Test Details
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.
Result 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.
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)).
Special Instructions
This assay currently is not available in New York state.
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.
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 Instructions
**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.
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 |
Storage Instructions
Hb A1c: Room temperature whole blood;
CHI3L1, A2M and miR-34A: Frozen serum.
Patient Preparation
Patient must fast at least 12 hours before the blood draw.
Causes for Rejection
Gross hemolysis; unfrozen serum
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 | |
| Order Code | 504960 | |||||
| Order Code Name | NASHnext (NIS4) | |||||
| Order Loinc | 93692-2 | |||||
| Result Code | 504964 | |||||
| Result Code Name | NIS4 Test | |||||
| UofM | ||||||
| Result LOINC | 93692-2 |