Table 2 Comparison of characteristics of HBeAg rapid diagnostic tests and the reference ELISA test

Assay format

IC

IC

IC

ELISA

Analyte

Serum or plasma

Serum or plasma

Serum or plasma

Serum or plasma

Sample volume

100ul

120 μl

3 drops (approx. 75 μl)

100 μl

Regulatory approval

None

None

CE marked

CE marked

Wait time

5–20 min

10–20 min

15 min

1.5 h set up, 4 h incubation

Kit storage conditions

2–30 °C

2–30 °C

2–30 °C

2–8 °C

Cost per unit^a

2.1

4.5

0.4

3.1

Reported sensitivity^b (%, (95% CI))

95.5 (88.9–98.2)

96.3 (92.1–98.6)

99.9 (97.7–100)

99.5 (97.3, 100)

Reported specificity^b (%, (95% CI))

98.6 (96.1–99.5)

97.9 (96.1–99.1)

98.8 (97.0–99.7)

100 (98.5–100)