Our Experience of FIT Screening

We have a lot of experience of engaging FIT: from national screening program to testing at local clinics.

Eiken Chemical launched sales of fully automated FIT analyzer in 1989. Since then, we have been developing automated FIT system “OC-SENSOR” for 30 years worldwide. Approximately 100 million tests are performed per year in more than 45 countries. OC-SENSOR has been used in many academic publications and national guidelines [*3, and see publication page]. 

In some countries, national guidelines recommend fecal immunochemical test (FIT) as a method of population based screening for colorectal cancer [*1 European Commission, *2 UK, *3,4 US, *5 Canada]. In the recommendation statement of U.S. Preventive Service Task Force, our product OC-Sensor is mentioned as “the best test performance characteristics (ie, highest sensitivity and specificity) [*3].”

 

Unique stool collection tool for patients

Collection Paper

Stool sample collection paper: To take stool sample easily and adequately, placing a Collection paper can help catch stool in the toilet bowl. Eiken Chemical provides flushable paper that sampling instruction is printed.

OC-Auto Sampling Bottle 3

Stool sampling devices: OC-Auto Sampling Bottle 3 is a palm-sized stool collection device. Patients scrape the surface of stool with the probe and insert it into the bottle. After closing the device properly, the liquid does not leak out easily. To ensure hygienic transportation and viable measurement of samples each and every time, OC-Auto Sampling Bottle 3 surpasses the testing required by UN3373 (Packaging Requirements for Biological and Infectious Substances).

Envelope (left: for 1 day, right: for 2 days)

Envelope for mailing: We developed an envelope integrating absorbent pat, called Special Envelope, for OC-Auto Sampling Bottle 3. Two types of envelope are available; for 1-day and 2-day sampling method.

Data example

Eiken Quality Control Survey (EQCS): It is an originally developed external quality assessment service for OC-SENSOR users through our distributors. The service started in 1995 and currently more than 600 laboratories from 18 countries (except Japan) participate in the program every year. EQCS supports laboratories to assess their performance objectively by comparison of the testing results among participants.

FIT analyzers for test laboratories

Cutoff value adjusting: Users can choose cutoff to maximize sensitivity and specificity. Studies were conducted to suggest the appropriate values in population screening [*7].

2 sized analyzers: We can offer two different sized fully automated analyzers OC-Sensor PLEDIA and OC-Sensor io which can be chosen according to the scale of screening.

References

  1. Halloran S, Launoy G, Zappa M. European Commission. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First edition – Faecal Occult Blood Testing. Endoscopy 2012; 44:SE65–SE87
  2. National Institute for Health and Care Excellence. NICE guideline NG12. Suspected cancer: recognition and referral. https://www.nice.org.uk/guidance/ng12 Published 2015.
  3. U.S. Preventive Services Task Force. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(23):2564–2575.
  4. U.S. Multi-Society Task Force. Colorectal Cancer Screening: Recommendations for Physicians and Patients From the U.S. Multi-Society Task Force on Colorectal Cancer. Gastrointestinal Endoscopy, 2017; Volume 153, Issue 1, 307 - 323.
  5. Canadian Task Force on Preventive Health Care. Recommendations on screening for colorectal cancer in primary care. CMAJ Mar 2016, 188 (5) 340-348
  6. National Health Service. How should I collect and store a poo (stool) sample?. https://www.nhs.uk/common-health-questions/infections/how-should-i-collect-and-store-a-stool-faeces-sample/ Accessed November 2019.
  7. van Rossum L, van Rijn A, Laheij R, et al. Cutoff value determines the performance of a semi-quantitative immunochemical faecal occult blood test in a colorectal cancer screening programme. Br J Cancer 2009;101, 1274–1281.

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