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FIB-4 With Reflex to NASH FibroSure® Plus

Test Number 402146
Test number copied
CPT

84450; 84460; 85049
Synonyms
  • Fatty Liver Disease
  • Liver Fibrosis
  • MASH
  • MASLD
  • Metabolic Dysfunction-Associated Steatohepatitis
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • NAFLD
  • NASH
  • Nonalcoholic Fatty Liver Disease
  • Steatohepatitis Cirrhosis

Test Details

Methodology

See individual test components.

Result Turnaround Time

Within 1 day

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

Test Includes

Alanine aminotransferase (ALT/SGPT); aspartate aminotransferase (AST/SGOT); FIB-4 Index (by calculation); platelet count. If FIB-4 Index is >1.29, testing will reflex to NASH FibroSure® Plus, performed at an additional charge.

Use

FIB-4 index is reported to be a simple, accurate, non-invasive and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD), now known as metabolic dysfunction-associated steatotic liver disease (MASLD), for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications.

Special Instructions

The patient's age and gender must be submitted, but the patient's height and weight are not required for NASH FibroSure® Plus testing.

Limitations

Clumping may cause false low platelet count. Platelet satellitism around neutrophils will cause a pseudothrombocytopenia. RBC or WBC fragments including fragmented fragile leukemic cells and neutrophil pseudoplatelets may cause falsely elevated counts. NASH FibroSure® Plus is recommended for patients with suspected nonalcoholic fatty liver disease, now known as metabolic dysfunction-associated steatotic liver disease (MASLD). It is not recommended for patients with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute hepatitis, acute inflammation of the liver, autoimmune hepatitis, extrahepatic cholestasis, transplant patients, and/or renal insufficiency patients. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary.

References

Angulo P, Bugianesi E, Bjornsson ES, et al. Simple noninvasive systems predict long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology. 2013 Oct;145(4):782-789.e4.23860502
Poynard T, Munteanu M, Charlotte F, et al. Diagnostic performance of a new noninvasive test for nonalcoholic steatohepatitis using a simplified histological reference. Eur J Gastroenterol Hepatol. 2018 May;30(5):569-577.29406435
Poynard T, Peta V, Munteanu M, et al. The diagnostic performance of a simplified blood test (SteatoTest-2) for the prediction of liver steatosis. Eur J Gastroenterol Hepatol. 2019 Mar;31(3):393-402.30516570
Ratziu V, Massard J, Charlotte F, et al. Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2006 Feb 14;6:6.16503961
Shah AG, Lydecker A, Murray K, et al. Comparison of noninvasive markers of fibrosis in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2009 Oct;7(10):1104-1112.19523535
Vallet-Pichard A, Mallet V, Nalpas B, et al. FIB-4: an inexpensive and accurate marker of liver fibrosis in HCV infection. Comparison with liver biopsy and fibrotest. Hepatology. 2007 Jul;46(1):32-36.17567829

Custom Additional Information

FIB-4 index is calculated first; if FIB-4 index value is between 0 and 1.29, testing stops; if FIB-4 index value is greater than 1.29, testing is reflexed to NASH FibroSure® Plus at an additional cost.

NASH FibroSure® Plus test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (NAFLD). Quantitative results of 10 biochemicals in combination with age and gender are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.41) precludes the diagnosis of NASH, now known as metabolic dysfunction-associated steatohepatitis (MASH).

The FIB-4 index value is calculated using the 4 parameters formula: FIB-4 = [Age(Years) x AST(IU/L)]/[Platelets(10E3/L) x ALT^.5 (IU/L)]

Specimen Requirements

Specimen

Serum and whole blood

Volume

Serum: 4 mL divided into two tubes, 0.5 mL for initial testing and 3.5 mL for possible reflex

Whole blood: tube filled to capacity

Minimum Volume

Serum: 3 mL divided into two tubes, 0.5 mL for initial testing and 2.5 mL for possible reflex

Whole blood: tube filled to capacity

Container

Gel-barrier tube or red-top tube and lavender-top (EDTA) tube

Collection Instructions

Serum: Separate from cells within 45 minutes of collection.

Whole blood: Invert EDTA tube immediately 8 to 10 times once tube is filled at the time of collection.

Stability Requirements

TemperaturePeriod
Room temperatureSerum: 7 days; Whole blood: 1 day
RefrigeratedSerum: 14 days; Whole blood: 3 days
FrozenUnstable
Freeze/thaw cyclesUnstable

Storage Instructions

Serum sample for initial testing and whole blood can be stored room temperature. Serum sample for possible reflex can be stored refrigerated a 2°C to 8°C for 72 hours.

Patient Preparation

Patient should be fasting for at least eight hours.

Causes for Rejection

Serum: Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient younger than 14 years of age

Whole blood: Hemolysis; clotted specimen; tube not filled with minimum volume; improper labeling; transfer tubes with whole blood; specimen diluted or contaminated with IV fluid; specimen received with plasma removed; specimen collected in any anticoagulant other than EDTA

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
402146 FIB-4 w/Rx NASH FibroSure Plus 98488-0 001123 AST (SGOT) IU/L 1920-8
402146 FIB-4 w/Rx NASH FibroSure Plus 98488-0 001545 ALT (SGPT) IU/L 1742-6
402146 FIB-4 w/Rx NASH FibroSure Plus 98488-0 015172 Platelets x10E3/uL 777-3
402146 FIB-4 w/Rx NASH FibroSure Plus 98488-0 011582 FIB-4 Index 98488-0
Order Code402146
Order Code NameFIB-4 w/Rx NASH FibroSure Plus
Order Loinc98488-0
Result Code001123
Result Code NameAST (SGOT)
UofMIU/L
Result LOINC1920-8
Order Code402146
Order Code NameFIB-4 w/Rx NASH FibroSure Plus
Order Loinc98488-0
Result Code001545
Result Code NameALT (SGPT)
UofMIU/L
Result LOINC1742-6
Order Code402146
Order Code NameFIB-4 w/Rx NASH FibroSure Plus
Order Loinc98488-0
Result Code015172
Result Code NamePlatelets
UofMx10E3/uL
Result LOINC777-3
Order Code402146
Order Code NameFIB-4 w/Rx NASH FibroSure Plus
Order Loinc98488-0
Result Code011582
Result Code NameFIB-4 Index
UofM
Result LOINC98488-0
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550963 Fibrosis Score 48795-9
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550963
Result NameFibrosis Score
UofM
Result LOINC48795-9
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550964 Fibrosis Stage 48794-2
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550964
Result NameFibrosis Stage
UofM
Result LOINC48794-2
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550965 Steatosis Score 93695-5
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550965
Result NameSteatosis Score
UofM
Result LOINC93695-5
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550966 Steatosis Grade 93696-3
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550966
Result NameSteatosis Grade
UofM
Result LOINC93696-3
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550967 NASH Score 93692-2
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550967
Result NameNASH Score
UofM
Result LOINC93692-2
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550968 NASH Grade 93693-0
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550968
Result NameNASH Grade
UofM
Result LOINC93693-0
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550398 Methodology: 62364-5
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550398
Result NameMethodology:
UofM
Result LOINC62364-5
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 122137 Alpha 2-Macroglobulins, Qn mg/dL 1835-8
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code122137
Result NameAlpha 2-Macroglobulins, Qn
UofMmg/dL
Result LOINC1835-8
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001629 Haptoglobin mg/dL 4542-7
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code001629
Result NameHaptoglobin
UofMmg/dL
Result LOINC4542-7
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 016874 Apolipoprotein A-1 mg/dL 1869-7
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code016874
Result NameApolipoprotein A-1
UofMmg/dL
Result LOINC1869-7
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001100 Bilirubin, Total mg/dL 1975-2
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code001100
Result NameBilirubin, Total
UofMmg/dL
Result LOINC1975-2
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001960 GGT IU/L 2324-2
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code001960
Result NameGGT
UofMIU/L
Result LOINC2324-2
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001547 ALT (SGPT) P5P IU/L 1743-4
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code001547
Result NameALT (SGPT) P5P
UofMIU/L
Result LOINC1743-4
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001125 AST (SGOT) P5P IU/L 30239-8
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code001125
Result NameAST (SGOT) P5P
UofMIU/L
Result LOINC30239-8
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001067 Cholesterol, Total mg/dL 2093-3
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code001067
Result NameCholesterol, Total
UofMmg/dL
Result LOINC2093-3
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001036 Glucose, Serum mg/dL 2345-7
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code001036
Result NameGlucose, Serum
UofMmg/dL
Result LOINC2345-7
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001175 Triglycerides mg/dL 2571-8
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code001175
Result NameTriglycerides
UofMmg/dL
Result LOINC2571-8
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550969 Interpretations: 93694-8
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550969
Result NameInterpretations:
UofM
Result LOINC93694-8
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550107 Fibrosis Scoring: N/A
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550107
Result NameFibrosis Scoring:
UofM
Result LOINCN/A
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550971 Steatosis Scoring N/A
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550971
Result NameSteatosis Scoring
UofM
Result LOINCN/A
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550972 NASH Scoring N/A
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550972
Result NameNASH Scoring
UofM
Result LOINCN/A
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550973 Limitations: 62364-5
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550973
Result NameLimitations:
UofM
Result LOINC62364-5
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550974 Comment: 8251-1
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code550974
Result NameComment:
UofM
Result LOINC8251-1
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 123099 Comment: 77202-0
Reflex 1
Order Code550960
Order NameNASH FibroSure(R) Plus
Result Code123099
Result NameComment:
UofM
Result LOINC77202-0