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Instructions for Use
380362-A

SSP available in EUDAMED

OC-SENSOR FIT Latex Reagent

REAGENTS

for OC-SENSOR DIANA, PLEDIA
for OC-SENSOR io
for OC-SENSOR MICROREF V-PZ01
REF V-PH18
REF V-PH33

for OC-SENSOR DIANA, PLEDIA
for OC-SENSOR MICRO, io

REF V-PZ03
REF V-PH46

for OC-SENSOR Ceres

REF V-PH01

OC- SENSOR FIT Buffer
OC- SENSOR FIT

Reagents are stable until the date printed on the label assuming the container remains
unopened at a storage temperature of 2-10 °C.
Latex Reagent (Suspension of latex particles coated with anti-human HbA0 rabbit IgG)
for OC-SENSOR DIANA, PLEDIA ･････15 mL x 5 bottles; approx. 250 tests/bottle
for OC-SENSOR Ceres ･････6 mL x 2 bottles; approx. 115 tests/bottle
Stable for 4 weeks if stored back in a refrigerator after use with cap closed.
Stable for 4 weeks on-board with cap closed after use on DIANA, PLEDIA, and Ceres.
for OC-SENSOR MICRO, io ･････7 mL x 2 bottles; approx. 100 tests/bottle
Stable for 2 weeks on-board with cap closed after use on io and MICRO.
Buffer (50 mM N-2-Hydroxyethylpiperazine-N’-2-ethanesulfonic acid (HEPES))
for OC-SENSOR DIANA, PLEDIA ･････ 500 mL x 1 bottle
for OC-SENSOR MICRO, io ･･････････ 200 mL x 1 bottle
for OC-SENSOR Ceres ･･････････････ 20 mL x 2 bottles; approx. 115 tests/bottle
Stable for 4 weeks on-board on all analysers.
Note: The number of tests per bottle varies depending on the usage.

INTENDED USE

OC-SENSOR FIT reagents are i n v i tr o diagnostic reagents intended for the quantitative
measurement of human haemoglobin in faeces. OC-SENSOR FIT reagents aid in the
diagnosis of colorectal cancer, neoplasia, dysplasia, polyps, and other disorders
associated with gastrointestinal bleeding in conjunction with other clinical findings.
The test can be utilized in colorectal cancer screening for asymptomatic population as
well as in diagnostic aid and monitoring for symptomatic patients. The test isnoninvasive, using stool/faeces as test sample. The reagents are used on the dedicatedautomated analysers by qualified personnel in clinical laboratories and hospitals.

WARNINGS AND PRECAUTIONS

1. For i n v i tr o diagnostic use only.
2. Before performing measurement, be sure to read the instruction manual of theanalyser.
3. Fully prepare and adjust the analyser before measurement.
4. Use OC-FIT Calibrator (REF V-PH51, V-PH52, V-PH02) suitable for the analyser tocreate calibration curve. Follow its instruction for use when to create a new
calibration curve.
5. If the measurement results exceed the measurement range, use Diluent of
Calibrator or OC-SENSOR Sample Diluent (REF V-PH19, V-PH08) to dilute thesample and perform measurement again.
6. Store the reagents at 2-10 °C and avoid freezing.
7. Do not use reagents that have passed their expiration date.
8. On-board stability can vary depending on the conditions of measurement, such as
tests/day and laboratory environment. It is advised to close the bottle of Latex
Reagent with a cap when the measurement is not in process, especially with OCSENSOR MICRO and io.
9. The test sample may contain pathogens. Handle with care. After use, all samples
and other materials must be considered as medical waste and properly disposedof.
Example of treatment: Soak for 1 hour or longer in a sodium hypochlorite solution(available chlorine concentration 1000 ppm or greater). (Neutralize any
substances that contain acids before soaking.) Alternatively, treat in an autoclave
at 121 °C for 20 minutes. (Do not treat any items which sodium hypochlorite haveadhered to in this way.)
10. Dispose of used reagents and containers as medical waste in accordance with local
regulations.
11. If the product is used in any way other than that specified here, the reliability ofmeasurement results cannot be guaranteed. Be sure to follow the procedure.
12. A clinical diagnosis based on the measurement results must be a comprehensive
judgment made by the attending physician, including factors such as clinicalsymptoms and other test results.

SUMMARY

The amount of haemoglobin in faeces increases with illnesses that are accompanied byhaemorrhagic lesions in the digestive tract, particularly in the lower digestive tract.
Therefore, measuring the amount of haemoglobin in faeces is an effective means ofscreening for early detection and treatment of colorectal cancer and other lower
digestive tract illnesses that are accompanied by haemorrhaging.1-7
OC-SENSOR FIT Reagents are immunoassay test reagents and used together with anautomatic analyser for measurement of haemoglobin in faeces. OC-SENSOR FIT Latex
Reagent contains the latex particles coated with anti-human haemoglobin A0 (HbA0)
polyclonal antibodies for optical measurement of the latex agglutination reaction.

PRINCIPLE OF THE METHOD

The test method is based on a latex agglutination reaction. A latex reagent is preparedby coating polystyrene latex particles with anti-human HbA0 antibodies. When thisreagent is mixed with a sample, the anti-human HbA0 antibodies on the latex particles
react with the haemoglobin in the sample, and the latex aggregate is formed in thelatex agglutination reaction. The change in absorbance per unit time resulting from thelatex agglutination reaction is proportional to the concentration of haemoglobin in thesample. A dose response curve of the absorbance unit (OD) vs. concentration is
generated using the results obtained from the calibrators. The concentration of
haemoglobin in the patient sample is determined from this curve.

MATERIALS PROVIDED
Pr od u ct cod e

Pr od u ct n a m e

Co n ten t s

S t o r a ge
2-10 °C

Co m p a ti b l e
a n a l y se r

V-PZ01

OC-SENSOR FIT Latex Reagent

5 x 15 mL

V-PZ03

OC-SENSOR FIT Buffer

1 x 500 mL 2-10 °C

V-PH18

OC-SENSOR FIT Latex Reagent

2 x 7 mL

2-10 °C

io

V-PH33

OC-SENSOR FIT Latex Reagent

2 x 7 mL

2-10 °C

MICRO

V-PH46

OC-SENSOR FIT Buffer

1 x 200 mL 2-10 °C

MICRO, io

V-PH01

OC-SENSOR FIT
Latex Reagent
Buffer2 x 6 mL2 x 20 mL

DIANA,PLEDIA

2-10 °C

LIMITATIONS

The test has not been validated for testing of patients with all existinghaemoglobinopathies. Clinical consideration is recommended.8

SAMPLE COLLECTION• Use the following designated sampling device for collecting specimens.
OC-Auto Sampling Bottle 3 ( REF V-PZ25, V-PZ26） : Sold separately• Collect faecal samples by scraping the surface of the stools in different areas.
• Collect the amount necessary to cover the groove of the probe.
• Check that the faecal sample has become fully suspended in the buffer solution
inside OC-Auto Sampling Bottle 3.

Ceres

PREPARATION OF REAGENTS

OC-SENSOR FIT Latex Reagent for OC-SENSOR PLEDIA, DIANA, MICRO, io

MATERIALS REQUIRED BUT NOT PROVIDED
Pr od u ct cod e

Pr od u ct n a m e

Co n ten t s

Co m p a ti b l e
S t o r a ge
a n a l y se r

V-PH51

OC-FIT Calibrator

1 x 3 mL

2-8 °C

V-PH52OC-FIT Calibrator

1 x 3 mL

2-8 °C

V-PH02
V-PH53
V-PH54
V-PH59OC-FIT Calibrator
OC-FIT Control LV1
OC-FIT Control LV2
OC-FIT Control LV32-8 °C
2-8 °C
2-8 °C
2-8 °C

V-PZ25

OC-Auto Sampling Bottle 3

V-PZ26

OC-Auto Sampling Bottle 3
without barcode

6 x 1 mL
2 x 5 mL
2 x 5 mL
2 x 5 mL
100
bottles
100
bottles

V-PH19
V-PH08

OC-SENSOR Sample Diluent

English3 x 45 mL

MICRO,DIANA
io,
PLEDIA
Ceres

OC-SENSOR FIT Buffer for OC-SENSOR DIANA, PLEDIA, MICRO, io

Ready to use.
Before use, bring the buffer to room temperature (20-25 ℃).
Do not mix buffer from another bottles.
Do not use precipitated buffer, as precipitate may cause problems on analysers.

All

1-30 °C

OC-SENSOR FIT Latex Reagent for OC-SENSOR Ceres

Ready to use.
Before use, invert the bottle gently several times to assure uniform suspension.
Do not mix reagent with another bottle.

All

1-30 °C

2-8 °C

Ready to use.
Before use, bring it to room temperature (20-25 ℃) and invert the bottle gently
several times to assure uniform suspension.
Do not mix reagent with another bottle.

OC-SENSOR FIT Buffer for OC-SENSOR Ceres

Ready to use.
Do not mix buffer from another bottle.
Do not use precipitated buffer, as precipitate may cause problems on analysers.
Note: OC-SENSOR Ceres is equipped with refrigerated reagent slots so that thereagents do not need to be brought to room temperature.

DIANA,PLEDIA,MICRO, io

2 x 20 mL

Ceres

TEST PROCEDUREREQUIRED MATERIALS NOT PROVIDED BY THE MANUFACTURER

Perform measurements according to the instruction manual of the analyser.
1. Set the OC-SENSOR FIT Latex Reagent and Buffer on the designated locations in theanalyser.
2. Input the parameters into the analyser.
3. Check water, wash solution and drain tank volumes.
4. Create calibration curve.
5. Set control materials, OC-FIT Controls as internal control and start measurement.
Make sure the control values are within the acceptable range set by each laboratory.
6. Set samples sampled with OC-Auto Sampling Bottle 3 and start measurement.

Prepare these materials before measurement• Wash solution: Sodium hypochlorite 0.15% (0.10%–0.30% is acceptable)• Purified water for wash: Distilled or de-ionized water(1.0-10.0 MΩcm is acceptable)• Sample cups
• Printer paper: Thermal printer paper which fits the analyser

RESULTSThe reaction of each sample is compared to the calibration curve that has been createdpreviously. The concentration of human haemoglobin (ng/mL) is calculated.
Conversion of units in OC-SENSOR systems is done in the following equation:µg Hb/g stool = 0.2 x (ng Hb/mL buffer)

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Instructions for Use
380362-A
INTERNAL QUALITY CONTROL

Colorectal Cancer and Advanced Adenoma detection rate at cut-off 150 ng/mL (30 µg/
g stool)

Each laboratory should establish a quality control program to monitor the performanceof OC-SENSOR system. It is recommended to use OC-FIT Controls for the quality
control in a laboratory.

Country

OC-FIT Controls : Liquid, ready-to use controls sold separately
LV1 (REF V-PH53)
LV2 (REF V-PH54)
LV3 (REF V-PH59)

FrancePERFORMANCE CHARACTERISTICS

17

CancerAdvanced Adenoma

PPV
(%)
8.5
30.5

Detection Rate(per 1000)
2.3
8.3

N
88,796

1. Specificity
In comparison with haemoglobin A0, OC-SENSOR FIT reagents can measure humanhaemoglobin variants Hb-S and Hb-C. The reactivity of variants can vary.8

One study showed the reference intervals are 25-45 ng/mL (N=739) in the population
with normal colonoscopy findings, and 435-759 ng/mL (N=91) in that with cancer andadvanced adenoma, respectively as 95% confidence interval.2

2. Accuracy
When control samples of known concentration were measured, the value obtained waswithin ±15% of the indicated value.

REFERENCES
1.

3. Cut-off value
It is recommended for each laboratory to establish the cut-off value suitable forpurposes in screening programs or diagnostic use.9-122.

4. Repeatability and Precision
When the same samples were measured in 2 replicates, twice a day, for 20 days
(2x2x20), the coefficient of variation (CV) for the values obtained was 10% or less,using ANOVA analysis. Examples of measurement of controls and faecal samples (N=80
each) using OC-SENSOR PLEDIA and Ceres are shown below.

3.

OC-SENSOR PLEDIA
Repeatability
Mean
Samples(ng/mL)
SD
CV
LV1
148.7
2.0
1.4%
LV2
450.2
8.1
1.8%
LV3
71.4
1.1
1.5%
S1
73.6
1.7
2.3%
S2
109.4
2.3
2.1%
S3
474.3
5.3
1.1%

5.
Between-Run
SD
CV
2.4
1.6%
1.2
0.3%
0.6
0.9%
3.2
4.4%
3.6
3.3%
6.4
1.3%

Between-Day
SD
CV
2.0
1.3%
1.3
0.3%
0.8
1.2%
1.4
1.9%
1.6
1.5%
0.8
0.2%

Precision
SD
CV
3.7
2.5%
8.3
1.8%
1.5
2.1%
3.9
5.3%
4.5
4.1%
8.2
1.7%

OC-SENSOR Ceres
Mean
Samples(ng/mL)
LV1
145.7
LV2
453.0
LV3
73.9
S1
76.2
S2
124.3
S3
461.3

Between-Run
SD
CV
0.5
0.3%
2.5
0.6%
0.9
1.2%
1.4
1.8%
0.9
0.8%
3.4
0.7%

Between-Day
SD
CV
1.7
1.2%
5.4
1.2%
1.1
1.5%
0.7
1.0%
1.1
0.9%
6.3
1.4%

Precision
SD
CV
2.4
1.7%
6.9
1.5%
1.7
2.3%
1.8
2.3%
1.8
1.4%
7.8
1.7%

Repeatability
SD
CV
1.6
1.1%
3.4
0.8%
0.9
1.2%
0.8
1.1%
1.0
0.8%
3.1
0.7%

4.

6.

7.
8.
9.
10.
11.

12.

5. Measurement range
Up to 1000 ng/mL (200 μg/g stool)
Examples of measurement using OC-SENSOR PLEDIA result showed LOD of 9 ng/mL(1.8 µg/g), LOQ of 25 ng/mL (5 µg/g); OC-SENSOR Ceres showed LOD of 6 ng/mL (1.2µg/g), and LOQ of 20 ng/mL (4 µg/g). The values can vary due to faecal samples andwhether/how haemoglobin is spiked

13.
14.

6. Interference and Cross-reactivity
Following substances were added to sample and the test results showed nointerference or cross-reactivity.
-Animal haemoglobin
600 ng/mL of bovine, equine, porcine, goat, sheep, rabbit, turkey and fish Hb-Animal meat extracts
2.0% from beef, pork, chicken, lamb, and fish
2.5% rabbit-Toilet cleaners
10 mg/mL of Nuriper
10 mg/mL Bleach
1.3 mg/mL of Blue Enzyme-Co-existing substances
25 mg/dL Bilirubin (free and conjugated)
2.5 g/dL Protein
0.6% Lipids (intralipids)
4.0 g/dL Glucose
25 µg/mL Peroxidase-Supplements and drugs
2 µg/mL Ascorbic acid
3.1 µg/mL Iron
25 mg/dL Barium sulphate
0.2 µg/mL Laxative
2 mg/mL Glycerol in enema

15.
16.
17.

Mandel JS, Bond JH, Church TR, et al. Reducing mortality from colorectal cancer byscreening for fecal occult blood. Minnesota Colon Cancer Control Study [publishedcorrection appears in N Engl J Med 1993;329(9):672]. N Engl J Med. 1993;328(19):13651371.
Levi Z, Rozen P, Hazazi R, et al. A quantitative immunochemical fecal occult blood test
for colorectal neoplasia. Ann Intern Med. 2007 Feb 20;146(4):244-55.
Ciatto S, Martinelli F, Castiglione G, et al. Association of FOBT-assessed faecal Hbcontent with colonic lesions detected in the Florence screening programme. Br J
Cancer. 2007;96(2):218-221.
Halloran SP, Launoy G, Zappa M; International Agency for Research on Cancer.
European guidelines for quality assurance in colorectal cancer screening and diagnosis.
First Edition--Faecal occult blood testing. Endoscopy. 2012;44 Suppl 3:SE65-SE87.
Mowat C, Digby J, Strachan JA, et al. Faecal haemoglobin and faecal calprotectin as
indicators of bowel disease in patients presenting to primary care with bowel
symptoms. Gut. 2016 Sep;65(9):1463-9.
Lin JS, Perdue LA, Henrikson NB, Bean SI, Blasi PR. Screening for Colorectal Cancer:
An Evidence Update for the U.S. Preventive Services Task Force [Internet]. Rockville(MD): Agency for Healthcare Research and Quality (US); 2021 May. Report No.: 2005271-EF-1.
National Institute for health and Care Excellence. Quantitative faecal immunochemical
tests to guide referral for colorectal cancer in primary care. Diagnostics guidance.
Manchester, UK; 2017 July. DG-30.
Carroll MR, John C, Mantio D, et al. An assessment of the effect of haemoglobin
variants on detection by faecal immunochemical tests. Ann Clin Biochem.
2018;55(6):706-709.
van Rossum LG, van Rijn AF, Laheij RJ, et al. Cutoff value determines the performanceof a semi-quantitative immunochemical faecal occult blood test in a colorectal cancer
screening programme. Br J Cancer. 2009;101(8):1274-81.
Grazzini G, Visioli CB, Zorzi M, et al. Immunochemical faecal occult blood test: numberof samples and positivity cutoff. What is the best strategy for colorectal cancer
screening? Br J Cancer. 2009;100(2):259-65.
Rozen P, Levi Z, Hazazi R, et al. Identification of colorectal adenomas by a quantitative
immunochemical faecal occult blood screening test depends on adenoma
characteristics, development threshold used and number of tests performed. Aliment
Pharmacol Ther. 2009;29(8):906-17.
Fraser CG, Rubeca T, Rapi S, et al. Faecal haemoglobin concentrations vary with sex
and age, but data are not transferable across geography for colorectal cancer
screening. Clin Chem Lab Med. 2014;52(8):1211-1216.
van Rossum LG, van Rijn AF, Laheij RJ, et al. Random comparison of guaiac andimmunochemical fecal occult blood tests for colorectal cancer in a screening
population. Gastroenterology. 2008 Jul;135(1):82-90.
Raginel T, Puvinel J, Ferrand O, et al. A population-based comparison of
immunochemical fecal occult blood tests for colorectal cancer screening.
Gastroenterology. 2013;144(5):918-25.
Zubero MB, Arana-Arri E, Pijoan JI, et al. Population-based colorectal cancer screening:
comparison of two fecal occult blood test. Front Pharmacol. 2014;4:175.
Chiang TH, Chuang SL, Chen SL, et al. Difference in performance of fecal
immunochemical tests with the same hemoglobin cutoff concentration in a nationwide
colorectal cancer screening program. Gastroenterology. 2014;147(6):1317-26.
Pellat A, Deyra J, Coriat R, et al. Results of the national organised colorectal cancer
screening program with FIT in Paris. Sci Rep. 2018;8(1):4162.

NOTICEIn case of occurrence of any serious incident that has occurred in relation to the device
shall be reported to the authorised representative, the manufacturer, and thecompetent authority of the Member State in which the user and/or the patient isestablished.
OC-SENSOR FIT Latex Reagent contains the following material.
ProClin300 CAS No. 55965-84-9
May cause an allergic skin reaction.
Avoid breathing dust/fume/gas/mist/vapours/spray.
Wear protective gloves.
If on skin: Wash with plenty of soap and water.
If skin irritation or rash occurs: get medical attention.
WARNING
Dispose of contents/container in accordance withlocal/regional/national/international regulations.

7. Sample Stability
Performance testing with the sample collection device demonstrated that samples
stored at 2-10 °C for 28 days had 95±14.7%, at 25 °C for 7 days had 96±20.4%, for 14
days had 93±23.5%, and at 30 °C for 7 days had 89±20.5%, for 14 days had 84±23.6%of haemoglobin recovery (in-house data, recovery rate shown as mean±2SD).
However, the haemoglobin in some samples may undergo rapid denaturation ordegradation, resulting in decreased haemoglobin values or false negatives. Samples
should be stored at 2-10 °C and analysed as soon as possible.

Eiken Chemical Co., Ltd.
4-19-9 Taito, Taito-ku, Tokyo, 110-8408 JAPAN
Tel: +81-280-56-1250 Fax: +81-280-56-2422

8. Comparison between analysers
When OC-SENSOR analysers, DIANA, MICRO, io and Ceres are compared with PLEDIA,
there were no significant differences in measurement.

EXPLANATION OF SYMBOLS

9. Traceability and Standard Material
WHO International Standard NIBSC code 98/708, Certified Reference Material (CRM)
522 is used as the standard material. The value was assigned using
cyanmethemoglobin method from the standard material to the internal standard.
10. Clinical Performance
Reports from different screening programs using OC-Sensor systems are
summarized.
Colorectal Cancer detection rate at cut-off 100 ng/mL (20 µg/g stool)
Country
Netherlands
14France15
Spain
16
Taiwan13

Positive Rate
(%)
5.5
3.5
6.6
3.8

PPV
(%)
8.6
7.2
5.1
6.8

Detection Rate(per 1000)
2.3
2.2
3.1
2.1

N
10,322
19,797
11,162747,076

Date of issuance: 2022-05-26

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