Faecal immunochemical tests for haemoglobin: Analytical challenges and potential solutions.

Area of Science:

• Clinical Chemistry
• Gastroenterology
• Cancer Screening

Background:

• Quantitative faecal immunochemical tests (FIT) are increasingly utilized globally for colorectal cancer (CRC) screening.
• FIT aids in patient triage for lower bowel symptoms, guiding decisions for further investigations like colonoscopy.
• While clinical utility is established, analytical challenges impact FIT's widespread adoption.

Purpose of the Study:

• To address analytical challenges in quantitative faecal immunochemical tests (FIT).
• To provide an overview of pre-analytical variables affecting FIT performance.
• To discuss quality assurance strategies and propose solutions for internal quality control materials in FIT.

Main Methods:

• Review of pre-analytical variables impacting FIT.
• Discussion of external quality assurance (EQA) schemes for FIT.
• Proposal for third-party internal quality assurance (IQA) materials.
• Summary of standardization and harmonization challenges for FIT methods.

Main Results:

• Identified key pre-analytical variables affecting FIT accuracy.
• Evaluated various approaches for external quality assurance in FIT.
• Proposed a practical solution for accessing third-party IQA materials.
• Highlighted the ongoing need for standardization and harmonization of FIT methods.

Conclusions:

• Addressing pre-analytical variation and implementing robust quality assurance are critical for reliable FIT.
• Standardization and harmonization of FIT methods are essential for consistent global application in CRC screening and diagnostics.
• The International Federation of Clinical Chemistry FIT Working Group's efforts aim to overcome current analytical hurdles.