Verification of the fecal immunochemical test on The OC-SENSOR Ceres device
Year: 2025
Type: article
Abstract: Organized screening programs for the detection of colorectal cancer (CRC) in the Republic of Croatia include testing for occult bleeding in the stool. Traditionally, the guaiac fecal occult blood test (gFOBT) has been used. Another well-established method is the fecal immunochemical test (FIT). In the Department of Medical Biochemistry in Oncology laboratory, at the University Hospital for Tumors, Sestre milosrdnice University Hospital Center, FIT verification was performed on the OC-SENSOR Ceres device according to CLSI guidelines. The parameters of precision, trueness, carryover, stability, and a comparison with gFOBT were assessed. Precision was demonstrated with the calculated expanded relative measurement uncertainty, which was 2,54%, 1,24%, and 5,38%. Accuracy was calculated and shown as bias (2,1%, 0,8%, and 1,3%). Hemoglobin stability in the sample was determined for up to 10 days at 2–8°C (4,95%) and even at room temperature (9,57%). The obtained result for analyte carryover was -0,43%. A comparison of gFOBT and FIT found that gFOBT shows a higher number of false-negative results (38%). Considering all the advantages of FIT compared to gFOBT and the successful verification of the method, it is justified to replace gFOBT with FIT.
Institution: Sisters of Charity Hospital
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4408277853