Diesse Chorus fT4 Instrucciones De Uso página 7

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10. INTERPRETATION OF THE RESULTS
The Chorus TRIO instrument expresses the result in pmol/l (ng/dl
= pmol/l/12.87) calculated on the basis of a lot-dependent graph
stored in the instrument.
The test on the examined serum can be interpreted as follows:
Hypothyroid
Euthyroid
Hyperthyroid
11. LIMITATIONS
All the values obtained require a careful interpretation that must
consider other indicators relative to the patient.
The test, indeed, cannot be used alone for a clinical diagnosis
and the test result should be evaluated together with the patient
history and other clinical diagnostic evaluation.
12. CALIBRATION RANGE
Calibration range 2.6 - 96.5 pmol/l
For samples > 96.5 pmol/l repeat the test pre-diluting the sample
in PBS 1X.
13. REFERENCE RANGE
Among the normal population the expected values, which have
been determined by examining 120 sera from healthy donors,
were between 11.7 and 24.5 pmol/l.
14. ANALITICAL SPECIFICITY
A study has been conducted using the kit reagents in presence
of potentially interfering substances such as Triiodothyronine,
Monoiodotyrosine, Diiodotironine, Triiodothyroacetic acid and
Tetraiodothyroacetic acid.
The presence of these substances does not significantly alter the
test results.
15. METHOD COMPARISON
In an experimentation 90 samples have been tested with Diesse
kit and with a competitor kit.
Data are summarized in the following table:
Correlation
Pearson
Spearman
The correlation between the two methods is very high (Pearson)
and high (Spearman).
16. PRECISION AND REPEATIBILITY
Within run
Sample
Mean
(pmol/l)
1 27.7
2 16.4
3 33.2
4 42.6
< 11.6
11.6 – 25.7
> 25.7
r 95%CI
0.92 0.88-0.95
0.70 0.52-0.76
Between run
Mean
CV% CV%
(pmol/l)
4.2 13.1 7.5
3.5 18.8 11.5
2.5 37.5 5.9
2.8 8.70 10.1
Between lots
Sample Mean
(pmol/l)
1 14.6
2 23.9
3 38.2
4 9.27
17. REFERENCES
1. Rousset B, Dupuy C., Miot F. and Dumond J. Rhyroid
Hormone Synthesis and Secretion. South Dartmouth (MA):
MDText.com, Inc.; 2000-2015 Sep 2
2. Sapin R., Schlienger JL. Thyroxine (T4) and tri-iodothyronine
(T3) determinations: techniques and value in the
assessment of thyroid function. Ann Biol Clin (Paris). 2003
Jul-Aug; 61(4):411-20.
3. Truter I. Clinical review: hyper- and hypothyroidism S Afr
Pharm 2011 Vol 78 No 6.
4. Petrone L., Forti G.. Diagnosi e monitoraggio nei pazienti con
sospetto ipertiroidismo e ipotiroidismo. Toscana Medica
8/2017, 34-37.
5. Daval S., Tridon A., Mazeron N., Ristori J.M. and Evrard B.
The Effect of freezing, thawing and short and long-term
storage on serum thyrotropin, thyroid hormones and thyroid
autoantibodies: implications for analyzing samples stored in
serum banks. Clin Chem. Nov; 53(11): 1986-1987 (2007).
DIESSE Diagnostica
S.p.A.
Via delle Rose 10
53035 Monteriggioni (Siena)
Italy
IO-09/335-C IFU 86520 – Ed. 07.06.2018
EN 7/22
Between Instruments
Mean
CV% CV%
(pmol/l)
10.1 14.6 4.2
13.1 23.9 1.0
2.1 38.2 2.6
7.6 9.26 10.9
Senese