Diesse CHORUS Tetanus Instructions Pour L'utilisation page 7

10. INTERPRETATION OF THE RESULTS
The Chorus/Chorus TRIO instrument expresses the result in
milli-International Units (mIU/ml) (Who Reference Preparation
76/589), calculated on the basis of a batch-dependent curve
stored in the instrument.
The test on the examined sample can be interpreted as follows:
<100 mIU/mL Basic immunisation reccomended
100-1000 mIU/mL To be controlled after 1-2 years
>1000 mIU/mL To be controlled after 2-4 years
Attention: do not consider the qualitative report N; D/E; P
on the instrument.
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 50-2500 mIU/ml.
13. ANALYTICAL SPECIFICITY
3 samples were spiked with the following potentially interfering
factors and then tested:
Bilirubin (1.9 mg/dl – 30 mg/dl)
Triglycerides (31 mg/dl – 500 mg/dl)
Hemoglobin (0.5 mg/ml – 8 mg/ml)
The presence in the sample of the interfering substances
described above does not affect the test result.
14. METHOD COMPARISON
In an experimentation 173 samples have been tested with
Diesse kit and with a competitor kit.
Data are summarized in the following table:
Immune
Diesse Not immune
Total
Percent Positive Agreement (~Diagnostic Sensitivity):
98.6% CI : 95.0-99.6
95%
Percent Negative Agreement: (~Diagnostic Specificity):
100% CI : 88.9-99.3
95%
The agreement between the two methods is excellent with a
Cohen's Kappa of 0.97.
15. PRECISION AND REPEATIBILITY
Sample
Mean (mIU/ml)
1
2
3
4
Reference
Immune Not immune
139 0
2 32
141 32
Within run
CV%
483.0 3.8
328.9 3.5
93.0 9.5
246.5 10.9
Sample
1
2
3
4
Sample
1
2
3
4
16. REFERENCES
1. Bell, F. et al Combined diphtheria, tetanus, pertussis and
Haemophilus influenzae type b vaccines for primary
immunisation; Archives of Disease in Childhood 75: 298-
303 (1996).
2. Chandler, H.M. et al. A new rapid semi-quantitative
enzyme immunoassay for tetanus. J. Infect., 8: 137
(1984).
3. Eisel, U. et al. Tetanus toxin: primary structure, EMBO J.,
5: 2495 (1986).
4. Melville-Smith, M.E. et al. A comparison of ELISA with the
toxin neutralisation test for the estimation of tetanus
antitoxin. J. Biol. Standard., 11: 137 (1983).
5. Sedgwick, A.K. et al. Rapid quantitative microenzyme-
linked immunosorbent assay for tetanus antibodies. J.
Clin. Microbiol., 18: 104 (1983).
Total
139
34
173
IO-09/381-C IFU 81270-81270/12 – Ed. 16.09.2020
Between run
Mean (mIU/ml)
533.6
317.7
89.8
248.2
Between lots
Mean
CV%
(mIU/ml)
581.6 14.6
383.4 11.6
92.8 11.3
280.6 13.0
DIESSE Diagnostica Senese S.p.A.
Strada dei Laghi 39
53035 Monteriggioni (SIENA)
Italy
EN 7/34
CV%
14.8
14.1
12.2
11.5
Between Instruments
Mean
CV%
(mIU/ml)
583.1 11.8
312.1 13.9
98.8 13.5
256.2 9.8