Liver Fibrosis Risk Profile With Hepatic Function Panel, Complete Blood Count (CBC) With Differential, FIB-4, and APRI

CPT: 80076; 85025
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Synonyms

  • Fatty Liver Disease
  • Liver Fibrosis
  • NAFLD
  • NASH
  • Nonalcoholic Fatty Liver Disease
  • Noninvasive Liver Biopsy
  • Steatohepatitis Cirrhosis

Test Includes

Hematocrit; hemoglobin; mean corpuscular volume (MCV); mean corpuscular hemoglobin (MCH); mean corpuscular hemoglobin concentration (MCHC); red cell distribution width (RDW); percentage and absolute differential counts; platelet count (RBC); red cell count; white blood cell count (WBC); Alanine aminotransferase (ALT/SGPT); albumin, serum; alkaline phosphatase, serum; aspartate aminotransferase (AST/SGOT); bilirubin, direct; bilirubin, total; protein, total, serum


Expected Turnaround Time

Within 1 day


Related Documents

For more information, please view the literature below.

NAFLD-NASH Capabilities Brochure


Specimen Requirements


Specimen

Serum and whole blood


Volume

4 mL (serum); fill-tube to capacity (whole blood)


Minimum Volume

2.5 mL (serum) and 0.5 mL (whole blood) (Note: This volume does not allow for repeat testing.)


Container

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


Collection

Separate serum from cells within 45 minutes of collection; invert EDTA tube immediately 8 to 10 times once tube is filled at the time of collection.


Storage Instructions

Room temperature


Stability Requirements

Temperature

Period

Room temperature

Serum: Direct Bilirubin-2 days; All others-3 days; Whole blood: 1 day

Refrigerated

Serum: Bilirubin and Direct Bilirubin-3 days; All others-14 days; Whole blood: 3 days

Frozen

Serum: SGPT(ALT)-Unstable; All others-14 days; Whole blood: Unstable

Freeze/thaw cycles

Serum: SGPT(ALT)-Unstable; All others-Stable x3; Whole blood: Unstable


Causes for Rejection

Serum: Gross hemolysis; improper labeling

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


Test Details


Use

Screening patients suspected to be at risk for liver fibrosis.

AST to Platelet Ratio Index (APRI) is reported to be a simple, noninvasive, and readily available laboratory test index that can stratify patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) who are at high or low risk for significant fibrosis and cirrhosis with high degree of accurancy.

FIB-4 index is reported to be a simple, accurate, noninvasive, and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications.


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.


Methodology

See individual test components.


Additional Information

Assessments of stained smears are performed if results meet specific numeric and/or instrument flagging criteria. Smear review includes assessment of WBC cell populations, presence of WBC and/or RBC inclusions, RBC morphology, and platelet evaluation.

Presence of one or more of the following may be indication for further investigation: hemoglobin <10 g/dL, hemoglobin >18 g/dL, MCV >100 fl, MCV <80 fl, MCHC >37%, WBC >20,000/ mm3, WBC <2000/mm3, presence of sickle cells, spherocytes, Pappenheimer bodies, basophilic stippling, stomatocytes, schistocytes (fragmented RBCs), target cells, oval macrocytes, teardrop red blood cells, abnormal cell populations, nucleated red blood cells in other than the newborn, blood parasites (malarial or Babesia organisms or the possibility of parasitic organisms), hypersegmented neutrophils, agranular neutrophils, hyposegmented neutrophils (Pelger-Huet anomaly or pseudo-Pelger-Huet [pelgeroid] cells), mononuclear cells in which apparent nucleoli are prominent (blast-like cells), presence of metamyelocytes, myelocytes, promyelocytes, neutropenia, presence of plasma cells, peculiar atypical lymphocytes, significant increase or decrease in platelets or bizarre platelets.

A six-part differential reported in some lab locations includes IG % and IG absolute counts. IG (immature granulocytes) includes metamyelocytes and myelocytes. It does not include bands or blast cells.1,2 Promyelocytes and blasts are reported separately to denote the degree of left shift. An elevated percentage of IG has not been found to be clinically significant as a sole clinical predictor of disease. IGs are associated with infections, a variety of inflammatory disorders, cytokine therapy; neoplasia, hemolysis, tissue damage, seizures, metabolic abnormalities, myeloproliferative neoplasms, and with the use of certain medications such as steroids.3

Pregnancy-associated leukocytosis may also show increased immature granulocytes without clinical significance. There is a significant increase of normoblastic erythropoiesis and, to a lesser extent, of granulopoiesis during pregnancy, which is associated with an increase in immature cells (shift to the left) of both erythropoietic and granulopoietic tissues. A possible physiologic explanation for the appearance of immature granulocytes in the peripheral blood of pregnant women, increased alkaline phosphate activity in granulocytes, and increased glycogen content of lymphocytes may be found in the excretion curves of hormones during pregnancy. There is a sharp rise in the fifth month then a decrease in the eighth month and a subsequent rise in the ninth month.4

AST to Platelet Ratio Index (APRI) is calculated using 2 parameters formula: APRI = [AST/AST(ULN)] / platelet count (109/L) x 100 Where AST(ULN) is upper limit of AST reference interval.5 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)]6

The FIB-4 index was reported in a study of patients with HCV infection to correctly identify patients with severe fibrosis (METAVIR F3-F4) with area under the ROC curve of 0.85. A FIB-4 index of less than 1.45 had a negative predictive value of 94.7% to exclude extensive fibrosis (F3-F4) with a sensitivity of 74.3% and a specificity of 80.1%. A FIB-4 index of greater than 3.25 had a positive predictive value of 82.1% to confirm the existence of significant fibrosis (F3-F4) with a specificity of 98.2% and a sensitivity of 37.6%. In the same study, FIB-4 index was in agreement with FibroTest (known in the US as FibroSure) test results of 92.1% for exclusion of severe fibrosis (F3-F4) using a cutoff of less than 1.45, and agreement of 76.0% for detection of severe fibrosis (F3-F4) using a cutoff of greater than 3.25.

In more recent studies of patients with NAFLD, FIB-4 index was reported to have area under ROC curve of 0.802 for prediction of advanced fibrosis (F3-F4) using slightly different cutoffs of 1.30 and 2.67. A negative predictive value for the absence of advanced fibrosis at a cutoff of 1.30 was 83% and a positive predictive value for the presence of advanced fibrosis and hazard ratio for developing liver related events at a cutoff of 2.67 was 80% and 14.6 respectively. A liver biopsy had been appropriately avoided in 54% of cases.5-14


Footnotes

1. Fernandes B, Hamaguchi Y. Automated enumeration of immature granulocytes. Am J Clin Pathol. 2007 Sep;128(3):454-463.17709320
2. Ansari-Lari M, Kickler TS, Borowitz MJ. Immature granulocyte measurement using the Sysmex XE-2100. Relationship to infection and sepsis. Am J Clin Pathol. 2003 Nov;120(5):795-799.14608908
3. Henry MR, Howell LP. CAP Today, August 2010. CAP Today Web site. http://captodayonline.com/Archives/0810/0808_checklist.html. Accessed December 2019.
4. Efrati P, Presentey B, Marglaith M, Rozenszajn L. Leukocytes of normal pregnant women. Obstet Gynecol. 1964 Mar;23:429-432.14128474
5. 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
6. 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
7. 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
8. Boursier J, Vergniol J, Guillet A, et al. Diagnostic accuracy and prognostic significance of blood fibrosis tests and liver stiffness measurement by FibroScan in nonalcoholic fatty liver disease. J Hepatol. 2016 Sep;65(3):570-578.27151181
9. Chou R, Wasson N. Blood tests to diagnose fibrosis or cirrhosis in patients with chronic hepatitis C virus infection: a systematic review. Ann Intern Med. 2013 Jun 4;158(11):807-820.23732714
10. Lin ZH, Xin YN, Dong QJ, et al. Performance of the aspartate aminotransferase-to-platelet ratio index for the staging of hepatitis C-related fibrosis: an updated meta-analysis. Hepatology. 2011 Mar;53(3):726-736.21319189
11. Rinella ME, Sanyal AJ. Management of NAFLD: a stage-based approach. Nat Rev Gastroenterol Hepatol. 2016 Apr;13(4):196-205.26907882
12. Sanyal A, Ratziu V, Goodman Z, et al. 507 APRI and FIB-4 index scores can enrich for subjects with fibrotic nonalcoholic steatohepatitis (NASH) in Clinical Trials - The CENTAUR trial data. Gastroenterology. 2016 Apr;150(4)Supp1:S1037-S1038.10.1016/S0016-5085(16)33508-9
13. Shaheen AA, Myers RP. Diagnostic accuracy of the aspartate aminotransferase-to-platelet ratio index for the prediction of hepatitis C-related fibrosis: a systematic review. Hepatology. 2007 Sep;46(3):912-921.17705266
14. Tapper EB, Krajewski K, Lai M, et al. Simple non-invasive biomarkers of advanced fibrosis in the evaluation of nonalcoholic fatty liver disease. Gastroenterol Rep (Oxf). 2014 Nov;2(4):276-280.25002154

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
402145 Liver Fibrosis Risk Profile 98491-4 001073 Protein, Total g/dL 2885-2
402145 Liver Fibrosis Risk Profile 98491-4 001081 Albumin g/dL 1751-7
402145 Liver Fibrosis Risk Profile 98491-4 001099 Bilirubin, Total mg/dL 1975-2
402145 Liver Fibrosis Risk Profile 98491-4 001222 Bilirubin, Direct mg/dL 1968-7
402145 Liver Fibrosis Risk Profile 98491-4 001107 Alkaline Phosphatase IU/L 6768-6
402145 Liver Fibrosis Risk Profile 98491-4 001123 AST (SGOT) IU/L 1920-8
402145 Liver Fibrosis Risk Profile 98491-4 001545 ALT (SGPT) IU/L 1742-6
402145 Liver Fibrosis Risk Profile 98491-4 011579 APRI Index 86465-2
402145 Liver Fibrosis Risk Profile 98491-4 011582 FIB-4 Index N/A
402145 Liver Fibrosis Risk Profile 98491-4 005025 WBC x10E3/uL 6690-2
402145 Liver Fibrosis Risk Profile 98491-4 005033 RBC x10E6/uL 789-8
402145 Liver Fibrosis Risk Profile 98491-4 005041 Hemoglobin g/dL 718-7
402145 Liver Fibrosis Risk Profile 98491-4 005058 Hematocrit % 4544-3
402145 Liver Fibrosis Risk Profile 98491-4 015065 MCV fL 787-2
402145 Liver Fibrosis Risk Profile 98491-4 015073 MCH pg 785-6
402145 Liver Fibrosis Risk Profile 98491-4 015081 MCHC g/dL 786-4
402145 Liver Fibrosis Risk Profile 98491-4 105007 RDW % 788-0
402145 Liver Fibrosis Risk Profile 98491-4 015172 Platelets x10E3/uL 777-3
402145 Liver Fibrosis Risk Profile 98491-4 015107 Neutrophils % 770-8
402145 Liver Fibrosis Risk Profile 98491-4 015123 Lymphs % 736-9
402145 Liver Fibrosis Risk Profile 98491-4 015131 Monocytes % 5905-5
402145 Liver Fibrosis Risk Profile 98491-4 015149 Eos % 713-8
402145 Liver Fibrosis Risk Profile 98491-4 015156 Basos % 706-2
402145 Liver Fibrosis Risk Profile 98491-4 115398 Immature Cells N/A
402145 Liver Fibrosis Risk Profile 98491-4 015909 Neutrophils (Absolute) x10E3/uL 751-8
402145 Liver Fibrosis Risk Profile 98491-4 015917 Lymphs (Absolute) x10E3/uL 731-0
402145 Liver Fibrosis Risk Profile 98491-4 015925 Monocytes(Absolute) x10E3/uL 742-7
402145 Liver Fibrosis Risk Profile 98491-4 015933 Eos (Absolute) x10E3/uL 711-2
402145 Liver Fibrosis Risk Profile 98491-4 015941 Baso (Absolute) x10E3/uL 704-7
402145 Liver Fibrosis Risk Profile 98491-4 015108 Immature Granulocytes % 71695-1
402145 Liver Fibrosis Risk Profile 98491-4 015911 Immature Grans (Abs) x10E3/uL 53115-2
402145 Liver Fibrosis Risk Profile 98491-4 015945 NRBC % 58413-6
402145 Liver Fibrosis Risk Profile 98491-4 015180 Hematology Comments: 18314-5
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115400 Bands % 35332-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115401 Metamyelocytes % 28541-1
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115403 Myelocytes % 26498-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115404 Promyelocytes % 26498-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115405 Blasts/blast like cells % 26498-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115406 Megakaryocytes % 19252-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115265 Other, Lineage Uncertain % 55433-7

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