Q-tube® AFP-L3

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Product Name:Q-tube® AFP-L3


CFDA Approval No.:


Clinical Discipline:Tumor marker

Q-tube® Lectin-Reactive Alpha-Fetoprotein (AFP-L3) Affinity Isolation Kit


Q-tube® AFP-L3 Affinity Isolation kit is used to quickly and efficiently isolate the more hepatocellular carcinoma-specific isoform L3 of Alpha-fetoprotein (AFP-L3) for subsequent AFP-L3% assay.


AFP-L3: A more specific hepatocellular carcinoma biomarker than total Alpha Fetoprotein


AFP-L3 is an isoform of Alpha-fetoprotein (AFP), a substance typically used in the triple test during pregnancy and for screening chronic liver disease patients for hepatocellular carcinoma (HCC). AFP can be fractionated by affinity electrophoresis into 3 glycoforms: L1, L2, and L3 based on the reactivity with the lectin Lens culinaris agglutinin (LCA). AFP-L3 binds strongly to LCA , which is in contrast to the L1 isoform. The L3 isoform is more specific to malignant tumors and its detected presence can serve to identify patients whom need increased monitoring for the development of HCC in high risk populations (i.e. chronic hepatitis B & C and/or liver cirrhosis).


AFP-L3% assay

Isolated AFP-L3 and total AFP are quantified respectively using chemiluminesence immunoassay or traditional ELISA on an automated platform. Results for AFP-L3 are represented as a ratio of LCA-reactive AFP to total AFP (AFP-L3%).

Total AFP has been used as a tumor marker for hepatocellular carcinoma (HCC) for several decades, the problem is that its sensitivity and specificity for HCC is low with many chronic liver disease patients also showing increased level. Doctors usually have difficulty differentiating HCC from chronic liver disease for patients that have AFP concentrations in the indeterminate range of 20-200+ ng/mL and a small or indeterminate mass on imaging.

Elevated AFP-L3 values (>=10%) have been shown to be associated with a 7-10 fold increased risk of HCC development within the next 21 months for chronic liver disease patients.

An elevation in AFP-L3 has been shown to correlate to various phases of HCC development. Increased AFP-L3 values have been reported to correlate with a greater malignant potential of HCC  and increased hepatic arterial supply.  AFP-L3 values are also correlated to pathologic features of HCC such as infiltrative tumor growth pattern, capsule infiltration, and vascular invasion.

AFP-L3 could alert about the early development of HCC before it can be detected by imaging modalities and is useful for identifying patients at an increased risk for HCC.

The AFP-L3% assay will help to identify at-risk subjects earlier, allowing for more intense evaluation for evidence of HCC according to existing practice guidelines in oncology.

Ultimately AFP-L3% may be used as a rule-in or rule-out assay for transplantation consideration and/or an intermediate step in surveillance precluding costly imaging on patients with fluctuating AFP results but negative for HCC.


Benefits of AFP-L3 test in summary:

A sensitive and specific biomarker for hepatocellular carcinoma (HCC)

Use as screening or confirmative test  for HCC

Differentiate HCC from chronic hepatitis and cirrhosis

Risk assessment of HCC for at-risk subjects including patients suffering from HBV, HCV positive chronic hepatitis and cirrhosis

Evaluate the level of malignance of HCC


Q-tube® AFP-L3 Affinity Isolation Kit Principle

Glyco-catch method taking advantage of its high affinity to LCA


Q-tube® AFP-L3 Affinity Isolation Kit Features

Simple and quick procedure

Efficient and sufficient isolation of AFP-L3 from total AFP

Ready-to-use reagents

Long shelf life 

Single dose format: run only the test you need

Copyright:Hotgen Biotech Co., Ltd.