Laboratory Medicine and Quality Assurance

Table. 3.

Critical differences based on goals set by accrediting agencies (V)

Items Minimum Quality Specification [9] RCPA [10] SEKK Dmax* [11] CLIA [12] CAP KEQAS
AFP ±20% ±5 kIU/L <25 kIU/L
±20% >25 kIU/L
±20% ±3SD ±3SD ±3SDI
CA125 - ±10 kU/L <50 kU/L
±20% >50 kU/L
- - ±3SD ±3SDI
CA15-3 - ±3 kU/L <20 kU/L
±15% >20 kU/L
- - ±3SD ±3SDI
CA19-9 - ±3 kU/L <20 kU/L
±15% >20 kU/L
- - ±20% ±3SDI
CEA ±16% ±2.0 μg/L <10.0 μg/L
±20% >10 μg/L
- - A greater value between ±25% and ±1.2 ng/mL ±3SDI
PSA, total ±17% ±1.5 μg/L <10.0 μg/L
±15% >10.0 μg/L
±15% - A greater value between ±3SD and ±0.2 ng/mL ±3SDI
Free PSA - ±1.5 μg/L <10.0 μg/L
±15% >10.0 μg/L
- - A greater value between ±3SD and ±0.2 ng/mL ±3SDI
T3 ±24% ±0.3 nmol/L <1.5 nmol/L
±20% >1.5 nmol/L
±0.225 nmol/L <1.5 nmol/L
±15% >1.5 nmol/L
±3SD ±3SD ±3SDI
T4 ±24% ±8 nmol/L <50 nmol/L
±15% >50 nmol/L
13% ±3SD A greater value between ±20% and ±1.0 μg/dL ±3SDI
Free T4 ±16% ±1.5 pmol/L <10 pmol/L
±15% >10 pmol/L
13% ±3SD ±3SD ±3SDI
Thyroglobulin - - - - ±3SD ±3SDI
TSH ±15% ±0.6 mU/L <4.0 mU/L
±15% >4.0 mU/L
14% ±3SD ±3SD ±3SDI
Estradiol ±26% ±100 pmol/L <500 pmol/L
±20% >500 pmol/L
±44 pmol/L <200 pmol/L
±22% >200 pmol/L
- - ±3SDI
FSH ±14% ±4.0 IU/L - - - -
LH ±17% ±2.0 IU/L <10.0 IU/L
±20% >10.0 IU/L
- - - -
Testosterone ±23% ±0.5 nmol/L <2.5 nmol/L
±20% >2.5 nmol/L
- - - ±3SDI
Prolactin ±22% ±20 mIU/L <100 mIU/L
±20% >100 mIU/L
- - - ±3SDI

Abbreviations: RCPA, Royal College of Pathologists of Australasia; CLIA, Clinical Laboratory Improvement Amendments; CAP, The College of American Pathologists; KEQAS, Korean Association of External Quality Assessment Service; SD, standard deviation; SDI, standard deviation index; 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

*The lists of analytical quality performance specifications of Czech external quality assessment program

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