Table 1 ARCHITECT assay performance characteristics [22, 23]
From: Validation of a novel model for the early detection of hepatocellular carcinoma
Parameter | AFP assay | PIVKA-II assay |
|---|---|---|
20-Day precision | Total within-laboratory %CV of ≤ 7.5% | Total within-laboratory %CV ≤ 8.6% |
LOQ | 2.0 ng/mL | 5.06 mAU/mL |
LoD | ≤1.0 ng/mL | 1.45 mAU/mL |
Dilution Linearity | Within ± 1 ng/mL for samples < 10 ng/mL, ± 10 ng/mL for samples 10–2000 ng/mL | Within ± 10% for samples 20–30,000 mAU/mL |
Range | 2–2000 ng/mL | 5.06–30,000 mAU/mL |
Extended range with autodilution | 1:10 autodilution to 20,000 ng/mL | 1:10 autodilution to 300,000 mAU/mL |
HAMA/RF and Interferences | Within ± 10% for HAMA/RF and potential interferents, no notable endogenous interferences observed | Within ± 10% for HAMA/RF and potential interferents, no notable endogenous interferences observed |