UV.D.

Lateral flow, stool test

Serum IgG ELISA

Stool Specimens

Ab* alone

Ab Plus samples (Ags)

Approved device

0.43

0.25

+

(Positive control) HpAg in buffer

N/A

N/A

0.43

0.23

+

Negative stool spike with HpAg

N/A

Spiked negative

0.43

0.29

+

Positive

+

3

0.45

0.24

+

Positive

+

3 repeat

0.43

0.28

+

weak Pos.

+/-

1

0.43

0.43

−

Negative

N/D

2**

0.40

0.40

−

Negative

N/D

4

0.43

0.40

−

Negative

N/D

6

0.43

0.40

−

Negative

N/D

4 repeat

0.43

0.43

−

Negative

N/D

3 repeat***

0.43

0.42

−

Negative

N/D

1 repeat ***