Evaluation of the analytical performance of the novel NS-Prime system and examination of temperature stability of fecal transferrin compared with fecal hemoglobin as biomarkers in a colon cancer screening program

Abstract

Objective: To examine the analytical aspects of fecal transferrin (Tf) and hemoglobin (Hb) measured on the NS-Prime analyzer for use in a colon cancer screening program. Designs and methods: Method evaluation and temperature stability studies for fecal Tf and Hb were completed. A method comparison was carried out against the NS-Plus system using samples collected from 254 screening program participants. A further 200 samples were analyzed to help determine suitable reference limits for fecal Tf using these systems. Results: The assay for fecal Tf showed acceptable linearity, precision, and recovery, and showed minimal carryover with low potential for impact by the prozone effect. The 95th percentile for fecal Tf obtained for the reference population was 4.9 µg/g feces. The collection device sufficiently maintained fecal Tf and Hb stability for at least 7 days at room temperature, 4 °C, and −20 °C. Fecal Tf and Hb were most stable at 4 °C and −20 °C, but showed considerable loss (20–40%) of both proteins at 37 °C within the first 7 days. Mixing small amounts of blood into diluted fecal samples maintained at 37 °C for various time periods showed >50% loss of both proteins within 1 h of incubation. Conclusions: The NS-Prime analyzer showed acceptable performance for fecal Tf and Hb. These studies suggest that use of both Tf and Hb together as biomarkers will result in higher positivity rates, but this may not be attributed to greater stability of Tf over Hb in human feces. Keywords: Transferrin, Hemoglobin, Colorectal cancer screening, Fecal biomarkers, Fecal occult blood test