TY - JOUR
T1 - Impact of preanalytical factors on fecal immunochemical tests
T2 - need for new strategies in comparison of methods
AU - Rubeca, Tiziana
AU - Cellai, Filippo
AU - Confortini, Massimo
AU - Fraser, Callum G.
AU - Rapi, Stefano
PY - 2015
Y1 - 2015
N2 - Background: Harmonization of fecal immunochemical tests for hemoglobin (FIT-Hb) is crucial to compare clinical outcomes in screening programs. The lack of reference materials and standard procedures does not allow the use of usual protocols to compare methods. We propose 2 protocols, based on artificial biological samples (ABS), to discriminate preanalytical and analytical variation and investigate clinical performances. The protocols were used to compare 2 FIT systems available on European markets: the OC-Sensor Diana (Eiken, Tokyo, Japan) and HM-JACKarc (Kyowa-Medex, Tokyo, Japan). Methods: ABS were obtained adding Hb to Hb-free feces. In the first procedure, 35 ABS were collected for each collection device and analyzed on both systems. In the second, 188 ABS (106 positive and 82 negative) were collected and tested on the specific systems. Passing-Bablock (PB), Pearson’s correlation coefficients (R) and Bland-Altman difference analysis were used to compare data. Results: PB, R and mean standard errors for Bland-Altman analysis (Diana vs. Arc) results were 0.93x-0.56: R = 0.97 and 19%; and 1.09x + 5.60: R = 0.96 and -18%; for Diana and Arc devices, respectively. No correlations and no difference in positive/negative assessment were observed with the second protocol. Conclusions: A good correlation was observed in comparing data generated using collection devices on the 2 systems. Manufacturers have developed different sample collection procedures for feces: therefore, data from different systems cannot easily be compared. Adoption of protocols to discriminate preanalytical and analytical variation would be a significant contribution to harmonization of FIT, facilitating data comparison and information acquisition for sample collection strategy and effect of buffers on systems.
AB - Background: Harmonization of fecal immunochemical tests for hemoglobin (FIT-Hb) is crucial to compare clinical outcomes in screening programs. The lack of reference materials and standard procedures does not allow the use of usual protocols to compare methods. We propose 2 protocols, based on artificial biological samples (ABS), to discriminate preanalytical and analytical variation and investigate clinical performances. The protocols were used to compare 2 FIT systems available on European markets: the OC-Sensor Diana (Eiken, Tokyo, Japan) and HM-JACKarc (Kyowa-Medex, Tokyo, Japan). Methods: ABS were obtained adding Hb to Hb-free feces. In the first procedure, 35 ABS were collected for each collection device and analyzed on both systems. In the second, 188 ABS (106 positive and 82 negative) were collected and tested on the specific systems. Passing-Bablock (PB), Pearson’s correlation coefficients (R) and Bland-Altman difference analysis were used to compare data. Results: PB, R and mean standard errors for Bland-Altman analysis (Diana vs. Arc) results were 0.93x-0.56: R = 0.97 and 19%; and 1.09x + 5.60: R = 0.96 and -18%; for Diana and Arc devices, respectively. No correlations and no difference in positive/negative assessment were observed with the second protocol. Conclusions: A good correlation was observed in comparing data generated using collection devices on the 2 systems. Manufacturers have developed different sample collection procedures for feces: therefore, data from different systems cannot easily be compared. Adoption of protocols to discriminate preanalytical and analytical variation would be a significant contribution to harmonization of FIT, facilitating data comparison and information acquisition for sample collection strategy and effect of buffers on systems.
KW - Colorectal cancer screening
KW - Fecal sampling
KW - Fecal test comparison
KW - Fecal test standardization
KW - FIT
KW - Quantitative fecal immunochemical test for hemoglobin
UR - http://www.scopus.com/inward/record.url?scp=84937850538&partnerID=8YFLogxK
U2 - 10.5301/jbm.5000150
DO - 10.5301/jbm.5000150
M3 - Article
C2 - 26044774
AN - SCOPUS:84937850538
VL - 30
SP - e269-e274
JO - International Journal of Biological Markers
JF - International Journal of Biological Markers
SN - 0393-6155
IS - 3
ER -