Diesse CHORUS Instructions D'utilisation page 8

4. Place the devices in the Chorus TRIO instrument. Perform
the calibration (if necessary) and the test as reported in the
instrument Operating Manual.
9. TEST VALIDATION
Use the control serum to check the validity of the results
obtained. It should be used as reported in the instrument
Operating Manual. If the instrument signals that the control
serum has a value outside the acceptable range, the calibration
must be repeated. The previous results will be automatically
corrected.
If the result of the control serum continues to be outside the
acceptable range, contact the Scientific Support.
Tel: 0039 0577 319554
Fax: 0039 0577 366605
email: scientificsupport@diesse.it
10. INTERPRETATION OF THE RESULTS
The Chorus TRIO instrument expresses the result in ng/ml
(BCR-457 reference material), calculated on the basis of a lot-
dependent graph stored in the instrument.
The test on the examined serum can be interpreted as follows:
Euthyroid patients with
normal TSH
Patients who underwent
total thyroidectomy with
suppressed TSH
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.
The presence of thyroglobulin antibodies can interfere with the
test results; therefore, parallel dosing of these autoantibodies is
recommended.
12. CALIBRATION RANGE
Calibration range 0.10-78.0 ng/ml
For samples > 78.0 ng/ml retest the diluted sample in the
Negative Control/Sample Diluent (REF 83607 - not supplied with
the kit).
13. REFERENCE RANGE
The expected values in the normal population are between 3 and
50 ng/ml.
14. ANALITICAL SPECIFICITY
A study was conducted using the critical reagents of the kit.
5 samples (3 Negative and 2 Positive) were spiked with the
following potentially interfering factors and then tested:
Rheumatoid factor (1.25 IU/ml - 20 IU/ml)
Bilirubin (5 mg/dl - 100 mg/dl)
Triglycerides (50 mg/dl - 3000 mg/dl)
Hemoglobin (0.6 mg/dl - 10 mg/dl)
The presence in the serum sample of the interfering substances
described above does not affect the test result.
50 ng / ml
(upper limit of normal average
expected)
<0.29 ng/ml
(functional sensitivity)
15. METHOD COMPARISON
In an experimentation 162 samples have been tested with the
Diesse kit and with a competitor kit.
Data are summarized in the following table:
Correlation
Pearson
Spearman
The degree of correlation between the two methods results to
be very high.
16. PRECISION AND REPEATIBILITY
Within run
Sample
Mean
(ng/m)
1 58.3
2 30.1
3 18.8
4 7.5
5 2.4
Between lots
Sample
Mean
(ng/m)
1 58.2
2 37.6
3 20.7
4 5.4
5 2.2
17. REFERENCES
1. Indrasena B.S.H. Use of thyroglobulin as a tumor
marker. World J Biol Chem 2017 February 26; 8(1) ; 8(1):
81-85.
2. Spencer C. A. Clinical Utility of Thyroglobulin Antibody
(TgAb) Measurement for Patients with Differentiated
Thyroid Cancers (DTC). J Clin Endocrinol Metab,
December 2011, 69(12):3615-3627.
3. Giovannella L., M.Clark P., Chiovato L.,Duntas L., Elisei
R., Feldt-Rasmussen U., Leenhardt L., Luster M.,
Schalin-Jantti C., Schott M., Seregini E., Rimmele H.,
Smith J., and A Verburg F.DIAGNOSIS OF ENDOCRINE
DISEASE. Thyroglobulin measurement using highly
sensitive assay in patients with differentiated thyroid
cancer: a clinical position paper. European Jurnal of
Endocrinology (2014) 171, R33-R46.
4. Spencer C., LoPresti J., and Fatemi S. How sensitive
(second-generation) thyroglobulin measurement is
changing paradigms for monitoring patients with
differentiated thyroid cancer, in the absebce or presence
of thyroglobulin autoantibodies. Curr Opin Endocrinol
Diabetes Obes 2014, 21:394-404.
5. Gunter E. Analyte stability and treeze-thaw information
Specimen solution LCC.
DIESSE Diagnostica Senese S.p.A.
Strada dei Laghi 39
53035 Monteriggioni (SIENA)
Italy
IO-09/255-C IFU 86110 - Ed. 23.10.2020
EN 8/24
R 95%CI
0.96 0.95-0.97
0.97 0.96-0.98
Between run
Mean
CV% CV%
(ng/m)
3.0 64.5 6.4
8.3 39.2 7.3
8.5 22.4 5.4
11.7 11.6 6.2
3.8 1.6 5.0
Between Instruments
Mean
CV% CV%
(ng/m)
5.1 63.1 8.1
4.8 39.4 5.7
11.2 21.4 7.2
14.1 11.2 12.5
4.5 1.7 7.6