Context: - Although promising for colorectal cancer screening, hemoglobin (Hb) stability remains a concern with fecal immunochemical tests. This study implemented a novel, standardized method to compare Hb stability across various fecal immunochemical tests. The method can be used to inform decisions when selecting a kit for use in colorectal cancer screening. In so doing, this work addressed a critical need for standardization in this field.
Objective: - To compare the stability of Hb across 5 different immunochemical kits and one guaiac kit.
Design: - The stability of Hb was analyzed in collection devices inoculated with Hb-spiked feces and (1) stored at various temperatures (frozen, refrigerated, ambient, and elevated) for more than 60 days; (2) after undergoing 3 controlled, freeze-thaw cycles; and (3) after being transported by courier or postal services in uncontrolled temperature conditions from 3 locations in Ontario, Canada, to a central testing center.
Results: - The stability of Hb varied with time and temperature and by kit. Lower Hb recoveries occurred with increasing temperature and increasing time from sample collection to testing. Refrigeration provided the best stability, although results varied across kits (eg, from 4.2 days to >60 days before a prespecified threshold [<70% probability of the test results remaining positive] was reached). Freeze-thaw stability varied across kits and cycles (Hb recoveries: NS Plus [Alfresa Pharma, Chuo-ku, Osaka, Japan], 91.7% to 95.4%; OC Diana [Eiken Chemical, Taito-ku, Tokyo, Japan], 57.6% to 74.9%). Agreement regarding Hb levels before and after transportation varied across kits (from 57% to 100%).
Conclusions: - Important differences in Hb stability were found across the included fecal immunochemical tests. These findings should inform practice-based and population-based colorectal cancer screening.