Abstract:
BACKGROUND & AIMS:Although different brands of fecal immunochemical tests (FITs) are used for colorectal cancer (CRC) screening, few studies have compared their accuracy in detecting advanced neoplasia. METHODS:We performed a large prospective cohort study within the Dutch national CRC screening program to evaluate 2 quantitative FITs: FOB-Gold (Sentinel, Milan, Italy) and OC-Sensor (Eiken Chemical, Tokyo Japan), from May 2016 through March 2017. We randomly selected 42,179 screening-naïve individuals (55-75 years old), who were asked to perform both FITs themselves using the same bowel movement. Participants with positive results from 1 or both FITs (≥15 μg hemoglobin/gram feces) were invited for colonoscopy examination (reference standard). Equivalence in detection of advanced neoplasia was evaluated with a predefined margin of 0.15%. RESULTS:Of 42,179 invitees, 22,064 (52%) participated and FITs were completed for 21,078 participants. Of 2112 participants (9.6%) with 1 or 2 positive results from FITs, 1778 (84%) underwent a colonoscopy. Of all invitees, the FOB-Gold test detected advanced neoplasia (confirmed by colonoscopy) in 610 participants (1.45%) and the OC-Sensor detected advanced neoplasia (confirmed by colonoscopy) in 606 participants (1.44%)-an absolute difference of 0.01% (95% confidence interval [CI], -0.06% to 0.08%). Of the 21,078 participants who completed both FITs, 1582 (7.5%) had a positive result from the FOB-Gold test and 1627 (7.7%) a positive result from the OC-Sensor test (P = .140). The relative true-positive rate of FOB-Gold vs OC-Sensor in detecting advanced neoplasia was 0.97 (95% CI, 0.92-1.01) and 0.95 (95% CI, 0.87-1.03) for CRC. The relative false-positive rate of the FOB-Gold test vs the OC-Sensor test in detecting advanced neoplasia was 0.99 (95% CI, 0.93-1.05). CONCLUSIONS:In a large prospective study of individuals invited for CRC screening in The Netherlands, we found equivalent accuracy of the FOB-Gold FIT vs the OC-Sensor FIT in detecting advanced neoplasia. These results are relevant for selecting FITs for CRC screening programs worldwide. Dutch National Trial Registry: NTR5874.
journal_name
Gastroenterologyjournal_title
Gastroenterologyauthors
Wieten E,de Klerk CM,van der Steen A,Ramakers CR,Kuipers EJ,Hansen BE,Lansdorp-Vogelaar I,Bossuyt PM,Dekker E,Spaander MCWdoi
10.1053/j.gastro.2018.07.021subject
Has Abstractpub_date
2018-11-01 00:00:00pages
1392-1399.e5issue
5eissn
0016-5085issn
1528-0012pii
S0016-5085(18)34809-1journal_volume
155pub_type
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