A multi-target blood test found early HCC three times as often as ultrasound

Design

Prospective multicentre diagnostic accuracy study with CT/MRI reference

Population

2,293 US adults with cirrhosis or chronic HBV under HCC surveillance

Primary outcome

Early-stage HCC sensitivity vs ultrasound; blood test specificity

Effect

Early-stage sensitivity 66.7% vs 22.2%; specificity 81.8% vs 98.6%

ALTUS was a prospective US multicentre study in adults with cirrhosis or chronic hepatitis B eligible for HCC surveillance. Each had a multi-target blood test and ultrasound, with CT or MRI as the reference standard. Of 3,089 enrolled, 2,293 had paired results.

Thirty-seven HCCs were found, 27 at an early stage by Milan criteria. Sensitivity for early-stage HCC was 66.7% with the blood test and 22.2% with ultrasound (paired difference 44.4 points), meeting non-inferiority. Sensitivity for any stage was 73.0% against 29.7%. Specificity for the blood test was 81.8%, just short of its 82% target, while ultrasound specificity was 98.6%.

Ultrasound surveillance performed poorly here, consistent with its known limits in obesity and steatotic liver. The blood test finds more cancers, but nearly one in five people without HCC would test positive and need cross-sectional imaging. It is a candidate complement to ultrasound, not yet a replacement.

• Ultrasound detected only about one in five early HCCs in this cohort — be aware of its limits, especially in obesity.
• The blood test found two thirds of early HCCs but gave false positives in about 18% of those without cancer.
• Consider CT or MRI surveillance in patients with poor ultrasound windows, as guidelines allow.
• Keep surveillance six-monthly; adherence is the biggest gap in practice.
• The blood test is not yet a standard surveillance tool.

Why it matters

It quantifies how many early cancers ultrasound misses and how a blood test could change surveillance.

Don't overread it

Only 27 early-stage cancers were found, so the sensitivity estimates have wide confidence intervals.

The statistics, in plain English

The blood test's early-stage sensitivity interval runs from 47.8% to 81.4% because so few cancers were found. A specificity of 81.8% means about 18 in 100 people without cancer would be called positive.

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