The FIT used in both health areas is OC‐SensorTM (Eiken Chemical Co.). Use of this FIT in our community has been reported before.15 In short, patients were told to collect a faecal sample from one bowel movement without specific diet or medication restrictions, and each sample was processed as previously reported at each regional reference hospital's laboratory.16 Estimates of f‐Hb were quantitated as μg Hb/g of faeces so that results could be compared across analytical systems.17 FIT performance was assessed using the thresholds of 10 and 20 μg Hb/g faeces. When a patient had more than one FIT determination in the database, only the former was used. Reasons for FIT request were classified into three groups: (a) opportunistic screening (outside the scope of regional CRC screening programmes), (b) study of symptoms and (c) follow‐up of gastrointestinal pathology. An overview of FIT data collection is shown in Figure S1 .
Oc sensor
Manufactured by Eiken Chemical
Sourced in Japan
The OC-Sensor is a laboratory equipment designed to measure and analyze certain chemical compounds. It is a compact and automated device capable of precise quantitative analysis. The core function of the OC-Sensor is to detect and measure the levels of specific chemical substances in a sample, providing accurate data for various analytical applications.
Automatically generated - may contain errors
55 protocols using oc sensor
1
Quantifying Fecal Hemoglobin for Colorectal Cancer Screening
2
Serum CEA and Fecal Hemoglobin in Colorectal Lesions
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Serum CEA levels (ng/mL) were measured using a chemiluminescent microparticle immunoassay (UniCel DXI 800; Beckman Coulter, CA, USA). Abnormal levels were defined as levels above 3 ng/mL [15 (link)]. Fecal hemoglobin (f-Hb) was measured using OC-SensorTM (Eiken Chemical Co., Tokyo, Japan), as previously reported [17 (link)]. Results with f-Hb ≥ 20 µg/g were defined as positive [18 (link)].
All the colonoscopies were conducted by endoscopists who perform at least 200 colonoscopies per year [19 (link)]. Significant colonic lesion (SCL) was defined as histologically confirmed colitis (any etiology), colonic ulcer, advanced adenoma (any adenoma ≥ 10 mm, with high-grade dysplasia or villous histology), polyposis (>10 polyps of any histology), polyps ≥ 10 mm, bleeding angiodysplasia and complicated diverticular disease (diverticulitis, bleeding). Any diagnosed polyp during baseline colonoscopy was removed either upon that exploration or afterwards.
All the colonoscopies were conducted by endoscopists who perform at least 200 colonoscopies per year [19 (link)]. Significant colonic lesion (SCL) was defined as histologically confirmed colitis (any etiology), colonic ulcer, advanced adenoma (any adenoma ≥ 10 mm, with high-grade dysplasia or villous histology), polyposis (>10 polyps of any histology), polyps ≥ 10 mm, bleeding angiodysplasia and complicated diverticular disease (diverticulitis, bleeding). Any diagnosed polyp during baseline colonoscopy was removed either upon that exploration or afterwards.
3
FIT Samples Collection and Analysis
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All patients referred for FIT were posted a faecal sample collection device (OC-Sensor TM Eiken Chemical Co., Tokyo, Japan) as previously described [13] . Participants were asked to sample their faeces according to enclosed instructions, date the sampling device, and return by post within 14 days. Returned samples were logged prospectively, stored and analysed for f-Hb using the automated OC-Sensor TM -iO (Eiken Chemical Co.) according to the manufacturer's protocols, alongside f-Hb controls and with regular calibration as described elsewhere (Appendix S4) [13] .
Analyses were carried out in our United Kingdom Accreditation Service-accredited (ISO 15189) laboratories located at the Eastern Bowel Cancer Screening Hub, Nottingham, UK. These laboratories also take part in the UK National External Quality Assessment Service external quality assessment schemes.
Analyses were carried out in our United Kingdom Accreditation Service-accredited (ISO 15189) laboratories located at the Eastern Bowel Cancer Screening Hub, Nottingham, UK. These laboratories also take part in the UK National External Quality Assessment Service external quality assessment schemes.
4
Fecal Immunochemical Test Utilization in Colorectal Cancer Diagnosis
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All symptomatic patients were allocated to one of two groups as a function of the route to diagnosis:
- Group 1: symptomatic patients with a positive FIT in the 12 months before diagnosis.
- Group 2: “others”: Symptomatic patients that either have not performed any FIT in the previous 12 months before diagnosis or displayed a negative FIT.
We identified all FIT requested between 2009 and 2016 in our health region, the laboratory at Donostia Hospital being the referral laboratory for this region. The system used for testing for occult blood in our region is the OC-Sensor® (Eiken Chemical), an immunochemical test for the specific detection of human haemoglobin with a cut-off for positivity ≥10 μg Hb/g and using a single sample. The cut-off f-Hb was as recommended in NICE DG30 [2 ]. Results < 10 μg Hb/g faeces were reported as f-Hb not detected. The results of this analysis are assessed qualitatively (positive or negative).
- Group 1: symptomatic patients with a positive FIT in the 12 months before diagnosis.
- Group 2: “others”: Symptomatic patients that either have not performed any FIT in the previous 12 months before diagnosis or displayed a negative FIT.
We identified all FIT requested between 2009 and 2016 in our health region, the laboratory at Donostia Hospital being the referral laboratory for this region. The system used for testing for occult blood in our region is the OC-Sensor® (Eiken Chemical), an immunochemical test for the specific detection of human haemoglobin with a cut-off for positivity ≥10 μg Hb/g and using a single sample. The cut-off f-Hb was as recommended in NICE DG30 [2 ]. Results < 10 μg Hb/g faeces were reported as f-Hb not detected. The results of this analysis are assessed qualitatively (positive or negative).
5
Quantitative FIT Screening for CRC
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A subgroup of Hong Kong samples (n=642; 178 CRC, 118 advanced adenoma, 86 non-advanced adenoma and 260 control subjects) were examined by FIT using the automated quantitative OC-Sensor test (Eiken Chemical, Japan). The quantitative OC-Sensor test was performed as our previous description,36 (link) with a positive cut-off value equivalent to a concentration of 100 ng of haemoglobin per millilitre.
6
Population-based CRC Screening in Italy
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In the Emilia-Romagna Region (northern Italy), a population-based CRC screening program has been ongoing since March 2005. The target population includes the residents of both sexes ages 50 to 69 years (n ¼ 1,037,532 on January 1, 2005). The program is run at the health care district level (n ¼ 11) according to a standard protocol.
Every 2 years, eligible subjects are invited with a personal letter to perform a single-sample FIT. Most kits are distributed by public pharmacies and primary care facilities. 9 Nonresponders to the invitation are mailed a reminder, usually within 6 months. The screening test is a latex agglutination test (OC-Sensor; Eiken Chemical Co, Tokyo, Japan) without dietary restrictions. The cut-off value for positivity is 20 mg hemoglobin/g feces (100 ng hemoglobin/mL of buffer). Subjects are notified of negative FIT results by mail. Subjects with positive results are contacted by telephone, invited to attend a screening center, and referred for complete conventional colonoscopy under sedation. In the case of incomplete colonoscopy, patients are presented Q16 with the option of a virtual colonoscopy. Patients with positive FIT results and a negative colonoscopic assessment are re-invited to a FIT screening 5 years later.
Every 2 years, eligible subjects are invited with a personal letter to perform a single-sample FIT. Most kits are distributed by public pharmacies and primary care facilities. 9 Nonresponders to the invitation are mailed a reminder, usually within 6 months. The screening test is a latex agglutination test (OC-Sensor; Eiken Chemical Co, Tokyo, Japan) without dietary restrictions. The cut-off value for positivity is 20 mg hemoglobin/g feces (100 ng hemoglobin/mL of buffer). Subjects are notified of negative FIT results by mail. Subjects with positive results are contacted by telephone, invited to attend a screening center, and referred for complete conventional colonoscopy under sedation. In the case of incomplete colonoscopy, patients are presented Q16 with the option of a virtual colonoscopy. Patients with positive FIT results and a negative colonoscopic assessment are re-invited to a FIT screening 5 years later.
7
Quantitative Fecal Immunochemical Test
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A quantitative FIT (OC-sensor, Eiken Chemical Company, Japan) was used by following the standard operating procedure. Briefly, one fecal sample collection tube containing 2.0 mL of stabilization buffer designed to minimize hemoglobin degradation was distributed to the participants along with an operation brochure. Participants were instructed to collect fecal sample from one bowel movement, and the fecal collection material was sealed in a plastic bag. No medical or dietary restriction was required before conducting the test. The participants were instructed to return the sample collection tube to the community healthcare center in 72 h, where the laboratory tests were performed by the trained staff. For this study, a positivity threshold of 100 ng Hb/mL buffer (equivalent to 20 μg Hb/g feces) was used. The specimens having values ≥20 μg Hb/g feces were classified as positive, and the participants were further recommended to undertake the colonoscopy examination.
8
Faecal Immunochemical Test Screening Protocol
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One of two FIT kits (OC-SENSOR, Eiken Chemical, Tokyo, Japan and HM-JACK, Kyowa Medex, Tokyo, Japan) was provided based on the purchasing policy of the individual municipality or hospital, and a single-spot stool sample was used for testing in this screening programme. A positive test was defined as a result above the defined cut-off of 20 µg haemoglobin (Hb)/g faeces. Test results of FIT, including the measurements of faecal Hb concentration (FHbC), were stored in the screening database of the regional and central governments and all participants were notified of the results by mail and telephone. Participants with positive tests were then referred for colonoscopy as a diagnostic examination within 6 months. The cut-off and number of FIT used for first screening, subsequent screenings and after negative colonoscopy were completely the same.
9
Quantitative Fecal Immunochemical Testing
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The biennial one-day method was adopted, and the choice of FIT kit was based on a local bidding process by each Public Health Bureau or hospital/clinic. Two major brands were available, including the OC-Sensor (Eiken Chemical Co, Tokyo, Japan) and the HM-Jack (Kyowa Medex Co Ltd, Tokyo, Japan) tests; both were quantitative and their cutoff values for a positive test were 100 and 12 ng hemoglobin/mL buffer (8 ng/mL during the period of 2004–2009 for HM-JACK), respectively. Test for equivalence between two tests has been reported previously [3 (link)]. Subjects were asked to submit the stool samples immediately after they were obtained. The analyses of FIT were performed at approximately 125 laboratories certified according to ISO 15189 quality standards.
10
Quantitative Fecal Occult Blood Test
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Blood and a stool sample were obtained one week before colonoscopy. Blood samples were coagulated at room temperature for 20 min, and centrifuged at 2000× g for 15 min. Serum was stored at −20 °C. There were no diet or medication restrictions for stool collection.
The fecal occult blood (µg hemoglobin/g feces) was measured using a quantitative immunological test for the automated OC-Sensor (Eiken Chemical, Tokyo, Japan).
The fecal occult blood (µg hemoglobin/g feces) was measured using a quantitative immunological test for the automated OC-Sensor (Eiken Chemical, Tokyo, Japan).
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