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Instructions for Use380317-C

EnglishOC-FCa Calibrator

V-PH12

INTENDED USE
OC-FCa Calibrator is intended for use as a calibrator used together
with OC-FCa Reagent on the dedicated automated immunochemical
analysers [OC-SENSOR series] to measure faecal calprotectin.
OC-FCa Reagent is in vitro diagnostic assay reagent intended for thequantitative measurement of calprotectin, inflammatory protein, infaeces. The OC-FCa Reagent aids in diagnostic and monitoring of
inflammatory bowel diseases (IBD; e.g. ulcerative colitis, andCrohn’s disease) in conjunction with other clinical findings. The test
can be utilized in diagnostic aid and in monitoring for symptomaticpatients. The test is noninvasive, using stool/faeces as test sample.
The reagent is used on the dedicated automated analysers by
qualified personnel in clinical laboratories and hospitals.
MATERIALS PROVIDED
Product
Product namecode
V-PH12 OC-FCa Calibrator

ContentsStorage

6 × 1 mL

2-8 °C

MATERIALS REQUIRED BUT NOT PROVIDED
Product
Product nameContentscode
OC-FCa Reagent
2 × 8 mL
V-PH11 (OC-SENSOR PLEDIA)
2 × 15 mLReagent
2 × 8 mL
V-PH09 OC-FCa(OC-SENSOR Ceres)2 × 15 mL
V-PH13 OC-FCa Control LV1
2 × 5 mL
V-PH14 OC-FCa Control LV2
2 × 5 mL
V-PH15 OC-FCa Control LV3
2 × 5 mL
V-PH19 OC-SENSOR Sample
3 × 45 mL
V-PH08 Diluent
2 × 20 mL

Storage
2-10 °C
2-10 °C
2-8 °C
2-8 °C
2-8 °C
2-8 °C
2-8 °C

V-PZ25 OC-Auto Sampling Bottle 3

100 bottles

1-30 °C

OC-Auto Sampling Bottle 3
V-PZ26 without barcode

100 bottles

1-30 °CREQUIRED MATERIALS NOT PROVIDED BY THE MANUFACTURER
Prepare these materials before measurement• Wash solution: Sodium hypochlorite 0.15% (0.10%–0.30% isacceptable)• Purified water for wash: Distilled or de-ionized water (1.0-10.0MΩcm is acceptable)• Sample cups
• Printer paper: Thermal printer paper which fits the analyser
REAGENTS
OC-FCa Calibrator is liquid and ready to use requiring no preparation.
For OC-SENSOR PLEDIA, and Ceres
OC-FCa Calibrator
6 × 1 mL
CAL1. 0 µg/g
CAL2. 85 µg/g
CAL3. 340 µg/g
CAL4. 850 µg/g CAL5. 1700 µg/g CAL6. 2720 µg/g
STORAGEOC-FCa Calibrator is stable until the date printed on the label whenstored at 2-8 °C.

6.

7.
8.

9.

No human-derived materials are contained in this product;
however, the risk of infection and the possible existence of otherpathogens cannot be ruled out completely. The product should
be handled carefully in the same manner as patient samples toensure safety.
If reagents get into eye or mouth, rinse it out with large volumeof running water, and perform other first aid required. If
necessary, seek medical attention.
Avoid contamination and evaporation by sealing the bottle
properly with a cap and put it back in the refrigerator after use.
It is advised to minimize the time left in room temperature andkeep the calibrator refrigerated when not in use. In-use stability
can be altered if the instruction is not followed.
Disposal of used reagents and containers should be treated as
medical waste in accordance with applicable regulations.

PROCEDURE
Create the calibration curve in the manner described in the user
manual of the automatic analysers.
[OC-SENSOR PLEDIA]
Add 200 μL (4 drops or more) of 6 levels of OC-FCa Calibrator
individually into 6 sample cups. Set these sample cups on a rackaccording to the user manual and create calibration curve.
[OC-SENSOR Ceres]
Add 150 μL (3 drops or more) of 6 levels of OC-FCa Calibrator
individually into 6 sample cups. Set these sample cups on a rackaccording to the user manual and create calibration curve.
Note: Volume of 1 drop from the vial of OC-FCa Calibrator isapproximately 50 μL.
New calibration should be created:-When the lot of OC-FCa Reagent is changed.
-When the measurement value of OC-FCa Control (LV1/LV2/LV3)
is not within the indicated range or the control range set by eachlaboratory.
-When opened OC-FCa Reagent bottles are re-used after over 2weeks of storage at 2-10 °C.
-When opened OC-FCa Reagent bottles are left onboard for morethan 2 weeks.
-After maintenance support procedures.
In-Use Stability
OC-FCa Calibrator is stable for 2.5 months (10 weeks) afteropening. The stability for this period is kept if it is capped properly
and put back in the refrigerator when not in use. In-use stability canbe altered in case of contamination, evaporation and/or storage at
improper temperatures.
NOTICEIn case of occurrence of any serious incident that has occurred inrelation to the device shall be reported to the authorised
representative, the manufacturer, and the competent authority of theMember State in which the user and/or the patient is established.
EXPLANATION OF SYMBOLSWARNINGS AND PRECAUTIONS
1.
For in vitro diagnostic use only.
2.
Do not freeze this product.
3.
Do not use expired products.
4.
Start analysis immediately after setting the calibrators on a rackto avoid evaporation.
5.
Air bubbles on the surface of the product after being added into
sample cups can cause an erroneous measurement. Thebubbles should be removed.

Date of issuance: 2022-05-26