Diagnostic performance of Liver FibraChek Dx©, a blood-based test for the non-invasive detection of liver cirrhosis and cancer

Table 1 Demographics and clinicopathological characteristics of study cohort, n (%)

Parameter	Control (n = 12)	Metabolic dysfunction-associated steatotic liver disease (n = 14)	Hepatocellular carcinoma (n = 19)
Age (years) (mean ± SD)	60.9 ± 13.3	59.9 ± 8.0	74.4 ± 7.6
Sex
Male	5 (41.7)	9 (64.3)	12 (63.2)
Female	7 (58.3)	5 (35.7)	7 (36.8)
Race/ethnicity
African-American/Black	9 (75.0)	4 (28.6)	8 (42.1)
Asian	2 (16.7)	7 (50.0)	3 (15.8)
White/Caucasian	1 (8.3)	2 (14.3)	8 (42.1)
Other race	0 (0.0)	1 (7.1)	0 (0.0)
Hispanic	0 (0.0)	0 (0.0)	0 (0.0)
Fibrosis stage
S0-2		9 (64.3)
S3-4		5 (35.7)
Tumor stage
TX T0-1			13 (68.4)
T2-3			5 (26.3)
Unknown			1 (5.3)

Table 2 Cases and controls calculated as low vs higher risk of liver disease, n (%)

Parameter	Cases1	Control	Total
> 0.25 score	31 (93.9)	3 (25)	34
≤ 0.25 score	2 (6.1)	9 (75)	11
Total	33	12	n = 45

¹Cases include chronic liver disease and hepatocellular carcinoma.

Table 3 Diagnostic performance of Liver FibraChek Dx^© assay and algorithm

Sensitivity and specificity
Statistical parameter	Estimate	Standard error	95%CI
Sensitivity	0.9394	0.0415	0.8580-1.0000
Specificity	0.7500	0.1250	0.5050-0.9950
Positive predictive value	0.9118	0.0486	0.8164-1.0000
Negative predictive value	0.8182	0.1163	0.5903-1.0000
Accuracy	0.8889	0.0468	0.7971-0.9807