α-Fetoprotein (AFP) With AFP-L3%

CPT: 82107
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Synonyms

  • AFP With AFP-L3%
  • Alpha-Fetoprotein (AFP) With AFP-L3%

Special Instructions

Values obtained with different assay methods should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor each patient's course of therapy. This procedure does not provide serial monitoring; it is intended for one-time use only. If serial monitoring is required, please use the serial monitoring number 480300 to order.


Expected Turnaround Time

1 - 3 days



Related Documents


Specimen Requirements


Specimen

Serum


Volume

0.5 mL


Minimum Volume

0.2 mL (Note: This volume does not allow for repeat testing.)


Container

Red-top tube or gel-barrier tube


Collection

If a red-top tube is used, transfer separated serum to a plastic transport tube.


Storage Instructions

Refrigerate.


Stability Requirements

Temperature

Period

Room temperature

9 days

Refrigerated

9 days

Frozen

9 days

Freeze/thaw cycles

Stable x3


Causes for Rejection

Gross icterus


Test Details


Use

The AFP-L3% assay is intended for use in the assessment of risk for the development of hepatocellular carcinoma (HCC) in patients with chronic liver diseases.1


Limitations

Samples from patients with acute hepatitis or fulminant hepatitis can show high values of AFP-L3% and AFP. Pregnancy can cause high values of AFP-L3% and AFP. AFP producing tumors other than HCC can show high values of AFP-L3% and AFP. Bilirubin at a concentration >20 mg/dL can cause a negative influence on the AFP-L3% and AFP values. Glucose at a concentration >600 mg/dL can cause a negative influence on AFP-L3% values. With regard to AFP, normal values apply only to males and nonpregnant females. Normal infants younger than 18 months of age may have higher values.

Results for this test should not be used as absolute evidence of presence or absence of malignant disease without confirmation of the diagnosis by another medically established diagnostic product or procedure. Values obtained with different assay methods or kits cannot be used interchangeably.


Methodology

Liquid-phase binding assay


Reference Interval

See table.

Age

Male

Female

AFP, Serum

(ng/mL)

AFP, Serum

(ng/mL)

0 to 7 d

0.0–75265.8

0.0–75265.8

8 to 30 d

0.0–32556.4

0.0–32556.4

1 m

0.0–1747.8

0.0–1600.3

2 m

0.0–391.1

0.0–550.0

3 m

0.0–225.8

0.0–339.9

4 m

0.0–230.6

0.0–230.6

5 m

0.0–118.0

0.0–234.0

6 m

0.0–97.2

0.0–97.2

7 to 11 m

0.0–60.3

0.0–60.3

1 y

0.0–21.4

0.0–21.4

2 y

0.0–9.4

0.0–10.1

3 to 4 y

0.0–5.5

0.0–5.5

5 y

0.0–3.6

0.0–4.2

6 to 12 y

0.0–3.9

0.0–3.9

13 to 17 y

0.0–4.3

0.0–4.3

18 to 30 y

0.0–5.7

0.0–4.7

31 to 50 y

0.0–6.9

0.0–6.4

51 to 80 y

0.0–8.4

0.0–9.2

>80 y

0.0–6.4

0.0–8.7

Reference Interval developed by in-house study.

Normal values apply only to males and to nonpregnant females. These results are not interpretable for pregnant females.

AFP-L3%, Serum

All

0.0–9.9

0.0–9.9


Additional Information

Serum AFP levels are markedly elevated in the neonate because AFP is synthesized in large quantities during embryonic development by the fetal yolk sac and by the fetal liver.2 Serum AFP concentrations decrease gradually after birth until they reach adult levels by 12 to 18 months of age.2 Due to fetal production, AFP becomes elevated in maternal serum during pregnancy.2 Pathologically, increased AFP levels have been associated with both acute and chronic liver disease as well as hepatocellular carcinoma (HCC).2,3 AFP can also be elevated in a number of other malignancies including gastric, lung, pancreatic, biliary tract, and testicular carcinomas.2 Patients with chronic liver disease are at a greatly increased risk for developing HCC.2,3 Early detection of HCC is important, especially in high-risk populations.3 Unfortunately, increased AFP is often observed in patients with chronic liver disease that has not progressed to HCC.2,3 This serves to limit the utility of AFP measurements as an early indicator of progression to HCC in these patients.2,3

AFP is a glycoprotein with a single glycosylation site at a specific arginine residue.2 Three glycosylation variants occur in serum reflecting different carbohydrate chains linked at this single position.2 These variants can be differentiated based on their relative binding to a lectin (carbohydrate-binding protein) isolated from lentil seeds.4 This lectin, referred to as Lens culinaris agglutinin (LCA), binds to variants AFP-L1, AFP-L2, and AFP-L3 with increasing affinity. AFP-L1, which has the weakest binding to LCA, is the predominant fraction in patients with nonmalignant liver diseases, such as chronic hepatitis and liver cirrhosis.2

A number of clinical studies have shown that the AFP-L3 fraction (the glycosylation variant that binds strongest to LCA) is produced predominantly by malignant cells.2,5 Liver cancer cells that express AFP-L3 have been shown to have an increased tendency for early vascular invasion and development of intrahepatic metastasis.3,5 Studies suggest that the measurement of AFP-L3% can allow earlier detection of HCC than imaging techniques.5-7 Elevated AFP-L3% has been associated with poorer prognosis for patients with HCC.8-17 In a recent multisite clinical trial, elevated AFP-L3% (≥10%) has been shown to be associated with a sevenfold increase in the risk of developing HCC within the next 21 months.1 This study concluded that patients with elevated serum AFP-L3% should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.1


Footnotes

1. LBA APF-L3 Manufacturer's package insert, Rev.#1/0505 DDD00K, Wako Pure Chemical Industries, Ltd., 1/05/05.
2. Li D, Mallory T, Satomura S. AFP-L3: A new generation of tumor marker for hepatocellular carcinoma. Clin Chim Acta. 2001 Nov; 313(1-2):15-19. 11694234
3. Khien VV, Mao HV, Chinh TT, et al. Clinical evaluation of lentil lectin-reactive alpha-fetoprotein-L3 in histology-proven hepatocellular carcinoma. Int J Biol Markers. 2001 Apr-Jun; 16(2):105-111. 11471892
4. Yamagata Y, Shimizu K, Nakamura K, et al, Simultaneous determination of percentage of Lens culinaris agglutinin-reactive alpha-fetoprotein and alpha-fetoprotein concentration using the LiBASys clinical auto-analyzer. Clin Chim Acta. 2003 Jan; 327(1-2):59-67. 12482619
5. Oka H, Saito A, Ito K, et al, Multicenter prospective analysis of newly diagnosed hepatocellular carcinoma with respect to the percentage of Lens culinaris agglutinin-reactive alpha-fetoprotein. J Gastroenterol Hepatol, 2001 Dec; 16(12):1378-1383. 11851836
6. Taketa K, Endo Y, Sekiya C, et al. A collaborative study for the evaluation of lectin-reactive alpha-fetoproteins in early detection of hepatocellular carcinoma. Cancer Res. 1993 Nov 15; 53(22):5419-5423. 7693340
7. Kumada T, Nakano S, Takeda I, et al, Multicenter prospective analysis of newly diagnosed hepatocellular carcinoma with respect to the percentage of Lens culinaris agglutinin-reactive alpha-fetoprotein. J Hepatol. 1999 Jan; 30(1):125-130. 9927159
8. Yamashita F, Tanaka M, Satomura S, Tanikawa K. Prognostic significance of Lens culinaris agglutinin A-reactive alpha-fetoprotein in small hepatocellular carcinomas.Gastroenterology. 1996 Oct; 111(4):996-1001. 8831594
9. Hayashi K, Kumada T, Nakano S, et al Usefulness of measurement of Lens culinaris agglutinin-reactive fraction of alpha-fetoprotein as a marker of prognosis and recurrence of small hepatocellular carcinoma.Am J Gastroenterol. 1999 Oct; 94(10):3028-3033. 10520864
10. Aoyagi Y, Isokawa O, Suda T, Watanabe M, Suzuki Y, Asakura H. The fucosylation index of alpha-fetoprotein as a possible prognostic indicator for patients. Cancer. 1998 Nov 15; 83(10):2076-2082. 9827711
11. Yamashiki N, Seki T, Wakabayashi M, et al. Usefulness of Lens culinaris agglutinin A-reactive fraction of alpha-fetoprotein (AFP-L3) as a marker of distant metastasis from hepatocellular carcinoma. Oncol Rep. 1999 Nov-Dec; 6(6):1229-1232. 10523686
12. Okuda K, Tanaka M, Kanazawa N, et al. Evaluation of curability and prediction of prognosis after surgical treatment for hepatocellular carcinoma by lens culinaris agglutinin-reactive alpha-fetoprotein. Int J Oncol. 1999 Feb; 14(2):265-271. 9917501
13. Leerapun A, Suravarapu SV, Bida JP, et al. The utility of Lens culinaris agglutinin-reactive alpha-fetoprotein in the diagnosis of hepatocellular carcinoma: evaluation in a United States referral population. Clin Gastroenterol Hepatol. 2007 Mar; 5(3):394-402. 17368240
14. Sterling Rk, Jeffers L, Gordon F, et al. Clinical utility of AFP-L3% measurement in North American patients with HCV-related cirrhosis. Am J Gastroenterol. 2007 Oct; 102(10):2196-2205. 17617202
15. Toyoda H, Kumada T, Kiriyama S, et al. Prognostic significance of simultaneous measurement of three tumor markers in patients with hepatocellular carcinoma. Clin Gastroenterol Hepatol. 2006 Jan; 4(1):111-117. 16431313
16. Carr BI, Kanke F, Wise M, Satomura S. Clinical evaluation of lens culinaris agglutinin-reactive alpha-fetoprotein and des-gamma-carboxy prothrombin in histologically proven hepatocellular carcinoma in the United States. Dig Dis Sci. 2007 Mar; 52(3):776-782. 17253135
17. Volk ML, Hernández JC, Su GL, Lok AS, Marrero JA. Risk factors for hepatocellular carcinoma may impair the performance of biomarkers: A comparison of AFP, DCP, and AFP-L3. Cancer Biomark.2007; 3(2):79-87. 17522429

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
141300 AFP with AFP-L3% 141303 AFP, Serum ng/mL 1834-1
141300 AFP with AFP-L3% 141302 AFP-L3%, Serum % 42332-7

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