CALIBRATION
Use FOB Calibrator. The value of the calibrator is traceable to Reference
Material WHO International Standard Haemiglobincyanide NIBSC(98/708).
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.
PERFORMANCE CHARACTERISTICS
1.Linearity limit: Up to the maximum value of the calibrator
(aprox.1000 ng/mL), under the described assay conditions. Samples with
higher concentrations should be diluted 1/5 in sample diluent (obtained
from
sample collection tube).The linearity limit depends on the
sample/reagent ratio and the analyzer used.
2.Quantification limit: Values less than 30 ng/mL give non reproducible results.
3.Prozone effect: No prozone effect was detected up to 10000 ng/mL.
4.Precision effect: The reagent has been tested during 20, using two
different hemoglobin concentrations in a EP5(CLSI)-based study.
5.Accuracy: 110 fecal samples were tested, including 12 positives. All results were reported correctly, at the cutoff of 100ng/mL. Results were compared against a immunocromatographic method from another manufacturer.
The results of the performance characteristics depend on the analyzer used
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
Use sample collection tube, following the instructions included in the
package.Store stool samples in collection tube during maximum 7 days
at 2-8ºC. For longer periods freeze the samples at -20ºC and thaw
prior to use.
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