Lab Med Online.  2021 Oct;11(4):245-253. 10.47429/lmo.2021.11.4.245.

Analysis of the Current Status of Liver Cancer Screening Institutions and Proficiency of Institutions that Conduct Alpha-fetoprotein Tests

• Lee JK
• Kim TS
• Song J
• Lee WI
• Jang D
• Kim Y
• Suh M
• Chun S
• Park HD

• KMID: 2526086
• DOI: http://doi.org/10.47429/lmo.2021.11.4.245

Abstract

Background
We sought to evaluate the performance of alpha-fetoprotein (AFP) qualitative reagents and understand the current status of AFP testing by liver cancer screening institutions.
Methods
Using commercial control materials or pooled serum, several AFP qualitative test kits were assessed four times over a total of two years: Humasis AFP Card (Humasis, Korea), Asan Easy Test AFP (Asan Pharmaceutical, Korea), HiSens AFP card (HBI, Korea), Genedia AFP Rapid II (Green Cross MS, Korea), BioTracer (NanoEntek, Korea), and SD Bioline AFP (Alere, Korea). A survey of 600 institutions was conducted in 2016 and 500 institutions in 2018 to determine the current status of AFP testing by liver cancer screening centers. Proficiency testing was conducted on 400 institutions in 2016 and 200 institutions in 2018.
Results
The average concentration of AFP substances was 9.7–275.5 ng/mL after four assessments for AFP qualitative test kits. Given the cutoff value, only one AFP test reagent showed adequate performance in all cases. In the 2016 survey, 29.2% (75/257 institutions) directly conducted the AFP test and 42.7% (32/75 institutions) conducted a qualitative test. In 2018, 19.4% (27/139 institutions) directly conducted the AFP test and 40.7% (11/27 institutions) conducted a qualitative test. The percentage of institutions conducting AFP qualitative testing that participated in the external quality control program was 37.5% (12/32 institutions) in 2016 and 0% (0/11 institutions) in 2018.
Conclusions
It is necessary for institutions that conduct liver cancer screening using AFP qualitative tests to maintain the performance of reagents through internal and external quality control.

Keyword

Alpha-fetoprotein; Cutoff; Quality control; Qualitative reagent; Proficiency testing

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