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10.4 Accuracy<br />
Accuracy of the method has been checked by parallelism test.<br />
Parallelism test<br />
A medium TGAb concentration serum was tested at different dilutions with the<br />
Diluent sample.<br />
Dilution Expected<br />
Measured<br />
(IU/mL)<br />
(IU/mL)<br />
S1 undiluted 225.99<br />
1: 2 112.99 86.1<br />
1: 4 56.49 54.42<br />
1: 8 28.24 20.72<br />
1: 16 14.12 12.91<br />
10.5 High-dose Effect<br />
High-dose effect was verified with samples containing high antibody<br />
concentrations .<br />
Concentrations of IgG to Tg ≤ 3.000.000 IU/ml were observed with B/T higher<br />
than last calibrator concentration .<br />
11. LIMITS OF THE ASSAY<br />
The results of the assay must be carefully interpreted and confirmed by clinical<br />
evaluations and further diagnostic tests.<br />
12. SYMBOLS LEGEND: see pag. 19<br />
KT8<strong>CT</strong> – <strong>TgAb</strong> irma <strong>CT</strong><br />
M91 – Rev.01 – 09/2004 – Pag. 18/24
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