CALIBRATION
Use calprotection Calibrator. Recalibrate when control results are out of
specified tolerances, when using a different lot of reagents and when the instrument is adjusted.
QUALITY CONTROL
Control solutions are recommended to monitor the performance of assay
procedures(Control 1 and Control 2). If control values are found outside
the defined range, check the instrument, reagents and technique for
problems.
Each laboratory should establish its own Quality Control scheme and
corrective actions if controls do not meet the acceptable tolerances.
REFERENCE VALUES
Each laboratory should determine its own normal reference value. A
value＜ 50μg/g might be considered negative for Inflammatory Bowel
Disease, between 50 and 200μg/g weakly positive, and ＞200μg/g high
positive.
PERFORMANCE CHARACTERISTICS
1.Linearity limit: A linearity limit of 2000 μg/g was validated, under the
described assay conditions. Samples with higher concentrations should be
diluted 1/3 in sample diluent (obtained from sample collection tube) and
re-tested.The linearity limit depends on the sample/reagent ratio and the
analyzer used.
2.Quantification limit: Values less than 30 μg/g give non- reproducible
results.
3.Prozone effect: No prozone effect was detected up to 5000 μg/g.
4.Precision effect: Ten replicates of two levels were obtained in two
different days.
STORAGE AND STABILITY
Store at 2-8ºC.
Components are stable once opened until the expiry date marked in the
label if kept at the recommended storage temperature, well closed and if
contamination is prevented during their use.
On board stability: The reagents opened and stored in the refrigerated
compartment of the analyzer are stable for 30 days.
Do not freeze. Reagent deterioration: presence of particles (R1,R2)and
turbidity (R1).
SAMPLES
Collect a sufficient amount of human stool in a clean and dry container
(no preservatives or transport media is necessary).
The raw stool samples can be stored at 2-8ºC for 7 days. If not
immediately tested, stool samples can be frozen and stored at -20ºC for a
maximum of 6 months. In this case, the sample must be totally thawed,
and brought to room temperature (15-30℃) before testing.
Stool samples must be homogenised as thoroughly as possible prior to
preparation.
Use sample collection tube, following the instructions included in the
package. Stool extract is stable at 2-8ºC for 7 days.
NOTES
The clinical diagnosis should not be based on a single test result; the
complete medical history of the patient should be taken into
consideration.
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