TY - JOUR
T1 - Equivalent Accuracy of 2 Quantitative Fecal Immunochemical Tests in Detecting Advanced Neoplasia in an Organized Colorectal Cancer Screening Program
AU - Wieten, Els
AU - de Klerk, Clasine M.
AU - van der Steen, Annemieke
AU - Ramakers, Christian R.
AU - Kuipers, Ernst J.
AU - Hansen, Bettina E.
AU - Lansdorp-Vogelaar, Iris
AU - Bossuyt, Patrick M.
AU - Dekker, Evelien
AU - Spaander, Manon C.W.
N1 - Publisher Copyright:
© 2018 AGA Institute
PY - 2018/11
Y1 - 2018/11
N2 - 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.
AB - 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.
KW - Accuracy
KW - Diagnostic Yield
KW - iFOBT
KW - Occult Blood Test
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U2 - 10.1053/j.gastro.2018.07.021
DO - 10.1053/j.gastro.2018.07.021
M3 - Article
C2 - 30055170
AN - SCOPUS:85055892843
SN - 0016-5085
VL - 155
SP - 1392-1399.e5
JO - Gastroenterology
JF - Gastroenterology
IS - 5
ER -
