Evaluation of Hemo Techt NS-Plus system for use in a province-wide colorectal cancer screening program

Objectives: The NS-Plus automated analyzer and fecal immunochemical testing (FIT) testing system (Alfresa Pharma) was evaluated for use in Newfoundland and Labrador's provincial colorectal cancer (CRC) screening program. Design and methods: Various method performance characteristics were evaluated including the sample stability. The sensitivity for detecting neoplastic lesions was evaluated in 249 patients scheduled for colonoscopy. Each patient collected up to 2 samples for both guaiac based testing (Hemoccult (R) SENSA; gFOBT) and FIT using the NS-plus system (cutoff= 20 mu g Hb/g feces or 100 mu g Hb/L) over 2 days. Data was analyzed comparing 1- and 2-day testing strategies. Results: The analyzer showed acceptable linearity, precision, and accuracy. The collection device maintained acceptable sample stability for at least 7 days at: 37 degrees C, room temperature (similar to 23 degrees C), 4-8 degrees C, and -20 degrees C. The 2-day sampling strategy identified 30% (21 of 69) of all neoplastic lesions (low and high grade adenomas and CRC) including 2 of 4 high-grade adenomas and 2 of 2 CRCs. The single day strategy identified the same high-grade adenomas and CRCs but fewer low-grade adenomas (23% of all neoplasia). Reducing the screening cutoff to the estimated 95th percentile of FIT results in the healthy adult population (10 mu g Hb/g feces), detected all high-grade adenomas in the 2-day strategy. Conclusions: The NS Plus automated analyzer system detects clinically significant neoplasms and shows acceptable performance for use in a CRC screening program with the potential for gains in sensitivity by modifying the number of days of screening or through lowering the cutoff. (c) 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.