Laboratory Medicine and Quality Assurance

Table. 5.

Selection of acceptance criteria for critical difference

Items CD% according to approaches* Selection of optimal CD


I II III V VI CD% Accepted criteria
AFP - 20.0 39.6 20.0 10.8 20.0 II
CA125 - 28.6 25.8 20.0 8.4 8.4 VI
CA15-3 - 40.0 35.5 15.0 10.2 10.2 VI
CA19-9 - 20.0 76.8 15.0 7.8 20.0 II
CEA - 20.0 86.2 16.0 12.0 20.0 II
PSA, total 6.0 20.0 20.9 17.0 6.3 6.0 I
Free PSA - 20.0 20.0 15.0 - 20.0 II
T3 - 10.0 18.3 15.0 10.5 10.0 II
T4 - 14.3 43.7 13.0 7.2 14.3 II
Free T4 - 12.5 28.9 13.0 8.4 12.5 II
Thyroglobulin - 16.9 45.6 - 8.7 16.9 II
TSH 6.0 40.0 78.5 14.0 7.5 6.0 I
Estradiol - 22.2 47.1 20.0 9.3 22.2 II
FSH - 22.9 31.6 14.0 - 22.9 II
LH - 20.0 61.5 17.0 - 20.0 II
Testosterone - 10.0 54.4 20.0 11.4 10.0 II
Prolactin - 25.0 64.2 22.0 7.2 25.0 II

Abbreviations: CD, critical difference; AFP, alpha-fetoprotein; CA, cancer antigen; CEA, carcinoembryonic antigen; PSA, prostate-specific antigen; T3, tri-iodothyronine; T4, thyroxine; TSH, thyroid-stimulating hormone; FSH, follicle-stimulating hormone; LH, luteinizing hormone

*Critical differences based on well-designed clinical study’s outcomes (I), clinician’s questionnaire (II), biological variability (III), goals set by accrediting agencies (V), and the general capability according to the Korean Association of External Quality Assessment Service (VI)

Lab Med Qual Assur 2022;44:88~98 https://doi.org/10.15263/jlmqa.2022.44.2.88
© Lab Med Qual Assur