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Clin Biochem. 2013 Mar;46(4-5):365-8. doi: 10.1016/j.clinbiochem.2012.12.010. Epub 2012 Dec 20.

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

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  • 1Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, Canada A1B 3V6. ed.randell@easternhealth.ca

Abstract

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 SENSA; gFOBT) and FIT using the NS-plus system (cutoff=20 μg Hb/g feces or 100 μg 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 °C, room temperature (~23 °C), 4-8 °C, and -20 °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 μg 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.

Copyright © 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

PMID:
23262404
[PubMed - indexed for MEDLINE]
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