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Table 4 Clinical evaluation of the Deki Reader v100

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

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

  1. 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
  2. bSOC positive and Deki Reader invalid. Specimen was incorrectly processed and reported; this a HCW error. See Fig. 3c