Which Fecal Immunochemical Test Should I Choose?

Area of Science:

• Gastroenterology
• Clinical Chemistry
• Medical Diagnostics

Background:

• Fecal immunochemical tests (FITs) are widely used for colorectal cancer (CRC) screening.
• Numerous FITs are available in the United States, but their performance characteristics require thorough evaluation.

Purpose of the Study:

• To review available FITs in the U.S.
• To analyze 2014 proficiency testing (PT) program results for FITs.
• To summarize literature on FIT test characteristics for detecting advanced adenomatous polyps (AAP) and CRC.

Main Methods:

• Searched the FDA's CLIA database for fecal occult blood tests.
• Reviewed 2014 FIT PT program data.
• Conducted a literature review on FIT accuracy using colonoscopy as the gold standard.

Main Results:

• Identified 65 FITs in the CLIA database, with 26 commercially available in the U.S.
• Thirteen FITs underwent regular PT program evaluation, showing high sensitivity (99.1%) and specificity (99.2%) for hemoglobin detection.
• Human studies indicated automated FITs outperform CLIA-waived FITs in detecting AAP and CRC.

Conclusions:

• While many FITs exist, few are validated through PT programs or human studies.
• Automated FITs exhibit the most promising test characteristics for AAP and CRC detection.