- Design
- Prospective multicentre paired diagnostic study
- Population
- 2,293 adults with cirrhosis or chronic HBV under HCC surveillance
- Primary outcome
- Early-stage HCC sensitivity and test specificity
- Effect
- Sensitivity 66.7% vs 22.2% (ultrasound); specificity 81.8% vs 98.6%
ALTUS, a prospective multicentre US study in the Journal of Hepatology, compared a multi-target HCC blood test with surveillance ultrasound in adults with cirrhosis or chronic hepatitis B, using CT or MRI in everyone as the reference.
Of 2,293 participants with paired results, 37 had HCC, 27 at early stage. The blood test detected 66.7% of early-stage cancers and ultrasound 22.2%, a paired difference of 44.4 points. Specificity was 81.8% for the blood test, just below the prespecified 82% target, against 98.6% for ultrasound.
Ultrasound surveillance misses many early cancers, especially in patients with obesity or steatotic liver disease, and adherence is poor. A blood test could catch more cancers and be easier to repeat. But a specificity near 82% means roughly one in five patients without cancer would be recalled for imaging at each round.
The number of cancers was small, so sensitivity estimates are imprecise. This is a promising test, not yet a replacement for ultrasound surveillance.
- Continue six-monthly ultrasound, with or without AFP, as standard HCC surveillance
- Note that ultrasound missed most early cancers in this study, particularly relevant in obese patients
- Expect about one in five false positives per round if a blood test like this is used
- Plan imaging capacity before adopting any blood-based surveillance test
Why it matters
Ultrasound's poor sensitivity for early HCC is now quantified against a practical alternative.
Don't overread it
Only 27 early cancers, and the test missed its specificity target; it is not ready to replace ultrasound.
The statistics, in plain English
With only 27 early cancers, the blood test's sensitivity interval runs from 47.8% to 81.4%. Specificity of 81.8% versus 98.6% means about 18 false alarms per 100 people screened, against fewer than 2 with ultrasound.
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