DiaSorin PTH-MM II RIA Kit Manual De Instrucciones página 11

Printed For Final Review: 10/10/03
ECO Number: 27341
15.2 TRUENESS: THE ASSAY TRUENESS HAS BEEN CHECKED BY THE
LINEARITY AND THE RECOVERY TEST.
Dilution Parallelism
Serial Dilution Study of Three Patient Samples (values = pmol/L)
Sample Neat
1 >1200
2 800
3 721
ACCURACY
Recovery Study
The PTH-MM II kit demonstrates recovery of known amounts of analyte added.
Recovery values averaged 109.5% ± 14.4% (n = 12).
Background*
Set No.
1 405.9
2 127.7
3 179.3
15.3 Analytical Sensitivity
When defined as the apparent concentration at 2 standard deviations from the counts
at maximum binding, the minimum detectable amount is 9.8 pmol/L.
15.4 Analytical Specificity
Comparison of the cross-reactivity of PTH-MM antibody was made with the following
reference preparations:
Reference Preparation
PTH-MM II Calibrator (hPTH 44-68)
hPTH 1-34
hPTH 65-84
hPTH 1-84
hPTH 39-84
Human PTH values then are reflected most satisfactorily by the synthetic mid-molecule
calibrator and there is good linearity of the hPTH 1-84 with the synthetic mid-molecule
calibrator.
REFER TO LAST PAGE FOR REFERENCES
10:45 AM
1:2 1:4
1,416 1,500
766 892
743 724
Calibrator Measured
Added Value
55.8 469
116.9 508
237 682
590 1186
55.8 189
116.9 281
237 402
590 805
55.8 176
116.9 244
237 385
590 610
% Cross-reactivity
100
<0.01
<0.02
70.2
75.5
9
1:8
1,542
857
634
Percent
Recovery
112.9
897.1
116.5
127.6
109.3
131.7
115.8
114.8
98.9
105.2
111.6
82.9