DiaSorin PTH-MM II RIA Kit Manual De Instrucciones página 9

Printed For Final Review: 10/10/03
ECO Number: 27341
PTH-MM II SAMPLE CALIBRATOR CURVE
FIGURE 1
13. LIMITATIONS OF THE PROCEDURE
13.1 Counting times should be sufficient to prevent statistical error (for example,
accumulation of 2,000 CPM will yield 5% error; 10,000 CPM will yield 1%
error).
13.2 The results of this assay should be used in conjunction with information
available from clinical evaluations and other diagnostic procedures.
13.3 No drugs have been tested for assay interference.
13.4 Any sample reading below the limit of detection of the test (9.8 pmol/L) should
be reported as <9.8 pmol/L.
14. EXPECTED VALUES
Each laboratory should establish its own normal range. Serum human parathyroid
(hPTH) levels were measured in 99 normal males and females using the PTH-MM II
kit. The average hPTH was found to be 48.1 ±11.9 pmol/L (1 S.D.). Individual values
ranged from 28.5 (minimum) to 90.7 (maximum) pmol/L. The average serum hPTH
level in females was 47.0 and in males was 49.4 pmol/L.
There are several ways to express this data:
Normal Value
Range (2 S.D.)
The normal data presented here should be considered as guidelines only. Each
laboratory should establish its own normal range limit based on their own reference
group selection.
10:45 AM
ng/mL
pmol/L hPTH (Tyr 43) 44-68
48.1 ± 11.9 0.14 ± 0.04
24.3 - 71.9 0.07 - 0.22
7
ng/mL
hPTH 1-84
Equivalents
0.45 ± 0.11
0.23 - 0.68