CagA IgG EIA WELL REF K6HPG - Radim S.p.A.

Description Expected values
Negative Control < 0.100
OD Cal 240 RU/mL / OD Cal 15 RU/mL > 2.5
OD Cal 15 RU/ mL / OD Cal 0 RU/mL >3.5
If the values obtained are not as expected, it will be necessary to repeat the
assay.
9.3 Interpretation of Results
Reactive and/or questionable samples are to be considered positive for anti-CagA
IgG antibodies, thus indicating that the patient is infected by a CagA-positive H.
pylori strain.
Non-reactive samples are to be considered negative for anti-CagA IgG antibodies,
which indicates that the patient is either not infected by H. pylori, or else is
infected by a CagA-negative H. pylori strain.
10. PERFORMANCES OF THE ASSAY
10.1 Diagnostic Specificity
The diagnostic specificity of the method was evaluated with respect to a Western
Blot assay, over a panel of true negative sera for anti-CagA IgG antibodies. The
result was 100%.
10.2 Diagnostic Sensitivity
The diagnostic sensitivity of the method was evaluated with respect to a Western
Blot assay, over a panel of true positive sera for anti-CagA IgG antibodies. The
result was 93.7%.
10.3 Precision
Precision was evaluated determining the repeatability and the reproducibility of
the assay (intra- and inter-assay variability), on 3 sera at different anti-CagA IgG
concentrations.
Repeatability (Intra-assay)
Sample Mean ± S.D. C.V. Replicates
(RU/mL) % no.
K6HPG –CagA IgG EIA WELL
M197 – Rev.9 – 06/2008 – Pag. 18/ 24