OC-Sensor™ is a quantitative FIT (Faecal Immunochemical Test). It detects and measures specifically occult human haemoglobin in stools. FIT may also still be referred to under the traditional label iFOBT (Immunochemical Faecal Occult Blood Test).
Why should you decide on OC-Sensor™?
Comprehensive trial status
The OC-Sensor™ FIT has been assessed throughout Europe in Randomised Controlled Clinical Trials (RCTs), with over 100,000 participants and under stringent evidence-based conditions. The OC-Sensor is a worldwide market-leader, processing over 120 million tests per year, and is used in national screeining programmes in several European countries for the early detection of colorectal cancer (CRC). Some significant trials are detailed here
Higher detection rates
In comparison to the Guaiac test, the detection rate of screening for colorectal cancer is 2-3 times higher with OC-Sensor™ FIT.
In a direct comparison with colonoscopy the OC-Sensor™ demonstrated in a one-off participation (1st round of screening) a sensitivity of 88% for CRC, showing specificity of 91%.
Higher patient participation rates
In contrast to the conventional gFOBT, FIT has no dietary requirements or restrictions and only one stool sample is required (as opposed to three samples needed when using gFOBT). The innovative OC-Sensor™ sample tubes make sample-taking easy and hygienic, which contributes to the higher acceptance rate of this test. Participation rates for FIT screening with OC-Sensor™ were calculated as more than 12% higher compared to gFOBT in pilots.
This higher participation rate is responsible for a higher detection rate. Clinical trials involving OC-Sensor™ FIT also showed a participation rate around 10% higher than that of colonoscopy. In the ‘Intention to screen analysis’ (a result relating to the total number of screening participants invited), even in the first round of screening, the same detection rates were observed for colorectal carcinoma as colonoscopy.
Quality-assured quantitative analysis
The precise, standardised evaluation of OC-Sensor™ FIT takes place in medical laboratories using the latest analysis technology. The fully automated analysis guarantees the best precision and reproducibility – the imperative precondition for quality-assured analysis and quality-assured screening.
The OC-Sensor™ is a quantitative FIT: the exact concentration of haemoglobin in the stool sample is ascertained. The borderline (cut-off) value can be adjusted according to medical-scientific knowledge or the specifications of the screening programme. This corresponds with the requirements of the European guidelines.
In contrast, qualitative FIT can deliver only a yes/no results, relating to a cut-off value that is determined by the respective manufacturer of the test and is unchangeable or unverifiable.