OC-FCa Reagent
For
OC-SENSOR PLEDIA
OC-SENSOR Ceres
MEASUREMENT OFFAECAL CALPROTECTIN

OC-FCa Control LV1
OC-FCa Control LV2OC-FCa Control LV3OC-FCa Calibrator

OC-FCa Reagent

OC-FCa Reagent FEATURES■ The same OC-Auto Sampling Bottle 3 and OC-SENSOR series can be used
as for the Faecal Immunochemical Test (FIT).
■ Wide measurement range up to 2,720 μg/g
■ OC-Auto Sampling Bottle 3 can be stored at 1 - 30 C before specimen collection.

WHAT IS FAECAL CALPROTECTIN?
Calprotectin is an inﬂammatory protein abundantly presentin neutrophils. 1 The amount of calprotectin in faeces increases
accompanied with intestinal mucosal inﬂammation. 2
OC-Auto Sampling Bottle 3

USE OF CALPROTECTIN
Measuring the amount of calprotectin in faeces can be used for
disease monitoring of inﬂammatory bowel disease (IBD; e.g. ulcerative
colitis, Crohn’s disease) patients and distinguishing IBD fromfunctional intestinal disorders (e.g. Irritable bowel syndrome). 3-5
PRINCIPLE

MEASUREMENT RANGE

Latex agglutination
immunoturbidimetry

Up to 2,720 μg/g
■ OC-SENSOR Ceres■ OC-SENSOR PLEDIALimit of Detection (LOD): 5 μg/g
Limit of Detection (LOD): 9 μg/g
Limit of quantiﬁcation (LOQ): 23 μg/g Limit of quantiﬁcation (LOQ): 22 μg/g

ANALYSERS
OC-SENSOR PLEDIA (Left)
OC-SENSOR Ceres (Right)

MEASUREMENT OF FAECAL CALPROTECTIN
ANALYTICAL PERFORMANCE■ Repeatability and Precision■ DILUTION LINEARITY *Calprotectin solution
3,000

Samples

Precision

SDCVSD

CV

SD

CV

SD

CV

Control LV1

252.7

2.8

1.1%

2.2

0.9%

2.9

1.2%

4.6

1.8%

Control LV2

496.0

4.1

0.8%

2.3

0.5%

4.4

0.9%

6.5

1.3%

Faecal Sample 153.0

3.0

5.6%

1.5

2.8%

0.7

1.4%

3.46.4%

Faecal Sample 2 284.3

2.60.9%

1.3

0.4%

2.7

0.9%

3.9

1.4%

3,000

Correlation below 2,720 μg/g
n=166
y=0.759x + 44.69
r=0.949

2,500
2,000
1,500
1,000
500
00 500 1,000 1,500 2,000 2,500 3,000 3,500
Comparative product (FEIA) (mg/kg)

600
500

2,000
1,500
1,000
500
0500 1,000 1,500 2,000 2,500 3,000
Theoretical Value (μg/g)■ COMPARISON BETWEEN ANALYSERS(OC-SENSOR PLEDIA vs OC-SENSOR Ceres)*Faecal sample*Faecal sample

Correlation below 400 μg/g

3,000

n=121
y=0.926x + 0.47
r=0.929

400
300
200
1000

y=1.009x + 32.400
r=0.9992

2,500

0OC-SENSOR Ceres (μg/g)

3,500OC-FCa Reagent (μg/g(mg/kg))

OC-FCa Reagent (μg/g(mg/kg))■ COMPARISON BETWEEN OTHER PRODUCT(Comparative product (FEIA) vs OC-SENSOR PLEDIA)

Measurement Value (μg/g)

Mean(μg/g)

Repeatability Between-Run Between-Day

2,500

n=168
y=1.034x + 3.105
r=1.000

2,000
1,500
1,000
500
000100 200 300 400 500 600
Comparative product (FEIA) (mg/kg)

500 1,000 1,500 2,000 2,500 3,000
OC-SENSOR PLEDIA (μg/g)

Agreement at each cut-off value

Cut-off value
50 μg/g 6(Distinguishing IBD from functional intestinal disorders)

300 μg/g 6(Monitoring UC disease activity)

Positive agreement

Negative agreement

Overall agreement

95.6% (108/113)

96.9% (62/64)

96.0% (170/177)

96.7% (58/60)

96.6 % (113/117)

96.6% (171/177)

PRODUCT SERIES AND STORAGE
Ready-to-Use: Reagents, Calibrator, Control and Sample Diluent

Product CodeContents

StorageOC-FCa Reagent

V-PH11

Latex 8mL x 2
Buffer 15mL x 2

2-10°C

OC-SENSOR Sample Diluent

V-PH1945mL x 32-8°C

OC-FCa Reagent

V-PH09Latex 8mL x 2
Buffer 15mL x 2

2-10°C

OC-SENSOR Sample Diluent

V-PH0820mL x 22-8°C

Product Name

OC-FCa Calibrator

V-PH12

1mL x 62-8°C

OC-FCa Control LV1

V-PH135mL x 22-8°COC-FCa Control LV2

V-PH145mL x 22-8°COC-FCa Control LV3

V-PH155mL x 22-8°C

OC-Auto Sampling Bottle 3

V-PZ25100 bottles

1–30°C

OC-Auto Sampling Bottle 3 (without barcode)

V-PZ26100 bottles

1–30°C

Compatible Analyser
OC-SENSOR PLEDIA

OC-SENSOR Ceres

OC-SENSOR PLEDIAand OC-SENSOR Ceres*Please check the IFU (instructions for use) carefully before use of this product.
*Reference
1. Dale I et al. Puriﬁcation and partial characterization of a highly immunogenic human leukocyte protein, the L1 antigen.
Eur J Biochem. 1983;134(1):1-6.
2. Røseth AG et al. Assessment of the neutrophil dominating protein calprotectin in feces. A methodologic study.
Scand J Gastroenterology. 1992;27(9):793-798.
3. Tibble et al. A simple method for assessing intestinal inﬂammation in Crohn's disease. Gut. 2000;47(4):506-513.
4. Tibble JA, et al. Use of surrogate markers of inﬂammation and Rome criteria to distinguish organic fromnonorganic intestinal disease. Gastroenterology. 2002;123(2):450-460.
5. Schoepfer AM, et al. Discriminating IBD from IBS: comparison of the test performance of fecal markers,
blood leukocytes, CRP, and IBD antibodies. Inﬂamm Bowel Dis. 2008;14(1):32-39.
6. K. Matsuoka et al. Clinical utility of fecal calprotectin in Japanese patientsJapanese Journal of Medicine and Pharmaceutical Science. 2017;74(6):717-726.
https://www.eiken.co.jp/en/ourﬁelds/gastroenterology/fecal_calprotectin/

6185 BIB
October,2022