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  5. Clinical Benefits of The Enhanced Liver Fibrosis Test

Assess the Risk of NAFLD/NASH Progression and Liver-Related Events with a Simple Blood Test 

Clinical Benefits of The Enhanced Liver Fibrosis (ELF™) Test 

The Enhanced Liver Fibrosis test is a non-invasive blood test that measures three direct markers of fibrosis. Direct assessment of fibrosis has proven valuable for identifying patients at risk of progressing to cirrhosis and/or liver-related events. 

The most widely studied direct marker is the ELF Test which can assess active, dynamic fibrosis rather than the damage it has caused. This allows the ELF Test to be used as a prognostic marker to identify the patients most at risk of progression to cirrhosis and LREs in patients with chronic liver disease. 

Why choose the ELF Test?

Characteristics of an Ideal Non-invasive Liver Fibrosis Test

Validated Across Multiple Settings

Primary Care

Secondary Care

Tertiary Care

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Applicability in Different Patients/Conditions

Adults

Children

Obesity

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Economic Health Value

(Cost effectiveness)

Add clinical value

Decrease unnecessary Referrals

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Access

Simple Blood Test

Large Installed Base

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1. Day J, et al. J Appl Lab Med. 2019 Mar; 3:815-26.

2. Parkes J, et al. Gut. 2010; 59:1245-51.

3. Irvine KM, et al. Liver Int. 2016; 36:370-7.

4. Rosenburg WM, et al. Gastroenterology. 2004; 127:1704-13

5. Nobili, et al. Gastroenterology. 2009; 136:160-7

6. Srivastava A, et al. J Hepatol. 2019; Apr 6: 50168-8278{19}30227-2. doi: 10.1016/j.hep.2019.03.033.

Clinical Benefits of ELF

Ilustración de una enfermera recolectando un análisis de sangre en un paciente

A simple blood test. Any patient. Any provider.

Blood-based tests can readily support high-volume testing, do not require patient access to specialized imaging equipment or highly trained operators, and generally have lower incidence rates of failure and unreliable results reported for imaging modalities.1,2

  • Access non-invasive testing with a simple blood test available to all healthcare practitioners and patients, including those with type 2 diabetes mellitus and obesity.2,3
  • Improve patient care by identifying NAFLD patients and stratifying those at risk of progressing to cirrhosis and LREs.4
  • Enhance prognostic patient management with a test that has been shown to outperform biopsy for the risk assessment of progression to cirrhosis and LREs.4 

Reduce Unnecessary Referrals and Save Healthcare Costs

To reduce the burden of unnecessary referrals and improve detection of advanced liver disease, a “NAFLD pathway” was developed comprised of testing first with FIB-4 and reflexing indeterminate results to ELF. After 2 years the pathway data was compared to the Standard of Care.5

ELF Literature Compendium Vol 2

Literature Compendium Volume 2:

ELF Test in NAFLD/NASH

This compendium highlights a small subset of the extensive number of ELF publications in NAFLD and NASH patients, including recent studies evaluating therapies in development that used ELF testing.

Diagnostic Accuracy and Cost-effectiveness

ELF Ranks First in Cost-Effectiveness Analysis 

The population considered for analysis were persons with NAFLD who were suspected of having developed NASH with fibrosis or cirrhosis. This analysis found that, given a retesting frequency of 3 years, ELF was the highest ranking of the 13 tests compared at a cost-effectiveness threshold of £20,000 per QALY gained, followed by Siemens Healthineers ARFI.

The Guideline Development Group concluded that ELF is both the most cost-effective and the most appropriate test for advanced fibrosis in adults with NAFLD and should be offered to people with NAFLD.6

Advanced fibrosis test ranking based on diagnostic accuracy and cost-effectiveness

Test

Mean cost (£)

Mean QALYs

NMB (£) at £20,000/QALY

Rank

ELF Test at 10.51

9,632

13.70

264,301

1

ARFI at 4.24

10,142

13.71

264,060

2

MRE at 4.15

10,259

13.70

263,751

3

FibroTest at 0.47

9,949

13.68

263,596

4

NFS at 0.676

9,208

13.64

263,541

5

TE (M) at 7.8–7.9

11,056

13.72

263,426

6

APRI at 0.98-1 

10,184

13.68

263,403

7

FIB-4 at 1.45

11,295

13.73

263,277

8

BARD at 2

11,350

13.72

263,105

9

AST/ALT at 0.8

11,280

13.71

262,996

10

TE (XL) at 5.7

11,685

13.73

262,964

11

No test—monitor all

12,319

13.75

262,641

12

Ferritin at 2x

9,206

13.58

262,433

13

Liver biopsy

11,543

13.68

262,071

14

No test—monitor nobody

7,563

13.48

261,939

15

Cost-effectiveness = the value of the net monetary benefit (NMB) attributed to every test.

The comparator with the highest NMB is the most cost-effective option at the specified £20,000 per extra QALY threshold.

Clinical Guidelines

Multiple Clinical Guidelines Recommend Use of Non-invasive Markers

Chronic Liver Disease Foundation (CLDF) 


"To date, the ELF score demonstrates good correlations with progression of fibrosis in a number of chronic liver diseases." 

Younossi ZM, et al. Am J Gastro. 2020;00:1–9. https://doi.org/10.14309/ajg.0000000000001054

The National Institute for Health and Care Excellence (NICE) 


"Consider using the Enhanced Liver Fibrosis (ELF) Test in people who have been diagnosed with NAFLD to test for advanced fibrosis.”

National Guideline Centre; Royal College of Physicians. NICE guideline NG492016. ISBN 978-1-4731-1996-3.

European Association for the Study of the Liver (EASL)


“Surrogate markers of fibrosis (NFS, FIB-4, ELF Test or FibroTest) should be calculated for every NAFLD patient, in order to rule out significant fibrosis (≥F2).” 

EASL–EASD–EASO. J Hepatol. 2016;64:1388–1402.

American Association for the Study of Liver Diseases (AASLD)


“NFS or FIB-4 index are clinically useful tools for identifying NAFLD patients with higher likelihood of having bridging fibrosis (stage 3) or cirrhosis (stage 4).”

Chalasani N, et al. Hepatology. 2018;67:328–357.


American Diabetes Association (ADA)



"Noninvasive tests, such as elastography or fibrosis biomarkers, may be used to assess risk of fibrosis, but referral to a liver specialist and liver biopsy may be required for definitive diagnosis.”

American Diabetes Association. Diabetes Care. 2019;42(suppl1):S1–S193.


British Society of Gastroenterology (BSG)


"Patients with intermediate risk should undergo second-line non-invasive testing either by additional tests like ELF test or FibroTest or by measuring liver stiffness.7,8 If advanced fibrosis is ruled out, patients can be treated as low risk and referred back to primary care.”

https://www.bsg.org.uk/clinical-articles-list/naflddiagnosis-assessment-and-management/

The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed.

References
1
Staufer K, et al. Evaluation and comparison of six noninvasive tests for prediction of significant or advanced fibrosis in nonalcoholic fatty liver disease. United European Gastroenterol J. 2019 Oct;7(8):1113-23.
2
Karlas T, et al. Evaluation of transient elastography (TE), acoustic radiation force impulse imaging (ARFI), and Enhanced Liver Function (ELF) score for detection of fibrosis in morbidly obese patients. PLoS One. 2015;10:e0141649.
3
Patel P, et al. Hepatol Commun. 2018;2:893–905.
4
Sanyal AJ, et al. Hepatology. 2019;70(6):1913-1927.
5
Srivastava, A. et al. Prospective evaluation of a primary care referral pathway for patients with non-alcoholic fatty liver disease. J Hepatol. 2019 Aug;71(2):371-378. doi: 10.1016/j.jhep.2019.03.033. Epub 2019 Apr 6.
6
NICE guideline NG49. National Institute of Health and Care Excellence; 2016.
7

Eddowes PJ, Sasso M, Allison M, et al. Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology 2019;156:1717-30. 

8

Vilar-Gomez E, Chalasani N. Non-invasive assessment of non-alcoholic fatty liver disease: Clinical prediction rules and blood-based biomarkers. J Hepatol 2018;68:305-15.