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Table 2 HIV-1 and HIV-2 results (RDTs with separate target lines for HIV-1 and HIV-2)

From: Continuous quality monitoring in the field: an evaluation of the performance of the Fio Deki Reader™ for rapid HIV testing in South Africa

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)

  1. aConcordance includes invalid specimens, but excludes errors and specimens that were not processed
  2. bSpecimens not uploaded to Fionet™ (n = 3)
  3. cSpecimens not captured (n = 4)
  4. dPresence of artefact: discordant HIV-2 positive results affecting overall HIV result
  5. ePresence of cross reactivity: concordant HIV-2 positive results (this was linked to two specimens)
  6. fHCW transcription error
  7. gDeki Reader error