Instructions for Use

IFU on our website / IFU sul nostro sito web
https://www.eiken.co.jp/en/ifu

341760A-C

SSP available in EUDAMED

OC-LightTM S FIT
Test Strips
Sampling Bottles

English

V-PC52
V-PH82
MATERIALS REQUIRED BUT NOT PROVIDEDINTENDED USE

OC-LightTM S FIT (Faecal Immunochemical Test, also known as iFOBT,
immunochemical faecal occult blood test) is an in vitro manual
immunochemical test intended for the qualitative detection of humanhaemoglobin in faeces. OC-LightTM S FIT aids in the diagnosis ofcolorectal cancer, neoplasia, dysplasia, polyps, and other disorders
associated with gastrointestinal bleeding in conjunction with otherclinical findings. The test can be utilized in colorectal cancer screening
for asymptomatic population as well as in diagnostic aid and monitoringfor symptomatic patients. The test is noninvasive, using stool/faeces
as test sample. The test is used by qualified personnel in clinicallaboratories and hospitals.

• Timing device• Gloves• External Control

WARNINGS AND PRECAUTIONS• For in vitro diagnostic use only.
• For professional and laboratory use.
• The directions for use must be followed carefully for accurate
results.
• Do not reuse Test Strips and Sampling Bottles.
• Do not use Test Strips if canister is damaged or does not seal.
• Do not touch the reagent area of Test Strip or disassemble.
• In case of contact with collection buffer to eye, mouth, or skin,wash thoroughly with plenty of water and see a doctor for proper
treatment if necessary.
• Treat the sample dissolved solution (faecal extraction) and used
Test Strips as if they are potentially infectious.
• Wear disposable gloves when performing the test to avoid
infection.
• In case of sample spill, bleach is recommended for cleaning anddisinfecting.
• Do not use beyond the labelled expiration date. The expiration
date can be found on the carton and bottle labels of the Test
Strips and the bag and bottle labels of the Sampling Bottles.
• Do not use sampling probe directly on a human body.
• Dispose of used Sampling Bottles and Test Strips in accordancewith local requirements.

SUMMARY

The presence of faecal occult blood is associated with gastrointestinal
disorders. Detection of haemoglobin in faeces is an effective means ofscreening for early diagnosis and treatment of colorectal cancer andother lower digestive tract illnesses that are accompanied byhaemorrhaging.1-6 Conventional manual test methods used for thedetection of faecal occult blood do not provide a high degree of
accuracy. Immunochemical tests developed to detect humanhaemoglobin (hHb) are more accurate and do not require special
dietary restrictions.7

PRINCIPLE OF THE METHOD

OC-LightTM S FIT is an in vitro diagnostic device, a qualitative test
designed for the immunochemical detection of hHb in stool specimens.
When the sample end of the Test Strip is dipped in the faecal extract,
the liquid faecal extract wicks through a series of absorbent materials
and contacts colloidal gold conjugated with monoclonal antibodies
specific to hHb. If hHb is present in the sample, it reacts with theantibodies on the colloidal gold. When the gold conjugate with hHbreaches the test region of the membrane, it binds with the immobilised
antibodies also specific to hHb to form a visible reddish/pink line. The
procedural control region of the membrane contains immobilised antimouse antibodies that capture the conjugate independent of thepresence of the hHb, thereby always producing a distinct reddish/pinkline. The reddish/pink line in the procedural control region
demonstrates the validity of the test and assures the operator that thedevice is working properly.

MATERIALS PROVIDED
Productcode

Product nameContents

Storage

V-PC52

OC-LightTM S FIT
Test Strips

10 x 50 strips

2-30 ºC

V-PH82

OC-LightTM S FIT
Sampling Bottles

20 x 50 bottles

2-30 ºC

SPECIMEN COLLECTION

1. Open green cap by turning to the left and pulling upwards.
2. Collect faecal sample by scraping surface of stool widely with thesample probe. Cover the grooved portion of the sample probe
completely with stool sample.
3. Close Sampling Bottle by inserting the sample probe and screwing
the cap tightly to the right. Shake the Sampling Bottle.
DO NOT REOPEN.
4. Fill in all required information and place in a transport bag andsend/bring to laboratory immediately for assay.
Note:• No special dietary restrictions are necessary.
• The faecal samples collected in the OC-LightTM S FIT Sampling
Bottles may be stored at room temperature for up to 15 days or at 28 ºC for up to 30 days. DO NOT FREEZE.

OC-LightTM S FIT Test Strips ---------------------------10 x 50 strips/bottle
Test Strip contains monoclonal anti-hHb antibodies conjugatedcolloidal gold and immobilised anti-mouse antibodies andimmobilised anti-hHb antibodies.
Store Test Strips at 2-30 ºC in their original canister. DO NOTFREEZE. Test Strips are stable until the expiration date printed on
the label.
OC-LightTM S FIT Sampling Bottles ------------------------- 20 x 50 bottles
Sampling Bottle contains 2 mL of buffer solution, containing 50 mM
HEPES buffer and <0.1% sodium azide. It is stable until the
expiration date printed on the label when stored at 2-30 ºC.

1 / 3

TEST PROCEDURE

1. Bring Test Strips and Sampling Bottle containing patient’s faecal
sample to 20-30 ºC. Shake the Sampling Bottle vigorously.
2. Remove an OC-LightTM S FIT Test Strip from the canister. Minimize
the amount of time that the canister is left open and ensure that thecanister is securely closed after opening.
3. Remove the white cap on the Sampling Bottle. Drop the sample endof the Test Strip into the Sampling Bottle.
4. Start a timer.
5. When the timer reaches 5 minutes, read results. Read results asshown under “INTERPRETATIN OF RESULTS”.

INTERPRETATION OF RESULTS

POSITIVE
Carefully look for the appearance of a test line in the Test Region.
ANY reddish/pink coloured line in the Test Region with a coloured
line in the Procedural Control Region is a positive result. Neither theintensity nor the colour should be compared to that of the Procedural
Control line.
NEGATIVE
If no reddish/pink line appears in the Test Region and one line in theProcedural Control Region, the result is negative.
INVALID
If no reddish/pink line appears in the Procedural Control Region, thetest is invalid and must be repeated with a new Test Strip.

• Certain medications such as aspirin and non-steroidal antiinflammatory drugs may cause gastrointestinal irritation andsubsequent bleeding in some patients and cause positive results.
• As with any occult blood test, results obtained with OC-LightTM S FIT
should not be considered conclusive evidence of the presence orabsence of GI bleeding or pathology. The OC-LightTM S FIT isdesigned for preliminary screening. It is not intended to replace otherdiagnostic procedures such as colonoscopy or sigmoidoscopy in
combination with double contrast barium x-ray.
• Because gastrointestinal lesions may bleed intermittently and bloodin faeces is not distributed uniformly, a negative test result does notassure absence of lesion.
• Use of stool samples that are not collected in a Sampling Bottle (REF
V-PH82) following bowel movement may affect the result due toinstability of haemoglobin in stool.
• Urine and excessive dilution of samples with water from the toilet
bowl may cause erroneous test results.
• OC-LightTM S FIT is not for use in testing urine, gastric specimens, orother body fluids.
• OC-LightTM S FIT has not been validated for testing of patients withall existing haemoglobinopathies. Clinical consideration isrecommended.

EXPECTED RESULTS

Positive rates with immunochemical faecal occult blood tests havebeen shown to vary in each patient population depending on the test
used, age and ethnicity of the patient and the predisposition tocolorectal disease and other factors that may be associated with lower
gastrointestinal bleeding.8-10 The OC-LightTM S FIT detects Hb infaeces at levels as low as 50 ng/mL buffer or 10 μg/g stool.

PERFORMANCE CHARACTERISTICS
Clinical Cut-off
10 μg hHb/g stool, or 50 ng hHb/mL buffer

The ability of OC-LightTM S FIT to detect hHb variants was determinedby testing HbS and HbC, in comparison to a reference, HbA0. OCLightTM S FIT detected the presence of these variants, HbA0, HbS andHbC.

QUALITY CONTROLGood laboratory practices recommend the use of appropriate controls
to ensure the proper performance of the test.
Procedural Control
The Procedural Control is found in the Procedural Control Region of
the Test Strip. This control assures the operator that (A) sample
addition and migration through the Test Strip has occurred and that (B)the control anti-mouse antibody and the reporter MAb are intact andfunctional. This control does not ensure that the capture antibody isaccurately detecting the presence or absence of hHb in the sample.
External Control
External controls are used to assure the operator that the capture andconjugated antibodies are present and reactive. External controls will
not detect an error in performing the patient test procedure. Controls
should be assayed once per bottle of Test Strips. To use, unscrew thewhite cap on the Sampling Bottle. Add commercially available control
with known hHb concentration. Replace the white cap and shakevigorously. Follow step three to five of the test procedure. If controls
do not perform as expected, do not use the test results, and repeat thetest.
The buffer in Sampling Bottle may be used as a negative control.

Reproducibility
Reproducibility studies were conducted at three laboratories, using
hHb spiked stool samples, 7 levels of hHb concentrations ranging from0 to 2000 ng/mL (400 μg/g stool). Total of nine operators participatedin the study for over twenty days of testing, utilizing three lots of Test
Strips and Sampling Bottles. The results were compared against the
expected. Repeatability, between lot, between run, between site
reproducibility are analysed, and each were satisfactory. When
combined, overall percent agreement was 98.9% (95%CI 98.3-99.3%),
positive percent agreement was 99.8% (95%CI 99.4-100%), andnegative percent agreement was 97.1% (95%CI 95.5-98.3%).
Sample Stability
Sample stability studies were conducted in house. Human
haemoglobin-free stool was spiked with a known level of humanhaemoglobin to result in the following concentrations: 0, 5, 8, 10, 12,15, and 400 µg/g stool that are equivalent to 0, 25, 40, 50, 60, 75 and2000 ng/mL sampling buffer. The samples in Sampling Bottles are
stored at 15, 25, and 30 °C for 15 days, and at 2, 4, and 8 °C for 30
days. Overall percent agreements against expected results werefavourable at all the temperatures tested.
(1) Stored at room temperature for 15 days
Actual Results

Day 1515ºC

LIMITATIONS• OC-LightTM S FIT is intended only for the detection of hHb in faeces.
It is not advised for use in patients suspected of upper GI bleeding.
• Patients with the following conditions should not be considered fortesting as these conditions may interfere with the test results:• Bleeding haemorrhoids• Constipation bleeding• Urinary bleeding• Menstrual bleeding

25ºC

30ºC

2 / 3

OC-Light S FIT
Positive Results
Negative Results
Total Results
Positive Results
Negative Results
Total Results
Positive Results
Negative Results
Total Results

Expected Results
Positive
Results
284
0
284
284
0
284
283
1
284

Negative
Results
3
154
157
2
155
157
0
157
157

Total
Results
287
154
441
286
155
441
283
158
441

Overall
Percent
Agreement
99.3%

99.5%

99.8%

Clinical Performance
Clinical sensitivity, specificity, positive predictive value (PPV), andnegative predictive value (NPV) of OC-LIGHT by two studies areshown as references. Due to limitation of published study using OCLightTM S FIT with sufficient sample size, studies with OC-LIGHT werecited as equivalence of the two tests were verified in the comparison
study.

(2) Stored in refrigerator for 30 days
Actual Results

Day 30
2ºC

4ºC

8ºC

OC-Light S FIT
Positive Results
Negative Results
Total Results
Positive Results
Negative Results
Total Results
Positive Results
Negative Results
Total Results

Expected Results
Positive
Results
283
1
284
284
0
284
280
4
284

Negative
Results
6
151
157
4
153
157
0
157
157

Total
Results
289
152
441
288
153
441
280
161
441

Overall
Percent
Agreement
98.4%1) In asymptomatic population in screening reported by Chiu et al.11
N=18,296

99.1%

99.1%

Interference Testing
Cross-reactivity studies were performed by adding the following nonhuman haemoglobin (Hb) and tissue extracts as samples. Hb frombovine, equine, goat, porcine, rabbit, sheep, turkey, and fish wasadded to normal stool extracts containing 0 and 50 ng/mL hHb. All tests
with 0 ng/mL hHb with non-human Hb were negative, indicating nocross-reactivity, and all with 50 ng/mL hHb were positive, indicating nointerference to the test. The same test was performed with addition oftissue extracts from beef, chicken, fish, horse, pork, rabbit, goat, andsheep, resulting in no cross-reactivity or interference to the test.
Dietary Testing
A potential interference of dietary substances on the OC-LightTM S FIT
was assessed. Aqueous extracts of raw broccoli, cauliflower,
cantaloupe, horseradish, red radish, parsnip, and turnip were added tothe test device to determine if vegetable extracts cross react with thetest. The extracts were prepared by homogenizing raw vegetable in afood processor and then subsequently centrifuging the extract toseparate the solid and liquid phases. Dietary Iron and Vitamin C
supplements were also tested for cross-reactivity. No cross-reactivity
was evident.
Comparison Study
OC-LightTM S FIT was compared with a previous generation device,
OC-LIGHT. The study was performed at total of six laboratories (threephysician office laboratories and three professional medicallaboratories) with 953 specimens. The overall percent agreement
between OC-LightTM S FIT and OC-LIGHT was 99.9% with positive
percent agreement of 100% and negative percent agreement of 99.9%,
demonstrating that the analytical performance of the two devices issubstantially equivalent.
OC-LIGHT
OC-Light S
Positive Negative
Total
FIT
Results Results Results
Positive121
1
122
Results
Negative
0831
831
Results
Total
121
832
953
Results

Overall
Positive
Percent
Percent
Agreement Agreement(95% CI)(95% CI)

Negative
Percent
Agreement(95% CI)

99.9%

100%

99.9%

(99.4%100%)(97.0%100%)(99.3%100%)

OC-LightTM S FIT was compared with OC-SENSOR FIT, measured
with an automated analyser, with 160 specimens with a cut-off set at
50 ng/mL (10 μg/g stool). The overall percent agreement was 96.9%
with positive percent agreement of 96.0% and negative percent
agreement of 98.3%.
Overall
Positive
Negative
OC-SENSOR FIT
OC-Light S
Percent
Percent
Percent
Positive Negative
Total
FIT
Agreement Agreement Agreement
Results Results Results (95% CI)(95% CI)(95% CI)
Positive97
1
98
Results
96.9%
96.0%
98.3%
Negative
4
58
62
Results(92.9%(90.3%(91.0%Total
98.7%)
98.5%)
99.7%)
101
59
160
Results

Sensitivity

Specificity

PPV

NPV

CRC

78.6%

92.8%

1.65%

99.9%

Advanced neoplasia

30.2%

93.6%

15.0%

97.3%

Advanced adenoma

28.0%

93.5%

13.3%

97.3%

2) In symptomatic population reported by Kaul et al.12
N=112

CRC

Sensitivity

Specificity

PPV

NPV

100%

86.3%

56.6%

100%

REFERENCES
1.

Mandel JS, Bond JH, Church TR, et al. Reducing mortality from colorectal cancer
by screening for fecal occult blood. Minnesota Colon Cancer Control Study[published correction appears in N Engl J Med 1993;329(9):672]. N Engl J Med.
1993;328(19):1365-1371.
2. Levi Z, Rozen P, Hazazi R, et al. A quantitative immunochemical fecal occult blood
test for colorectal neoplasia. Ann Intern Med. 2007;146(4):244-255.
3. Ciatto S, Martinelli F, Castiglione G, et al. Association of FOBT-assessed faecal
Hb content with colonic lesions detected in the Florence screening
programme. Br J Cancer. 2007;96(2):218-221.
4. Valori R, Rey JF, Atkin WS, et al. European guidelines for quality assurance incolorectal cancer screening and diagnosis. First Edition--Quality assurance inendoscopy in colorectal cancer screening and diagnosis. Endoscopy. 2012;44
Suppl 3:SE88-SE105.
5. 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;65(9):1463-1469.
6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for
Colorectal Cancer: US Preventive Services Task Force Recommendation
Statement. JAMA. 2021;325(19):1965-1977.
7. Levin B, Lieberman DA, McFarland B, et al. Screening and surveillance for the
early detection of colorectal cancer and adenomatous polyps, 2008: a joint
guideline from the American Cancer Society, the US Multi-Society Task Forceon Colorectal Cancer, and the American College of Radiology. Gastroenterology.
2008;134(5):1570-1595.
8. van Rossum LG, van Rijn AF, Laheij RJ, et al. Cutoff value determines theperformance of a semi-quantitative immunochemical faecal occult blood test ina colorectal cancer screening programme. Br J Cancer. 2009;101(8):1274-81.
9. 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.
10. Chen SL, Hsu CY, Yen AM, et al. Demand for Colonoscopy in Colorectal Cancer
Screening Using a Quantitative Fecal Immunochemical Test and Age/SexSpecific Thresholds for Test Positivity. Cancer Epidemiol Biomarkers Prev.
2018;27(6):704-709.
11. Chiu HM, Lee YC, Tu CH, et al. Association between early stage colon neoplasms
and false-negative results from the fecal immunochemical test. Clin
Gastroenterol Hepatol. 2013;11(7):832-8.e82.
12. Kaul A, Shah A, Magill FH, Hawkins SA, Skaife P. Immunological faecal occult
blood testing: a discriminatory test to identify colorectal cancer in symptomaticpatients. Int J Surg. 2013;11(4):329-331.

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 the Member State inwhich the user and/or the patient is established.
EXPLANATION OF SYMBOLS

Date of issuance: 2022-05-26
341760A-C

3 / 3