Validation of the novel GLAS algorithm as an aid in the detection of liver fibrosis and cirrhosis based on GP73, LG2m, age, and sex

Table 1 Performance characteristics of the prototype GP73 and LG2m assays

Parameter	GP73 ARCHITECT Assay	LG2m Alinity i Assay
20-day precision	Total within-laboratory %CV of less than 3.0%	Total within-laboratory %CV of less than 4.6%
LoQ	0.20 ng/mL	3.45 pg/mL
LoD	0.04 ng/mL	0.13 pg/mL
Dilution linearity	Deviation from linearity (DL) of < 10% within the range of 10 ng/mL to 1,000 ng/mL	Deviation from linearity (DL) within ± 3 pg/mL for sample < 30 pg/mL, ± 10% for samples 30 to 5,000 pg/mL
Measuring interval	LoQ – 1000 ng/mL	LoQ – 50,000 pg/mL
Extended range with autodilution	n/a	1:10 autodilution to 50,000 pg/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

CV, coefficient of variation; HAMA, human anti-mouse antibodies; LoD, limit of detection; LoQ, limit of quantitation; RF, rheumatoid factor
*The LG2m assay showed differences in measured concentration of LG2m within ± 10% for samples when spiked with HAMA at a concentration of 900 ng/mL and purified RF at a concentration of 600 IU/mL.

ISSN: 1559-0275