- Design
- Prospective multicentre diagnostic accuracy study with liver biopsy as the reference standard
- Population
- 255 patients with chronic liver disease of mixed aetiology, mean age 51.3 years, 148 men; 57.25% with no steatosis
- Primary outcome
- Area under the ROC curve for detecting hepatic steatosis of grade S1 or above, S2 or above, and S3
- Effect
- AUC 0.914 (95% CI 0.873 to 0.946), 0.950 (0.916 to 0.974) and 0.916 (0.875 to 0.947); optimal cutoffs 7%, 11% and 18%
Two hundred and fifty-five patients with chronic liver disease were enrolled prospectively across multiple centres between October 2024 and June 2025, each with a liver biopsy as reference; mean age 51.3 years, 148 men, and 146 (57.25%) with no steatosis at all. Ultrasound-derived fat fraction, measured with a dedicated probe, gave an area under the curve of 0.914 (95% CI 0.873 to 0.946) for detecting steatosis of grade S1 or above, 0.950 (0.916 to 0.974) for S2 or above, and 0.916 (0.875 to 0.947) for S3. The optimal cutoffs were 7%, 11% and 18%.
The subgroup results are the reason this is worth acting on. Steatosis quantification by ultrasound has historically been undermined by the things that come with real livers — inflammation, fibrosis, and a thick body wall. Here the area under the curve stayed above 0.9 for detecting any steatosis in patients with necroinflammation, in those with advanced fibrosis, in those with a skin-to-capsule distance of 1.9 cm or more, and in the mixed-aetiology group with isolated metabolic dysfunction-associated steatotic liver disease excluded.
For Indian practice this matters more than the average paper on liver imaging does. MRI proton density fat fraction is the reference non-invasive method and is out of reach for most patients here on cost and scanner time, while ultrasound is the first and often only cross-sectional study available outside the metros. A quantitative fat fraction on a machine already in the room, with published cutoffs, changes what can be offered — for diagnosis and, more usefully, for monitoring a patient over years. Confirm your own equipment reports the same metric before adopting the 7%, 11% and 18% thresholds; vendor implementations are not interchangeable.
- Check which fat quantification metric your machine reports before applying the 7%, 11% and 18% cutoffs.
- Use it for serial monitoring as much as for diagnosis — that is where repeated MRI is least affordable.
- Advanced fibrosis and necroinflammation did not degrade performance in this cohort.
- A skin-to-capsule distance of 1.9 cm or more did not degrade it either, which matters in obese patients.
- Report the numerical fat fraction, not just a subjective grade of echogenicity.
The statistics, in plain English
An area under the curve of 0.95 for moderate or worse steatosis means the test almost always ranks a steatotic liver above a non-steatotic one — good discrimination, but it says nothing about how a single reading should be interpreted. That is what the cutoffs are for, and a cutoff always trades sensitivity against specificity; the 7% threshold for any steatosis will label some normal livers as abnormal. The other limit is the reference standard. Biopsy grades steatosis semi-quantitatively from one small sample of a heterogeneous organ, so some of the apparent error in the ultrasound measurement is error in the comparator. A prospective design with biopsy in every patient, rather than only those with abnormal scans, is what keeps these estimates honest.
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