two specimens)
fHCW transcription error
gDeki Reader error