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NASHnext™

CPT: 81599

Synonyms

  • Liver disease
  • NIS4™
  • Non-alcoholic fatty liver disease (NAFLD)
  • Non-alcoholic steatohepatitis (NASH)

Special Instructions

This assay is currently not available in New York state.




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 6 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 2 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. This test is intended for use in assigning the risk level of NASH.


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.


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