Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A...

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Biomarker Analysis

Background:

• The harmonization status of most tumor markers (TMs) is largely unknown.
• This study investigates the feasibility of using external quality assessment (EQA) programs to assess TM harmonization.
• Focus on six key TMs: alpha-fetoprotein (AFP), prostate specific antigen (PSA), carcinoembryonic antigen (CEA), cancer antigen (CA)125, CA15-3, and CA19-9.

Purpose of the Study:

• To determine the current harmonization status of six common tumor markers.
• To evaluate the utility of EQA programs in providing insights into TM harmonization.
• To identify specific TMs that may require further harmonization efforts.

Main Methods:

• Utilized EQA sample results from six international EQA providers between 2020-2021.
• Calculated consensus means from common measurement procedures (Abbott Alinity, Beckman Coulter DxI, Roche Cobas, Siemens Atellica) as reference values.
• Compared relative differences of EQA sample means to consensus means against established bias criteria (minimum, desirable, optimal).

Main Results:

• Harmonization was within optimal bias criteria for AFP and desirable bias for PSA across all measurement procedures.
• Carcinoembryonic antigen (CEA) generally met minimum bias criteria, but results <8 µg/L exceeded this threshold.
• Cancer antigen 125 (CA125), CA15-3, and CA19-9 exhibited harmonization outside the minimum bias criteria, indicating systematic differences.

Conclusions:

• EQA programs provide valuable data on the harmonization status of key tumor markers.
• While AFP and PSA demonstrate good harmonization, CEA, CA125, CA15-3, and CA19-9 require further investigation.
• A pilot harmonization study for CEA, CA125, CA15-3, and CA19-9 is recommended.