title: Evaluation of Hemo Techt NS-Plus system for use in a province-wide colorectal cancer screening program.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, Canada A1B 3V6. ed.randell@easternhealth.ca
authors.forename: Edward
authors.initials: E
authors.lastname: Randell
authors.forename: Marina
authors.initials: M
authors.lastname: Kennell
authors.forename: Altaf
authors.initials: A
authors.lastname: Taher
authors.forename: Scott
authors.initials: S
authors.lastname: Antle
authors.forename: Ford
authors.initials: F
authors.lastname: Bursey
authors.forename: Tony
authors.initials: T
authors.lastname: Tavenor
authors.forename: Michelle
authors.initials: M
authors.lastname: Hammond
authors.forename: Sandra
authors.initials: S
authors.lastname: Stone
authors.forename: Darlene
authors.initials: D
authors.lastname: Mahar
authors.forename: Sharon
authors.initials: S
authors.lastname: Smith
authors.forename: Farah
authors.initials: F
authors.lastname: McCrate
authors.forename: Jerry
authors.initials: J
authors.lastname: McGrath
mesh_terms: D000236:Adenoma / Q000175:diagnosis*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D055088:Early Detection of Cancer / Q000379:methods*; D005243:Feces; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009523:Newfoundland and Labrador; D011446:Prospective Studies