NASHnext™

TEST: 504960
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CPT: 81599
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Synonyms

  • Liver disease
  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)
  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
  • NIS4™
  • Non-alcoholic fatty liver disease (NAFLD)
  • Non-alcoholic steatohepatitis (NASH)

Special Instructions

This assay currently is not available in New York state.

Expected Turnaround Time

5 - 7 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Information

Related Documents

For more information, please view the following literature.

NASH-NAFLD Capabilities Brochure

NASHnext™: Non-invasive testing for diagnosing NASH Flyer

Keeping score against NASH: How biomarker assays can help identify patients with non-alcoholic steatohepatitis White Paper

Specimen Requirements

Specimen

Serum and whole blood

Volume

4 mL whole blood and 4 mL serum

Minimum Volume

1 mL whole blood and 2 mL serum

Container

Whole Blood: Lavender-top (EDTA) tube;

Serum: Gel-barrier serum tube or red-top tube.

Collection

**Please draw whole blood sample first.**

Whole Blood: Draw blood into lavender-top (EDTA) tube and ensure tube is completely filled. Gently invert tube six times to mix. Label tube with patient name, identification number, date and time of collection. The usual precautions in the collection of venipuncture should be observed. The sample must be free of clots. Samples with any hematocrit disorders can lead to erroneous results.

Serum: Separate serum from cells within 30 to 60 minutes after collection. Transfer specimen to two separate plastic transport tubes. Freeze and ship frozen.

Storage Instructions

Hb A1c: Room temperature whole blood;

CHI3L1, A2M and miR-34A: Frozen serum.

Stability Requirements

Temperature

Period

Period

Whole Blood

Serum

Room temperature

14 days

2 hours

Refrigerated

14 days

2 hours

Frozen

14 days

1 week: -20 °C

180 days: -70°C

Freeze/thaw cycles

Stable x3

Stable x3

Patient Preparation

Patient must fast at least 12 hours before the blood draw.

Causes for Rejection

Gross hemolysis; unfrozen serum

Test Details

Use

Labcorp's NASHnext is a non-invasive blood test that reflects both NASH activity and fibrosis in a single score by combining the results of four individual NASH-associated biomarkers. The intended use of this test is for predicting likelihood of at-risk NASH. (NASH is now referred to as metabolic dysfunction-associated steatohepatitis (MASH)).

Limitations

This test was validated and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Methodology

NIS4 test produces a score from the results of the following assays:

HbA1c, Whole Blood, Roche;

a2-macroglobulin, serum, Roche;

miR34a, serum RT-qPCR;

CH13L1/YKl40 serum, immunoassay.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
504960 NASHnext (NIS4) 93692-2 504964 NIS4 Test 93692-2

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