FIT can be processed, developed, and interpreted at point of care (POC) by different types of health-care professionals or at centralized, automated, accredited laboratories by professionals in laboratory medicine experienced in using analytical systems and interpretation of numerical data. Most FIT in the USA are marketed for POC use. Automated analytical systems for FIT have many advantages [5, 49] over POC manual use and interpretation, including higher throughput and improved analytical accuracy and precision, while eliminating the potential for visual bias by observers. The person developing and interpreting manual tests often needs to wait for a prescribed period of time specified by the manufacturer after application of the feces in solution to the test cassette or strip before reading the test. This is prone to difficulties in a busy clinical setting and accurate interpretation of results for manually developed and interpreted fecal tests requires training and supervision, especially when interpreting borderline results [50–52] (Fig. 4.1). These facts should discourage those who might recommend patients screen themselves with over-the-counter FIT and “at home” development. Another advantage of laboratory analysis is that the user can select the f-Hb cutoff that will initiate further investigation, usually colonoscopy. To enable high analytical quality, we recommend the use of automated FIT systems and interpretation in accredited laboratories in preference to that of POC testing. We strongly recommend the use of laboratories accredited to internationally accepted standards, such as “ISO 15189: Medical Laboratories–Particular Requirements for Quality and Competence.” These will have comprehensive quality management systems in operation and will collect numerical quality indicators such as positivity rate, internal quality control data showing test result variation, imprecision and changes in bias over time, and performance in proficiency testing and external quality assessment.

If we recommend automated development and interpretation of FIT, we must be able to demonstrate the quality and accuracy of the recommended instruments for this task. To this end, the EWG has supported the evaluation of four quantitative FIT systems by the established Guildford Medical Device Evaluation Centre (GMEC) based in England [48]. At the commencement of the evaluation in December 2012, all systems (specimen collection devices and associated measurement instruments) that met criteria prescribed by the NHS Bowel Cancer Screening Programme were included in the evaluation. The following criteria for evaluation were required for systems to be suitable for population-based CRC screening:

For the evaluation, each manufacturer was asked to supply:

Four automated, quantitative FIT devices/analyzers were found to be eligible for evaluation, having met the simple criteria above:

The evaluation assessed the suitability of the specimen collection device for use in a population-screening program, including that of sending it through a postal system, performing to a consistently high analytical quality including analytical precision, suitable measurement range, adequate linearity, appropriate reporting units, and other performance characteristics. The suitability of the specimen collection devices was assessed by a large panel of users and is summarized in the report.

The idea that fecal tests are inferior to structural examinations has been promoted by US gastroenterology and endoscopy societies since 2000 when two screening colonoscopy studies were published in The New England Journal of Medicine [53, 54]. It was reinforced in 2008 with the publication of the “Joint guidelines from the American Cancer Society, the US Multi-society Task Force on Colorectal Cancer, and the American College of Radiology” and with the publication in 2009 of the American College of Gastroenterology “Guidelines for colorectal cancer screening” [1, 3]. Since 2000, screening rates for CRC have increased, but as of 2012 [55]:

This information has led the Centers for Disease Control (CDC) to recommend promoting both fecal test for blood and colonoscopy as viable screening test options to increase CRC screening rates and reduce health disparities. The ACS and the National Colorectal Cancer Roundtable have advised physicians that fecal tests have been shown to decrease both incidence of and mortality from CRC and are reasonable screening test choices [56]. Endoscopic journals have published articles on CRC screening where experts have said: “Colonoscopy remains the dominant CRC screening strategy in the USA but is less effective at preventing right sided CRC than previously thought” and, “FIT has emerged as an effective low cost alternative to colonoscopy and is considered by some an equivalent or superior approach to screening as compared to colonoscopy.” [57] The American College of Physicians (ACP) in its Guidance Statement on Screening for CRC (2012) stated, “Shared decision making is important when selecting a screening test because the currently available colorectal cancer screening tests are believed to be similarly efficacious” [58]. Even a recently published Journal of the American Medical Association (JAMA) patient page on options for colorectal cancer screening states “Evidence does not yet support any one screening test over another, so in deciding which screening option is best for you, consider your personal health situation and talk with your doctor” [59].

This change in US institutional and professional society thinking about the value of screening tests other than optical colonoscopy is very welcome, although with acceptance comes responsibility. More well-designed and comparative, analytical, and clinical effectiveness studies must be government-funded. They are necessary to identify FIT products best qualified for population screening. Further standardization of the analytical and clinical performance characteristics of FIT is urgently needed. Those of us who promote the use of FIT for CRC screening must be sure that only the best FIT are chosen for population screening and that the conditions for collection and handling of samples, analysis, and interpretation of results are of the highest quality. We hope that publication of this chapter will help to achieve this goal.