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Two FIT brands accurately detect advanced colorectal neoplasia
Two brands of fecal immunochemical tests were equally accurate in detecting advanced neoplasia, according to data from a head-to-head trial published in Gastroenterology.
Manon C. W. Spaander, MD, PhD, of Erasmus MC University Medical Center in Rotterdam, the Netherlands, and colleagues wrote that FITs are becoming the norm in population screening for colorectal cancer, but the lack of studies comparing different brands has made it difficult to choose the right one.
“In the European guidelines, the quantitative immunochemical tests are recommended as test of choice for population screening,” they wrote. “These guidelines also indicate that a screening program should assess individual device characteristics, including accuracy, ease of use by participant and laboratory, suitability for transport, sampling reproducibility and sample stability. However, comparative data with enough power from head-to-head comparisons to decide on equivalence of FIT brands in detecting [advanced neoplasia] in population screening are not yet available, hindering informed decision making.”
In a large, prospective trial within the Dutch CRC screening program, Spaander and colleagues compared two quantitative brands of FITs – FOB-Gold (Sentinel) and OC-Sensor (Eiken). They randomly invited 42,179 screening-naive individuals to participate in the trial.
Investigators asked participants to perform both FITs using a sample from the same bowel movement. They invited any individual with a positive result – defined as at least 15 µg hemoglobin/gram of feces – from one or both tests to undergo a colonoscopy.
Overall, 21,078 patients completed the tests, 2,112 had at least one positive result (9.6%) and 1,778 completed a colonoscopy.
The FOB-Gold test detected advanced neoplasia in 610 individuals confirmed by colonoscopy (1.45%), while the OC-Sensor test detected advanced neoplasia in 606 participants (1.44%, absolute difference in accuracy = 0.01%; 95% CI, –0.06- 0.08).
Spaander and colleagues determined that 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 for detecting CRC (95% CI, 0.87–1.03). Additionally, they found the false-positive rate of the FOB-Gold vs. OC-Sensor was 0.99 in detecting advanced neoplasia (95% CI, 0.93–1.05).
“As we found no evidence that FOB-Gold and OC-Sensor differ in detecting [advanced neoplasia] and CRC, other features can now guide informed decision making when selecting one of these two brands for FIT-based CRC screening. Probably the next most important consideration is ease of use of the test and its effect on participation rate.”
Other factors, such as costs, speed and sample stability, could also factor into choice of FIT, they wrote. – by Alex Young
Disclosures: The authors report no relevant financial disclosures.