Ostalo
https://doi.org/10.20471/LO.2024.52.02-03.19
Verification of the fecal immunochemical test on the OC-SENSOR Ceres device
Antonia Šoić
; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Sanja Langer
; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Zvjezdana Špacir-Prskalo
; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Mihaela Gaće
; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Milica Vrbančić
; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Ines Sever
; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Ljiljana Mayer
; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Sažetak
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.
Ključne riječi
fecal immunochemical test (FIT); verification; colorectal cancer screening; stability; guaiac fecal occult blood test (gFOBT)
Hrčak ID:
328798
URI
Datum izdavanja:
6.3.2025.
Posjeta: 1.216 *