Interleukin 28 B (IL28B)-Associated Variants, 2 SNPs
2004680
Ordering Recommendation
Detects genetic variants associated with interleukin 28 B (IL28B) that may aid in predicting probability of treatment response.
Mnemonic
IL28B
Methodology
Polymerase Chain Reaction/High Resolution Melt Analysis
Performed
Mon, Thu
Reported
7-10 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
  
Collect
Lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B).  
Specimen Preparation
Transport 3 mL whole blood. (Min: 1 mL)  
Storage/Transport Temperature
Refrigerated.  
Unacceptable Conditions
  
Remarks
  
Stability
Ambient: 72 hours; Refrigerated: 1 week; Frozen: Unacceptable  
Reference Interval
By report  
Interpretive Data
Background Information for Interleukin 28 B (IL28B)Associated Variants, 2 SNPs:
Characteristics:
Hepatitis C is an infectious disease that can result in cirrhosis, liver failure, and hepatocellular carcinoma in chronically infected individuals. Hepatitis C virus (HCV) is categorized into six genotypes; HCV genotype 1 (HCV-1) accounts for 75 percent of U.S. cases. Therapy for chronic infection consists of a combination of peginterferon (PEG IFN alpha) and ribavirin (RBV), which is effective in eliminating HCV-1 in 40 to 50 percent of individuals. Single nucleotide polymorphisms (SNPs) rs12979860 C/T and rs8099917 T/G located upstream of the IL28B gene (encoding for lambda or type III interferons), have been associated with both spontaneous clearance and response to PEG-IFN alpha/RBV therapy in individuals infected with HCV-1. For SNP rs12979860, the CC genotype is associated with a two-to threefold greater rate of sustained virological response (SVR) following PEG-IFN alpha/RBV therapy, while the TC and TT genotypes are less likely to respond to treatment. For SNP rs8099917, the TT genotype is associated with a higher rate of SVR after PEG-IFN alpha/RBV therapy, while the GT and GG genotypes are less likely to respond to treatment and achieve SVR.
Prevalence:
4.1 million Americans (1.6 percent of the U.S. population) have anti-HCV antibodies.
Allele Frequency:
SNP rs12979860 favorable C allele: East Asian 0.90, Caucasian 0.75, Hispanic 0.70, and African American 0.50. SNP rs8099917 favorable T allele: Caucasian 0.75, Asian 0.88, and unknown in other ethnicities.
Variants Tested:
SNP rs12979860 C/T and SNP rs8099917 T/G.
Clinical Sensitivity:
Unknown.
Methodology:
Polymerase Chain Reaction/High Resolution Melt Analysis.
Analytical Sensitivity & Specificity:
99 percent.
Limitations:
SNPs other than those targeted will not be detected. Mutations in other genes and non-genetic factors that may affect response to hepatitis C therapy are not detected. For HCV genotypes other than type 1, the usefulness of these SNPs for predicting response to therapy is unknown. Diagnostic errors can occur due to rare sequence variations.





See Compliance Statement C: www.aruplab.com/CS
Statement C: The performance characteristics of this test were validated by ARUP Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. ARUP is authorized under Clinical Laboratory Improvement Amendments (CLIA) and by all states to perform high-complexity testing.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online.
 
Note
 
CPT Code(s)
81400
Components
Component Test Code*Component Chart Name
2004681IL28B-Assoc Variants, 2 SNPs Specimen
2004682IL28B rs12979860
2004683IL28B rs8099917
2004684IL28B-Assoc Variants, 2SNPs Interp
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Hepatitis C Virus Genotyping
  • IL28B.12979860
  • Interleukin 28B Polymorphism
  • Lambda Interferon Genotyping
  • Ribavirin Genotyping (Interleukin 28 B (IL28B)-Associated Variants, 2 SNPs)